Is a new 510(k) needed? Add Non Medical Device into a Medical Device App

W

wangyang

#1
Hi all:

We are designing an apps which can measure some body signal such as the blood pressure, and i know we have to submit 510(k) because it is an accessory/part of the medical device. If we decide to measure other type of body signal by such apps, for example the body weight, and we all know that a device only measure the body weight which does claim any medical puepose will not be considered to be a medical device. Does such kind of design modification trigger a new 510(k)?

Any input will be appreciated.
 
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M

Mondo 22

#2
Hi,

This guidance document may be a good place to start - http: //www. fda. gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm265274.htm - DEAD (404) LINK DELINKED

Hope this helps,
Ray
 
Last edited by a moderator:
W

wangyang

#3
Thank you and i know that guidance document, and i just want someone who can give me any judgement and suggestion.
 
G

Gert Sorensen

#4
Hi all:

We are designing an apps which can measure some body signal such as the blood pressure, and i know we have to submit 510(k) because it is an accessory/part of the medical device. If we decide to measure other type of body signal by such apps, for example the body weight, and we all know that a device only measure the body weight which does claim any medical puepose will not be considered to be a medical device. Does such kind of design modification trigger a new 510(k)?

Any input will be appreciated.
Have a look at this guidance document:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

It is quite instructive, and should help you determine what you need to do.
:bigwave:
 

Michael Malis

Quite Involved in Discussions
#5
Hi all:

We are designing an apps which can measure some body signal such as the blood pressure, and i know we have to submit 510(k) because it is an accessory/part of the medical device. If we decide to measure other type of body signal by such apps, for example the body weight, and we all know that a device only measure the body weight which does claim any medical puepose will not be considered to be a medical device. Does such kind of design modification trigger a new 510(k)?

Any input will be appreciated.
Wangyang,

Don't look at this as "design modification", - look at this as different intended use of the medical device. And different "Intended use" will require a new 510(k)!

Regards,
Mike
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Wangyang,

Don't look at this as "design modification", - look at this as different intended use of the medical device. And different "Intended use" will require a new 510(k)!

Regards,
Mike
I'm not that sure that adding an intended use which is outside the Medical Device definition scope would constitute a new medical-device-intended-use. In other words, as far as medical device regulation is concerned, the regulated intended use may be unchanged; it may be just another (non-medical-device) use added to the same device. Would such a change significantly affect the existing medical device? Maybe, I'm not saying it won't; but that should be the subject of a design / functional analysis, the results of which are not that obvious to me. It could just end in a letter-to-file.
 

Michael Malis

Quite Involved in Discussions
#7
I'm not that sure that adding an intended use which is outside the Medical Device definition scope would constitute a new medical-device-intended-use. In other words, as far as medical device regulation is concerned, the regulated intended use may be unchanged; it may be just another (non-medical-device) use added to the same device. Would such a change significantly affect the existing medical device? Maybe, I'm not saying it won't; but that should be the subject of a design / functional analysis, the results of which are not that obvious to me. It could just end in a letter-to-file.
Ronen,

You maybe right! I took it as another medical device use, but we need more information to clarify if changes apply to medical device or not. Without this information, I can't be sure is new application is medical or not.
 

sagai

Quite Involved in Discussions
#8
I tend to agree with Mike.
We can do it even more simple.
Does the change involve any level of safety consideration?
However this can be answered with knowing exactly the intended use and indication of use of the device.

I think non medical device software are mostly software have non medical functionality, like remote access to the installed system, servicing related functionalities, but measuring body weight for me sounds obviously a medical functionality. Cheers!
 
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