Medical Devices

510(k) Memorandum - #G95-1 Attachment B - Table 2 Supplementary Evaluation Tests for Consideration

Device Categories			Biological Effect
Body Contact (see 4.1)		Contact duration (see 4.2) A-limited (-24h) B-prolonged (24h to 30 days) C-permanent (>30days)
Surface devices	Skin	A	.	.	.	.
		B	.	.	.	.
		C	.	.	.	.
	Mucosal membrane	A	.	.	.	.
		B	.	.	.	.
		C	o	.	.	.
	Breached or compromised surfaces	A	.	.	.	.
		B	.	.	.	.
		C	o	.	.	.
External communicating devices
	Blood path, indirect	A	.	.	.	.
		B	.	.	.	.
		C	x	x	.	.
	Tissue/bone/ dentin communicating	A	.	.	.	.
		B	.	.	.	.
		C	o	x	.	.
	Circulating blood	A	.	.	.	.
		B	.	.	.	.
		C	x	x	.	.
Implant devices
	Tissue/ bone	A	.	.	.	.
		B	.	.	.	.
		C	x	x	.	.
	Blood	A	.	.	.	.
		B	.	.	.	.
		C	x	x	.	.

X = ISO Evaluation Tests for Consideration
O = Additional Tests which may be applicable

*See Table 1 for Initial Evaluation Tests.