(176 days)
The V.A.C. ® Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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 ActiV.A.C.® Therapy Unit is designed for the application of V.A.C. Therapy in the acute, extended and home care settings. 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 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. Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via an IrDA or USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.
The provided K063692 document is a 510(k) premarket notification for the ActiV.A.C.® Therapy Unit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel studies.
Here's an analysis based on the information provided, explicitly addressing each point requested, even if the information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) document for the ActiV.A.C.® Therapy Unit does not define explicit acceptance criteria in quantifiable terms for a new study. Instead, it relies on demonstrating equivalence to a predicate device (V.A.C. Freedom® Therapy Unit) through technological characteristics and existing clinical data for the predicate.
Therefore, a table of acceptance criteria and reported device performance as typically understood for a new study isn't presented in this document. The "performance" is implicitly deemed acceptable if it is equivalent to the predicate.
| Acceptance Criteria (Not explicitly stated for new study) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| *Implicit: Equivalent technological and performance | The ActiV.A.C.® Therapy Unit and the V.A.C. Freedom® Therapy Unit have the same technology and performance specifications for the delivery of negative pressure wound therapy. The ActiV.A.C.® Therapy Unit provides optional, ancillary features that make it easier to use by the caregiver and patient, improving upon the predicate in elements affecting safety and usability. Verification and validation testing confirmed conformance to design specifications for these new features. Existing clinical data for the predicate's safe use are considered applicable to the ActiV.A.C.® Therapy Unit. |
| specifications to the predicate device.* | |
| Implicit: New ancillary features meet specifications. | Nonclinical tests (verification and validation) were performed on the new optional, ancillary features to assure conformance to design specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No new clinical "test set" in the context of typical AI/medical device performance evaluation was used. The submission relies on existing clinical data for the predicate device and nonclinical (engineering) verification/validation for the new features.
- Data Provenance: The "clinical data" referenced is from "randomized controlled trials, literature reports, and registry/MDR databases" related to the predicate V.A.C. Freedom® Therapy Unit. The country of origin is not specified, but these are generally international sources if not specified otherwise. This data is retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. As no new clinical "test set" requiring ground truth establishment by experts for performance evaluation was conducted, this information is not provided. The study relies on existing clinical evidence from the predicate.
4. Adjudication Method for the Test Set
Not applicable. No new clinical "test set" requiring adjudication for ground truth was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This document pertains to a hardware device (negative pressure wound therapy unit) with software control and optional ancillary features, not an AI or imaging diagnostic algorithm applied to human interpretation. Therefore, an MRMC study and AI assistance effect size are not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a therapy unit, not an AI algorithm performing a diagnostic task. Its "performance" involves delivering negative pressure therapies and managing alarms, which are functions of the integrated system, not a standalone algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus) doesn't directly apply here. Instead, the "truth" for the device's function is its ability to:
- Deliver negative pressure wound therapy with performance characteristics equivalent to the predicate.
- Monitor and maintain target pressure.
- Signal alarms correctly (tubing blockages, full canister, low battery, leaks).
- Perform its ancillary features (Seal Check, Therapy Settings Guide, screen guard, data export, log tool) as designed.
These are verified through engineering analysis, verification, and validation testing against design specifications and comparison to the predicate's established performance. The clinical safety and efficacy are inferred from the predicate device's substantial body of clinical data and literature.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves training data in the typical sense. The "training" for the device's development involves engineering design, prototyping, and iterative testing, not a dataset for algorithm training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the development and testing of the device's functions (e.g., proper pressure delivery, correct alarm activation) would be engineering specifications, validated measurement equipment, and established medical standards for negative pressure wound therapy.
§ 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.