In a 510(k) submission, what does 'predicate device' refer to?

In a 510(k) submission, a 'predicate device' is a legally marketed device that is used as a benchmark for comparison to demonstrate that the new device is safe and effective. The 510(k) process is essentially a premarket notification to the FDA that allows manufacturers to demonstrate that their device is "substantially equivalent" to an existing, legally marketed device rather than undergoing the more rigorous premarket approval (PMA) process.

Using a predicate device allows the manufacturer to show that the new device has similar characteristics, intended uses, and performance levels compared to the already approved device. This is significant because it helps to expedite the review process and provides assurance to the FDA about the device's safety and efficacy based on proven data from existing devices.

In contrast, other options describe devices that do not fulfill the criteria needed for a predicate. A recently launched device might not have sufficient market data yet. A recalled device typically indicates safety or efficacy concerns and cannot be used as a benchmark for comparison. A prototype device, being in development and not legally marketed, would lack the necessary data to serve as a reliable point of comparison. Thus, defining a predicate device accurately is crucial for regulatory clarity and successful device approval through the 510(k)