Is a new 510k needed if modifying to add bluetooth for data transmission?

[PL.]

Hi,

We have a cleared blood pressure monitor, and we intend to add a Bluetooth function to it (for data transmission) and we also develop a iOS APP for it (as to manage the data from the monitor).
(1) I?m not sure whether should we submit a new 510k or not (after referring to the guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device)?
(2) And, if a new 510k is needed, should it be a traditional or a special?


Can anyone give me a piece of advice?

 

[isoalchemist]

I believe a new 510k would be required at first glance based on Chart B. You have an operating principal change, you are now transmitting the data. You have a SW/FW change that may depending on your system affect the indication for use. Additionally You will need to verify and validate the Bluetooth signal for Safety & Effeteness.

A better understanding of your product might change my thought process, but right now you have some paperwork ahead of you IMHO.

 

[snowball852]

I agree that a new 510(k) would be required. I also think FDA would consider it a traditional as I think they would consider the bluetooth new technology added to the current device. HOwever, if you are into taking risks, you could submit as a special and plan to have the reports ready when/if they come back with a conversion to a traditional. You would probably only lose a couple of weeks if they convert it. But, the upside is that if they accept it as a special, then you get a quicker approval.

 

[RansomEli]

I agree with the previous posts - you need a new 510(k).

A couple bits of advice: make sure you produce a detailed risk assessment that shows you have seriously analyzed all the potential hazards of your devices. Then, make sure you have a very well-written (and executed) software test plan. The extra preparation time you spend in these areas will be well rewarded.

 

[PL.]

Thanks for the advice!! It helps!

But, I found out that we have a cleared device that has a bluetooth fuction, and the modification to the device is:

deleting data managing fuction (like averaging results) of the cleared device itself and creating a iOS APP for it to manage the data. (please note that the modified device can work without the APP)

In this case, is a new 510k needed?

 

[sagai]

My opinion is that this Bluetooth stuff explodes a bunch of safety questions and looks obvious at least for me a new 510k.
Nevertheless there is another apps for iphone, so it is really drifting this to a new 510k.
Let's make it simple ...
Is this modification changes the intended use of your original 510k?

In doubts, I would not hesitate to pick up and call FDA's small manufacturer's hot line for free of charge.

Regards

 

[PL.]

Hi, sagai
thanks for the response!
The APP is actually developed to replace the original data management function (the original data management function is deleted and the APP is employed). In this regard, the intended use is not changed.

And, I've tried to consult DSMICA, but they refer me to the guidance: when to submit a new 510k anyway...

 

[Ronen E]

The new app might be considered a new medical device in its own right >>> look at the new FDA guidance applicable to apps.

The fact that you have another cleared device with Blue Tooth functionality is less relevant for the decision whether or not the monitor's change requires a new submission. However, if this monitor we're discussing already has it, then it may not require a 510(k) after all - depending on whether or not the change would raise new questions regarding safety and effectiveness (be careful when answering). If it does require a 510(k) I'd say it'd be a special 510(k).

Cheers,
Ronen.

 

[PL.]

Hi, Ronen

Do you mean that,
when it comes to making decision of whether or not to submit a new 510k of the monitor, we do not have to take the APP into consideration, because the APP should be another medical device itself?

And, you mentioned there is a new FDA guidance on apps, could you kindly tell which one is that? (as I can only find the draft released in 2011: Draft Guidance for Industry and Foodand Drug Administration Staff: MobileMedical Applications)

 

[Ronen E]

Do you mean that,
when it comes to making decision of whether or not to submit a new 510k of the monitor, we do not have to take the APP into consideration, because the APP should be another medical device itself?

I mean that you first have to consider the bigger picture. My gut feeling is that the app might be a separate device. I didn't check it in detail. If, after reviewing the details and the applicable guidance, you come to the same conclusion, it might bear on how you handle the change in the monitor.

And, you mentioned there is a new FDA guidance on apps, could you kindly tell which one is that? (as I can only find the draft released in 2011: Draft Guidance for Industry and Foodand Drug Administration Staff: MobileMedical Applications)

Perhaps I shouldn't have used the word "new". Everything is relative...