Design Verification for special 510(k) - Size modification to an existing medical device

D

drewsky1

#1
I am writing a Special 510k for a line extension for a size modification to an existing device. Some specifications that completed design verification for the predicate device really are not clinically necessary and were only for "nice to have". As these are not really applicable to the proposed device, do I need to include in the Special 510K?

Also, as this change is only to a new larger size which does not impact safety or effectiveness as the material is all that was validated for the predicate, can we just give a justification as to why design validation is not necessary?

Thanks
 
Elsmar Forum Sponsor
Y

yana prus

#3
Hi Mijenca,

I am writing a Special 510k for a line extension for a size modification to an existing device. Some specifications that completed design verification for the predicate device really are not clinically necessary and were only for "nice to have". As these are not really applicable to the proposed device, do I need to include in the Special 510K?
Based on your risk analysis results, you can present the verification activities results for the size modification only and to mention that the test methods used are the same as those submitted in the original submission.

I'm attaching the template for the Design Control Activities Summary for 510(k).

Are you sure there are no additional risks in this size modification? For example, in the case of strerile device when it's packaging is blister, there could be implications on the packaging validation for example.

Hope that helps,

Yana
 

Attachments

D

drewsky1

#4
Yana:
Thanks for responding. The packaging is the same packaging we are using for a similar product which is the same size. A pouch will be used. We are reassessing and think we may choose the letter to file path. Appreciate your input. So thrilled about this forum.
Regards,
Mijenca
 
Q

Quality96 - 2011

#6
Hi Mijenca,

If you are not significantly changing or modifying the design, components, method of manufacture, or intended use, and the change or modification does not significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process, then you may not require a 510(k), Special or otherwise.

If it was my decision, given your description of the issue, I would not submitt a 510(k), special or otherwise. I would of course adhere to all of the CFR 21 Part 820 requirements when introducing a new or modified medical device.

Best Regards,
 
Q

Quality96 - 2011

#8
I think that's the right descision. FYI: Offically, there is no such thing as a "Letter to File" according to the FDA. That's a hold over, old school thing. All you really need to do to comply with the FDA is follow the design controls described in CFR 820.30 and properly document everything properly.
 
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