Table 35 4SEAL® Hemostatic powder biocompatibility testing summary
From: ISO 10993 biological evaluation of novel hemostatic powder – 4SEAL®
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 |