Nerve Wrap (07-DW-001-TAB)

The Nerve Wrap is a bioabsorbable nerve cuff composed of decellularized porcine small intestinal submucosa (SIS) designed to wrap around damaged peripheral nerves without a gap. It provides a scaffold that becomes infiltrated and remodeled by the patient's cells, protecting the nerve during healing while maintaining a non-constricting interface between the nerve and surrounding tissue.

The Nerve Wrap is a flat rectangular sheet (45mm × 22mm, 100–1000 µm thick when wrapped) made of layered porcine SIS without a coating. The primary predicate (AxoGuard HA+ Nerve Protector) uses identical SIS material but includes a sodium hyaluronate and sodium alginate coating. Both devices use ethylene oxide sterilization, are supplied sterile, and are intended for single use. The reference predicate (Nerve Tape) contains integrated NiTiNOL microhooks; the proposed Nerve Wrap does not.

ISO 10993-1:2018 (biocompatibility evaluation), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), ISO 10993-11:2017 (systemic toxicity), ISO 10993-3:2014 (genotoxicity), ISO 10993-6:2016 (local implantation effects), ISO 10993-7:2008 (EO residuals), ISO 11135:2014 (ethylene oxide sterilization validation), and AAMI TIR28:2016 (sterilization process equivalence).

The device uses identical SIS material composition, form factor (flat sheet), sterilization method, and indications (management of peripheral nerve injuries with no gap) as the primary predicate AxoGuard HA+ Nerve Protector. While the Nerve Wrap lacks the coating present in AxoGuard HA+, the underlying SIS substrate, mechanism of action (scaffold provision and nerve protection), and biocompatibility profile are identical. The removal of the coating does not affect safety or efficacy because the coating's friction-reducing function is unnecessary for a device intended only for non-transected nerve protection without gap closure. Comprehensive biocompatibility and animal implantation studies confirm the device is well-tolerated and performs equivalently to the predicate.