Level of Concern for Class II Medical Device Software 510(k) Submission

tebusse

Involved In Discussions
#1
Greetings,

I am currently writing the 510(k) submission for my company, which manufactures a class II medical device that is software (PACS).

I have utilized the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and determined that the Level of Concern is Moderate.

However, according to the FDA's "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices" the Level of Concern is considered to be Minor.

I'm a bit confused regarding what constitutes the proper Level of Concern for a PACS system. Has the FDA changed it's preference regarding the level since the release of the latter guidance document in 2000?

Regards, Tonia
 
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sagai

Quite Involved in Discussions
#2
Sorry for the dumb question, but are you sure for a PACS software you can say "certainly not" for this question?
Prior to mitigation of hazards, could a failure of the Software Device result in death or serious injury, either to a patient or to a user of the device?
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm

I am lost in your second question actually due to I have found any reference to LoC in that guidance.

Many thanks, Cheers
 
Last edited:
A

arnaudl

#3
I think that the level of concern depends of the of use of your application. If it just dealing with files and a basic viewing of images, the loc is indeed minor. But there are plenty of proofs that the FDA is expecting a moderate level if the application offers advanced imaging functions (measure or analysis).
 
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