Hello,
This can be confusing because indeed while you are writing the submission often times the content in Section 5, Section 10, and Section 12 (and even Section 11) often are quite the same. How we like to separate these sections out is including the information in the following sections:
- Section 5, 510(k) Summary (or 510(k) Statement though we never use Statement because too much of a pain if a request is made): This is the actual 510(k) Summary, the document that gets loaded up onto the FDA's 510(k) database. it includes information like device description, regulatory description, predicate device, predicate device comparison (a table), and summary of the (bench) performance and any clinical performance testing done. As mentioned this is a public document, so you will want to write this accordingly. We always use the content of Section 10 and 12 and "pear it down" meaning we take out proprietary information, confidential information, or other non-essential information. As an example, in Section 12 SE comparison table we may specific 302SS anodised with such and such, but in Section 5 SE comparison table, we just put stainless steel.
- Section 10, Executive Summary: This often has a lot of repeat information from Section 5 and Section 12, but also includes much more information if required. As an example, if there was a Q-Submission done all of this information is included here. If there are reference devices used or marketing history or previous generations of the device needing to be explained, this is done in this section. We do provide a comparison table between the subject device and predicate device, but do not have a column for why there is no differences - this is kept for Section 12. If we use any reference devices, this is where we discuss this in much more detail than Section 12. This section also should be used if you had submitted a previous 510(k) which was withdrawn or cancelled. You should go point-by-point on how all the deficiencies in the previous submission have been addressed. So yes, there is a reason Section 10 is used, because having Q-Submissions, IDEs, or previous submissions withdrawn, this is the place and opportunity to describe how this 510(k) addresses all those points !
- Section 12, Substantial Equivalence Discussion: To continue we do not want Section 12 to get "convoluted" with lots of unnecessary information. We may have a very short discussion on reference devices we use, but the majority of the section is the SE comparison table where we compare the subject device and predicate device - with now a column supporting any differences between the device and an explanation of why there is no additional questions of safety or efficacy. As mentioned, we do put the SE comparison table in Section 5, but it definitely is summarised and confidential/proprietary information removed.
Hopefully that helps, while there is some redundancy in the information presented in these different sections, there are reasons for each of these sections. The biggest thing to make sure is the information between the sections is consistent, i.e. the indications for use statement is the same between the sections. If the device is a well recognised device, been on the market for a long time, often Section 5, 10, and 12 become an exercise in cut and paste ! However, for complicated devices or new technology introduced into existing devices, Section 10 and Section 12 do have necessary information there.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Sep-2020 00:27
From: Shilpa Pillai
Subject: 510k summary vs. executive summary vs. substantial equivalence discussion sections
Hi
For Section 12 :Substantial Equivalence; Run it through the SE determination flowchart in Appendix A of the guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" https://www.fda.gov/media/82395/download
Compare your device to the predicate using both narrative as well as a tabular format (Similarities and Differences). Detailed comparison between device and predicate
sufficient to demonstrate the substantial equivalence of the devices that explains the below;
- Indications for use
- Technology
- Performance specifications including any testing
Section 5 : Could be either a summary or a statement . Refer to the link for details https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k#link_7
( Other useful links " Format for Traditional and Abbreviated 510(k)s" https://www.fda.gov/media/130647/download )
Hope this helps!
Best
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Shilpa Pillai
Naperville IL
United States
Original Message:
Sent: 21-Sep-2020 05:34
From: Anonymous Member
Subject: 510k summary vs. executive summary vs. substantial equivalence discussion sections
This message was posted by a user wishing to remain anonymous
Hi all,
I am trying to create my own 510k template following the FDA guidance on 510k format. I am not sure I get the difference between sections 5, 11 and 12 of the 510k:
5) 510(k) Summary
11) Executive Summary/Predicate Comparison
12) Substantial Equivalence Discussion
I understand that section 5 is the summary that will be publicly available to competitors in the FDA database. I understand what should go in the section 11.SE discussion, i.e., a tabular comparison of technological characteristics and a discussion of the differences.
What about section 12. Executive summary/Predicate comparison? Isn't this a duplicate of section 5 and section 12? What is the scope of such a chapter? The description in the guidance sounds very similar to what goes in section 12.
Thanks for your help.
Best