Meaning of "direct diagnosis" (Annex IX, Rule 10)

C

curzio.basso

#1
Hi everyone,

I'm looking for some clarification of the meaning of "direct diagnosis" as stated in Rule 10 of Annex IX.

The concrete situation is as follows: stand-alone sw that processes diagnostic images and modifies them, with the ultimate purpose of allowing diagnosis of a specific condition. Thus, it qualifies as medical device. It is an active MD with diagnostic purposes, but: my understanding of Rule 10 is that even if an active MD has a diagnostic purpose, it does not automatically fall under IIa unless one of the cases listed in the rule is true.

Hence my doubt on the "direct diagnosis". Does it mean that the use of the MD alone has to be sufficient to perform the diagnosis? In this case the sw at hand would not be IIa, since the processed images have to be viewed with another SW (e.g. PACS).

I'm going to ask my NB but I was wondering what are your thoughts...

thanks!

q.
 
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Marcelo

Inactive Registered Visitor
#2
You may take a look at the following documents:

- MEDDEV 2. 4

- MEDDEV 2.1/6

- FAQ on EN 62304:2006 (Annex 4 has a discussion on direct diagnosis)

Anyway, (and I don?t have the time to think about it now), if the software 1 process images from a Class IIa medical device, even if you need another software 2 for viewing, I would say that software 1 is also IIa, as the risks are, in principle, the same as the results of the class IIa device (I tend to think in those cases that the software is part of the diagnosing process).

The question on direct diagnosis happens because the classification was not created for software, so there?s a need to interpret them to software.
 
C

curzio.basso

#4
Thanks to both,

I had read all documents except the FAQ, and it seems that is what I was looking for.

Its Annex 4 states:

A device is considered to ?allow direct diagnosis? when it provides the diagnosis of the disease or condition by itself or when it provides decisive information for the diagnosis. Indicative information is not sufficient to imply a ?direct diagnosis?.
Which basically answers to my question.

thanks again!
 

Marcelo

Inactive Registered Visitor
#5
Thanks to both,

I had read all documents except the FAQ, and it seems that is what I was looking for.

Its Annex 4 states:

Quote:
A device is considered to ?allow direct diagnosis? when it provides the diagnosis of the disease or condition by itself or when it provides decisive information for the diagnosis. Indicative information is not sufficient to imply a ?direct diagnosis?.
Which basically answers to my question.

thanks again!
Please note that this Annex is an interpretation from COCIR, which is a meddev manufacturers association, so it does not mean that it will be accepted in principle (but you can obviously use it as a rationale).
 

c.mitch

Quite Involved in Discussions
#6
Hi curzo
I'd like to add that a PACS is not necessarily a viewer. A piece of software on the server side doing medical image processing is also a PACS.
Please take time to verify that your sw doesn't fall in any case in the borderline manual (document edited by EU Commission, so of higher precedence than the Cocir document).
Hope it helps
 

dgrainger

Trusted Information Resource
#7
If the software is modifying the data then it could be considered to be enhancing the image. The Borderline manual states - "Standalone software, e.g. software which is used for image enhancement is regarded as driving or influencing the use of a device and so falls automatically into the same class. Other standalone software, which is not regarded as driving or influencing the use of a device, is classified in its own right"
So if your software is modifying CT data it will be IIb. If the device can modify IVUS data it will be class III!
 
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