Additional Intended Use Predicate

G

gathagmador

#1
I have a implantable device which was 510k cleared a couple of years ago. I just submitted and had cleared a 510k modification to that same device using the previously cleared device as my predicate. Now I want to submit an abbreviated 510k to add an additional intended use to the same devices mentioned above. My question is. Can I use my 2 already cleared device as my predicates, or should I use other cleared devices by different manufacturers with the exact intended use. Note: Other cleared device have 3 intended uses stated. my device has 2 of the same 3. I am adding the 3rd use which will be identical at that point to the other manufacturer intended use.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Addional Intended Use Predicate

Hi,

In my understanding the predicate has to have the same intended use, so you'll have to utilize something different from your own cleared devices.

I'm not sure how your intention to submit an abbreviated 510(k) is related, or why you chose this path. Are you going to rely on recognized standards?

Either way, good luck!
Ronen.
 
Last edited:
G

gathagmador

#3
Thank you for the reply. Do you think I should go another route other than an a abbreviated 510k? I am going to rely on recognized standards such as EMC 60601... testing since this is a electrical device, as well as 10993... Biocompatibility since its implantable. Once again do you think I should go a different route?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thank you for the reply. Do you think I should go another route other than an a abbreviated 510k? I am going to rely on recognized standards such as EMC 60601... testing since this is a electrical device, as well as 10993... Biocompatibility since its implantable. Once again do you think I should go a different route?
Hi,

Please note that you can rely on mainstream recognized standards (such as 60601, 10993 etc.) to support a traditional 510(k) as well. I don't want to make strong recommendations as I don't have a lot of experience with abbreviated 510(k)'s, but my gut feeling was always that the "abbreviated" route does not provide a significant abbreviation... :lol: It may expedite the review process but then again it can take more time and work to prepare, hence the overall benefit would be questionable. You should preferably closely look at all options and make a rational decision.

I hope you get my point.

Cheers,
Ronen.
 
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