MFUSE (MS001)

MFUSE™ is a sterile, single-use hemostatic device composed of polyacrylic acid (PAA) in a chitosan matrix mixed with mineral oil, delivered in a 5gm syringe. It is indicated for temporary external use to control moderate to severe bleeding by creating a mechanical barrier over the wound that adheres to tissue and allows natural clot formation.

MFUSE™ uses polyacrylic acid (PAA) as the active material, whereas the predicate TRAUMAGEL® uses sodium alginate. Both devices use chitosan, are packaged in syringes, form hydrogels, and are terminally sterilized with gamma irradiation to a SAL of 10⁻⁶. The key difference is the material composition, with PAA replacing sodium alginate.

ISO 10993-1:2018 (biocompatibility overview), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 10993-18 (material characterization), ISO 10993-17 (toxicological risk assessment), and ANSI/AAMI ST72:2019 (bacterial endotoxins).

MFUSE™ is substantially equivalent to TRAUMAGEL® because both devices share identical indications for use, sterilization methods, removal procedures, packaging format, and mechanism of action (forming a mechanical barrier). Although MFUSE™ uses PAA instead of sodium alginate, performance bench testing, GLP animal studies, and comprehensive biocompatibility testing demonstrate that this material difference introduces no new safety or effectiveness concerns relative to the predicate device.