---------------------------------------------
Hi
This software is intended for controlling the operation of the system. It is an apps, user can download it from the app store of IOS. And it is only intended for use with the exact device.
How about if part of the predicted device system is comparable to the proposed device?

I can't see any FDA guidance document which prohibits such kind of comparation. On the other side, i am also afraid that the 510(k) will be treated as NSE because SE can't be established between the predicated device and the proposed device. The reason why i choose the "system" as an predicated device is for there is no other comparable( both from the intended use as well as the technology chracteristics perspectives) one.