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The Nisus Touch Negative Pressure Wound Therapy Pump is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Cork Medical Products has developed a negative pressure wound therapy pump with the same intended use as its predicate device (K140022) but has the addition of an integrated touch screen. The Nisus Touch and Nisus pumps are nearly identical in appearance and utilize the same buttons to power the device and adjust pump settings; however, the Nisus Touch offers the alternative touch screen to easily maneuver between settings based on operator preference. Visual and audible alarms are consistent with the predicate device K140022 and alert the user when critical battery, pressure leakage, system blockage, and full canister occurs. Additionally, the Nisus Touch mechanical components and therapy application are identical to the Nisus pump. The intent of the new model is to appeal to users who encounter touch screens in daily technology and might feel navigation by touch screen is more simplistic. The components included within the Cork Nisus Touch NPWT Pump are: - Nisus Touch Negative Pressure Wound Therapy Pump - Nisus Touch Pump Battery Charger Accessory components are required to operate the device. Iniection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The canister design was previously provided clearance within the Nisus NPWT system 510k application (K140022). The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. These components are used in coniunction with the pump to ensure safe transfer of the wound debris to the canister. The NPWT Accessories were previously provided clearance on K132004. Our application for the Nisus Touch NPWT system includes no revisions to these previously cleared components.