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U.S. Department of Health and Human Services

Medical Devices

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510(k) Memorandum - #G95-1 Table 1 Initial Evaluation Tests for Consideration

 

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)
Table 1 - Initial Evaluation Tests for Consideration - Biological Effect
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

X = ISO Evaluation Tests for Consideration
O = Additional Tests which may be applicable
Note + Tissue includes tissue fluids and subcutanous spaces
Note ^ For all devices used in extracorporial circuits

*See Table 2 for Supplementary Evaluation Tests