Hi, author here! I think my main concern with this process is that the predicate itself might never have gone through clinical trials.

So even if the new device works as well as the predicate, that predicate might be equivalent to a whole chain of devices that have never gone through clinical trials.

This might be fine if the device is low risk, but the 510(k) process has a history of clearing devices that have resulted in patient deaths.

Of course it's a balance between too much red tape and having unsafe devices, I was just personally surprised at where the FDA draws the line today.