NovoSorb® MTX

NovoSorb® MTX is a synthetic biodegradable wound dressing composed of a single open-cell polyurethane foam layer (2–6 mm thick, >90% porosity) supplied in sizes from 4 to 800 cm². It is intended for managing various wound types including pressure ulcers, diabetic ulcers, surgical wounds, and trauma wounds by providing a scaffold for tissue integration and natural healing. The device is for single use only in clinical settings by healthcare professionals.

NovoSorb® MTX uses the same synthetic biodegradable polyurethane material and manufacturing process as the predicate NovoSorb® Matrix device. Physical and material properties (average pore size, porosity, density), sterilization method, sterility assurance level, and shelf life remain identical. The primary difference is the foam thickness range (up to 6 mm versus 2 mm in earlier versions) and the addition of tunneled/undermined wounds to the indications for use.

Verification performance testing per predicate protocol; accelerated hydrolytic degradation study per ISO 10993 Part 13; biocompatibility risk assessment per ISO 10993–1 including endpoints for cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, genotoxicity, and carcinogenicity; in vivo implantation testing for local tissue response.

Substantial equivalence is established because the subject device shares identical intended use (wound management with scaffold function), principle of operation (cellular infiltration and vascularization via high-porosity structure), material composition, and manufacturing process as the predicate NovoSorb® Matrix. Verification testing confirms the device meets functional requirements using the same protocols as the predicate. Biocompatibility data from the predicate 2 mm device apply to the 4–6 mm versions because they use identical materials and processes; in vivo testing confirms similar tissue response. The addition of tunneled/undermined wounds to indications does not alter mechanism of action or introduce new risks.