BloodSTOP iX Trauma Matrix (TM-iX-20)

BloodSTOP iX Trauma Matrix is a sterile hemostatic wound dressing composed of etherified oxidized regenerated cellulose that absorbs blood, forms a gel, and adheres to wounds. It is intended for topical management of bleeding from cuts, lacerations, abrasions, surgical wounds, and traumatic injuries and is applied with pressure like other hemostatic dressings.

The subject device uses etherified oxidized regenerated cellulose as the hemostatic agent itself, whereas the predicate (Quikclot) uses kaolin mineral powder impregnated into gauze. Both are soft, single-use, sterile dressings provided in various sizes, applied with pressure, and removed mechanically with hydration. Both contain no drugs or biologics and are sterilized by gamma radiation to a SAL of 10⁻⁶.

ISO 10993-1 (biocompatibility evaluation), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-10:1996 (irritation), ISO 10993-11:2017 (acute systemic toxicity and pyrogenicity), and USP pyrogen testing. Performance testing conducted in a porcine femoral artery hemorrhage model.

BloodSTOP iX Trauma Matrix is substantially equivalent to the predicate Quikclot (K123387) because both devices share identical intended use, similar design and mechanism of action as hemostatic dressings for bleeding wounds, and substantially similar outcomes despite different hemostatic components. Performance testing demonstrated equivalent hemostasis success rates and safety in the same porcine arterial hemorrhage model, and no new safety or effectiveness concerns arise from the compositional differences.