If you have Device A that has its own software, but you decide to connect it to a standalone software installed on a PC which just extract data/information from Device A and provides reports and other data management related function. When submitting a 510k for the stand alone SW, one is required to indicate the Level of Concern for the SW based on FDA 2005 for Devices containing SW.
Since the Standalone SW is an accessory, one would need to answer the following (Q3). Is the Level of Concern in this case related to the SW(installed on the Device A and not the standalone SW) pre-mitigation hazards- meaning does one have to look up the Hazard Analysis for the Device A and if pre-mitigation hazard Severity is "Potential death or serious injury" then the level of concern for the standalone SW is "Major"? Or other aspect of Device A need to be considered as well.
If the answer to any one question below is Yes, the Level of Concern for the
Software Device is likely to be Major.
3. Is the Software Device an accessory to a medical device that has a Major Level of
Concern?
Medical Device Software Level of Concern Determination
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