Coaptium Connect with Tissium Light

COAPTIUM® Connect with TISSIUM® LIGHT is a bioabsorbable coaptation system for sutureless repair of peripheral nerve injuries without continuity, where a nerve gap of ≤1 cm exists or can be closed with flexion. It uses a photoactive polymer applied via syringe to secure a three-dimensional coaptation chamber to proximal and distal nerve segments, creating a protective interface and conduit for axonal growth without sutures.

The subject device is identical to the predicate in intended use, device type, shape (transparent flexible sleeve), biocompatibility, performance characteristics, mode of operation, and sterilization method. The subject device has slight differences in materials and dimensions of the TISSIUM® Light Cover component, which do not raise new or increased safety and performance risks.

Biocompatibility testing was performed per ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) and the FDA guidance document on the same standard issued September 8, 2023. Performance verification, shelf-life, and sterilization validations were performed to existing specifications.

This is a modification to the TISSIUM® Light Cover component of an already-cleared predicate device (DEN240066). Since the intended use is identical and the technological characteristics are substantially equivalent despite minor material and dimensional differences in the Light Cover, and since risk analysis and performance testing demonstrate equivalence, the modified device poses no new or increased risks and therefore maintains substantial equivalence to the predicate.