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  4. Reprocessing of Reusable Medical Devices: Information for Manufacturers
  5. Devices for which a 510(k) should contain validation data (Reprocessing Final Guidance Appendix E.)
  1. Reprocessing of Reusable Medical Devices: Information for Manufacturers

Devices for which a 510(k) should contain validation data (Reprocessing Final Guidance Appendix E.)

The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. This identification was based on knowledge gleaned through MDRs; recalls; periodic outbreaks of microbial transmission or patient infections reported in the literature or media; reports provided by the Centers for Disease Control (CDC), the Veterans Administration (VA), and other health care settings; and manufacturer-initiated surveillance studies.

Reprocessing instructions for medical devices should be validated. However, because of the greater risks to the public health posed by the devices listed below, 510(k) submissions for these devices should include protocols and complete test reports of the validation of the reprocessing instructions so that FDA has the information it needs to evaluate substantial equivalence. This includes validation of the cleaning instructions as well as the disinfection or sterilization instructions. The reprocessing validation data should demonstrate that the proposed reprocessing instructions will reprocess the subject device at least as well as the reprocessing instructions for the predicate device. The devices identified by FDA as within this subset are listed as follows:

Bronchoscopes (flexible and rigid) and accessories

Product CodeDevice NameRegulation Number
EOQBronchoscope (flexible or rigid)874.4680
KTIBronchoscope accessory874.4680
BTGBrush, biopsy, bronchoscope (non-rigid) 874.4680
JEIClaw, foreign body, bronchoscope (non-rigid)874.4680
JELCurette, biopsy, bronchoscope (rigid)874.4680
BSTCurette, biopsy, bronchoscope (non-rigid)874.4680
BWHForceps, biopsy, bronchoscope (non-rigid)874.4680
JEKForceps, biopsy, bronchoscope (rigid)874.4680
ENZTelescope, laryngeal-bronchial874.4680
KTRTube, aspirating, bronchoscope (rigid)874.4680
JEJTubing, Instrumentation, bronchoscope (brush sheath A/O aspirating)874.4680

Ear, Nose, and Throat (ENT) endoscopes and accessories

Product CodeDevice NameRegulation Number
EOXEsophagoscope (flexible or rigid)874.4710
GCLEsophagoscope, general & plastic surgery876.1500
FDWEsophagoscope, rigid, gastro-urology876.1500
EOBNasopharyngoscope (flexible or rigid)874.4760
EQNLaryngoscope, nasopharyngoscope874.4760
EWYMediastinoscope, surgical, and accessories874.4720

Gastroenterology and Urology Endoscopes* that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)]

Product CodeDevice NameRegulation Number
FDTDuodenoscope and accessories, flexible/rigid876.1500
FAKPanendoscope (gastroduodenoscope)876.1500
FTKPancreatoscope, biliary876.1500
ODFMini endoscope, gastroenterology-urology876.1500
FBNCholedochoscope and accessories, flexible/rigid876.1500
ODGEndoscopic ultrasound system, gastroenterology-urology876.1500

* For endoscopes that fall under the product codes above, 510(k) submissions should include reprocessing validation data for those endoscopes designed with elevator channels.

Automated Endoscope Reprocessors (AERs)

Product CodeDevice NameRegulation Number
FEBAccessories, cleaning, for endoscopes21 CFR 876.1500
NZAAccessories, germicide, cleaning, for endoscopes21 CFR 876.1500
KOGEndoscope and/or accessories21 CFR 876.1500
OUJHigh level disinfection reprocessing instrument for ultrasonic transducers21 CFR 892.1570

Colonoscopes (not including accessories)

Product CodeDevice NameRegulation Number
FDFColonoscope and accessories, flexible/rigid876.1500
FDAEnteroscope and accessories876.1500

Neurological endoscopes (not including accessories)

Product CodeDevice NameRegulation Number
GWGEndoscope, neurological882.1480

Arthroscopes and accessories

Product CodeDevice NameRegulation Number
HRXArthroscope888.1100

Laparoscopic instruments and accessories**

Product CodeDevice NameRegulation Number
GCJLaparoscope, general & plastic surgery876.1500
GEIElectrosurgical, cutting & coagulation & accessories878.4400
 

**For laparoscopic instruments and accessories that fall under the product codes above, premarket review of reprocessing validation data is only necessary for those with design features given in Table 1 below.

Laparoscopic instruments and accessories**

Table 1
510(k) Submissions Should Include Reprocessing Validation Data for Laparoscopic Instruments and Accessories with Any of the Following Design Features

Lumens (with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too small to permit a brush to pass through)
Hinges
Interior device channels
Sleeves surrounding rods, blades, activators, inserters, etc.
Adjacent device surfaces between which debris can be forced or caught during use
O-rings
Devices with these or other design features that cannot be disassembled for reprocessing
Stopcocks

In the future this list may be updated as additional information regarding reprocessing medical devices becomes available.