RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

The RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is an accessory used with negative pressure wound therapy systems to manage various wound types including chronic, acute, traumatic, and surgical wounds. It removes fluids and exudate from wounds by creating a closed environment that delivers negative pressure therapy, available with or without wound fillers (foam or gauze).

The subject device is identical to the predicate device except for removal of the wound filler retention strips component. Both devices use the same RENASYS Film with AIRLOCK Technology and function identically in delivering negative pressure wound therapy. The subject device adds closed surgical incisions as an approved wound type indication.

Not stated in this summary.

Substantial equivalence is established because the subject device maintains the same intended use, indications for use (with the addition of closed surgical incisions), and kit components as the predicate, differing only in the removal of wound filler retention strips. Non-clinical performance testing including simulated wound model testing and human factors validation demonstrated the subject device performs as intended with no new safety or effectiveness concerns raised.