(90 days)
The V.A.C. DERMATAC™ Drape is an accessory to the following V.A.C.® Therapy Negative Pressure Wound Therapy Systems: ACTIV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings. The V.A.C.ULTA™, INFOV.A.C™. and V.A.C.RX4™ Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. When used on open wounds, these systems are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention, by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts. When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. The V.A.C. DERMATAC™ Drape is also an accessory to the V.A.C. VERAFLO™ Therapy (Instillation) provided by the V.A.C.ULTA™ Therapy Unit. V.A.C. VERAFLO™ Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. V.A.C. VERAFLO™ Therapy is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
The V.A.C. DERMATAC™ Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C.® Therapy and V.A.C. VERAFLO™ Therapy Systems. The V.A.C. DERMATAC™ Drape is a single-use, sterile covering that provides a sealed environment for delivery of these therapies. It also allows for a moist wound environment. The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound skin, thus creating a sealed wound environment. The therapy systems with which it is used are comprised of the following: Software controlled therapy unit that provides negative pressure and, in the case of V.A.C. VERAFLO™ Therapy, a pump for controlled delivery of topical wound solutions. Disposable canister which collects wound exudate and, in the case of V.A.C. VERAFLO™ Therapy, instilled solutions Foam dressing for placement into the wound Semi-occlusive drape that covers the dressing Tubing set that connects the dressing to the therapy unit.
This document is a 510(k) Premarket Notification from the FDA regarding the V.A.C. DERMATAC™ Drape. It's a regulatory submission, not a study report detailing performance data based on an AI model. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment for an AI device is not present.
The document discusses the following:
- Device: V.A.C. DERMATAC™ Drape, an accessory for Negative Pressure Wound Therapy (NPWT) systems.
- Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device (V.A.C. DERMATAC™ Drape, cleared under K181505), primarily to expand its intended use to include V.A.C. VERAFLO™ Therapy.
- Acceptance Criteria for Regulatory Clearance (not for AI performance): The core acceptance criterion for this 510(k) submission is demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective as a device already on the market.
- Device Performance Reported:
- Non-clinical tests: "Negative pressure performance testing was conducted using simulated wound exudate, maximum air leak rate, worst case dressing configuration and for the maximum use life of the dressings. The results documented that the V.A.C. DERMATAC Drape™ is capable of maintaining negative pressure within specification."
- Clinical tests: "No clinical tests were required for a demonstration of substantial equivalence. However, a usability assessment was conducted."
Therefore, I cannot provide the specific information requested in the prompt related to AI device performance, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training and test sets, because this document is for a medical device (a wound care drape), not an AI-powered diagnostic or therapeutic device.
The provided text focuses on the regulatory pathway (510(k)) for a physical medical device, not the validation of an AI algorithm.
§ 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.