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Medical Device - Bundled 510(k) for multiple intended uses - Page 2

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510(k), convenience kits (medical device), intended use (medical devices)
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  Post Number #9  
Old 7th May 2017, 08:35 AM
Frodeno

 
 
Total Posts: 17
Re: Medical Device - Bundled 510(k) for multiple intended uses

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

Last edited by Frodeno; 8th May 2017 at 03:15 AM.

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  Post Number #10  
Old 8th May 2017, 04:13 AM
image182

 
 
Total Posts: 24
Re: Medical Device - Bundled 510(k) for multiple intended uses

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).
  Post Number #11  
Old 8th May 2017, 05:35 AM
Frodeno

 
 
Total Posts: 17
Re: Medical Device - Bundled 510(k) for multiple intended uses

Thank you for your reply! this is really helpful. Just for clarification though, do you mean that the predicates must use the same regulation as each other or that each of the predicates must use the same regulation as each respective indications for the subject device ?
  Post Number #12  
Old 8th May 2017, 06:04 AM
image182

 
 
Total Posts: 24
Re: Medical Device - Bundled 510(k) for multiple intended uses

Both. All of the predicates and the subject device must all have the same regulation number. If they have the same regulation number they can be viewed as the same device type and therefore you can (supposedly) combine various indications for use into a singular device.
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