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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 CategoriesBiological 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
SkinA....
B....
C....
Mucosal
membrane
A....
B....
Co...
Breached or
compromised
surfaces
A....
B....
Co...
External
communicating
devices
Blood path,
indirect
A....
B....
Cxx..
Tissue/bone/
dentin
communicating
A....
B....
Cox..
Circulating
blood
A....
B....
Cxx..
Implant
devices
Tissue/
bone
A....
B....
Cxx..
BloodA....
B....
Cxx..


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

*See Table 1 for Initial Evaluation Tests.