510k Predicates with different Intended Use

M

mr.mike

#1
Hi Everyone,

I'm wondering if it's possible to select predicate devices in a different use-category, only as they pertain to demonstrating the safety of a specific element/feature of the device being approved.

Consider the following (hypothetical) example:
I am developing a new knee-brace.
Its main differences from the competition is that it uses a special cotton liner, and the hinges are a new type of metal.

So, the potential risks might relate to biocompatibility of the cotton, and strength of the metal.

I can't use another knee-brace as predicate, because none on the market use either of these materials. BUT: there are band-aids that use the cotton, and crutches that use the metal.

Obviously, band-aids and crutches have totally different intended uses from knee-braces. However, with respect to the risks associated with the materials, these do demonstrate a history of safe use (biocompatibility wrt the cotton, and strength wrt the metal).

...long winded example, I know. But I think it illustrates the point. Technologies can be used in devices with completely different categorization/uses, but still serve the same function. In such cases, is it possible to select predicates outside the intended-use of the device in question?

Thanks,
MM
 
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M

mr.mike

#2
Ok, I think I've found an answer.

The FDA distinguishes between a Reference Device (as in the example above), as opposed to a Predicate Device (must have same indications for use).

The explanation is given in the following FDA guidance document:
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
(See page 12).

I'm still curious how common this is to do in practice. It would seem that a given device (especially one employing several technologies) could have a lot of potential "Reference Devices".

Is is common to include a lot of Reference Devices in a 510k submission?
 

yodon

Staff member
Super Moderator
#4
I think you sorted out your answer but I think you may have confused a few things getting there. Your device is a knee brace and so the intended use is support of the knee. You would show equivalence in efficacy to a comparable knee brace.

Skin-contacting materials need to be biocompatible and your risk assessment would need to address this but unless there's some efficacy-related aspect to the materials, I don't think materials would be the main consideration in determining (effectiveness) equivalency.
 
I

isoalchemist

#5
I agree with Yodon, regardless of the materials the intended use is to support the knee. You need to show that your product supports the knee as well as the predicate.

You will also need to demonstate that the material uesd will not have a biocompatibility issue.
 
M

MIREGMGR

#6
I agree with the analyses above. The fact that a prior knee brace may have used a different liner material is not likely to constitute a functional question, unless there is a significant distinction between the amount of cushioning, firmness, perspiration wicking, cleanability, or some other relevant performance parameter.

With regard to the predicate device vs. reference device question, this to some extent is a terminology issue, and not substantially important.

The predicate device must have substantially the same intended use. You could present a multi-predicate approach when one of your predicates is a knee brace that uses the same hinge approach...though not necessarily the same materials...and another predicate uses the same cushioning approach...though not necessarily the same materials.

You probably could not present a multi-predicate approach where some of the predicates are unrelated to knee braces, but use the same materials. The key is the same device intended use or functionality, not the same materials.

FDA does not like a 510(k) to identify two predicate devices, each of which is relevant to part of the submitted device's functionality, because this complicates the clearance process.

They however do recognize that that approach sometimes is needed.

And, they've cleared 510(k)s in the past with multiple predicates for this reason.
 
Last edited by a moderator:

JeantheBigone

Quite Involved in Discussions
#7
If it were me I would use the knee brace as the predicate device since the knee brace will have the same product code as your device. Focus on the intended use, safety and performance.

To document the safety of the materials used which are different from those used in the PD, you would use the reference devices. Just make sure you list them clearly and differentiate.

I think that reference devices are underused in 510(k)s as submitters tend to try to use multiple predicates and many are not aware of the reference device option.
 
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