Will it move fluids or solids into the blood without contact with the blood itself, into tissues such as muscle, teeth or bones or have actual contact with circulating blood?
For this externally communicating device will it have indirect contact with the circulatory system? For example will fluids pass through it to the blood stream, but this product will not be in the blood stream, like an extension set? Will it deliver another device or material to tissue, bone or dentin? And finally will it have direct contact with the blood stream, where blood would flow through it or over it?