(210 days)
The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. 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. They are indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The V.A.C. GranuFoam Silver® Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
The V.A.C. Instill® Therapy System is indicated for patients who would benefit from V.A.C.® Therapy coupled with controlled delivery of topical wound treatment solutions and suspensions over the wound bed. It is intended for patients with chronic acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps and grafts.
The software-controlled therapy unit applies negative pressure to the wound bed. The open cells of the V.A.C.® Foam Dressing to which the therapy unit is connected enable distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered.
The provided text describes a 510(k) summary for the V.A.C.® Therapy Systems, focusing on an expanded indication for use to include venous insufficiency ulcers. However, it explicitly states that no clinical or non-clinical studies were required for this change in indication, and therefore, no performance metrics or detailed study results are provided to define or prove acceptance criteria.
The submission relies on existing medical literature to document acceptable clinical experience with the V.A.C.® Therapy System for treating venous insufficiency ulcers. This means the acceptance criteria are implicitly those established by prior regulatory approvals and clinical use of the V.A.C.® Therapy System for its previously approved indications, and the "proof" is the existing body of medical literature.
Therefore, many of the requested details about acceptance criteria and studies cannot be extracted directly from this document.
Here's what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for clinical performance. The implicit acceptance criterion for the expanded indication is that the device's performance for venous insufficiency ulcers is "acceptable" and equivalent to its performance for previously approved indications, as supported by existing medical literature.
- Reported Device Performance: No specific performance metrics (e.g., wound healing rates, reduction in edema, granulation tissue formation rates) are reported in this document related to venous insufficiency ulcers from a new study. The document only references "acceptable clinical experience using the V.A.C.® Therapy System to treat venous insufficiency ulcers" in medical literature.
2. Sample size used for the test set and the data provenance:
- Not applicable. No new test set or clinical study was conducted for this submission. The "data provenance" is "Medical literature."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new test set or ground truth establishment process is described.
4. Adjudication method for the test set:
- Not applicable. No new test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not a study involving AI or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a negative pressure wound therapy system, not an algorithm.
7. The type of ground truth used:
- Medical Literature / Existing Clinical Experience: The "ground truth" for the expanded indication of venous insufficiency ulcers is based on the established clinical effectiveness and safety of the V.A.C.® Therapy System as documented in medical literature over time for wound healing, which is considered sufficient evidence for this 510(k) submission.
8. The sample size for the training set:
- Not applicable. No new training set was used for a device modification of this nature (expanded indication based on existing literature).
9. How the ground truth for the training set was established:
- Not applicable. No new training set or ground truth establishment process is described.
§ 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.