Several sections of traditional 510(K) have the same or similar requirement of content.

[Ashley Fu]

I find there several sections in traditional 510(K) have the same or similar requirement of content between 510(k) summary, Executive summary/Predicate comparison, device description, and substantial equivalence discussion. Do they have a different focus? Why do we need to repeat contain these contents ? Such as a detailed comparison is needed in both 510(k) summary, Executive summary/Predicate comparison and substantial equivalence discussion. why is device description as a separate section through the description of the device has appealed in other sections ?

 

[Watchcat]

Can't speak to specific redundancies, but, as I understand it, frequently different parts of a submission will get distributed to different reviewers (e.g., biocompatibility testing to a biocompatibility expert) and it is helpful to these reviewers to have a summary of the submission, SE comparison, and a device description.

Also, not sure if this explains any of the specific redundancies you are talking about, but it might be useful to remember that the 510(k) summary is intended to be posted publicly, while the rest of the 510(k) is not.

 

[Ashley Fu]

Can't speak to specific redundancies, but, as I understand it, frequently different parts of a submission will get distributed to different reviewers (e.g., biocompatibility testing to a biocompatibility expert) and it is helpful to these reviewers to have a summary of the submission, SE comparison, and a device description.

Also, not sure if this explains any of the specific redundancies you are talking about, but it might be useful to remember that the 510(k) summary is intended to be posted publicly, while the rest of the 510(k) is not.

Maybe, I have thought it may be distributed to several reviewers and/or different sections have their own focal points and/or for filing information. Allright, what we need to do seems to prepare the materials according to the guidance.

 

[monoj mon]

510k Summary: for public viewing purpose, so only put the information which are not confidential. Although it needs to be in detail, but it does not have to be too much in detail (e.g. don't put test report number etc.)
Executive Summary: This is the first document which the reviewer(s) is(are) going to read to get a firm grip on your submission. So, make it a concise document (without too much explanation) along with reference to the respective sections, test reports where the reviewer(s) shall look for more details. Put a table of comparison between your device and predicate device, don't need a justification of similarities/differences.
Substantial Equivalence: This section shall contain all about comparison between the devices including justification for the similarities/differences. Don't need to describe your device in detail.
Device Description: Describe your device and its related process in as much detail as you can. Put pictures and drawings, make it all about your device and don't necessarily need to describe the predicate device.

In preparing these documents some information might be repeating which is normal.

 

[Ashley Fu]

510k Summary: for public viewing purpose, so only put the information which are not confidential. Although it needs to be in detail, but it does not have to be too much in detail (e.g. don't put test report number etc.)
Executive Summary: This is the first document which the reviewer(s) is(are) going to read to get a firm grip on your submission. So, make it a concise document (without too much explanation) along with reference to the respective sections, test reports where the reviewer(s) shall look for more details. Put a table of comparison between your device and predicate device, don't need a justification of similarities/differences.
Substantial Equivalence: This section shall contain all about comparison between the devices including justification for the similarities/differences. Don't need to describe your device in detail.
Device Description: Describe your device and its related process in as much detail as you can. Put pictures and drawings, make it all about your device and don't necessarily need to describe the predicate device.

In preparing these documents some information might be repeating which is normal.

Monoj, these generalizations summarize the highlights of each document. My thought become more clearer. Thanks you very much.