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U.S. Department of Health and Human Services

Medical Devices

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

 

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)
Table 2 - Supplementary Evaluation Tests for Consideration - Biological Effect
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.