Software Library - could it be a medical device?

#1
Hi all!

Let's suppose that I want to build a software library whose main aim is to transfer data from a medical device to a mobile phone app.
The library will be embedded into the app.

Does the library become a Software as Medical Device (SaMD) even if its only aim is to move data from the medical device to the smartphone app?

Thank you in advance.
 
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John C. Abnet

Teacher, sensei, kennari
#2
Good day @zippo
ISO 13485 ; 3.11 defines medical device as follows...
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
  • — diagnosis, prevention, monitoring, treatment or alleviation of disease;
  • — diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
  • — investigation, replacement, modification, or support of the anatomy or of a physiological process;
  • — supporting or sustaining life;
  • — control of conception;
  • — disinfection of medical devices;
  • — providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others include: — disinfection substances; — aids for persons with disabilities; — devices incorporating animal and/or human tissues; — devices for in vitro fertilization or assisted reproduction technologies.

[SOURCE: GHTF/SG1/N071:2012, 5.1]

In short, it may depend on what data is included in your comment..."...aim is to transfer data ..."

Hope this helps.

Be well

J. Abnet
 
#3
Thank you John, it does help.

Aim to transfer data means that the library will facilitate the transfer of measurements (performed by the medical device) and will save them into the mobile phone via a smartphone app.

Given your previous definition and my further explanation, would you convene that the library IS NOT a medical device?
 

John C. Abnet

Teacher, sensei, kennari
#4
@zippo , I would indeed interpret (based on your description) that it is NOT a medical device. The logic is that your data is not making any recommendation (treatment) nor is it diagnosing or monitoring (such as a diabetes glucose meter).

If I understand correctly, your concept would simply make existing data available to the user.

Hope this helps.

Be well.
 

yodon

Staff member
Super Moderator
#5
When you say "library" I think that typically means software that does not stand on its own. For example, a math library might contain a square root function that you can call from your application. It sounds like your transfer software stands on its own so unless I'm misunderstanding, maybe "library" is not appropriate here.

Next, does the phone app require this data transfer software? If so, and the app is considered a device, maybe this becomes more of an accessory (which I think pushes it up into the 'device' category).

Will other applications use the transfer software?

The IMDRF (formerly GHTF) has a number of documents on SAMD. If you look at the one on risk categorization, you could make an argument that it might be, depending on what the phone app is doing.

It's a gray area. I can't argue with @John C. Abnet's logic unless the phone app can't run without the transfer software.
 
#6
@zippo , I would indeed interpret (based on your description) that it is NOT a medical device. The logic is that your data is not making any recommendation (treatment) nor is it diagnosing or monitoring (such as a diabetes glucose meter).

If I understand correctly, your concept would simply make existing data available to the user.

Hope this helps.

Be well.
Exactly, the data merely represents measurements taken from the device, thus, the library will make them available to the App ( the user will use the App and never the library itself).

When you say "library" I think that typically means software that does not stand on its own. For example, a math library might contain a square root function that you can call from your application. It sounds like your transfer software stands on its own so unless I'm misunderstanding, maybe "library" is not appropriate here.
Yes indeed, the library does not stand on its own, it will be called from the application using it.

The IMDRF (formerly GHTF) has a number of documents on SAMD. [removed link because the forum doesn't allow me to post links yet] depending on what the phone app is doing.
Thanks for the link.
The scope of the phone app is not in my scope and it has yet to be defined. If the phone app turns out to be SaMD I guess that they will have to apply their own controls as per current regulations.

I really appreciate your inputs (feel free to add more).
 
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