Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

The Nisus ONE Negative Pressure Wound Therapy System is a portable suction pump for negative pressure wound therapy (NPWT) in patients requiring wound management. It is designed for use with the Cork NPWT Wound Dressing Kit and is suitable for both professional healthcare facilities and home use environments.

The Nisus ONE features a simplified user interface with a single membrane switch button for device control, automatically defaulting to continuous therapy at 125 mmHg. Key differences from the predicate include increased suction capacity (7 liters/minute vs. 4), slightly larger dimensions and weight, availability of a 500-mL canister option (in addition to 250-mL), and an internalized USB port that is not user-accessible.

IEC 60601-1 (4th Edition), IEC 60601-1-2, IEC 60601-1-6/IEC 62366, IEC 60601-1-11, and compliance with AAMI ES 60601-1, CAN/CSA C22.2 No. 60601-1-08, and EN 60601-1. Bench performance testing, software verification and validation, electrical safety and EMC testing, and usability/human factors testing were conducted.

The Nisus ONE maintains identical mechanical components, therapy application, indications for use, and fundamental performance characteristics as the predicate device (K140022). Although the user interface has been simplified to a single-button design and the suction capacity increased, these modifications preserve the same therapeutic function and safety profile. The device was subjected to comprehensive bench performance, electrical safety, EMC, and usability testing demonstrating equivalence in critical operational parameters including pressure delivery, alarm functions, and clinical outcomes.