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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 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 1 - Initial Evaluation Tests for Consideration - Biological Effect
Surface
devices
SkinAxxx.....
Bxxx.....
Cxxx.....
Mucosal
membrane
Axxx.....
Bxxxoo.o.
Cxxxoxxo.
Breached or
compromised
surfaces
Axxxo....
Bxxxoo.o.
Cxxxoxxo.
External
communicating
devices
Blood path,
indirect
Axxxx...x
Bxxxxo..x
Cxxoxxxox
Tissue/bone/
dentin
communicating+
Axxxo....
Bxxoooxx.
Cxxoooxx.
Circulating
blood
Axxxx.o^.x
Bxxxxoxox
Cxxxxxxox
Implant
devices
Tissue/
bone
Axxxo....
Bxxoooxx.
Cxxoooxx.
BloodAxxxx..xx
Bxxxxoxxx
CxxxxxxXx

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