- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameRonald E. Prior
Recipient TitleChief Executive Officer
- 21st Century Scientific Inc
4931 N. Manufacturing Way
Coeur d’Alene, ID 83815
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
May 13, 2019
Dear Ronald E. Prior:
During an inspection of your firm located in Coeur d’Alene, ID on September 10, 2018 through September 12, 2018, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Bounder powered wheelchairs. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that these devices are misbranded within the meaning section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Our inspection found you are marketing the Bounder Powered Seating Systems as modification options to your Bounder VA Power Wheelchair (K901210), which was cleared as a powered wheelchair to provide mobility to individuals restricted to the sitting position. Specifically, you are marketing the following Bounder Powered Seating Systems: Power Recline System, Sliding Back Power Recline System, Power Tilt System, Reverse Power Tilt System, Power Seat Elevator 2, and the Power Front Load System. Upon review of your product labeling and website located at http://www.wheelchairs.com/bseatsys.htm, we found that these modification options add device functionality such as lifting the user, tilting the user, and bringing the user to a standing position to allow for various activities and aid in entering and exiting the wheelchair. Additionally, your website includes links to a video (http://www.wheelchairs.com/videogallery.html) highlighting your HVLP Off-Road Package. This video shows the wheelchair being used on rough terrain, sand, and snow. Use on these terrains and functions that enable the device to lift the user, tilt the user, and bring the user to a standing position were not cleared under K901210. These significant changes or modifications could significantly affect the safety or effectiveness of the device cleared in K901210 such that a new 510(k) premarket notification must be submitted. See 21 C.F.R. 807.81(a)(3).
Our concerns were discussed with you during our inspection on September 10-12, 2018. We have reviewed your FDA 483 responses dated September 11, 2018 and September 27, 2018, in which you include your justification for not submitting a new 510(k) notification for your Bounder Powered Seating Systems. Our review of these responses found that your responses are inadequate because, although your responses conclude that these seating systems do not add additional risk based on your risk analysis and you claim that your design validation and verification activities support your conclusion, you did not provide any description of these activities, any records demonstrating that these activities were conducted, or information that the results supported your conclusion that no additional risks were identified. However, despite the absence of this documentation, as discussed above, we have determined that the modifications to your device after clearance of K901210 were significant modifications that require you to submit a new 510(k) submission.
Our inspection also revealed that your Bounder Powered Wheelchairs are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Violations include, but are not limited to:
Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, the information included for Complaint 224663 reasonably suggests that your firm’s powered wheelchair may have caused or contributed to a serious injury (e.g., broken arm) to the user. There is no information in your firm’s complaint file to justify why the device would not be likely to cause or contribute to a reportable serious injury. Your firm became aware of the event on May 16, 2017, but you did not submit an MDR for the referenced event.
We reviewed your firm’s response dated September 27, 2018 and concluded that it is not adequate. In the response, your firm promised to process an MDR for the referenced event. However, your firm did not provide evidence of the systemic corrective actions, including a retrospective review of all adverse events.
Our inspection also revealed that you failed to adequately develop, maintain and implement written MDR procedures, as required by 21 C.F.R. 803.17. For example, after reviewing your firm’s MDR procedure titled “Complaint & MDR Procedure”, dated October 12, 2004, and the associated document titled “WHEN AND WHAT TO REPORT,” the following deficiencies were noted:
1. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 C.F.R. 803.17(a)(1). For example, there are no definitions of what your firm will consider to be a reportable event under 21 C.F.R. Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in section 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that meets the criteria for reporting under 21 C.F.R. 803.50(a).
2. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 C.F.R. 803.17(a)(2). For example:
a. There are no instructions for conducting a complete investigation of each MDR reportable event and evaluating the cause of the event.
b. The procedure, as written does not specify who makes the decision for reporting events to FDA.
c. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
3. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 C.F.R. 803.17(a)(3). Specifically, the following are not addressed:
a. The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, 5 day report and the requirements for such reports.
b. The procedure process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm
c. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within its firm.
4. The procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 C.F.R. 803.17(b), including:
a. Documentation of adverse event related information maintained as Medical Device Reporting (MDR) event files.
b. Information that was evaluated to determine if an event was reportable.
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d.Systems that ensure access to information that facilitates timely follow-up andinspection by FDA.
The adequacy of your firm’s response dated September 27, 2018 cannot be determined at this time. Your firm stated it would add clarification to its procedure for submitting an MDR. Without this documentation in hand, FDA cannot make an assessment with respect to adequacy.
If your firm wishes to discuss the MDR related issues noted above, please contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at ORADevices3 FirmResponse@fda.hhs.gov. Please identify your response with FEI 1000125727. If you have any questions about the contents of this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251, or via e-mail at Jeffrey.firstname.lastname@example.org.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Carlos L. Peña, PhD, MS
OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Ronald D. Davidson, COO
21st Century Scientific, Inc.
4931 N. Manufacturing Way
Coeur d’Alene, ID 83815