(64 days)
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing are accessories to the:
• 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.
· V.A.C.ULTA™, INFOV.A.C.™, and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which 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, they 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 Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit is a component of the V.A.C.® Negative Pressure Wound Therapy (NPWT) Systems. The V.A.C. NPWT System is comprised of:
- Powered Negative Pressure Wound Therapy (NPWT) Unit ●
- A disposable canister which collects wound exudate
- A wound interface dressing .
- Semi-occlusive wound drape
- o Sensing pad and lumen
The Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit provides sterile disposable components needed for delivery of negative pressure wound therapy. Dermatac™ Drape and V.A.C. Granufoam™ Dressing kit includes:
- (1) V.A.C.® Granufoam™ Dressings (small, medium, or large) ●
- (1 or 2) V.A.C. Dermatac TM Drapes
- (1) SensaT.R.A.C.™ Pad ●
- (1) Ruler
This document (K212320) is a 510(k) summary for the 3M™ Dermatac™ Drape and V.A.C. Granufoam™ Dressing. It describes the device, its intended use, and how its performance was evaluated for substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with corresponding "device performance" values for clinical efficacy. Instead, it focuses on verifying that the new device configuration (packaging Dermatac™ Drape with V.A.C. Granufoam™ Dressing and SensaT.R.A.C.™ Pad) and its sterilization method do not negatively impact its intended function or safety.
The acceptance criteria are implicitly met if the device functions as intended and maintains negative pressure within specifications, manages fluid exudate without unexpected alarms, and maintains sterile barrier integrity.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintenance of negative pressure within specifications and management of fluid exudate without unexpected alarms | The V.A.C.™ Negative Pressure Maintenance System Test demonstrates the Dermatac™ Drape and V.A.C. Granufoam™ Dressing, when used as part of the NPWT System, maintains negative pressure within specifications and manages fluid exudate without unexpected alarms. |
| Maintenance of sterile barrier integrity throughout labeled shelf life | Package Integrity testing ensures the sterile barrier integrity is maintained throughout its labeled shelf life. |
| Product function as intended after ETO sterilization throughout labeled shelf life | Product performance testing of dressing components after ETO sterilization verifies the product functions as intended throughout its labeled shelf life. |
| Overall safety and effectiveness | "In all instances, the Dermatac™ Drape and V.A.C. Granufoam™ Dressing functioned as intended and all test results observed were as expected." The conclusion states, "The subject device is as safe and effective as the predicate device," and "The performance data demonstrates that the Dermatac™ Drape and V.A.C. Granufoam™ Dressing is as safe and effective as the predicate." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for the individual tests (e.g., V.A.C.™ Negative Pressure Maintenance System Test, Package Integrity testing, Product performance testing). It states these were "non-clinical tests." Details regarding data provenance (e.g., country of origin, retrospective/prospective) are not provided as these were not clinical studies involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The tests performed were primarily engineering and performance verification tests, not diagnostic studies requiring expert adjudication of ground truth from clinical cases.
4. Adjudication Method for the Test Set:
Not applicable, as the tests were non-clinical performance and engineering evaluations, not clinical studies requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on non-clinical performance data to demonstrate substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance. The device in question is a wound dressing kit, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
Not applicable. This device is a physical wound dressing kit, not an algorithm or AI-based software.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods, and industry standards, rather than expert consensus, pathology, or outcomes data typically associated with clinical ground truth. For instance, negative pressure maintenance was likely compared against predefined operational ranges, and sterility against established integrity standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as item 8.
§ 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.