In Reply to Parent Post by Silvertabb
this standalone SW has a 510k and its own hazard analysis. However, the guidelines as I stated in my first post asks whether or not this standalone device is connected to a device that has a major level of concern. In my case, both class II and Class III can use this SW. So to determine the SW concern level I need to know whether or not I should consider on the pre-mitigation SW hazard of the device to which this standalone SW will be connected to extract data or all hazards associated.
Maybe I'm not understanding the system. Is the stand-alone software required to use the device? Does the stand-alone software operate while the device is in use? My original thought was that the device does its thing, gathering data. Then you plug it into a PC (or whatever) and pass the data gathered to the stand-alone software. In this case, even though it connects to the device, it can't have an impact on the device use and so I wouldn't consider it in device hazard analysis.
If, however, the device is connected while it's being used or can influence the device then you should consider potential hazards with the device coupled with the software. I think that's what the guidance is driving at (potential influence on the device).
On the stand-alone software side, I still would consider the device as a black box that just provides inputs.