Executive summary for Traditional 510(k)

Timothea

Involved In Discussions
#1
Hi, I hope somebody could help me solve my dilemma.

We are currently preparing 510(k) Traditional submission and I have a checklist and content of the submission. In some documents, and on some blogs, I've seen executive summary being mentioned. The thing that puzzles me the most is that it is essentially the same like the 510(k) summary. So, my question is - is it still necessary to write an executive summary or it is something that has been used previously and it is not applicable anymore?

I remember sending out the Special few months ago and we didn't send the executive summary.

Thanks in advance.
Cheers!
 
#2
We completed a traditional 510k last year.

We tried to 'go by the book' to smooth our path - that is we tried to match our submission exactly to guidance documents.
It had separate sections titled 'Summary' and 'Executive Summary', although they are pretty similar.

Note that your submission is likely to be 'split up' that is different sections will go to different desks, so some repetition may assist this process.

Note also, the section called 'Summary' will be the part that is copied to the publically available 510k database. Checking on what your chosen predicate has published there should give you an idea of what is needed (particularly if your predicate is reasonably modern).
 

Timothea

Involved In Discussions
#3
We completed a traditional 510k last year.

We tried to 'go by the book' to smooth our path - that is we tried to match our submission exactly to guidance documents.
It had separate sections titled 'Summary' and 'Executive Summary', although they are pretty similar.

Note that your submission is likely to be 'split up' that is different sections will go to different desks, so some repetition may assist this process.

Note also, the section called 'Summary' will be the part that is copied to the publically available 510k database. Checking on what your chosen predicate has published there should give you an idea of what is needed (particularly if your predicate is reasonably modern).
Thanks for the answer!
We are trying to do the same thing - do everything according to the checklist and guidance to avoid even minor bumps on the road. However, this one bothered me since it is virtually the same thing (more modern summaries have all the sections of the executive, even the depth).
I'm aware that summary goes public after the clearance, but I just wanted to have some kind confirmation of my thinking.
All the best.
 

katiesam

Starting to get Involved
#4
We gained 510k clearance last year. Our submission had a Summary section, which gave very basic information (being that it is made public) and an executive summary. This was a longer section which included the device's intended use and function (I included an image of the product here), along with summary comparisons in respect of technical characteristics, biocompatibility and performance testing. I also discussed any differences between our device and the predicate.
Our submission went straight through without any issues.
 

Timothea

Involved In Discussions
#5
We gained 510k clearance last year. Our submission had a Summary section, which gave very basic information (being that it is made public) and an executive summary. This was a longer section which included the device's intended use and function (I included an image of the product here), along with summary comparisons in respect of technical characteristics, biocompatibility and performance testing. I also discussed any differences between our device and the predicate.
Our submission went straight through without any issues.
Katiesam, thanks for the advice. I hope we will go through without any problem as yours did!
 

katiesam

Starting to get Involved
#6
Katiesam, thanks for the advice. I hope we will go through without any problem as yours did!
It sounds like you have been very thorough. The best advice we had was to make sure that in reading all the documents the lead reviewer would be able to sleep at night knowing that the device was as safe and effective as the predicate. Our submission contained so many summary tables and images, schematics etc. probably more than necessary but it was worth it to get through in the 90 days.
We did go to interactive review and were questioned on one aspect, but we sent back a one paragraph answer which was sufficient. This didn't hold up the process at all and it is always good to realise that there are real people at the other end! We have only had positive experiences with the FDA so far. I am still waiting for an answer on my query about extending the scope of the indications for use, but have had another email to say that they haven't forgotten. It will become the responsibility of another division so that is the hold up in the answer.
Best of luck with your submission. :)
 

Timothea

Involved In Discussions
#7
It sounds like you have been very thorough. The best advice we had was to make sure that in reading all the documents the lead reviewer would be able to sleep at night knowing that the device was as safe and effective as the predicate. Our submission contained so many summary tables and images, schematics etc. probably more than necessary but it was worth it to get through in the 90 days.
We did go to interactive review and were questioned on one aspect, but we sent back a one paragraph answer which was sufficient. This didn't hold up the process at all and it is always good to realise that there are real people at the other end! We have only had positive experiences with the FDA so far. I am still waiting for an answer on my query about extending the scope of the indications for use, but have had another email to say that they haven't forgotten. It will become the responsibility of another division so that is the hold up in the answer.
Best of luck with your submission. :)
Yes, it does really help to know that there are some nice reviewers. We had luck with ours on our last Special 510(k). And I really respect this aspect of communication through e-mails, because it is so much easier to get a piece of information. Thanks again. :)
 

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