How to Submit an Expansion of Claims 510(k)?

C

cookie36

#1
Hello,

I am thinking of writing a 510(k) that is purely an expansion of claims. This will not affect our indications for use, as our indications is general enough. My question are:

1) is there any format/guidelines on how to do this? Or, does it follow the typical 510(k) format?.
2) If it follows the typical 510(k) format, is it sufficient to submit simply a literature review (extensive) on the claims for evidence (ie. for lab/bench performance testing results)? Or, will an inhouse clinical study be required? (see background below)
3) Could this be submitted as a special 510(k) as I will not change the wording of the indications itself?

Please help! Thanks!

===================
Some background:
The device I work on is a large imaging medical device. Our current indications for use cover - "..disease states including, but not limited to applications in cardiology, neurology and oncology..". Granted, we mention "..not limited to" to keep our indications general - but we would like to be able to talk about applications in other areas such as: orthopedics, infection, and maybe also mention specific diseases in cardiology, neurology and oncology.

Is a literature review sufficient if additional diseases "claimed" is a widely adopted, well known application of our device?
 
Elsmar Forum Sponsor
C

cookie36

#5
Re: How to Submit a Claims 510(k)?

I guess my question is that, Has anybody done an "expansion of claims" 510(k) when you do NOT change the indications for use and/or using evidence that is purely literature review.

I have seen 510(k) summaries that are purely claims 510(k) but typically the "verification/validation" evidence actually consists of an in-house study. I am wondering if anybody has done it when there is NO in-house study.

The guideance documents arent very clear.
 
G

Gizmo Guru

#6
Hi, I'm confused by your statement that your firm wishes to "expand the claims" of your currently marketed device , but this will not require a change to your Indications for Use (IFU).

Your IFU states your claims. If you are making no changes to this, the materials, or the design of your device then you do not need to re-submit your 510(k). The only exception to this would be a change of labeling or a change in manufacturing/processing where you are using the identical Performance Criteria as those currently cleared. The latter would be appropriate for a Special 510(k).
 

Michael Malis

Quite Involved in Discussions
#7
Hello,

I am thinking of writing a 510(k) that is purely an expansion of claims. This will not affect our indications for use, as our indications is general enough...
it is a large imaging medical device.
Our current indications for use cover - "..disease states including, but not limited to applications in cardiology, neurology and oncology..". Granted, we mention "..not limited to" to keep our indications general - but we would like to be able to talk about applications in other areas such as: orthopedics, infection, and maybe also mention specific diseases in cardiology, neurology and oncology.

Is a literature review sufficient if additional diseases "claimed" is a widely adopted, well known application of our device?
Hello Cookie36,
Literature review will not be sufficient for wider claims!

You need to think about this from the FDA point of view - What proof do you have and plan to present to support these wider claims for your device?
Do you have any practical information of new applications that you plan to share?

Without this information you can have a number of issues with your 510k...

Regards,
Mike
 
Last edited:

Peter Selvey

Staff member
Super Moderator
#8
A 510(k) is formally based on "substantial equivalence", so technically the primary target is to prove that the intended purpose of your device is equivalent to an existing (predicate) device.

The regulation does allow for some variation, provided that those differences have no significant impact on safety. So, you could use your own device as the predicate device. To quote directly from 21CFR807.92:

If the indication statements are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled
This is different to the European approach, where substantial equivalence is important factor but the final target is to prove if the device is safe and effective, with a firm basis on real clinical data.

I think some of the responses above may be using the European thinking. It is worth to note that the European approach where clinical evidence is almost always required is not universally accepted, and there are arguments both for and against.
 
B

Bruce Banner

#9
You can and need to file a 510K to expand your claims. It will not be a special because the device is not changing. It will need to be a traditional.
 

Dramirez

Starting to get Involved
#10
Hi:

If your intention is to introduce new claims (referring to specific diseases areas of use) that will definitively impact your IFU. At the eyes of FDA, referring to specific diseases requires much more than literature review. You need to show that your device is actually safe and effective for the diagnosis/treatment of the "new" diseases.
 
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