Is my software an accessory? Telecommunication between HCP and patients

Cali_Kitson

Starting to get Involved
#1
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

Hey all, looking for some opinions on a point of contention.

Our software's intended use is for telecommunication between HCP and patients. However it also allows images from our camera device to be viewed and captured. Our hardware can be used with any old tablet, laptop or computer, however it is supplied with an accessory - a docking case integrated with a tablet, which is loaded with our software.

As the software does not "specifically" enable the device to be used, are we safe to say it is not an accessory?

Please fire away with your opinions.
 
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Cali_Kitson

Starting to get Involved
#3
Hi @shimonv, thanks for your reply!

The device is a handheld endoscope. The device can function without the software, but they are packaged together. The software does not modify the information captured by the camera in anyway.
 

shimonv

Trusted Information Resource
#4
Okay, I don't know enough about it, but it seems you could argue that you software is like a carrying case for the endoscope; it provides secondary services that are not essential for the primary use of the device.
I assume you are heading this way because you would like to classify it separately, and hopefully as class I.

Good luck.
Shimon
 

Cali_Kitson

Starting to get Involved
#5
Thanks Shimon.

Our interpretation of the guidance would lead us to believe that this would not be classified as a stand-alone medical device (SAMD) under the MDR.

The software will become a SAMD in the future (2/3 years down the line), as it will feature diagnostic functions. However, at this point, we are trying to avoid classification as an accessory to prevent unnecessary work whilst we are extremely busy!
 

yodon

Staff member
Super Moderator
#6
Does the tablet (via the software) hold the images taken by the endoscope? Do the HCPs collect any data about the case on the tablet / with your software? How are the communications between HCP and patient facilitated by your software and does it hold those communications?

Given the limited info, it's, as @shimonv says, hard to say for sure but, to me, it sounds more like it IS a SaMD (not an accessory).
 

Cali_Kitson

Starting to get Involved
#7
Thanks for this @yodon - you're input is much appreciated.

The software captures the images taken by the endoscope and they are held in the cloud.

HCPs do not collect any data about the case with the software.

The software allows real time communication between users of the application but those communications are not stored - neither in the cloud or on the tablet (it is just like Skype with a UI geared towards healthcare).

We used the following guidance to make the decision around the software and whether it is classified as an SaMD... https://assets.publishing.service.g.../890025/Software_flow_chart_Ed_1-06_FINAL.pdf
 

yodon

Staff member
Super Moderator
#8
It's a gray area. I know that PACS (Picture Archiving and Communication Systems) are regulated in the US.

In the IMDRF document "SaMD: Possible Framework..." in the examples section in the appendix, they state:

Software that is connected to a hardware medical device but is not needed by that hardware medical device to achieve its intended medical purpose is SaMD and not an accessory to the hardware medical device. For example, software that allows a commercially available smartphone to view images for diagnostic purposes obtained from a magnetic resonance imaging (MRI) medical device is SaMD and not an accessory to MRI medical device.

I guess it all depends on claims. I tend to suggest the conservative route.

If, as you say, you do intend to market the software as a device in the future, you'd probably be well-served by at least doing the development now under 62304. And since you say it will provide diagnosis, that raises the bar considerably.
 

Cali_Kitson

Starting to get Involved
#9
I am also risk-averse @yodon, therefore totally agreed development under 62304 must be adapted sooner rather than later.

The guidance you sent has thrown me off even more! The example in the appendix seems to relate very closely to our situation.
 
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