Genadyne DUO NPWT

The Genadyne DUO NPWT is a negative pressure wound therapy (NPWT) system with an optional instillation feature. It creates a healing environment by applying controlled suction (40–200 mmHg) to prepare wound beds, reduce swelling, promote tissue formation, and remove fluid and infectious material. The instillation option allows controlled delivery of topical wound treatment solutions. It is indicated for chronic, acute, traumatic, and dehisced wounds; burns; ulcers; and flaps and grafts.

The subject device and predicate device (V.A.C.ULTA Therapy System, K162790) share the same core technology for delivering negative pressure and instillation therapies with identical intended use and performance specifications. Differences include distinct software user interfaces, different physical dimensions, and use of different dressing kits and disposable canisters.

Bench testing per ISO 10079-1 was conducted, including pressure precision testing, absorption testing, alert capacity testing, and instillation therapy testing. Software documentation was assembled per FDA's May 11, 2005 guidance on software in medical devices, with software Level of Concern evaluated as Moderate.

Substantial equivalence is supported because the subject device delivers identical therapies using the same underlying technology as the predicate device, with no change to intended use or core performance specifications. Although the device has different software interfaces, physical dimensions, and disposables, these differences are design variations that do not affect the fundamental mechanism of action. Bench testing confirmed the device functions appropriately per ISO standards and safety testing demonstrated it is safe and effective for its intended use.