510(k) Memorandum - #G95-1 Table 1

Initial 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	x	x	x	.	.	.	.	.
		B	x	x	x	.	.	.	.	.
		C	x	x	x	.	.	.	.	.
	Mucosal membrane	A	x	x	x	.	.	.	.	.
		B	x	x	x	o	o	.	o	.
		C	x	x	x	o	x	x	o	.
	Breached or compromised surfaces	A	x	x	x	o	.	.	.	.
		B	x	x	x	o	o	.	o	.
		C	x	x	x	o	x	x	o	.
External communicating devices
	Blood path, indirect	A	x	x	x	x	.	.	.	x
		B	x	x	x	x	o	.	.	x
		C	x	x	o	x	x	x	o	x
	Tissue/bone/ dentin communicating+	A	x	x	x	o	.	.	.	.
		B	x	x	o	o	o	x	x	.
		C	x	x	o	o	o	x	x	.
	Circulating blood	A	x	x	x	x	.	o^	.	x
		B	x	x	x	x	o	x	o	x
		C	x	x	x	x	x	x	o	x
Implant devices
	Tissue/ bone	A	x	x	x	o	.	.	.	.
		B	x	x	o	o	o	x	x	.
		C	x	x	o	o	o	x	x	.
	Blood	A	x	x	x	x	.	.	x	x
		B	x	x	x	x	o	x	x	x
		C	x	x	x	x	x	x	X	x