Question re: Class II Medical Device Software - Label / Device Definition

W

WP_Regulatory

#1
Hi: I have two questions concerning medical device software:

1) The product in question is software, which is provided with a cart and monitor. The software itself allows clinicians to provide patient care by transmitting patient images from remote locations through the use of telecommunication lines and wireless communication infrastructure. The aspect of the device that makes it Class II is the software; therefore, is it appropriate to consider the software the device, and the other pieces of equipment accessories?

2) What kind of label should be included with the software to meet US label requirements? My thought is that this information should be on the initial splash screen, but I am struggling with whether the monitor and cart, etc., should also include a label specific to US label requirements.

Thanks in advance for any help!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi: I have two questions concerning medical device software:

1) The product in question is software, which is provided with a cart and monitor. The software itself allows clinicians to provide patient care by transmitting patient images from remote locations through the use of telecommunication lines and wireless communication infrastructure. The aspect of the device that makes it Class II is the software; therefore, is it appropriate to consider the software the device, and the other pieces of equipment accessories?

2) What kind of label should be included with the software to meet US label requirements? My thought is that this information should be on the initial splash screen, but I am struggling with whether the monitor and cart, etc., should also include a label specific to US label requirements.

Thanks in advance for any help!
Hello and welcome to the Cove :bigwave:

Is the software stand-alone, i.e. can it run (and is it supplied in a way that it can be installed) on an ordinary computer? Or is it "embedded" in you system (or a component of it)? Further, to meaningfully answer regulatory questions, it is quite important to have a complete description of the device / system. At the moment I understand that you provide a package that includes a software, a monitor, a cart, and some other type of console. Is that true? Are there other components? Which are essential for operation, and which are "nice to have"? Are all/some of the components "rigidly" connected together, or is it a rather modular system (phisically, electronically, functionally)? etc. etc.

It sounds that the software could be "the device" and the monitor and cart could be accessories. Please note that in the USA accessories to medical devices are classified and regulated under the same ProCode as the device which they are accessories to (execpt in specific few cases, where certain types of accessories have their own specific ProCodes).

If you sell the software and the accessories separately, each must comply with all applicable labeling requirements, on their own:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/
If, on the other hand, all the components are supplied as one system, which is the regulated object, one main set of labeling should suffice, with (as applicable) individual labels to address any requirements that can't be met via such a "central" set. If you intend to provide parts of the labeling in electronic format (e.g. some software screens etc.), pay attention to applicable requirements. Most of the labeling regulations and guidance are focused on hard labeling.

Cheers,
Ronen.
 
Last edited:
W

WP_Regulatory

#3
Hi Ronen:

Thanks so much for your fast and detailed reply. The software is installed on a laptop that is provided to the customer, with the cart and monitor. The only testing I see as being needed for this device is software V&V to support the 510(k); I do not see any other kind of performance testing that would be required.

The components are all sold together as the device - there will be an IFU and also a "label" on the splash screen when starting the program. But there are currently no plans for physical labels for the cart or monitor (or laptop).

Thanks again for your help.
 
I

isoalchemist

#4
You might want to take a look at the Medical Device Data System (MDDS) guidance, I think it was finalized, but I'm not 100%; based on what you stated earlier.

Also most "telecommunication carts" have 60601 certification or conformance statements associated with them. Don't know your system, but this safety evaluation should at least be considered.
 
W

WP_Regulatory

#5
Thanks; I did think of that. I need to check into the cart in more detail; it is not one that the software manufacturer designed, but it makes sense to determine what testing may have been performed on it previously by the company that does manufacture it. I will also check on the MDDS guidance.

Thanks again.
 
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