RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories used with Smith & Nephew's negative pressure wound therapy (NPWT) systems to create a closed environment over wounds. They enable removal of fluids, exudates, and infectious materials from chronic, acute, traumatic, and other wound types including ulcers, burns, flaps, and grafts.

The subject device replaces the RENASYS Transparent Film component with RENASYS Film featuring AIRLOCK Technology and Retention Strips. All other kit components—foam or gauze dressing, user manual, and accessories—remain identical to the predicate device.

Not stated in this summary.

The subject device has identical intended use and indications for use as the predicate device (K142979). The only change is substitution of the transparent film with an AIRLOCK-enabled film and retention strips. Non-clinical performance testing, including simulated wound model tests, human factors validation, and biological evaluation, demonstrated the subject device performs as intended with no different questions of safety or effectiveness raised by this design modification.