In the US FDA premarket notification or 510k approval, predicate medical 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 the FDA is known as a predicate medical device. This product details of a 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 medical device. Multiple predicate devices can be used as long as they have the same intended use as the device seeking 510k clearance.
A predicate device is a legally U.S marketed medical device that is most similar to the device under review in terms of indications of use and technological characteristics. The predicate device serves as a point of comparison to demonstrate safety and effectiveness of the new medical device seeking approval through FDA’s 510(k) Premarket clearance pathway.
Reference devices are other legally marketed devices that may be used to support scientific methodology and/or provide technical information to help address the safety and effectiveness of a new technological characteristic. They may be useful in comparing technologies used within devices, instead of the devices as a whole. If a selected reference device is used in an anatomical location or for a physiological purpose that is considerably different than that of the new device, its utility as a reference device may be limited.
The medical device that may be legally marketed in the U.S. and used as a point of comparison for new medical devices seeking approval through FDA’s 510(k) premarket clearance pathway is termed as Predicate device.
FDA recommends to identify the primary predicate device to simplify and facilitate the decision-making process. However the 510(k) process also allows multiple predicate devices during categorizing the same, the predicate devices and new device must have the same intended use and when multiple predicate devices combined, it should not raise any new risk factors that alter the safety and effectiveness of the new device so that a substantial equivalence comparison cannot be made.
Reference devices may be included to support scientific methodology or standard reference values in 510(k) submission. Applicants will identify the reference devices to support acceptable scientific methods. These devices do not assist as predicate devices because of differences in intended use but they are significant on other hand as they have same technological similarities to the new device.
FDA will not consider these reference devices as substitutes for predicate devices so applicants should provide scientific rationale to support their use of reference devices in their SE applications
A predicate device is a medical device that is legally marketed in the US which is used for to demonstrate substantial equivalence with a new device for the approval of 510(K).
A reference device allows its experience with other devices. Reference devices do not act as predicate devices because of differences in intended use or technological characteristics, but they are useful because of the technological similarities to the new device. Using reference devices in the 510(k) can able to fill the gap between a subject and a predicate device.