Can this device without tolerances be used as a predicate for our 510(k)?

franklymissshankly

Starting to get Involved
#1
My company got a 510(k) clearance for a class IIa device, X, a few years ago. For some reason, they never provided the FDA with any tolerances for the technical specifications of our device like frequency, average power etc. We have established tolerances for each specification that we use for manufacturing, batch testing etc. but they were never provided in the 510(k).
We now want to use X as a predicate for our new device Y. Y has technical specifications that fall within the tolerances we established for device X and hence we want to use X as a predicate. Is it acceptable to do so if we provide the tolerances in the new 510(k)? Does anybody have any insight on this? Thanks so much
 
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yodon

Leader
Super Moderator
#2
Not an expert here but maybe this gets the discussion going.

As far as I know, any cleared device is eligible to be identified as a predicate. You have to show substantial equivalence.

Pre-subs with FDA are good at giving you some level of confidence that you're on the right path.
 

Ronen E

Problem Solver
Moderator
#3
My company got a 510(k) clearance for a class IIa device, X, a few years ago. For some reason, they never provided the FDA with any tolerances for the technical specifications of our device like frequency, average power etc. We have established tolerances for each specification that we use for manufacturing, batch testing etc. but they were never provided in the 510(k).
We now want to use X as a predicate for our new device Y. Y has technical specifications that fall within the tolerances we established for device X and hence we want to use X as a predicate. Is it acceptable to do so if we provide the tolerances in the new 510(k)? Does anybody have any insight on this? Thanks so much
I don't see any issues (based on the very limited info provided here) with using X as a predicate for Y. Further, I would use X's submission as a baseline template for Y's submission, and wouldn't add ANYTHING that wasn't in X's submission unless there's a clear requirement for that in current guidance on 510k contents (make sure to review your draft submission against all current relevant guidance, including eCopy, RTA etc.). Why open a can of worms if you can leave the worms nice and warm in the can?...

I agree that Q-subs ("pre-subs") are a powerful tool, but keep in mind they take time to sort out. Additionally, I would think long and hard whether one is really necessary, because once out the worms are hard to put back in the can.
 

ChrisM

Involved In Discussions
#4
I agree with Ronen, provide information in the same format and see whether or not you get a remark about tolerancing on technical specifications. If none is received, great. If it is queried, don't make any remark about "well, we didn't provide it for the predicate device", just respond to what is requested.
 
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