Going of la82’s post, I think the way the FDA defines the line between a device of significant and non-significant risk is blurry. I think this guideline especially raises a few concerns:

• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject”

It’s a blanket statement and quite vague in what constitutes significant risk. The borderline between significant and non-significant devices should be clear. For example, what should glasses be classified as? They are an extracorporeal device and you can argue they pose a non-significant risk because of that. But should they fail, the person wearing them would lose their vision to some degree and potentially harm themselves. Even though the event occurs indirectly of proper function of the device, should the possibility of such harm make glasses be classified as a medical device that poses significant risk? I believe the line isn’t as clear as it needs to be based on the description you provided.