Manufacturers should attempt to make a comparison of the new device to its predicate as easy as possible for the FDA reviewer. The 510(k) notification should therefore include discussion of the similarities and differences between the device and its predicate device, and should make use of comparative tables whenever possible (Fig. 22.1). Comparisons might consider such areas as intended use, materials, design, energy used and delivered, anatomical sites, target population, physical safety, and compliance with standards, biocompatibility, and
performance. Information used to demonstrate the substantial equivalence of the device to its predicate should be provided in a clear and comprehensible format, making use of tables and graphs where these are helpful to clarify the manufacturer’s argument.
Manufacturers should also submit pertinent information about the predicate device, including its labeling, if available. For example, the notification should state whether the predicate is a legally marketed preamendment device or a Class I or Class II postamendment device that has been granted marketing clearance by FDA following the submission of a 510(k). If known, provide the 510(k) document control number (i. e., K followed by 6 digits) for the predicate device. Such 510(k) numbers are available via the Electronic Docket at CDRH.
Unlike a PMA, which requires demonstration of clinically proven safety and effectiveness, the 510(k) requires demonstration of substantial equivalence (SE). SE means that the new device is as safe and effective as the predicate device(s). Significantly, prior to the 1990 amendments, the FDA did not generally require human clinical trials in determining substantial equivalence.63 However, following the 1990 amendments, the FDA was given express authority to require the submission of performance data, including data from clinical trials, in order to make a substantial equivalence determination.64
A device is deemed SE if, in comparison to a predicate device it:
• has the same intended use as the predicate device, and
• has the same technological characteristics as the predicate device, or
• has different technological characteristics that do not raise new questions of safety and effectiveness, and the sponsor demonstrates that the device is as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. Detailed information on how FDA determines substantial equivalence can be found in the Premarket Notification Review Program (K86-3)65 blue book memorandum.
Until the applicant receives an order declaring a device SE, they may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the United States. If FDA determines that a device is not SE, the applicant may resubmit another 510(k) with new data, file a reclassification petition,66 or submit a premarket approval application (PMA). The SE determination is usually made within 90 days and is made based on the information submitted by the applicant.