Wound Treatment System (VHT-200)

The VHT-200 Wound Treatment System is a prescription medical device that delivers ultrasonically generated mist and concentrated oxygen to open, acute, and chronic wounds as adjunct therapy. It is designed for clinical office use to treat various wound types including diabetic ulcers, burns, skin grafts, and frostbite, with treatment sessions lasting 20 minutes, twice weekly.

The device generates oxygen at 95% +/- 5% concentration using an oxygen concentrator and vaporizer, delivers 4-7 L/minute flowrate, produces 90-98% humidity vapor, operates at 1 ATM pressure, and alternates between vapor and oxygen delivery in timed cycles with visible/audible alerts for refill fluid, missing vaporizer, and system faults.

Not stated in this summary.

The subject device and predicate device (K212121) have identical materials, hardware, and software with no physical or functional differences. The only change is a labeling clarification in the Indications for Use statement that specifies the device delivers ultrasonically generated mist and concentrated oxygen separately within treatment cycles—a clarification of what the device has always done and which does not alter the intended use of delivering oxygen to wounds in a humidified environment. Since the technological characteristics and intended use remain unchanged, only labeling was modified, no performance testing was required.