Demonstrating substantial equivalence - Requesting 510(k) data from company

[Matthias]

Hi there,

I have a question about how one acquires data to demonstrate the substantial equivalence of your device to the chosen predicate.

This quote from the 510k statement:
" I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any ..."
found in the FDA software review document.

This would seem to indicate that by submitting a device for 510k approval you agree to provide the non commercially sensitive parts of that document to any company that requests it for use in their substantial equivalence submission.

Do i understand this correctly?
In which case the normal process would be to identify a suitable predicate device and then contact the company responsible with a request for their 510k submission data, minus commercially sensitive portions of course.

Also, why is this statement only necessary in statement and not a summary, does this have an impact on ones obligation to make the data available to a third party?

Many thanks

Mat

[MIREGMGR]

In Reply to Parent Post by Matthias

This would seem to indicate that by submitting a device for 510k approval you agree to provide the non commercially sensitive parts of that document to any company that requests it for use in their substantial equivalence submission.

I think that's an overly broad interpretation. I wouldn't expect to get a significantly different level of information from the filer of a Statement-type 510(k) than you would see in the Summary filed with a 510(k) for a similar product.

[Matthias]

Thank you for the response.

I guess my confusion lies the the detail and volume of data one needs to submit to satisfactorily demonstrate substantial equivalence to a 510k review panel.

If you look at 510k summaries the most you get is a sentence saying; "out device x is very similar to their device y" and perhaps a comparison table with a list of device features.

Since you cannot establish:

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
  or
• has the same intended use as the predicate; and
• has different technological characteristics and the information submitted to FDA;
  • does not raise new questions of safety and effectiveness; and
  • demonstrates that the device is at least as safe and effective as the legally marketed device”

Then I am choosing to read some significance into the 510k statement which says:

......... The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information...................

So I can well imagine that what i receive will be greatly stripped down from the full 510k submission, but it should have a lot more detail than the 510k summary.

Am I correct in my assumption, and if not then how can one possibly demonstrate the device is at least as safe and effective as the legally marketed device?

Also, back to the question of statement and summaries; is only one type obligated to provide information, or are both types regadless of apparent wording?

Many thanks

[MIREGMGR]

In Reply to Parent Post by Matthias

So I can well imagine that what i receive will be greatly stripped down from the full 510k submission, but it should have a lot more detail than the 510k summary.

Am I correct in my assumption (

In my experience, no. Practically everyone considers providing any more information than the minimum required by regulation and established practice to be helpful to their present and future competitors...and of course your intent validates that obvious conclusion. The "trade secret" clause provides a justification for a minimum approach.

(...) if not then how can one possibly demonstrate the device is at least as safe and effective as the legally marketed device?

You are responsible for having a sufficient understanding of and experience with the predicate device to be able to provide objective information about it that you have gathered via your or others' efforts. This could include, for instance, obtaining a unit and investigating it or working with users of the device in the field.

Also, back to the question of statement and summaries; is only one type obligated to provide information, or are both types regadless of apparent wording?

The two approaches have theoretically equal requirements, except that the Summary approach's requirement is met at time of submission.

[Matthias]

Thank you again.

[Jodster24]

FYI-We were just contacted by a third party consultant requesting 510(k) minus sensitive information based on this clause given in our 510(k) statement. They gave advice to only submit as summary, as the safety and effectiveness information would have to be made available by FDA and not the applicant. I referenced this information on the FDA website as well.
Has anyone had to do this that can offer advice on how you have handled this situation?

[MIREGMGR]

We always submit a Summary, not a Statement, per http://www.fda.gov/MedicalDevices/De...651.htm#link_7. It's more work up front, but it allows less eventual disclosure.

Our understanding of the extent of information that is required in response to a Statement-additional-information request is (quoting the above-linked Guidance) "a copy of the 510(k) [with patient identifiers, trade secret and confidential information deleted]" (bold in the original). I see no obvious justification for exclusion of your safety and effectiveness data, unless for technical reasons it is impossible to effectively redact patient identification or trade-secret/confidential-information content out of it.

[Dramirez]

As MIREGMGR pointed you could get enough information to demonstrate substantial equivalence "working with users of the device in the field", also from the labeling material of the predicate and barely general technical information in the Summary or Statement.
Searching scientific literature could be beneficial (has worked for me). I don't think any company will voluntarily disclose sensitive data. The only other way to get more information would be trough a FOIA request but this usually takes to much time.
Using all this sources you should be able to demonstrate that:

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
  or
• has the same intended use as the predicate;
• has different technological characteristics and the information submitted to FDA;
  • does not raise new questions of safety and effectiveness; and
  • demonstrates that the device is at least as safe and effective as the legally marketed device”