(63 days)
The V.A.C. Therapy System is 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), 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 components of the V.A.C.® Therapy System work as an integrated product to optimize both the delivery and the benefits of negative pressure. An open pore foam (reticulated polyurethane foam (GranuFoam®, GranuFoam® Silver, and Abdominal Dressings, etc.) or polyvinyl alcohol foam (Vers-Foam™ Dressing)] is cut to fit the wound, then covered with a semi-permeable adhesive drape. The software-controlled Therapy Unit applies negative pressure to the wound bed. The user can select continuous or intermittent therapy, depending upon wound type and the needs of each patient. The open cells of the foam enable equal distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. T.R.A.C.® (Therapeutic Regulated Accurate Care) technology monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.
Analysis of Acceptance Criteria and Study for K062227 (V.A.C.® Therapy System)
This 510(k) submission (K062227) by KCI USA, Inc. is for a modification to the V.A.C.® Therapy System, specifically a revision to the Indications for Use statement. It's crucial to note that this is not a submission for a new device, but rather an update to the labeling of an already legally marketed device. Therefore, the typical structure for a new device's performance study and acceptance criteria may not apply in the same way.
The submission states: "Because the V.A.C.® Therapy System has not been modified for the purposes of this submission, the predicate products are the V.A.C.® Therapy Family of Products (Therapy Units ATS, Freedom and Instill and their associated disposable components), which were most recently cleared under 510(k)s: K032310 (V.A.C.® ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (V.A.C.® GranuFoam® Silver Protection Dressing) and K022011 (V.A.C.® Abdominal Dressing)."
Furthermore, under the "Summary of nonclinical tests" and "Summary of clinical tests" sections, it explicitly states:
- "Not applicable; no new nonclinical tests were performed for the purposes of this submission."
- "Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature."
This indicates that no new performance studies with pre-defined acceptance criteria were conducted or are being presented in this specific 510(k) for the V.A.C. Therapy System. The basis for the revised Indications for Use relies entirely on published literature documenting the effective use of the V.A.C.® Therapy System.
Therefore, instead of a table of specific acceptance criteria and device performance from this submission, the "acceptance criteria" here is met by demonstrating that the proposed revised indications are consistent with existing scientific and clinical evidence from published literature.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) as an "Indications for Use" revision based on existing literature, a traditional table of acceptance criteria and reported device performance from new studies in this submission is not applicable.
Instead, the "acceptance criteria" here would be demonstrating that the proposed revised indications are supported by the body of existing clinical evidence available in published literature.
| Acceptance Criterion (Implicit for revised Indications for Use) | Basis for Meeting Criterion (from submission) |
|---|---|
| Proposed Indications for Use are supported by clinical evidence | "Published literature documenting the effective use of the V.A.C.® Therapy System in a variety of wound types and clinical situations support the following revision to the Indications for Use statement." |
Reported Device Performance (as inferred from the literature review context): The V.A.C.® Therapy System is reported to effectively:
- Create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention.
- Prepare the wound bed for closure.
- Reduce edema.
- Promote granulation tissue formation and perfusion.
- Remove exudate and infectious material.
- Be indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
- The V.A.C.® GranuFoam® Silver™ Dressing acts as an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
2. Sample Size Used for the Test Set and Data Provenance
As per the submission, "Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature."
Therefore, there is no specific test set or associated sample size detailed within this 510(k) document. The clinical evidence is derived from the broad existing body of published literature on the V.A.C.® Therapy System. Details of specific studies (sample size, provenance, retrospective/prospective nature) would be found within the referenced published literature, which is not provided in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new clinical study with a defined test set and ground truth establishment process was conducted for this submission. The "ground truth" for the expanded indications is implicitly established by the consensus and findings across the body of published medical literature.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical study with a defined test set requiring adjudication was conducted for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission is not evaluating human reader performance or the improvement with AI assistance. It's focused on the clinical indications for a wound therapy device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The V.A.C.® Therapy System is a physical medical device (negative pressure wound therapy system), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the updated indications is based on published clinical outcomes data and expert consensus as documented in the medical literature. The submission explicitly states: "Published literature documenting the effective use of the V.A.C.® Therapy System in a variety of wound types and clinical situations support the following revision to the Indications for Use statement."
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. If "training set" refers to the data that informed the original clearance of the device, that information would be in the predicate 510(k) submissions, not this one.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device in the context of this 510(k) notification.
In summary: This 510(k) notice is a request for a labeling change (expanded Indications for Use) for an existing medical device. The "study" that proves the device meets the acceptance criteria is explicitly stated as the body of published literature on the V.A.C.® Therapy System, rather than new, dedicated preclinical or clinical studies conducted for this specific submission. Therefore, many of the typical data points for AI/ML device evaluations (test set, training set, expert consensus for ground truth, MRMC studies) are not applicable to this particular 510(k) document.
§ 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.