Can a Predicate device be a higher class?

When selecting predicate devices for 510k submissions, can the predicate device be a higher class than the device the submission is being done for?

Yes, but you'll have to explain to the examiner's satisfaction how and why that's the case.

I'm not sure this is true. I was trained by CDRH as a 3rd party reviewer. Their training to me was that a 510(k) must establish equivalence to a predicate that does not require a PMA. Consequently, a class III device could not be used as a predicate unless it has been reclassified. There are a few class I devices that require 510(k), so in this case you could use a class II device as a predicate.

I double checked against the regulation. To my surprise, 21CFR807.87 does have some provisions for using class III devices as predicates. I suggest reading it closely. I would not recommend this course of action, I think it is hard road to follow.

Brrrrr ....
For me the predicate device (if there is only one) should be in the same CFR as well as in a same product code to make your life easy.
And this inherently exclude to have a predicate higher than the class you are already in.
Cheers!

The point I was making, maybe without expressing it thoroughly enough, is that if the predicate candidate was cleared as Class III, then either there must have been a re-classification that you will have to point the examiner to, or you have applied a complicated classification analysis that you certainly will have to explain. That particularly will be the case if your application attempts to claim multiple predicates...for instance, one for function 1, another for function 2, a third for material, and so forth. My understanding is that FDA strongly frowns on multiple-predicate applications, but that such applications can be cleared when FDA agrees that that approach is unavoidable.

A full explanation of predicate complexity is at http://www.fda.gov/MedicalDevices/D...sions/PremarketNotification510k/ucm134571.htm.

Actually I agree all the words you had, I am challenging only the amount of common sense may involved by FDA at the review.

Thanks for the responses.

The device itself is a dental mouth mirror anti-fog solution (Regulation #872.4565 product code EAX, Accessory to Dental Mouth Mirror is what I figured).

Of similar devices that are being sold on the market, of those that are even listed with the FDA, they have been listed as Anti-Fog Solutions for Endoscopes (Example: a product called DeeFog, Reg #876.1500 Product Code KOG), which then also makes it a Class II device instead of Class I, even though it is being sold for mouth mirrors.

So the product is the same, the intent is the same, what is different is that it has been listed to be used on a different device.

Sheppi76 said:

...So the product is the same, the intent is the same, what is different is that it has been listed to be used on a different device.

Click to expand...

???

If it is "listed to be used on a different device" (= intended to be used with a different device) then the intent is NOT the same.

***

The way I understand the mechanism behind part 807 / 510(k) clearance, the submitter is suggesting classification under a certain 3-letter product code (which effects a specific regulation and thus the class I/II classification as well). That code is the predicate's code. A "SE" decision signifies that the FDA concurs with the code suggested by the submitter, therefore not only enabling market clearance of the device but also officially placeing it under that 3-letter code, the associated regulation and the associated class. So I find it a bit challenging to understand how all that would work with a predicate from a different 3-letter code, let alone from a higher class.

I realize that the above may be less applicable when multiple predicates (from multiple codes) are necessary, but that would be the (rather rare) exception, and as such would probably call for special reviewer consideration anyway.

My employer has one 510(k), that I wrote, for which the predicate had a different classification (ProCode) than the requested/approved classification of the submitted device. I've heard of other similar instances.

There are a number of device types for which more than one ProCode can apply, for FDA legacy reasons. Most of these are exempt, but some require a 510(k).

(In at least one interesting instance involving microscope drapes, it's possible by precedent to classify either as exempt or non-exempt. In the early days when classification decisions were made by the 19 modality committees, two devices were submitted for classification, and they went to separate committees because those committees also have overlapping and vague scope-definitions...and one decided exempt, the other non-exempt, and no one caught the conflict. And, it still exists.)

In my experience, a 510(k) examiner normally considers the predicate as a device, and is willing to accept the proposed ProCode for the submitted device as long as the predicate could have been classified per that ProCode, whether it in fact was classified that way or with another overlapping ProCode.