Classification of Instrumentation Used to Place Implant

[ortho_engineer]

Hello, everyone - long time lurker, first time poster!

I am a development engineer at one of the "Big Five" orthopaedic companies. I am currently finishing a Master's degree in Regulatory and Clinical Affairs (Amazing how much better I am at my job now that I know a lot more about RA/CA), and right now I am working on a project to develop regulatory and clinical strategies to support a feasibility proposal recommending my company to pursue a new market sector (Spine).

Anyway, I've come across a tiny sticking point that I cannot seem to find an answer for - I've tried searching through these forums, FDA's website, FDAnews.com, and taken a shotgun-approach to Google...But I cannot find any definitive evidence either way. So my question to all of you out there is:

If I develop an instrument that is specifically designed to be used only during the implantation of a unique medical device, does that instrument's US classification default to the same class as said implant device? When I am at work doing real-world medical device engineering projects, I have always just included instrumentation in with the 510(k) and whatnot... So I am not real sure if this is just something I misinterpreted along the way, or if unique instrumentation used for the implantation of a specific device really are upclassified.

I've asked a regulatory specialist at work also, and she said they do default to the implant's classification - but she couldn't find any objective evidence to show the FDA's stance actually is that.... I can't post links yet, but the only thing I could find even mentioning it was a linkedin discussion that did not really get anywhere or cite sources.

Thanks for any guidance you can provide

 

[ascherp]

Hi,

We've encountered that situation several times in orthopedics and in other branches such as GU, ENT... and the FDA, as represented by 510(k) reviewers, branch chiefs, inspectors etc., has always confirmed that device-specific accessories are upclassified.

I'm not aware of any specific regulation that states it though. Maybe 21 CFR 870.9, Limitations of Exemptions? There it says that a device is not exempt if it "is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose".

An accessory designed specifically for use with a class 2 implant obviously has a different intended use than a similar device (forceps or whatever) belong to the same generic group of devices.

 

[Chrisx]

So, to follow this train of logic the instrument must now have a predicate. However, we have performed several 510(k)s and have not required to indicate predicate instruments. All of the various trials, rasps, inserters, drill guides, etc. work specifically with the implant. It does not seem that this is being applied consistently by FDA. I am not sure how any orthopedic company could comply.

 

[ascherp]

The "up-classified" accessory is not a device in its own right, but an accessory that is required for a specific device (implant) to achieve its function or intended use. As such, you wouldn't need a predicate device, since you're not comparing it with anything.

What you do need is to show what it does and how it works. Typically, you may require some sort of (bench) testing or discussion of its design in relation to the device it serves, which you can probably base on your design verification activities. Depending on the specific mechanism of use of the accessory, we've had to provide mechanical tests or a usability analysis. If it is something very simple and straight-forward to use, perhaps such as a special driver that is needed to lock the screws to the implant, a simple description or discussion of its design and use should suffice.