'Special' 510k as a Predicate Medical Device?

[Eurodep]

Hello All,

As a new memeber, I have researched my question on the forum first, but found no clear equivalent, so I would like to ask for some input.

In preparing for a 510k Class II device submission, the predicate device was selected prior to my arrival in the process. The 510k predicate device is listed as a 'Special' 510k.
The predicate device itself is a good choice for our device, but the fact that the 510k is listed as 'special' has me concerned.

Will the FDA accept a 'Special' 510k as the predicate device for our device? If so, will I have to prepare for unique issues or will I have any fundamental problems using a 'Special' 510k against which to compare our device?

Thanks for any insight.

 

[Ronen E]

Re: 'Special' 510k as a Predicate Device?

Hello and welcome to the Cove

In my opinion there's no concern.

The fact that the predicate was cleared under a "Special" 510k only means that it is a modified version of a previously cleared device. Nevertheless the resulting status is the same as a device cleared under a "Traditional" 510k, and there's no apparent reason why it shouldn't serve as a predicate.

Good luck,
Ronen.

 

[Eurodep]

Re: 'Special' 510k as a Predicate Device?

Thanks Ronen E, much appreciated.

 

[mihzago]

Re: 'Special' 510k as a Predicate Device?

Agree with Ronen.
There are several types of a 510(k) submission i.e. traditional, special, and abbreviated. The difference between them is the amount of data submitted. Special is typically used when you make a change to your device that requires a new submission.
In the end, any currently cleared device can be used as a predicate.