Medical Device - Bundled 510(k) for multiple intended uses

image182

Involved In Discussions
#1
Hi,

I have a question surrounding a bundled 510(k) for multiple intended uses which, as of yet, the FDA have been unable to answer.

Unfortunately I can't get into the specifics of what the product is so i'll have to resort to using examples to try to explain my situation.

We have one medical device. However, it is cleared under 3 different 510(k)'s each with a different product code and therefore a different intended use.

We want to launch a new device which has indications for use from all three devices.

Therefore the new device will:
  • Be physically identical to all three predicate 510(k) devices
  • Have specific indications for use from all three predicate 510(k) devices
  • Have three different product codes
  • As each product code is reviewed by a different "510(k) review panel" it will also be reviewed by three different FDA review panels.

So far I have gathered the following infomration

DICE stated that
  • a single device can have different product codes
  • we can't clear a device with three different product codes under a single 510(k) submission because there will be different intended uses.
  • they implied that a bundled submission may be appropriate

The bundling guidance document states that
  • It is possible to bundle multiple indications for use
  • Separate submissions are required if the device is required to be reviewed by multiple 510(k) review panels.

Based on this information I presume that we would need to pay for and submit multiple bundled 510(k) submissions (1 per each 510(k) review panel). Additionally within the bundled 510(k) submissions we would have three primary predicate devices?

Has anybody else had experience with a similar type of situation?

Thanks all

:thanx:
 

DCONN1

Starting to get Involved
#2
Hi image182,

I'm unaware of the nature or complexity of the component devices or the combined "new" device. However, is it possible that the "new" device would be classified as a convenience kit? It's my understanding that in such a case a new 510(k) would not be necessary. I can't post a link unfortunately but the relevant guidance is titled "Convenience Kits Interim Regulatory Guidance".
 

Marc

Retired Old Goat
Staff member
Admin
#3
If you want to put in a link, just put in something like example.com/whatever... One of us will make it into a "live" link. Limits on links by people with less than 10 posts is a spam control measure.
 

image182

Involved In Discussions
#4
Hi image182,

I'm unaware of the nature or complexity of the component devices or the combined "new" device. However, is it possible that the "new" device would be classified as a convenience kit? It's my understanding that in such a case a new 510(k) would not be necessary. I can't post a link unfortunately but the relevant guidance is titled "Convenience Kits Interim Regulatory Guidance".
Perhaps i'm bad at explaining! We have one device which has clearance for three different intended uses and product codes. However, we want to sell this device with indications for use from all three intended uses. So it would have three intended uses and presumably it would also have three primary predicate devices?
 

mihzago

Quite Involved in Discussions
#5
I may be bad in understanding, but do you already have the clearance or will you be submitting a new 510(k)?

how are you selling the device now?

are you combining the three intended uses into a new intended use? are your indications specific and are you trying to combine them into a general indications?

did you consider submitting a pre-sub? I never had a good luck with DICE providing a specific guidance.


P.S. if you already have the clearances, why can't you share the k-numbers, that way we may have a better idea what are you trying to do.
 

NicoleinFlorida

Inactive Registered Visitor
#6
Therefore the new device will:
  • Be physically identical to all three predicate 510(k) devices
  • Have specific indications for use from all three predicate 510(k) devices
  • Have three different product codes
  • As each product code is reviewed by a different "510(k) review panel" it will also be reviewed by three different FDA review panels.

Based on the information listed here. I think you will need to submit the application separately. Because it will require different review panels and three different predicate devices, and one single submission will not work in this way. But I will recommend to send your question to DICE help desk.
 

funkgirl

Starting to get Involved
#7
Hi! Curious as to how you proceeded with your project? I've been posed a similar question by my Marketing team about combining the labelling for our 2 separate clearances into a single product. No design changes, identical device with clearance for 2 different uses (a) treatment of 2nd degree burns and b) soft tissue reinforcement.

I don't think a new 510(k) would be warranted if we're not changing anything that's been cleared, we're just putting it all together in the same bucket. It's really just a labelling consolidation, but not sure how that would be viewed by FDA.
 

image182

Involved In Discussions
#8
We submitted a Qsub in the end to a more official response from the FDA on the matter.

We were told that if the indications of the predicate device have the same product code but a different regulation then we can't combine the indications for use into a singular device. All we would be able to do is submit 3 separate submissions to clear 3 identical devices with three separate indications for use.

But, if the indications of the predicate device have the same regulation but a different product code then confusingly we would be allowed to combine the indications for use into a singular device. We were told to submit this through a bundled 510(k). The FDA staff member stated that the instances we found where this had occurred were potentially mistakes by the FDA... However, as these devices are in existence we could potentially take advantage of this fact.
 

Frodeno

Starting to get Involved
#9
Hi There,

I found your post while looking for information on a similar question. Would you mind having a look at the following problem and giving your impression based on your own experience/Qsub:

We have a device that has four different indications and thus product codes that we are preparing a submission for. The different product codes are covered by three different review panels. We have selected four predicates, each one covering an indication and each one with the same product code and regulation as our device. All of the predicates and our device have the same technological characteristics.

When I read the Bundling guidance, it appeared that three different 510(k)s would be required given the different review panels. Based on your experience do you think this could still fall within a Bundled 510(k)? or is my example completely different to yours.

Any help would be greatly appreciated.

Thanks,

Frodo
 
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image182

Involved In Discussions
#10
From what I was told, you should be okay.

It's my current understanding that you can submit a bundled 510(k) and gain clearance for a device with multiple indications for use from different predicate devices, as long as the predicates have the same regulation (different product codes is okay).
 

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