A predicate device is an existing previously cleared 510k Certification and is marketed under a regulatory pathway that is used for the comparison between the proposed device to prove the substantial equivalent.
Multiple predicates can also be used for comparing the substantial equivalence when the proposed device has more than one intended use, but it is better to compare the substantial equivalent with one single predicate device.
Predicate devices are selected based on
- It should have a similar product code, regulation number, and intended use as same as the newlyproposed device.
- It should have the same technical characteristics as the proposed device.
- It should have the same design and material as the newly proposed device.
- It should have the same safety and effectiveness as the newly proposed device.
Predicate device identifications are verified when stating substantial equivalence and if the FDA 510k submission is provided with an incorrect predicate device, then FDA holds or withdraws the submission.
substantial equivalent
It means when the proposed device is the same as the predicate device and is safe and efficient for the user. Which has the same device intended use and similar technological characteristics.
Technological characteristics – performance testing, clinical testing, an additional requirement.
The device is said to be substantially equivalent if it has:
- Same intended use and same technological characteristics as legally marketed device
Or
- Have different characteristics but it does not raise any questions about its safety and effectiveness
Decision making of substantial equivalence for a 510K
- Identify predicate device for the newly proposed device
- Compare both the device
- Check if both the device has similar intended use and characteristics
- If both are similar, then it is substantially equivalent
Or
- If it has different technological characteristics, then sufficient testing is required
- Check if the data taken from testing passes the acceptance criteria
- If both are similar, then it is substantially equivalence
Difference between substantial equivalence and predicate device
PREDICATE DEVICE | SUBSTANTIAL EQUIVALENCE |
| It is a legally marketed device | It is a method to find the SE of the proposed device |
| It is used to find if the newly proposed device is safe and effective by comparing with the predicate device. | Comparison method between predicate device and proposed device to find the substantial equivalence. |
