(357 days)
AC Wound Management System is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates, and infectious materials. Examples of appropriate wound types include: Diabetic/Neuropathic ulcers, Pressure ulcers, Chronic wounds, Acute wounds, Dehisced wound, Partial-thickness burns, and Flaps and Grafts.
The AC Wound Management System is a powered suction pump that utilizes a pump drive to generate light negative pressure. The pump drive is powered by a rechargeable battery. Optionally the unit can be connected to mains power using an included power converter. AC Wound Management System has a negative pressure setting range of -50 mmHg to -175 mmHg which is electronically monitored and controlled. The system includes a keyboard for user interface as well as audible and visual alarm indicators. The system includes a 300cc canister. The system can be set on a countertop, carried using a shoulder bag or mounted to an IV pole or bedside rail using the AC Wound Management System's mount. The AC Wound Management System includes the following three components: The pump drive, The waste canister, with its suction tube (the two are connected permanently), FDA cleared generic NPWT dressing, which will be distributed by NanoVibronix. The pump drive is a non-disposable unit which contains a motor, a battery and a user interface. The drive has a piston which protrudes the drive and reciprocates to activate the suction pump, which is integral to the canister. In the drive there is also a vacuum level monitor which monitors the vacuum at all times and maintains the required set therapy. The waste canister attaches to the drive. The pump creates vacuum within the waste canister for the purpose of suctioning exudates from the wound and collecting them in the canister. The canister has a hydrophobic filter. The suction tube connects the waste canister to the wound dressing applying the vacuum generated within the waste canister to the wound site. The tube also transfers the exudates from the wound to the waste canister by maintaining flow from the wound site towards the waste canister at all times.
Here's a breakdown of the acceptance criteria and study information for the AC Wound Management System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Tests | ||
| Stability of operation | Stable operation compared to predicate device. | Both AC NPWT system and predicate device Renasys NPWT system provide stable operation. |
| Negative pressure accuracy | Deviation of determined negative pressure level from measured average negative pressure level |
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.