Computer-Aided Detection for Mammography - Class A, B or C?

X

Xanew

#1
Hello,

how i can classify according to the IEC 62304, a software that manages information supporting the diagnosis?
A software failure can mislead the doctor's judgment and lead to misdiagnosis. The medical device is not intended to diagnose, but to help the physician to determine who is mostly definitely healthy, so as to avoid unnecessary additional examinations.
I might classify it belonging to class b, because a software failure does not have a direct impact on patient health, as might be the software that controls an arm surgical, but indirectly as a result of its use by an inexperienced doctor, who may leave affect oneself by the medical device.
What do you think?
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

c.mitch

Quite Involved in Discussions
#3
Hi,

From my own experience, image processing or post-processing software that is a help for diagnosis, is usually in class B. This classification was accepted by auditors of CE mark and FDA reviewers of 510k.

Warning: I said a help for diagnosis. Your software only displays relevant information. Diagnosis shall remain the pratician's decision.

Regards,

Mitch.
 

sagai

Quite Involved in Discussions
#4
Actually most imaging falls to class C in 62304 as long as the patient anatomy could not be determined ahead of its use. And mostly it can not, one example is mixing the sides is not relevant for organs in the body, because it would be obvious, but does matter for brain scans for example.
Loosing slides is another example of Death or serious injury, for example vascular angiomas easily can not be detected in case slide scan(s) is missing or can be miss detected.

Doctors will cut the patient with zero thinking if medical imaging supports that decision, and we can not say than it will be obvious because they see the organs and can make overrules in the course of the operation, no, that is already a bloody serious injury, the patient already has been cut.

The thing is, regulatory investigators could believe they understand the safety aspect, however without medical discipline its only a wondering in medical science. (I am also not one of those rare species, but listening to ones more knowledgeable )

So sum it up, I suggest to please talk to the reading physician or the one has clinic expertise and a PhD in medical science, and get the answer he gave you, it is nothing to do neither with regulatory, nor with quality guys.

Cheers!
 
J

juanlu

#6
So, do you think that a software that takes images from pupil to estimate the refraction of the eye (astigmatism & myopia) is a class A because does not harm the patient or is class B because the diagnosys can lead to a wrong medical decision if software fails??

I think in this cases responsibility remains in the clinic expertise, not in the system.
 
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