Regulatory Open Forum

Happy New Year all!

Question regarding 510k strategy for my SAMDs.  We have two FDA Class II 510k cleared Software as Medical Devices (SAMDs).  We can call them devices A and B.  We would like to combine A and B into one Medical Device, device C, via a 510k.  Am I correct in assuming that my predicates for this new medical device, C, are A and B?  Is it just as simple as making the intended use of C = A + B intended use? Please note that C will also have minimal functionality outside of A and B functionalities (mainly MDDS functionality).

Thanks!

If device C is also a SAMD, then yes, you can use A and B as the predicates for device C. One thing that may make it not quite "as simple as making the intended use of C = A + B intended use" is any interaction that A and B could have that affects their original validation. FDA will likely ask for Software Validation for device C.

Good Luck!

I agree with Mark that the FDA typically does not like multiple predicates. From the new 510(k) guidance, "FDA encourages manufacturers to identify a single predicate device to simplify and facilitate the decision-making process. When a manufacturer does identify multiple predicates, the primary predicate refers to the one with indications for use and technological characteristics most similar to the device under review. Although using a single predicate is optimal, when multiple predicates are appropriate (as described in the examples below), FDA recommends identifying a primary predicate in the submission to facilitate a timely, well-supported decision." However, it is acceptable to use multiple predicates, it just may make it a little more difficult. One aspect that makes it easier is if you are using all of predicate A and all of predicate B to make device C, instead of only aspects of A and B. This logic is more applicable for physical devices than SAMD, but Mark's assertion that the argument must be made logically and persuasively is correct.  

Why do you want to pursue this via a 510(k) instead of a De novo?

De Novos are intended for devices that have no predicate.  To me, there are clear predicates; ie. devices A and B. 

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Rene' Hardee
Regulatory Affairs Specialist III
Sun Nuclear Corporation
Melbourne FL
United States

OK, from your original question I had understood that you wanted to combine the devices via 510(k), rather than having determined that 510(k) was the only option open to you.

As I understand the discussion, there is no clear predicate for device C.  That is, neither device A nor B nor any other legally marketed device will serve as a suitable predicate, so there is no legally marketed device to which C is substantially equivalent.  For this reason, you would like to argue that two legally marketed devices together serve as a predicate.  That's not an unreasonable argument, IMO, but to me it's also clearly stretching the concept of a predicate, to the point that the argument that there is no predicate strikes me as equally valid.

There also seems to be a consensus that you might well be able to get FDA to accept your argument, but that this might not be easy.  If it isn't going to be easy, then a De novo might be a better choice.