Does a 510(k) for a mobile medical app need to include a wireless technology/communication section?


I submitted a 510(k) for a mobile medical app (SaMD) through eSTAR and received a technical review deficiency report with Major Deficiencies on "Electrical safety, EMC, and Wireless." Is this relevant for an app (no hardware)? My app is downloaded from an app store and medical images can be loaded into the app from Microsoft OneDrive, so in my eSTAR I had checked the boxes for "Cloud Communication," "Network connection (active or not)," "Wireless communication in any form," and "Software upgrades (this includes patches)." The app does not control or communicate with any other medical devices - it simply performs analysis on images that you give it. It does store user credentials on the cloud. Should I uncheck the box for "Wireless communication in any form?" I wonder if this is the reason I got the deficiency response, and I don't want to deal with a deficiency response that is not relevant for my device. I submitted all the software validation and reporting, but I did not submit any specific testing/discussion related to the 2013 FDA guidance document “Radio Frequency Wireless Technology in Medical Devices," which is what the deficiency response is asking me to now provide. How is RF wireless security and Quality of Service (QoS) relevant for my submission? Or is it?
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