Table 35.
4SEAL® Hemostatic powder biocompatibility testing summary
| Test Performed | Extract(s) | Test and Control(s) Positive control (+) Negative control (−) |
4SEAL® results |
|---|---|---|---|
|
Chemical characterization ICP-MS ISO 10993-18 [8] |
Water for injection | Water for injection (−) | Elements <LOD |
|
Chemical characterization Headspace GC-MS ISO 10993-18 [8] |
Raw product |
Laboratory air (−) EPA VOC Mix 2 (+) |
<AET |
|
Chemical characterization GC-MS ISO 10993-18 [8] |
Water for injection |
Water for injection (−) Octane, decane, tridecane, tetradecane, hexadecane (+) |
<AET |
|
Cytotoxicity ISO 10993-5 [10] |
MEM |
Latex (+) HDPE (−) |
No cytotoxicity |
|
Sensitization ISO 10993-10 [17] |
Acetone: olive oil |
Acetone:olive oil (−) A-Hexylcinnamaldehyde (+) |
No sensitization |
|
Intracutaneous reactivity ISO 10993-10 [17] |
Saline and CSO | Saline and CSO (−) | No irritation |
|
Material mediated pyrogenicity ISO 10993-11 [19] |
Saline | Saline (−) | No pyrogenicity |
|
Endotoxin ISO 10993-11 [19] |
Water for injection |
Water for injection (−) Endotoxin standard (+) |
< 20 EU/ 5 g device < 2.15 EU/ 3 g device |
|
Acute systemic toxicity ISO 10993-11 [19] |
Saline and CSO | Saline and CSO (−) | No signs of toxicity |
|
Subacute toxicity combined with implantation ISO 10993-6 [18] ISO 10993-11 [19] |
Direct implantation | Starsil Hemostat (−) |
No signs of subacute toxicity No difference in tissue reaction |
|
Genotoxicity (Ames) ISO 10993-3 [11] |
Water for injection |
Water for injection (−) without S9: 2-NF, 4-NQO, N4-ACT, 9-AA (+) with S9: 2-AA, 2-AF(+) |
No mutagenic potential |
|
Genotoxicity (MLA) ISO 10993-3 [11] |
F5 |
F5(−) without S9: methylmethansulfonate (+) with S9: benzo [a] pyrene (+) |
No mutagenic potential |