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) |
 |
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| 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 |
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| 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 |
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| 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
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