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Decision tree
Heading
Invasive device
Body
Invasive in a body orifice or surgically invasive?
Body orifice:
- means a natural opening, or a permanent artificial opening, in a human being's body; and
- includes the external surface of a human being's eyeball
This type of medical device only enters a natural orifice such as the nasal cavity or the mouth, or a permanent created orifice; it does not cut through the surface of the body or any surface of the orifice.
Surgically invasive:
These types of medical devices are intended to be used with the aid, or in the context, of a surgical operation; and includes devices that penetrate the body in any way other than by entering a body orifice.
Question
Based on the above definitions, how is your device intended to be invasive?