Device Class when used in combination with a device of a higher class?

Hi - My name is Gary and this is my first post to Elsmar, though I've been lurking here nearly a year now. I've picked up a lot of valuable information here - its a great forum.

I seem to remember reading or hearing somewhere that in certain cases the class of a device is raised if it is intended to be used in combination with a device with a higher class.

I have a device that I'll call a "radio modem" that transmits physiological data from other medical devices. If my "radio modem" is to be used with a Class 3 device - it connects to it via a standard serial cable - does my device need to be class 3 as well? I could swear I read it in a guidance doc before but I can't find it now.

Can anyone help?

Re: Device Class when used in combination

An accessory for a classified "master" device may inherit the master device's class.

Sometimes, accessories for Class III devices are themselves Class II devices, because they function in such a way as to better meet that Class's definition. http://www.fda.gov/cdrh/devadvice/3132.html

Or, if that accessory can fit into a separate Product Code by itself without reference to the master device, and its use fits within the formal definition of "medical device", the marketer has the option of classifying it in that manner. There are about 5500 Product Codes at present.

A fourth option is that the product, by itself, may be clearly categorizable as not included within the formal definition of a medical device, in which case it isn't regulated as such.

If your product is sold independently, it probably needs its own freestanding regulatory context. I would assume you hope to find a way to achieve Class II, or even Class I, unclassified or non-device, status so as to make your marketing path easier and lower-cost.

We've seen a number of instances where an accessory to a major-$$$ Class II medical imaging system, usually sold by the maker of the major system, is slipstreamed into the overall 510(k) regulatory clearance of that system without a separate regulatory review of its own, and thereby is more easily marketed than would be the case if it were an independent product. Is there a way that your product could "piggyback" in such a manner on a "master-device" regulatory approval, if in fact it's an accessory of just one such product?

There are plenty of wireless data transmission techniques in use in various devices and systems. Does one of them provide a predicate context for you, and a precedent for a II or I classification?

Well I donot exactly know about your device. But if we have a pacemaker or pacemaker lead which is a class III device then the pacemaker programmer is also classified as Class III device.

Similary in EU, Programmers is classifed in AIMD devices (Impalantable), though that it is not implanted but works with a AIMD device

EU -- I meant for CE Mark in EU countries

From the mouth of the FDA Lead Investigator that was at a seminar I attended a couple weeks back: "A class II device used in a class III system is a class III device". She was pretty clear.

gholland said:

From the mouth of the FDA Lead Investigator that was at a seminar I attended a couple weeks back: "A class II device used in a class III system is a class III device".

Click to expand...

Was there a context to that? Is that entirely and exactly what she said?

If a device is already 510(k)ed into a Class II Product Code, and assuming no fraud, error or omission, there hasn't previously been a regulatory basis for the FDA changing that product's approved regulatory status based on a clinician's later decision of other devices or systems with which to use the device in question.

Thus on its face, without qualification, that statement would seem to represent a major change in FDA policy for devices with existing acceptance of premarket notification.

If on the other hand what she said in context was more along the line of "if you're deciding how your not-yet-classified device will be regulated, and it's intended to be used predominantly in a Class III system and has a risk-determinative function, expect it to be a class III device"...well, I know of approved situations at variance with that, but that's usually been true in the past.

The context was a discussion on 'if I have a device that is marketed as a Class II device and if it brought to my attention that it is used in a Class III device by a customer, does that change the classification?'

The skinny of the conversation was that if you know that your device (in our case an infusion pump) is used in a Class III setting (in our case used in a open heart surgery application) then FDA would consider it a Class III device. This should drive something like contraindications/labeling that the device is not intended as a Class III device if you don't intend it for use as a Class III.

Most end users (readers of labels) have no regulatory-technical knowledge of the significance of classification and the different product codes. Our understanding is that contraindications normally have to be specified in terms of procedures and conditions, i.e. consistently with the knowledge framework of the target audience for the labeling. In other words, you can't say "don't use this product in conjunction with any Class III devices or systems", because it's not meaningful to the targeted clinical users.

As far as I know, the statement in question as you explain it--that the FDA will regard an existing product classification via approved 510(k) as voided, and the device reclassified as a Class III, if end users decide to use the device procedurally in combination with a Class III device or system--amounts to a radical change in regulatory policy.

Certainly it could apply to us, since we market devices that have been Class II for 30 years, but could be used at any time by clinicians in conjunction with a Class III device or system.

Was there any mention that a policy-change statement would be forthcoming?

What did she have to say, once the FDA considers an approved-510(k)-Class II device to have become a Class III device, about the manufacturer's regulatory responsibility...such as responsibility for a PMA?

Reclassifying an existing device into Class III based on field use that isn't specifically encouraged by the manufacturer would be a pretty drastic change if it means a PMA obligation...given the typical >$150,000 cost of an average PMA.

The discussion was taking place in a Risk Management seminar and came up almost in passing. The comment was met with more then a few wide eyed stares as I'm sure you had when you first read it. :mg:

The Lead Investigator may have been reaching when she was stating these things. It sounded to me, and my colleagues, as if she was stating a long standing truth with FDA and that this was not 'new' ground and didn't go into much more detail.

I agree that the end user may not know what a 'Class III' device is but the Investigator certainly did make that leap.

She did not specifically say that you would be forced to submit a PMA for the device. She did state that if your company 'knows' that your device is being used in a class III device you are now responsible from a regulatory stand point for either bringing your device to class III status or having contraindications in place.

I cannot say that this is common knowledge as it was completely new to us. We work under the same understanding as you have outlined above. It certainly outlined a gap in understanding between this Investigator and the understanding in the industry as I could tell by the reaction in the room that everyone BUT the Investigator had your understanding.

I brought this to this particular thread because it would support what the original poster had heard and it may be worth it to bring it to FDA or your notified body for clarification. I know that I forwarded the information to my management as a 'this is what I heard from FDA today'.

Hmmm, I see I am not the only one now with these concerns. In my original post, I mentioned reading something that my poor memory tells me was guidance from FDA. Problem is, I cannot find it anymore. Perhaps it is something I googled and wasn't from FDA at all...

Anyway - if anyone knows of written guidance on this topic I am very interested. Thanks.