Predicate Medical Device
In the US FDA premarket notification or 510k approval, predicate device is a term that is frequently used. A medical device legally marketed in the US and can be used as a point of comparison to prove the performance and safety of the medical device that is seeking marketing clearance from FDA is known as a predicate device. This product details of predicate device, if proven to be substantially equivalent, can be used to demonstrate the effectiveness and safety of the medical device seeking clearance.
The use of split predicates is not encouraged by FDA. The reviewer must be able to verify the substantial equivalence to one predicate device. Multiple predicate devices can be used as long as they have the same intended use as the device seeking 510k clearance.
What is the difference between a Predicate device and a reference device found in some 510k summary?