CDRH Premarket Authorizations that Used Real-World Evidence
FDA Use of Real-World Evidence in Regulatory Decision Making
510(k) - 510(k) premarket notification
ACE - Angiotensin-converting enzyme
AEMS – Adverse Event Monitoring System
ARB - Angiotensin receptor blocker
BLA - Biologics License Application
CBER - Center for Biologics Evaluation and Research
CDER - Center for Drug Evaluation and Research
CDRH - Center for Devices and Radiological Health
CMS - Center for Medicare and Medicaid Services
DSC - Drug Safety Communication
EHR- Electronic health records
EMR - Electronic medical records
ESA - Erythropoietin stimulating agent
GBCA - Gadolinium-based contrast agent
GLP-1 RA - Glucagon-like peptide-1 receptor agonists
HCTZ - Hydrochlorothiazide
HDE - Humanitarian device exemption
IAA - Inter-Agency Agreement
IDE - Investigational Device Exemption
MACE - Major adverse cardiac event
NDA - New Drug Application
OSE - Office of Surveillance and Epidemiology
OUS - Outside the U.S.
PLLR - Pregnancy and Lactation Labeling Rule
PMA - Premarket approval application
PPI - Proton pump inhibitor
REMS - Risk Evaluation and Mitigation Strategy
RWD - Real-World Data
RWE - Real-World Evidence
SEE – Substantial Evidence of Effectiveness
U.S. - United States
VHA - Veterans Health Administration
VTE - Venous thromboembolism
| Product Name & Number | Sponsor/Applicant | Data Source(s) | Data Source Description(s) | Study Design(s) | Summary of RWE use and/or Regulatory Action | Type / Date of Regulatory Action(s) and/or Other Action(s) | Related Document(s) or Communication(s) |
|---|---|---|---|---|---|---|---|
23andMe Personal Genome Service (PGS) DEN160026 | 23andMe | Multiple | Data from clinically annotated biobanks, medical records, and registries. | Multiple | Data from peer-reviewed literature, which included publications of studies using RWD sources, was a primary source of clinical evidence for the classification of this De Novo. Authorization of the 23andMe GHR tests was supported by data from this peer-reviewed literature that demonstrated a link between specific genetic variants and each of the 10 health conditions. The published data originated from studies that compared genetic variants present in people with a specific condition to those without that condition. The sponsor also submitted published studies which demonstrated that 23andMe GHR tests correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample. The peer-reviewed literature included studies that utilized medical records, registries, and clinically annotated biobanks. | Decision date: 4/6/2017 | Medical Device Database |
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens K203571 | Acuity Polymers, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for modification to the indications for use to include management of irregular corneal conditions. The clinical evidence included data from the retrospective review of medical charts by 4 independent practitioners. | Decision date: 4/09/2021 | Medical Device Database |
AHI System K212219 | Fifth Eye Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion for this device software function to predict a patient’s likelihood of a future hemodynamic instability episode. The sponsor conducted an observational study using prospectively collected EHR data at 1 U.S. site to validate the device software function. The Analytic for Hemodynamic Instability Predictive Indicator predictive outputs were compared to a vital signs reference standard for episodes of hemodynamic instability. Performance was evaluated at the window level using probability estimates and lead-time metrics. | Decision date: 12/03/2021 | Medical Device Database |
alfapump® System P230044 | Sequana Medical NV | Multiple | Data from administrative healthcare claims and registry. Source(s) name: The North American Consortium for the Study of End Stage Liver Disease III (NACSELD III Registry) and Centers for Medicare and Medicare Inpatient & Outpatient Hospital Standard Analytical Files (SAFs) | Cohort | Administrative claims and registry data were supplemental sources of clinical evidence for the approval of this PMA for this breakthrough device. The POSEIDON trial, a single-arm trial, was the primary source of clinical evidence. To demonstrate the safety of the alfapump® System, the sponsor conducted 2 studies using external controls from 2 RWD sources, NACSELD III registry and Medicare, to compare with POSEIDON trial data. | Decision date: 12/20/2024 | Medical Device Database |
Analytic for Hemodynamic Instability (AHI) DEN200022 | Fifth Eye Inc. | Medical Records | Data from medical records. | Cohort | Hospital data was a primary source of clinical evidence for the classification of this De Novo. The sponsor conducted a prospective validation study using data from consecutive patients from critical care and emergency room units at the University of Michigan Medical Center. The study evaluated the performance of the device’s algorithm in identifying signs of hemodynamic instability by comparing the device output to a reference standard derived from continuous electrocardiogram and continuous arterial line blood pressure measurements. Performance was assessed on a per-window basis using pre-specified sensitivity and specificity acceptance criteria. | Decision date: 3/01/2021 | Medical Device Database |
APOLLO ESG, APOLLO ESG SX, APOLLO REVISE, APOLLO REVISE SX Systems DEN210045 | Apollo Endosurgery, Inc. | Multiple | Data from registry and public health surveillance. Source(s) name: System for Uniform Surveillance (SUS) | Multiple | Data from 2 registries, a literature review, and postmarket surveillance were supplemental sources of clinical evidence for the classification of this De Novo. The primary clinical evidence was the MERIT pivotal randomized controlled trial. The supplemental RWD included information from a professional society registry and a private-practice registry, a structured literature review (which included studies using registry data), and postmarket surveillance data which represented real-world device use and supported the overall assessment of safety and effectiveness for the device's new classification. | Decision date: 7/12/2022 | Medical Device Database |
APPRAISE-HRI K233249 | The Surgeon General, Department of the Army (TSG-DA) | Multiple | Data from medical records and registry. | Case-Control | Medical record and registry data were a primary source of clinical evidence for validation testing to support the clearance of this 510(k) for a new device. The sponsor conducted a retrospective validation study using vital-sign data collected during patient transport and emergency department care, along with trauma registry data used to establish hemorrhage status (hemorrhage vs. control patients). The device’s hemorrhage risk output was compared against the hemorrhage status identified in the trauma registry for both the hemorrhage and control patients. | Decision date: 4/05/2024 | Medical Device Database |
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II K221128 | Arthrex Inc. | Registry | Source(s) name: Surgical Outcomes System Registry | Cohort | Registry data was a source of clinical evidence for the clearance of this 510(k) for an indication expansion to patients less than 22 years old. The clinical evidence included literature review on the subject devices used in pediatric patients and RWD/RWE provided from the Surgical Outcomes System registry. | Decision date: 10/05/2022 | Medical Device Database |
| Atlas Gold PTA Dilatation CatheterK181323 | C. R. Bard, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include use in the venous system. The clinical evidence included data from a retrospective review of medical records of patients treated with iliofemoral vein compression at 1 U.S. site and from a literature review. | Decision date: 8/3/2018 | Medical Device Database |
BEAR® (Bridge-Enhanced ACL Restoration) Implant K243578 | Miach Orthopaedics, Inc | Registry | Source(s) name: BRIDGE Registry | Cohort | Registry data was a co-primary source of clinical evidence for the clearance of this 510(k), which expanded the indications for use of the device to patients < 14 years old and added partial rupture of anterior cruciate ligament to the indications for use. The sponsor conducted a retrospective cohort study using data from the BRIDGE Registry to compare effectiveness outcomes of the device in patients under 14 years old to patients ≥ 14 years old. The clinical evidence included a non-RWE study (BEAR III Study), which was a prospective, multicenter, single-arm cohort study, as co-primary clinical evidence to evaluate safety and effectiveness outcomes by pooling data from both studies. | Decision date: 3/06/2025 | Medical Device Database |
Bioptimal Bipolar Pacing Catheter K242863 | Bioptimal International Pte. Ltd. | Medical Records | Data from medical records. | Cohort | Medical records data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor conducted a retrospective study using medical records from patients from an OUS hospital. | Decision date: 6/15/2025 | Medical Device Database |
BrainsWay Deep TMS™ System K222196 | BrainsWay Ltd. | Medical Records | Data from medical records. | Cohort | Electronic health record data was a supplemental source of clinical evidence for the clearance of this 510(k) to support the expansion of the adult population to include subjects ≥ 22 and ≤ 86 years old suffering from major depressive disorder who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. The device was originally cleared for subjects ≥ 22 to ≤ 68 years old. The clinical evidence included data from a published double-blind, randomized, sham-controlled trial and a sponsor’s retrospective cohort study using EHR data to further support the safety and effectiveness of transcranial magnetic stimulation treatment in patients > 68 years old. The sponsor also conducted a literature review of studies using transcranial magnetic stimulation to treat late-life depression. A subset of the literature reviewed incorporated RWD, including multiple studies that utilized medical record data. | Decision date: 5/31/2024 | Medical Device Database |
Bunkerhill ECG-EF K250649 | BunkerHill Health | Medical Records | Data from medical records. | Cohort | Medical records data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted a retrospective validation study using patient records from 2 health systems across 5 geographically distributed sites in the U.S. to validate the diagnostic accuracy of the algorithm within a clinically and demographically diverse population. The device’s performance was evaluated by comparing the binary output from the device to echocardiogram-derived left ventricular ejection fraction measurements obtained within 15 days of the electrocardiogram. | Decision date: 9/19/2025 | Medical Device Database |
CavaClear Laser Sheath DEN210024 | Spectranetics, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the classification of this De Novo. The sponsor conducted a retrospective, multicenter study to evaluate the safety and performance of utilizing an excimer laser sheath during inferior vena cava filter removal procedures through abstraction of medical records (multiple sites) and use of an existing published dataset (single site) from U.S. sites. | Decision date: 12/21/2021 | Medical Device Database |
Cirrus Resting State fMRI Software K251009 | Sora Neuroscience, Inc. | Medical Records | Data from medical records. | Other | Medical record data described in 2 peer-reviewed publications was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted retrospective validation studies using previously collected patient magnetic resonance imaging datasets from brain tumor and epilepsy patients. Three validation studies were included: (1) comparison of sensorimotor and language network maps generated by Cirrus to resting-state network maps described in peer-reviewed literature using RWD and non-RWD sources, including literature in which resting-state maps were compared to electrical cortical stimulation mapping; (2) within-subject comparison of Cirrus visual network maps to same-patient task-activated functional magnetic resonance imaging visual maps; and (3) cross-scanner validation assessing reproducibility of network maps across different magnetic resonance imaging manufacturers. | Decision date: 6/06/2025 | Medical Device Database |
Clave™ Neutral-Displacement Needlefree Connectors K250616 | ICU Medical, Inc. | Public Health Surveillance Data | Source(s) name: Healthcare-associated infection (HAI) national database (via CMS Healthcare Associated Infections website) and Clave NC technologies (NCT) customer database | Cohort | Public health surveillance data (HAI national dataset) was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion for this intravascular administration set with needlefree connector. Clearance was based on a published retrospective study comparing hospitals from the healthcare associated infection national database that utilized CLAVE NCT with hospitals where patients received any other type of needlefree connector. The HAI national dataset was linked to the CLAVE NCT customer database to identify hospitals using NCTs. | Decision date: 6/05/2025 | Medical Device Database |
ClearGuard HD Antimicrobial Barrier Cap K180111 | Pursuit Vascular, Inc. | Public Health Surveillance Data | Source(s) name: National Healthcare Safety Network (NHSN) | Hybrid Trial | Postmarket clinical surveillance data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include information related to reduction of bloodstream infection. The sponsor conducted a cluster-randomized (1:1 ratio), multi-arm, unblinded study that analyzed routinely collected bloodstream infection surveillance data from 40 dialysis centers throughout the U.S. participating in the CDC National Healthcare Safety Network. | Decision date: 5/25/2018 | Medical Device Database |
ClearPoint System K171257 | MRI Interventions, Inc. | Registry | Data from registry. | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a modification to the indications for use statement to include positioning of deep brain stimulator leads. The sponsor provided clinical evidence from both literature and data from a registry of 35 participating institutions, which collected data on the device as used in standard practice. | Decision date: 10/20/2017 | Medical Device Database |
CLEWICU System K200717 | CLEW Medical Ltd. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted a retrospective validation study using patient-stay data from WakeMed Health System hospitals. A tagging system was developed and validated against human physician readers to generate clinical truth labels from the retrospective dataset. These labels were used to evaluate the performance of the CLEWICU predictive models in identifying patients at risk for future hemodynamic instability and those at low risk for deterioration. | Decision date: 1/09/2021 | Medical Device Database |
CLEWICU System K233216 | Clew Medical Ltd. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for expansion of intended use environment from only the intensive care unit to all critical care areas of a hospital. A retrospective validation study was conducted using patient-stay data from 2 separate health care systems. The performance of the CLEWICU predictive models in identifying patients at risk for future hemodynamic instability and those at low risk for deterioration was evaluated with a reduced input dataset to demonstrate that the system met the same statistical criteria established under the prior 510(k) (K200717) and could therefore be used in all critical care areas of the hospital. | Decision date: 1/13/2024 | Medical Device Database |
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems K240867 | Roche Molecular Systems, Inc. | Public Health Surveillance Data | Source(s) name: National Football League (NFL) COVID-19 Surveillance Program | Cohort | Public health surveillance data, in the form of occupational surveillance testing, was a supplemental source of clinical evidence for the clearance of this 510(k) to expand the intended use to include individuals without signs and symptoms of COVID-19. The primary clinical evidence included data from the 2021 Test Us at Home longitudinal study, a prospective clinical study in which clinical performance was estimated using a comparator algorithm based on 2 consecutive test results collected over 48 hours. The clinical performance of the cobas SARS-CoV-2 Qualitative with individuals without signs and symptoms of COVID-19 was additionally assessed using data collected from the 2020 NFL COVID-19 Occupational Surveillance Testing Program. Samples collected and tested between 8/2020 and 1/2021 were selected for analysis where the candidate test and the comparator test results were evaluable to establish the COVID-19 status for each sample. | Decision date: 2/11/2025 | Medical Device Database |
Comaneci Embolization Assist Device DEN170064 | Rapid-Medical Ltd | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the classification of this De Novo. The sponsor provided clinical evidence from a retrospective case series of patients with intracranial aneurysms consecutively treated with the subject device at 2 OUS sites. | Decision date: 4/24/2019 | Medical Device Database |
ContaCT DEN170073 | Viz.Al, Inc | Multiple | Data from medical records and a registry. Source(s) name: STRATIS Registry | Multiple | Medical record data was a supplemental source of clinical evidence for the classification of this De Novo. The clinical evidence included a standalone performance testing evaluating the sensitivity and specificity of the algorithm on CT images from 2 sites against expert-established ground truth. A secondary RWE analysis compared the standard-of-care notification time extracted from radiologist reports against a comparable metric from standalone testing of the device. The sponsor also provided literature with non-RWE and RWE, including from the STRATIS Registry. | Decision date: 2/13/2018 | Medical Device Database |
da Vinci® Xi Surgical System (Model IS4000), da Vinci® X Surgical System (Model IS4200) K173585 | Intuitive Surgical, Inc. | Registry | Source(s) name: Americas Hernia Society Quality Collaborative (AHSQC) Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a labeling modification to include ventral hernia repair procedures under the cleared “general laparoscopic surgical procedures” indication for use. The sponsor provided information collected from the AHSQC registry containing propensity-matched comparisons of key measures for robotic-assisted, laparoscopic, and open procedures for both non-complex and complex ventral hernia repair procedures. | Decision date: 7/19/2018 | Medical Device Database |
da Vinci® SP (SP1098) Surgical System K242318 | Intuitive Surgical, Inc. | Multiple | Data from medical records and registry. | Multiple | Data from studies identified in systematic literature reviews was used as a comparative source of clinical evidence for the clearance of this 510(k) for a labeling modification, including adding “colorectal surgical procedures” to the indications, and to add new representative, specific procedures in the Professional Instructions for Use. The sponsor conducted 2 systematic literature reviews on relevant literature published between 2010 and March 2024 to compare results with the pivotal clinical trial, the primary source of clinical evidence, on a U.S. and South Korean patient population. A subset of the literature reviewed in the systematic literature reviews incorporated RWD, including studies that utilized medical records and registry data. | Decision date: 11/26/2024 | Medical Device Database |
da Vinci® SP (SP1098) Surgical System K243714 | Intuitive Surgical, Inc. | Multiple | Data from medical records and registry. | Multiple | A systematic literature review was a primary source of clinical evidence for the clearance of this 510(k) for a labeling change to include transanal local excision. The sponsor conducted the systematic literature review on literature published between January 2018 and October 2024 that compared device-assisted transanal local excision to the same procedure performed using other existing instruments. A subset of the literature reviewed in the systematic literature review incorporated RWD, including studies that utilized medical record and registry data. | Decision date: 4/24/2025 | Medical Device Database |
da Vinci® Xi (IS4000) and X (IS4200) Surgical Systems K223080 | Intuitive Surgical, Inc. | Multiple | Data from chargemaster and/or billing and medical records. Source(s) name: Premier Health Database (PHD) | Cohort | Medical record and chargemaster data were a primary source of clinical evidence for the clearance of this 510(k) to support a labeling expansion to 4 specific duodenal switch bariatric surgical procedures. The sponsor conducted a retrospective study using data from the Premier Health Database to compare patients who underwent robotic-assisted procedures or laparoscopic procedures complex/highest risk, duodenal switch bariatric surgical procedures (“umbrella” procedures) to demonstrate substantial equivalence to the cleared predicate devices. | Decision date: 11/22/2022 | Medical Device Database |
da Vinci® Xi (IS4000) and X (IS4200) Surgical Systems
K240723 | Intuitive Surgical | Administrative Healthcare Claims | Source(s) name: Optum Clinformatics Data Mart de-identified administrative healthcare claims data | Cohort | Administrative claims data was a primary source of clinical evidence for the clearance of this 510(k) to support a labeling modification to the Precaution for Representative Uses statement for radical prostatectomy performed using the subject device. The sponsor conducted a retrospective cohort study using secondary administrative healthcare claims data of U.S. patients with treatment-naive prostate cancer. | Decision date: 5/24/2024 | Medical Device Database |
da Vinci® Xi (IS4000) and X (IS4200) Surgical Systems K240852 | Intuitive Surgical, Inc. | Multiple | Data from chargemaster and/or billing and medical records. Source(s) name: Premier Health Database (PHD) | Multiple | Medical record and chargemaster data were a primary source of clinical evidence for the clearance of this 510(k) for a labeling expansion to include tracheobronchoplasty for symptomatic, severe tracheobronchomalacia. Procedure codes and billing records from the Premier Healthcare Database were used to assess patients who underwent tracheobronchoplasty procedures at 6 U.S. hospitals from 2013 to 2023. The clinical evidence additionally included a systematic literature review, which included studies utilizing medical records, used to generate comparative data. | Decision date: 6/11/2025 | Medical Device Database |
DeepRESP K241960 | Nox Medical ehf | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted a retrospective cohort study to compare the device performance to a clinician’s manual scoring of the same sleep recordings from routine clinical practice and to confirm there was no statistically significant difference in clinical performance compared to the predicate device. | Decision date: 3/14/2025 | Medical Device Database |
DIGNICAP SCALP COOLING SYSTEM DEN150010 | DIGNITANA AB | Public Health Surveillance Data | Data from public health surveillance. | Cohort | Postmarket surveillance data was a supplemental source of clinical evidence for the classification of this De Novo. The primary clinical evidence included 2 DigniCap studies involving patients with early-stage breast cancer (a feasibility study of stage I patients receiving adjuvant chemotherapy) and a non-randomized, multicenter pivotal trial. The sponsor also submitted Dignitana OUS postmarket surveillance data from approximately 6,000 patients, which provided additional data on the risk of scalp metastasis. | Decision date: 12/8/2015 | Medical Device Database |
Easytech® Anatomical Shoulder System K201391 | FX Shoulder USA, Inc. | Multiple | Data from medical records and public health surveillance. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor conducted an OUS retrospective, single-arm, multicenter study, as part of the manufacturer’s postmarket surveillance for its shoulder devices, to evaluate the safety and effectiveness of the device for total shoulder arthroplasty. | Decision date: 2/16/2021 | Medical Device Database |
eCARTv5 Clinical Deterioration Suite ("eCART") K233253 | AgileMD, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor conducted retrospective and prospective validation studies using admissions and hospitalization data from 3 geographically distinct health systems. In both cohorts, eCART scores were categorized into pre-defined moderate- and high-risk groups (eCART ≥ 93 and ≥ 97, respectively), and these risk categories were evaluated against observed clinical deterioration and mortality. | Decision date: 6/21/2024 | Medical Device Database |
EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System DEN180062 | Cook Ireland, Ltd | Medical Records | Data from medical records. | Cohort | Medical record data described in a peer-reviewed publication was a primary source of clinical evidence for the classification of this De Novo. The clinical evidence from the publication included a single-arm, single-center cohort study to provide confirmatory evidence that the device could safely measure endoscopic ultrasound-portal pressure gradient. | Decision date: 11/20/2019 | Medical Device Database |
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System P140031/S112 | Edwards Lifesciences LLC | Registry | Source(s) name: Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA Supplement for an indication expansion to include patients with a failing transcatheter bioprosthetic aortic valve (i.e., THV-in-THV) who are at high or greater risk for surgical aortic valve replacement. The sponsor conducted a single-arm retrospective cohort study of patients from the STS/ACC TVT Registry to evaluate safety and effectiveness for this submission. | Decision date: 9/09/2020 | Medical Device Database |
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems P140031/S162 | Edwards Lifesciences LLC | Registry | Source(s) name: Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry | Cohort | Registry and prospective clinical trial data were primary sources of clinical evidence for the approval of this PMA Supplement for an indication expansion to include patients with a failing surgical bioprosthetic mitral valve who are at intermediate risk for open surgical therapy (i.e., THV-in surgical valve). The sponsor conducted a pooled analysis of data from the STS/ACC TVT Registry and a single-arm clinical trial (PARTNER 3 Mitral Valve-in-Valve study) assessing improvement in valve hemodynamics and against performance goals for the co-primary safety endpoints. | Decision date: 5/23/2024 | Medical Device Database |
Elecsys Anti-SARS-CoV-2 K250768 | Roche Diagnostics | Medical Records | Data from medical records. | Cohort | Medical record data was a supplementary source of clinical evidence for the clearance of this 510(k) for a new device. The primary clinical evidence included a traditional clinical study that assessed the negative percent agreement and the positive percent agreement of the immunoassay using 9,007 pre-pandemic specimens and 288 specimens (of which 254 tested positive) collected ≥ 15 days post-symptoms onset, respectively. The clinical evidence additionally included medical record and laboratory data that further confirmed the positive percent agreement of the immunoassay. | Decision date: 6/10/2025 | Medical Device Database |
Emboshield NAV6 Embolic Protection System K191173 | Abbott Vascular | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a modification to the indications for use to include use while performing atherectomy in lower extremity arteries. The sponsor provided clinical data from a retrospective review of medical records from the Mount Sinai Health Center of patients treated for lower extremity lesions using the subject device under the practice of medicine. | Decision date: 7/25/2019 | Medical Device Database |
Endurant II/Endurant IIs Stent Graft System P100021/S063 | Medtronic Vascular | Registry | Source(s) name: ANCHOR Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include treatment of infrarenal abdominal aortic aneurysms having neck lengths ≥ 4 mm and < 10 mm, when used in conjunction with the Heli-FX EndoAnchor System. RWE from the sponsor’s ANCHOR Registry was used to assess safety and effectiveness. The ANCHOR Registry collects clinical data from patients treated with the Heli-FX EndoAnchor System and endovascular grafts from several manufacturers, including the graft in the submission. The clinical evidence included data from the ANCHOR Registry of patients enrolled who were treated with Endurant or Endurant II/IIs Stent Graft Systems and met enrollment criteria at 22 sites (19 in the U.S., 3 OUS). The sponsor also provided supplemental clinical information from the literature. | Decision date: 9/29/2017 | Medical Device Database |
EnLite Neonatal TREC Kit DEN140010 | Wallac Oy | Multiple | Data from clinically annotated biobank and medical records. Source(s) name: Danish Newborn Screening Biobank | Multiple | Clinical evidence for the classification of this De Novo was based on a retrospective cut-off study and a pivotal study conducted using dried blood spot specimens from an OUS clinically annotated biobank linked to medical record data as a primary source of clinical screening samples and clinical assessment. The sponsor conducted the retrospective study using archived dried blood spot specimens from the DNS Biobank to obtain the clinical cut-off values for the EnLite Neonatal TREC Kit. The sponsor also evaluated the performance of the EnLite Neonatal TREC Kit using the DNS Biobank and confirmed positive severe combined immunodeficiency disorder samples, low-level T-cell receptor excision circle samples, and normal samples (to mask identification of the positive samples) from other newborn screening laboratories, with clinical assessment from Danish medical records. | Decision date: 12/15/2014 | Medical Device Database |
ENROUTE® Transcarotid Stent System P140026/S016 | Silk Road Medical, Inc. | Registry | Source(s) name: Carotid Artery Stenting (CAS) and Carotid Endarterectomy (CEA) Registries of the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA Supplement to expand the indication of the Transcarotid Stent System to standard surgical risk patients undergoing transcarotid artery revascularization. The clinical evidence included a retrospective, propensity-score matched cohort study using patient-level U.S. data from the SVS VQI CAS and CEA registries. | Decision date: 4/28/2022 | Medical Device Database |
Eonis SCID-SMA Kit DEN200044 | PerkinElmer, Inc. | Clinically Annotated Biobanks | Source(s) name: Danish Newborn Screening Biobank | Cohort | Clinical evidence for the classification of this De Novo was based on a retrospective screening study and accuracy study conducted using dried blood spot specimens from a clinically annotated biobank as a primary source of clinical screening samples. The sponsor conducted a clinical study to evaluate the performance of the Eonis SCID-SMA Kit using the Danish Newborn Screening Biobank. Retrospective archived newborn dried blood spot specimens from subjects confirmed positive for spinal muscular atrophy were included in the study data to enrich the Danish Newborn Screening Biobank cohort. Comparator test results were used for the spinal muscular atrophy-confirmed positive cases, while the clinical status of unaffected subjects from the biobank was determined through retrospective review by clinical experts. | Decision date: 11/09/2022 | Medical Device Database |
Eonis SCID-SMA Kit K203035 | PerkinElmer, Inc. | Multiple | Data from clinically annotated biobanks, medical records, and registry. Source(s) name: Danish Newborn Screening Biobank, Danish Neonatal Screening Biobank, and California Department of Public Health Genetic Disease Screening Program Biobank | Case-Control | Clinical evidence for the clearance of this 510(k) for a new device was based on a retrospective accuracy study conducted using anonymized residual dried blood spot specimens. The sponsor conducted a clinical study to evaluate the performance of the Eonis SCID-SMA Kit using specimens from the Danish Newborn Screening Biobank, Danish Neonatal Screening Biobank, California Department of Public Health Genetic Disease Screening Program Biobank, Danish medical records, and a Danish hospital registry. Retrospective archived newborn dried blood spot specimens from subjects confirmed positive for severe combined immunodeficiency disorder and X-linked agammaglobulinemia were included to enrich the Danish Newborn Screening Biobank cohort. Comparator test results were used for the severe combined immunodeficiency disorder- and X-linked agammaglobulinemia-confirmed positive cases, while the clinical status of unaffected subjects was determined through retrospective review of Danish hospital registry and patient medical records. A cutoff determination study was conducted using specimens from the Danish Newborn Screening Biobank to produce population distribution data and select clinical cutoff values for the pivotal study. | Decision date: 11/09/2022 | Medical Device Database |
ER-REBOA Catheter K170411 | Prytime Medical Devices, Inc. | Registry | Source(s) name: American Association for the Surgery of Trauma (AAST) Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to add a specific indication for “patients requiring emergency control of hemorrhage.” The sponsor provided clinical evidence from the AAST AORTA registry, which collected observational data on critically injured patients needing emergency hemorrhage control who were treated with the device. The clinical evidence included data from the AAST AORTA registry on successful aortic occlusion with and without imaging placement and a case series of additional patients managed with the ER-REBOA catheter in a military setting. | Decision date: 4/4/2017 | Medical Device Database |
ERIC™ Retrieval Device K211120 | MicroVention, Inc. | Registry | Source(s) name: Endovascular Treatment in Ischemic Stroke Follow-up Evaluation (ETIS) Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. Data from a prospective, multicenter, observational OUS study were used to demonstrate that the device performed similarly to the predicate devices in terms of successful reperfusion rate at the end of procedure, safety profile, and good clinical outcomes at 90 days post-procedure. | Decision date: 3/31/2022 | Medical Device Database |
ESOPHAGEAL COOLING DEVICE DEN140018 | Advanced Cooling Therapy, LLC | Medical Records | Data from medical records. | Other | Medical record data was a primary source of clinical evidence for the classification of this De Novo. The sponsor submitted clinical data summaries and patient body temperature charts of the device as used commercially OUS. | Decision date: 6/23/2015 | Medical Device Database |
everlinQ endoAVF System DEN160006 | TVA Medical, Inc. | Other | Data from OUS commercial use. Source(s) name: COMM Commercial Use Dataset | Cohort | OUS commercial use data was a supplemental source of clinical evidence for the classification of this De Novo. The sponsor submitted a pooled dataset with postmarket commercial data (COMM Commercial Use Dataset) on open-label use of the device in Europe as a supplemental source of clinical evidence for long-term endpoints. | Decision date: 6/22/2018 | Medical Device Database |
EXCOR Pediatric Ventricular Assist Device P160035 | Berlin Heart Inc. | Multiple | Data from commercial use and registry. Source(s) name: Extracorporeal Life Support Organization (ELSO) Registry. | Externally Controlled Trial | Registry data was a primary source of clinical evidence for the approval of this conversion of an HDE to a PMA for a pediatric ventricular assist device. The sponsor leveraged national registry data from the ELSO Registry as a historical control that was propensity-score matched to the HDE IDE trial population. The clinical evidence also included data from the HDE post-approval study, which was pooled with data from the pivotal study conducted under an IDE, compassionate use patients, and all non-post-approval study implanted patients. | Decision date: 6/6/2017 | Medical Device Database |
FreedomFlow™ Orbital Circumferential Atherectomy System K231538 | Cardio Flow, Inc. | Registry | Source(s) name: Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) Registry | Externally Controlled Trial | Registry data was a supplemental source of clinical evidence for the clearance of this 510(k) for a new device. The clinical evidence included a prospective, multicenter, single-arm clinical study to evaluate safety and effectiveness. The sponsor also conducted a hybrid study with a matched comparison of the FAST II FreedomFlow debulking effectiveness, with data from the VQI PVI Registry for other atherectomy devices, as a supplemental effectiveness analysis of the FAST II effectiveness performance. | Decision date: 9/27/2023 | Medical Device Database |
HeartStart FR3 Defibrillator Models 861388 (Text) and 861389 (ECG Display), Primary Battery (Models 989803150161, 989803150171), Rechargeable Battery (Model 989803150241), Charger for the Rechargeable Battery (Model 861394), SmartPads III (Models 989803149981, 989803149991), DP pads (Models 989803158211, 989803158221), and Pediatric Key (Model 989803150031) P160028 | Philips Medical Systems, Inc. | Multiple | Data from devices, medical records, and public health surveillance. | Cohort | Device-generated data from a published study was a primary source of clinical evidence for approval of this PMA for a new device in a pediatric population. The published study reported on a prospective study that analyzed pediatric patients who had been treated with an automated external defibrillator with pediatric pads. To support the safety and effectiveness of the device in the adult population, the clinical evidence additionally included 5 randomized controlled trials, which have been published in peer-reviewed journals. | Decision date: 5/11/2020 | Medical Device Database |
HeartWare Ventricular Assist System P100047 | Medtronic, Inc. | Registry | Source(s) name: Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS | Externally Controlled Trial | Registry data was a primary source of clinical evidence for the approval of this PMA for a new device. The clinical evidence included data from the ADVANCE Trial with patients in the intent-to-treat population and a contemporaneous control cohort from the INTERMACS patients, who met the study criteria. | Decision date: 11/20/2012 | Medical Device Database |
Hemospray Endoscopic Hemostat DEN170015 | Wilson-Cook Medical, Inc. | Multiple | Data from medical records and registries. Source(s) name: Survey to Evaluate the Application of Hemospray® in the Luminal Tract (SEAL) | Multiple | Registry and medical record data were primary sources of clinical evidence for the classification of this De Novo. The clinical evidence included an OUS early feasibility study in Hong Kong and 3 OUS postmarket investigations: the SEAL registry study (Europe and Canada), the HALT study (Europe and Canada), and the APPROACH study (Canada). The OUS early feasibility study included patients with peptic ulcers; the SEAL registry study included patients with upper gastrointestinal bleeds, including peptic ulcers and other gastrointestinal bleeding conditions; the HALT study was a single-arm study of patients with upper gastrointestinal bleeds, specifically Forrest 1a and 1b actively bleeding ulcers; and the APPROACH Study was a postmarket single-arm study of adult patients with nonvariceal lower gastrointestinal bleeding. The sponsor also submitted peer-reviewed literature describing the treatment of patients with the subject device, including 12 studies utilizing data from registries. | Decision date: 5/7/2018 | Medical Device Database |
Hintermann Series H3 Total Ankle Replacement System P160036 | DT MedTech, LLC | Multiple | Data from medical records and registry. Source(s) name: H3 Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA for a new device. The sponsor performed a retrospective analysis that compared data from an OUS registry (H3 Registry) against a performance goal derived from a meta-analysis of published literature and registry data for a control device legally marketed in the U.S. The sponsor also performed a safety analysis comparing adverse event data from the H3 Registry, a single-site registry in Switzerland, against adverse event data extracted from published literature and national joint registries.The published literature included studies that utilized RWD sources such as medical records and registries. | Decision date: 6/4/2019 | Medical Device Database |
Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay K124006 | Illumina, Inc. | Other | Data from a next generation sequencing database. Source(s) name: CFTR2 Database | Cohort | A publicly maintained Next Generation Sequencing database was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor estimated the clinical sensitivity and specificity of the device based on information from the CFTR2 database, using a published study. Information from the CFTR2 database was also used to establish which genetic variants were disease-causing. | Decision date: 11/19/2013 | Medical Device Database |
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay K132750 | Illumina, Inc. | Other | Data from a next generation sequencing database. Source(s) name: CFTR2 Database | Cohort | A publicly maintained Next Generation Sequencing database was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor estimated the clinical sensitivity and specificity of the device based on information from the CFTR2 database, using a published study. Information from the CFTR2 database was used to establish which genetic variants were disease-causing. | Decision date: 11/19/2013 | Medical Device Database |
IlluminOss Photodynamic Bone Stabilization System DEN160062 | IlluminOss Medical, Inc. | Registry | Source(s) name: EU Registry for the IlluminOss Bone Stabilization System | Cohort | Registry data was a supplemental source of clinical evidence for the classification of this De Novo. The sponsor provided clinical evidence from a postmarket registry study using data from the European Union (EU) Registry for the IlluminOss Bone Stabilization System. The EU Registry was initiated in September 2010 to collect technical and clinical outcomes on patients treated with the device for acute fractures or revision surgeries across 3 centers in Germany and 4 centers in the Netherlands. Data was collected from patients and uploaded to the sponsor's own web-based database. | Decision date: 12/19/2017 | Medical Device Database |
Impella 2.5 System P140003 | ABIOMED, Inc. | Registry | Source(s) name: USPELLA registry | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA for a new device. The primary clinical evidence was the PROTECT II randomized controlled clinical trial. The sponsor also provided supplemental information from the sponsor's USPELLA Registry, which captures routine care data for all Impella device models post 510(k) clearance, to provide a comparison for the clinical trial data. | Decision date: 3/23/2015 | Medical Device Database |
Impella 2.5, 5.0, CP, LD P140003/S004 | ABIOMED, Inc. | Registry | Source(s) name: USPELLA Registry | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include the treatment of ongoing cardiogenic shock that occurs immediately following acute myocardial infarction and to include additional Impella catheters for this indication. The sponsor leveraged data from their USPELLA Registry for analysis of survival-to-discharge and freedom-from-death rates between matched patients supported with the Impella device family and a temporary ventricular assist device comparator. The primary clinical study was a randomized clinical trial (ISAR-SHOCK trial) with 2 arms (intra-aortic balloon pump arm vs Impella 2.5 arm). | Decision date: 4/7/2016 | Medical Device Database |
Impella 2.5, 5.0, CP, LD P140003/S005 | ABIOMED, Inc. | Registry | Source(s) name: Impella Registry | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include treatment of ongoing cardiogenic shock that occurs immediately following open heart surgery and to include additional Impella catheters for this indication. The primary clinical study was a single-arm clinical trial (RECOVER I). Sponsor registry data served as a supplemental source of clinical evidence on freedom-from-death and adverse event rates, as well as benchmark analyses between the Impella device family and a temporary ventricular assist device comparator. | Decision date: 4/7/2016 | Medical Device Database |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter P140010/S015 | Medtronic Vascular | Registry | Source(s) name: Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry | Externally Controlled Trial | Registry data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include treatment of in-stent restenotic lesions. The sponsor conducted a prospectively designed, propensity score–adjusted superiority analysis comparing an IN.PACT Global Study device cohort against an SVS VQI standard-of-care percutaneous transluminal angioplasty cohort to evaluate target lesion revascularization at 12 months. The clinical evidence also included analyses of serious adverse events from the IN.PACT Global Study. | Decision date: 9/7/2016 | Medical Device Database |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter P140010/S037 | Medtronic Vascular, Inc. | Medical Records | Source(s) name: IN.PACT DCB Global Study database | Cohort | Medical record data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include treatment of lesions up to 360 mm in length. The clinical evidence included an analysis of data from patients meeting the retrospectively applied inclusion criteria, comprising the Long Lesion Sub-Cohort from the IN.PACT DCB Global Study database. | Decision date: 4/19/2018 | Medical Device Database |
Inspire Upper Airway Stimulation (UAS) System P130008/S090 | Inspire Medical Systems, Inc. | Registry | Source(s) name: Inspire Medical's ADHERE Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA Supplement for an indication expansion to include patients with obstructive sleep apnea, 18 years old or older, with apnea-hypopnea index ≤ 100 and support updating the body mass index warning. The sponsor conducted a retrospective study using data from their ADHERE Registry which captures data on patients implanted with the Inspire Upper Airway Stimulation System. | Decision date: 6/08/2023 | Medical Device Database |
INTUITY Elite Valve P150036 | Edwards Lifesciences, LLC | Registry | Source(s) name: Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database | Other | Registry data was a primary source of clinical evidence for the approval of this PMA for a new device. The sponsor evaluated 2 of the effectiveness endpoints of the TRANSFORM clinical trial, using data from the STS Adult Cardiac Surgery Database on mean aortic cross-clamp and cardiopulmonary bypass surgical times as a comparison metric. | Decision date: 8/12/2016 | Medical Device Database |
Kendall™ Multi-Function Defibrillation Electrodes, Medi-Trace™ Cadence Multi-Function Defibrillation Electrodes, Physio-Control/Stryker QUIK COMBO Pacing/Defibrillation/ECG Electrode P190007 | Cardinal Health | Multiple | Data from devices, medical records, and public health surveillance. | Cohort | Device-generated data from a published study was a co-primary source of clinical evidence for the approval of this PMA for a new device. This prospective study analyzed data from out-of-hospital cardiac arrest patients who were defibrillated by paramedics. The primary clinical evidence also included published clinical data from 2 peer-reviewed publications of randomized controlled trials evaluating adult and pediatric uses of the device. Supplementary clinical evidence included adult and pediatric postmarket complaint data from October 2013 to September 2018. | Decision date: 8/07/2020 | Medical Device Database |
Levita Magnetic Surgical System K180894 | Levita Magnetics International Corp. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include use to retract the liver in bariatric procedures and an expansion of the body mass index range. The sponsor provided 2 different studies: real-world evidence from a retrospective evaluation of patients treated with the subject device and an OUS prospective, open-label study. The retrospective study used medical records from patients treated with the subject device at 1 U.S. site with 10 participating surgeons. | Decision date: 9/19/2018 | Medical Device Database |
Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-2200, Lifeline/ReviveR ECG DDU-2450, and Lifeline/ReviveR ECG+ DDU-2475 Automated External Defibrillators P160032 | Defibtech, LLC | Multiple | Data from devices and medical records. | Multiple | Device-generated data was a primary source of clinical evidence for the approval of this PMA, submitted to fulfill the PMA filing requirement set forth in a classification order for automated external defibrillator systems. The sponsor submitted 2 postmarket studies that analyzed device-generated data and clinical details of out-of-hospital use of the subject devices. The first was a randomized, out-of-hospital study in Europe of the sponsor's automated external defibrillator in adults, with electrocardiogram and shock data obtained from the automated external defibrillators’ recording system and patient data collected from incidence and follow-up reports. The second was a U.S. and OUS postmarket observational study of the pediatric pads for the device that asked users to submit electrocardiogram and shock data from the automated external defibrillators, in addition to details about the patient and event. | Decision date: 2/1/2018 | Medical Device Database |
LIFEPAK CR Plus Defibrillator, LIFEPAK EXPRESS Defibrillator, and CHARGEPAK Battery Charger P160012 | Physio-Control, Inc. | Multiple | Data from devices and medical records. | Multiple | Device-generated data and medical records were primary sources of clinical evidence for the approval of this PMA, submitted to fulfill the PMA filing requirement set forth in a classification order for automated external defibrillator systems. The sponsor submitted 2 postmarket studies that analyzed device-generated data and clinical details of out-of-hospital use of the subject devices. The first was a randomized, out-of-hospital study in the Netherlands of the subject devices' use in adults, with electrocardiogram and shock data obtained from the automated external defibrillators and data obtained from medical records and study data collectors' interviews of witnesses at the scene. The sponsor also submitted results from a postmarket surveillance study of the use of the device with infant/child electrodes in a pediatric population. The clinical evidence also included an in-hospital randomized trial of monophasic vs. biphasic waveforms in patients in whom ventricular fibrillation was induced. | Decision date: 12/21/2017 | Medical Device Database |
LifeVest Wearable Cardioverter Defibrillator P010030/S056 | ZOLL Manufacturing Corporation | Multiple | Data from devices and medical records. Source(s) name: Zoll Database | Cohort | Device-generated data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include patients under 18 years of age and who meet specified chest-circumference and weight requirements. The sponsor submitted data from the Zoll Database, a clinical database that periodically receives electrocardiograms recorded before and after delivery of therapy or manually recorded by patients and subsequently reviewed by the patient’s physician; published retrospective analyses of the sponsor's database of patients 9–21 years of age; a single-site retrospective analysis of device-generated and clinical data from patients 18 years of age or younger who were prescribed a wearable cardioverter defibrillator; and a case report. | Decision date: 12/17/2015 | Medical Device Database |
Luminopia K243819 | Luminopia, Inc. | Registry | Data from registry. | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include 8 to < 13-year-old pediatric patients. The sponsor conducted a prospectively designed, retrospective analysis of data from a patient registry to evaluate improvement in amblyopic eye best-corrected visual acuity in pediatric patients aged 4 to < 13 years old following treatment with Luminopia, with follow-up extended up to 72 weeks after beginning treatment. Prior safety and effectiveness were established through a randomized controlled trial supporting the De Novo classification (DEN210005) for pediatric patients aged 4–7 years old. | Decision date: 4/09/2025 | Medical Device Database |
Lutonix 035 Drug Coated Balloon PTA Catheter P130024/S009 | Lutonix, Inc | Registry | Source(s) name: GLOBAL SFA Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion for treatment of in-stent restenosis (ISR) and long lesions (up to 300 mm) in native superficial femoral artery (SFA) or popliteal artery. The sponsor submitted primary clinical studies, including a real-world registry study (GLOBAL SFA Registry), a randomized clinical trial (SFA ISR Study), and a single-arm study (Long-Lesion SFA Study). The GLOBAL SFA Registry is an OUS registry which included patients treated with the device for stenotic or obstructive femoropopliteal arteries including those with ISR lesions. RWE from the GLOBAL SFA Registry was used in the primary assessment of effectiveness and safety for both the ISR and long-lesion indication expansions. | Decision date: 2/7/2017 | Medical Device Database |
MAGEC Spinal Bracing and Distraction System K233593 | NuVasive Specialized Orthopedics, Inc. | Registry | Data from registry. | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include skeletally immature patients of any age with early-onset scoliosis. The sponsor conducted a retrospective study using data from a registry to compare patients less than 10 years old treated with the subject device with patients 10 years old or older treated with the subject device to demonstrate substantial equivalence. | Decision date: 2/06/2024 | Medical Device Database |
MED-EL Cochlear Implant System P000025/S129 | MED-EL Corp. | Multiple | Data from medical records and registry. Source(s) name: MED-EL Hearing Solutions (MEHS) Registry Database | Cohort | Sponsor registry data was a primary source of clinical evidence for the approval of this PMA Supplement to support marketing claims regarding hearing preservation rates for the device. The primary clinical evidence additionally included a multicenter single-arm clinical trial for an indication expansion for individuals 18 years of age and older with bilateral, moderate to profound sensorineural hearing loss who obtain limited benefit from appropriately fit hearing aids in the ear(s) to be implanted. The sponsor conducted a multicenter, retrospective study using data from the MEHS registry to capture the residual hearing status after implantation among patients implanted with the MED-EL Cochlear Implant System, which was also supported by a systematic literature review, as the basis for the hearing preservation rates claims for the device. A subset of the literature reviewed incorporated RWD, including studies that utilized medical record data. | Decision date: 10/03/2024 | Medical Device Database |
Medtronic Evolut PRO+ system; Medtronic Evolut FX system; Medtronic Evolut FX+ system P130021/S174 | Medtronic, Inc. | Multiple | Data from administrative healthcare claims and registry. Source(s) name: Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and CMS claims and encounter data | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA Supplement for indication expansion to include patients with a failing transcatheter bioprosthetic aortic valve (redo transcatheter aortic valve replacement) who are deemed to be at high or greater risk for surgical therapy. The sponsor performed an analysis of real-world off-label use data captured in the STS/ACC TVT Registry using standardized data collection forms to establish reasonable assurance of safety and effectiveness of the Medtronic Evolut PRO+, FX, and FX+ systems in patients receiving redo transcatheter aortic valve replacement treatment. The sponsor linked the registry data to CMS claims and encounter data to obtain additional mortality events and follow-up time. The study was a retrospective cohort study with the objective to evaluate safety and effectiveness outcomes in patients who received commercially available Evolut valves for redo transcatheter aortic valve replacement. | Decision date: 8/27/2025 | Medical Device Database |
Melody TPV P140017/S005 | Medtronic, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include pulmonary valve-in-valve. The clinical evidence included RWD from medical records and data from 2 post-approval studies. The sponsor pooled data from medical records of consecutive patients from 10 sites implanted with a Melody TPV within a dysfunctional bioprosthetic pulmonary valve with data from the following post-approval studies: the Melody TPV Long-Term Follow-up PAS, a post-approval study with long-term follow-up of the HDE IDE population; and the Melody TPV New Enrollment PAS, a post-approval study following HDE approval. | Decision date: 2/24/2017 | Medical Device Database |
Minimally Invasive Deformity Correction (MID-C) System H170001 | ApiFix, Ltd. | Other | Data from OUS commercial use. Source(s) name: COMM Commercial Use Dataset | Cohort | OUS commercial use data was a primary source of clinical evidence for the approval of this HDE for a new device. The sponsor provided information gathered from OUS use of the device from sources that included an open-label clinical study and data from commercial use of the device. The clinical evidence included an OUS prospective, multicenter, non-randomized, open-label clinical study of patients with adolescent idiopathic scoliosis in Hungary, Romania, and Israel; OUS postmarket clinical studies data; and real-world data from patients implanted with the HDE device version of the MID-C System in the European Union, Singapore, and Israel. | Decision date: 8/23/2019 | Medical Device Database |
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear P180035 | CooperVision, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the approval of this PMA for a new pediatric device. The sponsor provided clinical evidence from a randomized controlled trial and was also required to demonstrate that the rate of microbial keratitis is no higher than 0.4% per patient-year. To meet the FDA premarket requirement, the sponsor conducted a retrospective study using medical records of pediatric patients, aged 8–12, wearing commercially available soft contact lenses from 7 U.S. community clinics. Severe adverse events and microbial keratitis were identified through a chart review conducted by an adjudication committee. | Decision date: 11/15/2019 | Medical Device Database |
Model 5071 Lead P120017 | Medtronic, Inc. | Multiple | Data from devices, public health surveillance, and registry. Source(s) name: Medtronic Registry System Longevity Study (SLS), Medtronic CareLink System, and Medtronic Product Surveillance Registry (PSR) | Multiple | Registry and device-generated data were primary sources of clinical evidence for the approval of this PMA, submitted to fulfill the PMA filing requirement set forth in a classification order. The Model 5071 lead was originally cleared on September 26, 1990 (K902002). The sponsor submitted analysis of clinical data from the sponsor’s postmarket surveillance registry study (SLS), remote monitoring data from the sponsor’s CareLink System, comparative data from 2 previous models (4965 and 4968) collected in a sponsor’s postmarket product surveillance registry (PSR), and data from the sponsor’s complaint-handling system. | Decision date: 4/27/2015 | Medical Device Database |
Motiva SmoothSilk Round and Round Ergonomix Silicone Gel-Filled Breast Implants P230005 | Motiva USA, LLC | Registry | Source(s) name: Australian Breast Implant Registry (ABDR) and the Dutch Breast Implant Registry (DBIR) | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA for a new device. The clinical evidence included results from the Motiva USA Core Clinical Study, a prospective, multicenter clinical trial and supplemental RWE from 2 international registries – ABDR and DBIR – supporting device safety and effectiveness. | Decision date: 9/26/2024 | Medical Device Database |
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) DEN170058 | Memorial Sloan-Kettering Cancer Center | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the classification of this De Novo. The sponsor submitted clinical data from an electronic medical record database of advanced cancer patients with associated pathological and clinical data generated as part of the routine workflow at Memorial Sloan Kettering Cancer Center. This database included patient-matched normal controls as well, to create a comprehensive catalog of tumor-specific mutations. This retrospective analysis provided evidence to support a pan-cancer claim, to validate a test cut-off, and to provide data on somatic mutation prevalence. | Decision date: 11/15/2017 | Medical Device Database |
N1™ TiUltra™ TCC Implant System K211109 | Nobel Biocare Services AG | Multiple | Data from medical records and public health surveillance. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor conducted a multicenter, single-arm, retrospective cohort study in Europe to evaluate clinical parameters for at least 12 months post-loading to support the success and safety of the device and its associated implant site preparation drilling technique. The clinical evidence also included a comparison of postmarket surveillance complaint rates in countries accepting CE-marks between the new device in its first year of CE-marketing and the predicate device during its first year of marketing. | Decision date: 12/21/2021 | Medical Device Database |
Natural Cycles DEN170052 | Natural Cycles Nordic AB | Patient-generated data | Source(s) name: Natural Cycles Software Application | Cohort | Patient-generated data was a primary source of clinical evidence for the classification of this De Novo. The sponsor performed a retrospective analysis of data from 15,570 OUS women who had registered in the software application. These women were prospectively followed, and pregnancy status was determined by the application's algorithm along with pregnancy tests or follow-up by email. Patient data were retrospectively analyzed to validate the accuracy of the algorithm in identifying ovulation by temperature and luteinizing hormone levels. | Decision date: 8/10/2018 | Medical Device Database |
Nerivio and Nerivio Infinity K250405 | Theranica Bio-Electronics Ltd | Multiple | Data from devices and patients. | Cohort | Device- and patient-generated data reported in a peer-reviewed publication was a primary source of clinical evidence for the clearance of this 510(k) for removal of precaution statements from the device labeling. Device- and patient-generated data from the use of the subject/predicate device were utilized to demonstrate safety with longer-term (1 year or greater) use of the device. The clinical evidence also included a peer-reviewed publication of a retrospective survey of pregnant women using the device, which provided evidence of safety of device use during pregnancy. | Decision date: 5/14/2025 | Medical Device Database |
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, and NeuroStar Advanced Therapy for Mental Health K220127 | Neuronetics, Inc | Multiple | Data from medical records and registry. Source(s) name: TrakStar Registry | Cohort | Registry and medical record data were supplementary sources of clinical evidence for the clearance of this 510(k) to support a modification in the indication for use for decreasing anxiety symptoms in adult patients suffering from major depressive disorder who may exhibit comorbid anxiety symptoms. The primary clinical evidence to support the safety and effectiveness of the device included 2 randomized controlled trials, and additional supplementary evidence included 2 retrospective chart review studies — 1 from a peer-reviewed publication and 1 using the TrakStar Registry as the data source. | Decision date: 7/15/2022 | Medical Device Database |
NeuRx® Diaphragm Pacing System (NeuRx DPS®) P200018 | Synapse Biomedical, Inc. | Multiple | Data from administrative healthcare claims, medical records, public health surveillance, and registry. Source(s) name: National Spinal Cord Injury Statistical Center (NSCISC), National Department of Veteran Affairs datasets, Nationwide Inpatient Sample database and National Nosocomial Infections Surveillance System (Japan) | Multiple | Data from published literature, including publications of studies using RWD sources, was a supplemental source of clinical evidence for this conversion of an HDE to a PMA. The clinical evidence included a prospective, single-arm, multicenter clinical trial. The sponsor conducted a meta-analysis of results from the clinical trial and from 4 published studies of HDE patients. The publications incorporated RWD as they utilized data from medical records, trauma registry, and a professional billing database. The RWE also provided comparative safety data for adverse event rates in real-world populations with spinal cord injuries receiving standard care from published literature compared to the diaphragm pacing system primary cohort. A subset of the literature reviewed incorporated RWD, including multiple studies that utilized data from registries, medical records, and national public health surveillance systems. | Decision date: 3/31/2023 | Medical Device Database |
Noris Medical Dental Implants System K210356 | Noris Medical Ltd | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a modification to a dental implant system including expanded abutment angulations and gingival height options. The clinical evidence included 2 studies using medical records: (1) a retrospective single-arm cohort study of patients treated with a reference device from published literature, and (2) a retrospective study of patients treated with Noris Medical Multi Unit abutments to demonstrate substantial equivalence. | Decision date: 2/04/2022 | Medical Device Database |
Novalung System K191407 | Fresenius Medical Care Renal Therapies Group, LLC | Registry | Source(s) name: Regensburg Extracorporeal Membrane Oxygenation (ECMO) Registry and Extracorporeal Life Support Organization (ELSO) Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The clinical evidence included a retrospective analysis of clinical data from the Regensburg ECMO Registry to support substantial equivalence. Mortality and survival rates for this analysis were compared to clinical data for comparator devices obtained from the ELSO Registry. | Decision date: 2/21/2020 | Medical Device Database |
Nucleus 24 Cochlear Implant System P970051/S205 | Cochlear Americas | Multiple | Data from administrative healthcare claims, medical records, and registry. | Cohort | Medical record data was a primary source of clinical evidence for the approval of this PMA Supplement to expand the indication of the implant system to single-sided deafness/unilateral hearing loss in children (≥ 5 years old) and adults. The clinical evidence included data from a feasibility study, which the sponsor pooled with RWD from 2 cochlear implant centers, and a systematic literature review that provided supplemental clinical evidence for safety and effectiveness in both adults and children. A subset of the literature reviewed in the systematic literature review incorporated RWD, including studies that utilized data from medical records, commercial insurance claims, and a registry. | Decision date: 1/10/2022 | Medical Device Database |
Oncospace K202284 | Oncospace, Inc. | Medical Records | Data from medical records. | Cohort | Clinician treatment plan record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor conducted a retrospective validation study of this software using a set of traditionally planned radiation treatment plans for prostate, thoracic, pancreas, and head and neck cancers to compare the number of iterations necessary with and without using Oncospace to demonstrate substantial equivalence to the predicate device. | Decision date: 3/12/2021 | Medical Device Database |
Organ Care System (OCS) Lung System P160013/S002 | TransMedics, Inc | Registry | Source(s) name: United Network for Organ Sharing (UNOS) Registry | Other | Registry data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include preservation of donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. The sponsor provided supplemental match-run data from the UNOS Organ Procurement and Transplantation Network Database, which contained data on the number of times U.S. lungs were rejected prior to enrollment in the EXPAND clinical trial. The primary clinical evidence was the EXPAND single-arm, multicenter, international, prospective clinical trial. | Decision date: 5/31/2019 | Medical Device Database |
PALMAZ MULLINS XD™ Pulmonary Stent P220004 | Cordis US Corp. | Registry | Source(s) name: Congenital Cardiovascular Interventional Study Consortium (CCISC) Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA for a new device. The sponsor conducted a retrospective study using data from an identical device indicated for a different anatomical site from the CCISC Registry. | Decision date: 7/21/2023 | Medical Device Database |
PartoSure Test P160052 | QIAGEN, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the approval of this PMA. The sponsor conducted a prospective observational study of pregnant patients enrolled across 15 U.S. sites who were symptomatic for preterm labor. Samples obtained from consented patients were tested with the PartoSure Test, and follow-up pregnancy and delivery outcomes were collected from the patients’ (and infants’) medical records. These data were used to evaluate the performance (positive predictive value, negative predictive value, test sensitivity and test specificity) of the device. The sponsor submitted additional supplemental data from an OUS retrospective single-site study. | Decision date: 4/11/2018 | Medical Device Database |
Paxman Scalp Cooler K173032 | Paxman Coolers Limited | Registry | Source(s) name: Dutch Scalp Cooling Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include all cancer patients with solid tumors. The sponsor conducted a multicenter study on cancer patients with multiple cancer types and various chemotherapy regimens using data from the Dutch Scalp Cooling Registry. The clinical evidence additionally included a literature review and a randomized clinical trial conducted in the U.S. | Decision date: 6/7/2018 | Medical Device Database |
PeraServer and PeraTrend System K172959 | PeraHealth, Inc. | Medical Records | Data from medical records. | Multiple | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The device is a software platform that extracts data from the EHR to compute a Rothman Index score. To demonstrate the validity of the Rothman Index score, the sponsor provided data from 3 publications. Two publications described the validation of the Rothman Index score calculated using data and outcomes retrospectively derived from the EMRs of adult and pediatric patients. The third publication provided a comparison between the Rothman Index score and the modified early warning score calculated using data derived from the EMRs. | Decision date: 5/1/2018 | Medical Device Database |
Perclose ProGlide Suture-Mediated Closure System P960043/S097 | Abbott Vascular Inc. | Registry | Source(s) name: EVEREST II/REALISM Continued Access Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include closing femoral artery access sites using sheaths up to 24F. A retrospective analysis of data from patients in the sponsor's continued access registry for a different device (EVEREST II/REALISM Continued Access Registry Study for the Abbott MitraClip device) supported the indication expansion of the suture delivery system. Patients from the registry who received the suture delivery system were selected based on usage of the subject device across the sites. | Decision date: 2/16/2018 | Medical Device Database |
Phagenyx System DEN220025 | Phagenesis Limited | Registry | Data from registry. | Cohort | Sponsor registry data was a supplemental source of clinical evidence for the classification of this De Novo. The primary clinical evidence included 4 randomized controlled trials and an additional single-arm prospective observational study, which provided evidence of safety and /or effectiveness of the new device. Sponsor registry data provided supplemental safety and effectiveness data in a broad range of patients with neurogenic dysphagia. | Decision date: 9/16/2022 | Medical Device Database |
Powerheart AED G3, Powerheart AED G3 Plus, and Powerheart AED G5 P160033 | Cardiac Science Corporation | Multiple | Data from devices and medical records. | Cohort | Device-generated data was a primary source of clinical evidence for the approval of this PMA, submitted to fulfill the PMA filing requirement set forth in a classification order for automated external defibrillator systems. The sponsor submitted prior clinical trial data and RWE, including device-generated data and clinical data recorded by the automated external defibrillators during routine field use in the U.S. and OUS. The clinical evidence included 4 studies: (1) the RhythmX Electrocardiogram Analysis IDE, a randomized controlled trial; (2) a retrospective postmarket analysis of RhythmX Analysis Algorithm performance using automated external defibrillators rescue data; (3) the Adult Defibrillation Waveform STAR Biphasic Waveform IDE, a randomized controlled trial; and (4) a retrospective postmarket analysis of STAR Biphasic Waveform performance using automated external defibrillators rescue data. | Decision date: 12/7/2018 | Medical Device Database |
Precision Flow HVNI DEN170001 | Vapotherm, Inc. | Medical Records | Source(s) name: Vermont Oxford Network Database | Cohort | Medical record data was a primary source of evidence for the neonate population for the classification of this De Novo. The sponsor submitted 4 studies in neonates, including 3 small prospective studies, and 1 retrospective study. The retrospective study analyzed medical chart data from patients treated with the subject device for high-velocity nasal infusion which were compared to neonate outcome data with continuous positive airway pressure treatment from the Vermont Oxford Network. | Decision date: 4/10/2018 | Medical Device Database |
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems P010032/S189 | Abbott Medical | Multiple | Data from administrative healthcare claims, medical records, and public health surveillance. Source(s) name: Centers for Medicare and Medicaid Services (CMS) Research Identifiable File Medicare Fee-for-service claims data, Medicare Supplemental Database, Nationwide Inpatient Sample, Truven MarketScan Commercial Claims and Encounters (CCAE) Database | Multiple | Administrative claims data was a supplemental source of clinical safety evidence for the approval of this PMA Supplement to support inclusion of diabetic peripheral neuropathy of the extremities for the tonic stimulation mode in the indications for use. The sponsor conducted 2 systematic literature reviews and a retrospective cohort study using CMS Medicare administrative claims data. A subset of the literature reviewed in the systematic literature reviews incorporated RWD, including multiple studies that utilized data from medical records, administrative claims, and public health surveillance. The retrospective cohort study linked patients identified in the Abbott Patient Device Tracking database with CMS claims data to assess safety outcomes. The primary clinical evidence came from 2 randomized controlled trials identified through the systematic literature review. | Decision date: 1/24/2023 | U.S. Food and Drug Administration, Center for Devices and Radiological Health, “Identifying Device Use in RWD to Support Premarket Decisions,” in FDA Convening: Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned, Washington, DC, 2025, pp. 136-147, [Online]. |
Prometra® Programmable Infusion Pump System P080012/S068 | Flowonix Medical, Inc. | Multiple | Data from medical records and registry. | Multiple | Data from a systematic literature review was a primary source of clinical evidence for the approval of this PMA Supplement for an indication expansion to allow use of the pump system for baclofen drug therapy in pediatric adolescents (12–21 years old). A subset of the literature reviewed in the systematic literature review incorporated RWD, including studies that utilized medical record and sponsor registry data. These studies provided real-world clinical performance of currently available implantable intrathecal drug delivery systems used to deliver baclofen therapy in pediatric populations. The clinical evidence additionally included an analysis of Prometra® Programmable Infusion Pump System performance in adults. | Decision date: 1/12/2022 | Medical Device Database |
RemOVE System DEN160014 | Ovesco Endoscopy AG | Other | Data from OUS compassionate use. | Cohort | OUS compassionate use data was a primary source of clinical evidence for the classification of this De Novo. The sponsor provided clinical evidence consisting of retrospective studies of compassionate use cases in Europe prior to commercial market launch, including a retrospective case series. | Decision date: 12/22/2017 | Medical Device Database |
Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Resolute Integrity Zotarolimus-Eluting Coronary Stent System P160043/S012 P110013/S088 | Medtronic Vascular | Multiple | Data from medical records and registries. Source(s) name: Global RESOLUTE Clinical Trial Program: RESOLUTE International Registry and RESOLUTE China Registry | Cohort | Registry and medical record data were a primary source of clinical evidence for the approval of these PMA supplements for an indication expansion to include treatment of coronary chronic total occlusions. The sponsor submitted RWE from a U.S. single-center observational study (PERSPECTIVE Study – Resolute CTO Cohort) collecting data from medical records and U.S. and OUS sponsor registry data (RESOLUTE International Registry and RESOLUTE China Registry), pooled for analysis of a cohort of patients treated with the subject devices. | Decision date: 12/14/2018 | |
Resolute Onyx Zotarolimus-Eluting Coronary Stent System P160043 | Medtronic, Inc. | Registry | Source(s) name: RESOLUTE INTERNATIONAL | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA for a new device. The RESOLUTE ONYX Core (2.25 mm – 4.0 mm) Clinical Study was the primary source of clinical evidence for the approval. The sponsor also provided clinical data from prior clinical investigations of stents in the Resolute device family, including clinical data collected in the RESOLUTE INTERNATIONAL, an all-comers observational registry with subjects treated per local, routine practice. | Decision date: 4/28/2017 | Medical Device Database |
restor3d Total Talus Replacement H230003 | restor3d, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the approval of this HDE for a new total talus replacement device. The sponsor conducted a retrospective chart review study, examining clinical and radiographic outcomes of patients who received a patient-specific restor3d total talus replacement implant to treat talar dysfunction. The clinical evidence included this retrospective chart review study to determine probable benefit and safety outcomes. | Decision date: 11/17/2023 | Medical Device Database |
Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems; Pisces, Specify and Vectris Spinal Cord Stimulation Leads P840001/S469 | Medtronic Neuromodulation | Multiple | Data from administrative healthcare claims, medical records, public health surveillance, and registry. Source(s) name: Medtronic Product Surveillance Registry (PSR), Nationwide Inpatient Sample, Truven MarketScan Commercial Claims and Encounters (CCAE) Database,and Medicare Supplemental Database | Multiple | Registry data was a supplemental source of clinical safety evidence for the approval of this PMA Supplement to support inclusion of diabetic peripheral neuropathy of the lower extremities in the indications for use. The evidence to support device safety in diabetic peripheral neuropathy patients included adverse event data from a sponsor registry and 2 systematic literature reviews. A subset of the literature reviewed in the systematic literature reviews incorporated RWD, including multiple studies that utilized data from medical records, administrative claims, and public health surveillance. Effectiveness was supported by a meta-analysis of 2 randomized controlled trials from peer-reviewed publications. | Decision date: 1/21/2022 | Medical Device Database |
s5/s5i/CORE/ CORE Mobile Precision Guided Therapy System K173860 | Volcano Corporation | Registry | Source(s) name: Swedish Coronary Angiography and Angioplasty Registry (SCAAR), Danish National Patient Registry, and Western Denmark Heart Registry | Hybrid Trial | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a modification to the indications for use statement to reflect use of the dichotomous 0.89 intravascular pressure index as a cut-point in guiding revascularization procedures. The sponsor submitted clinical evidence from 3 clinical studies: a multicenter observational study, a randomized controlled trial, and a second randomized controlled trial, Instantaneous Wave‐ free Ratio versus Fractional Flow Reserve in Patients with Stable Angina Pectoris or Acute Coronary Syndrome (iFR-SWEDEHEART), embedded in an OUS national registry, SCAAR. The iFR-SWEDEHEART trial utilized OUS national registries (SCAAR, the Danish National Patient Registry, and the Western Denmark Heart Registry) for patient enrollment, randomization, data collection, and follow-up of patients with coronary artery disease from all 30 coronary intervention centers in Sweden and 1 site in Iceland. | Decision date: 4/11/2018 | Medical Device Database |
SAPIEN 3 Transcatheter Heart Valve P140031/S028 | Edwards Lifesciences, LLC | Registry | Source(s) name: Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to include treatment of patients with failed surgical bioprosthetic aortic or mitral valves and in high-risk patients. The sponsor conducted an analysis of data from the STS/ACC TVT Registry of patients treated with SAPIEN 3 for failed surgical aortic prosthesis (aortic valve-in-valve) and patients treated with SAPIEN XT or SAPIEN 3 for failed surgical mitral prosthesis (mitral valve-in-valve) to support the safety and effectiveness of the device. | Decision date: 6/5/2017 | Medical Device Database |
SAPIEN XT Transcatheter Heart Valve P130009/S034 | Edwards Lifesciences, LLC | Registry | Source(s) name: SOURCE XT Registry | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include the treatment of a failed surgical bioprosthesis (“TAV-in-SAV”). The primary source of evidence was from the PARTNER II nested clinical studies, which included clinical evidence on 2 device sizes (23 mm and 26 mm). Supplemental RWE from the OUS SOURCE XT Registry, a post-approval registry collecting data on consecutive patients treated with the SAPIEN XT Transcatheter Heart Valve, provided additional clinical evidence for all 3 valve sizes (23 mm, 26 mm, and 29 mm), including an additional valve size (29 mm) not evaluated in the PARTNER II nested studies. FDA approved the indication expansion for all 3 valve sizes. | Decision date: 10/9/2015 | Medical Device Database |
SEEKER System DEN150035 | Baebies, Inc. | Public Health Surveillance Data | Source(s) name: Missouri State Public Health Laboratory (MSPHL) and Missouri Department of Health and Senior Services (MDHSS) Surveillance Program. | Cohort | Public health surveillance data was a primary source of clinical evidence for the classification of this De Novo. The pivotal trial was embedded in the MSPHL’s routine screening program. All dried-blood spot specimens submitted to the MSPHL for routine newborn screening between January 11, 2013, and January 14, 2015, were included in the study. Samples from 105,089 babies born on or after August 27, 2013, were included in the pivotal trial phase. The study also utilized the MDHSS’s active surveillance program to track false negatives reports and confirm diagnoses. | Decision date: 2/3/2017 | Medical Device Database |
Senhance Surgical System K171120 | TransEnterix, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor provided clinical data to support use of this device in laparoscopic colorectal surgery and laparoscopic gynecological surgery. For use in colorectal laparoscopic surgery, the sponsor conducted a retrospective review of medical records of patients undergoing colorectal procedures using the Senhance System and compared the results with those from published literature (11 publications) on the predicate device. For use in gynecological procedures, the sponsor conducted a prospective non-randomized clinical trial for patients undergoing gynecological surgery with the Senhance System and compared the data to results from published literature on the predicate device (8 publications). | Decision date: 10/13/2017 | Medical Device Database |
Senhance Surgical System K180163 | TransEnterix, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include inguinal hernia repair and cholecystectomy procedures. The sponsor submitted clinical evidence consisting of 2 retrospective chart reviews of robotic cholecystectomies performed with the subject device, compared to clinical data on the use of the predicate robotic device and conventional laparoscopic procedures derived from published literature. For the inguinal hernia procedures, the sponsor submitted a retrospective chart review of patients who underwent surgery with the subject device, compared to clinical literature on procedures performed with the predicate robotic device and with conventional laparoscopy. | Decision date: 5/25/2018 | Medical Device Database |
Senhance Surgical System K202166 | TransEnterix, Inc. | Medical Records | Data from medical records. | Multiple | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used. Chart review of patients who underwent Nissen fundoplication procedures with the Senhance System provided performance and safety results for the proposed indications. The clinical evidence also included 6 peer-reviewed publications describing clinical outcomes for 2 alternative surgical techniques, which provided comparison data for the chart review study. | Decision date: 3/02/2021 | Medical Device Database |
Senhance® Surgical System K233866 | Asensus Surgical, Inc | Registry | Source(s) name: TRUST Registry | Multiple | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for an indication expansion to include laparoscopic urological surgery. The sponsor conducted a retrospective study using data from the TRUST registry and a systematic literature review. The sponsor compared the registry data with the results from peer-reviewed publications describing clinical outcomes for laparoscopic urological procedures using 3 alternative surgical techniques. | Decision date: 7/19/2024 | Medical Device Database |
SignalHF K230842 | Implicity Inc. | Multiple | Data from administrative healthcare claims and devices. Source(s) name: Système National Des Données de Santé (SNDS) | Cohort | OUS administrative claims data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted a retrospective study to test the algorithm performance using data from the French SNDS national health database and Implicity proprietary databases. The device-generated heart failure risk score was assessed by comparing predicted alerts to hospitalizations with heart failure as the primary diagnosis. Performance was assessed based on sensitivity for detecting these events and alert timing relative to the hospitalizations. | Decision date: 10/25/2023 | Medical Device Database |
SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly P200040 | Delphinus Medical Technologies | Multiple | Data from medical records and registry. Source(s) name: Prospective Case Clinical (PCC) Registry | Cohort | Registry and medical record data were primary sources of clinical evidence for the approval of this PMA for a new device. The sponsor conducted multi-reader multi-case retrospective reader studies from multiple clinical centers to evaluate the safety and effectiveness of the SoftVue system as an adjunct to mammography for breast cancer screening in women with dense breast parenchyma. The prospectively maintained PCC registry was used for case selection. The retrospective reader studies validation studies were retrospective and used previously collected imaging data from the registry along with corresponding clinical data from patient medical records. These data were used to establish the ground truth for each case evaluated. | Decision date: 10/06/2021 | Medical Device Database |
SomnoMetry K221179 | Neumetry Medical Inc | Medical Records | Data from medical records. | Cohort | Medical record data associated with archived polysomnography files was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted a retrospective cohort study to compare the device performance to a clinician’s manual scoring of the same sleep recordings from routine clinical practice and to confirm there was no statistically significant difference in clinical performance compared to the predicate device. | Decision date: 9/21/2022 | Medical Device Database |
Spatz3 Adjustable Balloon System P190012 | Spatz FGIA, Inc | Public Health Surveillance Data | Data from public health surveillance. | Cohort | Clinical product surveillance data was a supplemental source of clinical evidence for the approval of this PMA for a new device. The clinical evidence included a randomized controlled trial conducted at U.S. investigational sites and data on adverse event complaints reported through OUS clinical product surveillance. | Decision date: 10/15/2021 | Medical Device Database |
STAR S4 IR Excimer Laser System iDesign Advanced WaveScan Studio System P930016/S044 | AMO Manufacturing USA | Medical Records | Data from medical records. | Cohort | Medical record data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include reduction or elimination of myopic astigmatism up to −11.00 D spherical equivalent, and up to 5.00 D cylinder, as measured by the iDesign Advanced WaveScan Studio system. The sponsor submitted literature from 2 OUS retrospective studies of de-identified patient data extracted from the EMR database of a LASIK provider. These studies provided additional safety and effectiveness data for the device during the early post-operative period. The primary evidence was a prospective, multicenter, open-label, non-randomized study. | Decision date: 5/6/2015 | Medical Device Database |
Stellarex™ 0.035" OTW Drug-coated Angioplasty Balloon P160049/S015 | Philips Image Guided Therapy Corporation | Registry | Source(s) name: Stellarex Vascular E-Registry (SAVER) | Cohort | Registry data was a supplemental source of clinical evidence for the approval of this PMA supplement for the indication expansion for the treatment of in-stent restenosis. The primary evidence was the ILLUMENATE Global in-stent restenosis prospective clinical study. RWD from the SAVER Registry provided real-world confirmation of safety and effectiveness in patients across Europe. | Decision date: 3/25/2022 | Medical Device Database |
TandemHeart Pump and Escort Controller K202751 | CardiacAssist, Inc. | Registry | Source(s) name: Extracorporeal Life Support Organization (ELSO) Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) to add extracorporeal membrane oxygenation to the indications for use. The sponsor conducted a study using propensity score analysis using ELSO Registry data to demonstrate the ability of the TandemHeart Pump to provide assisted extracorporeal oxygenation of adult patients’ blood. | Decision date: 3/26/2021 | Medical Device Database |
Tempus ECG-AF K233549 | Tempus AI, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The sponsor conducted a retrospective validation study using patient records and electrocardiogram tracings from 3 geographically distinct sites. The device’s binary risk output was compared against atrial fibrillation/flutter status determined through duplicate manual chart review of medical records. | Decision date: 6/21/2024 | Medical Device Database |
Tempus ECG-Low EF K250119 | Tempus AI, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device software function. The clinical evidence included a retrospective validation study conducted using retrospective medical record data from electrocardiogram – transthoracic echocardiogram pairs from 4 geographically distinct U.S. clinical sites, allowing the software’s performance to be assessed in its intended use population under real-world clinical conditions. Patients were included if they had at least 1 qualifying 12-lead resting electrocardiogram within 30 days prior to a transthoracic echocardiogram. The device’s output was compared against transthoracic echocardiogram-derived left ventricular ejection fraction measurements, which served as the reference standard. | Decision date: 7/15/2025 | Medical Device Database |
The Tether - Vertebral Body Tethering System H190005 | Zimmer Biomet Spine, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the approval of this HDE for a new device. The clinical evidence included data from a prospective study of pediatric patients with adolescent idiopathic scoliosis who have been implanted with the subject device, identified through a retrospective review of patient medical records from 1 U.S. site under an IDE and enrolled in a long-term follow-up study with prospective data collection. | Decision date: 8/16/2019 | Medical Device Database |
TheraSphere P200029 | Boston Scientific Corporation | Multiple | Data from medical records and public health surveillance. | Cohort | Medical record data was a primary source of clinical evidence to support the approval of this conversion of an HDE to a PMA. The sponsor conducted a retrospective, single-arm, multi-center study using medical records from consecutive patients with unresectable hepatocellular carcinoma treated with TheraSphere at U.S. sites. The sponsor also submitted supplemental clinical evidence, which included adverse events the sponsor has received since U.S. commercial distribution of the HDE device. Postmarket surveillance data included adverse events reported as product complaints or identified in the published medical literature. | Decision date: 3/17/2021 | Medical Device Database |
Tina-quant Lipoprotein(a) Gen.2 Molarity K241220 | Roche Diagnostics Operations | Clinically Annotated Biobanks | Source(s) name: UK Biobank | Cohort | UK Biobank Study data was a primary source of clinical evidence for the labeling of this 510(k) for a new device. The UK Biobank Study assessed the association between Lp(a) levels and atherosclerotic cardiovascular disease and provided clinical evidence to support labeling, using data from a large observational cohort of approximately 460,000 adults in the United Kingdom drawn from a clinically annotated biobank with linkage to hospital records and other longitudinal data. | Decision date: 1/24/2025 | Medical Device Database |
Trevo XP ProVue Retriever K190779 | Stryker Neurovascular | Registry | Source(s) name: Trevo Retriever Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for modifications to the labeling and instructions for use for using the subject device with an aspiration catheter (AXS Catalyst Distal Access Catheter) and aspiration pump (AXS Universal Aspiration System) as an alternative use. The clinical evidence included a study of the subject device used in combination with catheter aspiration from the Trevo Retriever Registry of ischemic stroke patients worldwide treated with the subject device as the initial device in mechanical neuro-thrombectomy, along with a literature review. | Decision date: 6/25/2019 | Medical Device Database |
truFreeze System K163244 | CSA Medical, Inc. | Registry | Data from registry. | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for expansion of the indication to include Barrett's Esophagus with high grade dysplasia. The sponsor provided clinical evidence from an all-comers, postmarket registry, which collected data on patients with Barrett's Esophagus, including those with high-grade dysplasia, treated using truFreeze. | Decision date: 5/24/2017 | Medical Device Database |
truFreeze System K171626 | CSA Medical, Inc. | Registry | Data from registry. | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for expansion of the indication to include Barrett's Esophagus with low-grade dysplasia. The sponsor provided clinical evidence from an all-comers, postmarket registry, which collected data on patients, treated using truFreeze including those with low-grade dysplasia. The clinical evidence also included peer-reviewed literature, some of which utilized data from registries. | Decision date: 8/30/2017 | Medical Device Database |
truFreeze® System, Vortex™ Radial Spray Catheter K201183 | CSA Medical, Inc. | Registry | Data from registry. | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a modification to the existing truFreeze® System adding a radial spray catheter configuration. To provide a safety profile of patients treated with circumferential spray of liquid nitrogen, clinical evidence was provided from an ongoing prospective, multicenter registry of patients treated with the predicate device who received circumferential ablation. The clinical evidence additionally included data from 3 peer-reviewed publications, which demonstrated the ability of the predicate device (i.e., linear spray) to achieve circumferential freezing of diseased tissue in the esophagus. | Decision date: 12/07/2020 | Medical Device Database |
Us2.ca K250151 | Eko.ai Pte. Ltd. d/b/a Us2.ai | Medical Records | Data from medical records. | Case-Control | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The clinical evidence included evaluation of device performance via a case-control study across various sites in the U.S. and Japan. Training and external validation datasets were sourced from separate data providers with no overlap and maintained full independence between development and evaluation. In the validation study, the device’s output was compared against the known cardiac amyloidosis status of each patient. | Decision date: 6/20/2025 | Medical Device Database |
VENOUS WALLSTENT P980033/S050 | Boston Scientific Corporation | Medical Records | Data from medical records. | Multiple | Medical record data was a primary and supplemental source of clinical evidence for the approval of this PMA Supplement for an indication expansion for the treatment of symptomatic iliofemoral venous outflow obstruction. The primary clinical evidence was a systematic literature review, which included multiple studies using medical record data and provided a critical review of the published information relevant to safety and performance of the VENOUS WALLSTENT. The clinical evidence additionally included a supplemental investigator-sponsored research study, which utilized retrospective chart review to evaluate the procedure, patency rates, and clinical outcomes among patients who were treated with the VENOUS WALLSTENT. | Decision date: 3/17/2020 | Medical Device Database |
VitalFlow™ Set with Balance™ Biosurface K240880 | Medtronic Inc. | Registry | Source(s) name: Extracorporeal Life Support Organization (ELSO) Registry | Cohort | Registry data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor submitted a summary of reports of the clinical experience with the VitalFlow Set from the ELSO Registry prepared by the ELSO to demonstrate the performance of the subject device. | Decision date: 9/12/2024 | Medical Device Database |
Viz HCM DEN230003 | Viz.ai, Inc. | Medical Records | Data from medical records. | Case-Control | Medical record data was a primary source of clinical evidence for the classification of this De Novo. The sponsor conducted a validation study using historical data from medical charts, imaging, and electrocardiograms from 3 U.S. hospitals. Cardiologist review of medical charts and imaging was used to establish hypertrophic cardiomyopathy status for each patient, and the device’s electrocardiogram-based output was compared against this diagnosis. | Decision date: 8/03/2023 | Medical Device Database |
VNS Therapy System P970003/S207 | Cyberonics, Inc. (LivaNova) | Multiple | Data from public health surveillance and registry. Source(s) name: Japan VNS Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of this PMA supplement for an indication expansion to reduce the frequency of seizures in patients 4 years of age and older. The primary source of clinical evidence was a postmarket study in Japan conducted through the Japan VNS Registry. The sponsor performed a Bayesian hierarchical analysis using data from 5 previous clinical trials as the source of prior information, and RWD from the registry as the source of current data. The sponsor also submitted adverse event reports and device tracking data from their postmarket surveillance database. | Decision date: 6/23/2017 | Medical Device Database |
WaveLight EX500 Excimer Laser System, ALLEGRETTO WAVE EYE-Q Excimer Laser System P020050/S023 | Alcon Laboratories, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include photorefractive keratectomy treatment. The sponsor submitted 3 published articles: 2 describing retrospective chart review studies of consecutive patients treated with photorefractive keratectomy at single sites, and a third describing data from a randomized study of tomography-guided vs. wavefront-optimized photorefractive keratectomy. The 2 RWE studies provided additional data on refractive and visual outcomes as well as complications. The primary evidence was a prospective, multicenter, open-label, non-randomized study with 2 stages. | Decision date: 11/21/2016 | Medical Device Database |
X Series, R Series, AED Pro, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, etc. (See Approval Order for full list) P160022 | Zoll Medical Corporation | Multiple | Data from devices and medical records. | Cohort | Device-generated data and medical records were primary sources of clinical evidence for the approval of this PMA, submitted to fulfill the PMA filing requirement set forth in a classification order for automated external defibrillator systems. The devices in this PMA were first cleared under K112432, K060559, and K041892. The sponsor submitted prior clinical trial data and RWE, including device-generated data and clinical data recorded by the automated external defibrillators during routine field use. The clinical evidence included a published observational study of out-of-hospital automated external defibrillator use by emergency medical technicians, including automated external defibrillator device data and patient survival outcomes, along with a randomized, multicenter, in-hospital clinical trial and a separate in-hospital study. | Decision date: 12/27/2017 | Medical Device Database |
XableCath Support Catheter Product Family K180986 | XableCath, Inc. | Medical Records | Data from medical records. | Cohort | Medical record data was a primary source of clinical evidence for the clearance of this 510(k) for a new device. The sponsor provided OUS data obtained from an extension of their product validation assessment, including a review of patients' medical records, which were analyzed for successful device use and adverse event occurrence in the real-world validation study cohort. | Decision date: 5/15/2018 | Medical Device Database |
XIENCE Family of Everolimus Eluting Coronary Stents P070015/S128 P110019/S075 | Abbott Vascular | Registry | Source(s) name: American College of Cardiology (ACC) CathPCI Registry | Cohort | Registry data was a primary source of clinical evidence for the approval of these PMA supplements for an indication expansion to include treatment of patients with diabetes mellitus. The sponsor performed a Bayesian hierarchical analysis using data from 4 clinical trial databases as the source of prior information, and RWD from the ACC CathPCI Registry as the source of current data. | Decision date: 9/23/2015 | |
Zilver PTX Drug-Eluting Peripheral Stent P100022/S020 | Cook Medical, Inc. | Public Health Surveillance Data | Data from public health surveillance. | Cohort | OUS postmarket surveillance data was a supplemental source of clinical evidence for the approval of this PMA supplement for an indication expansion to include treatment of lesions up to 300 mm in length. The primary evidence was from the Zilver PTX Single Arm Study, an OUS study with clinical sites in Europe, Canada, and Korea. The sponsor also conducted a postmarket surveillance study in Japan, which enrolled consecutive patients treated per standard of care and served as a supplemental source of clinical evidence. | Decision date: 12/28/2016 | Medical Device Database |