Manufacturers should attempt to make 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. Comparisons might consider such areas as intended use, materials, design, energy used and delivered, anatomical sites, target population, physical safety, 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.
For laser and light-based systems, one needs to demonstrate that the predicate and the investigational device has the same intended use, are similar in laser technology and that the investigational device has features that would provide at least a similar level of safety.
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.