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510(k) Data Aggregation

    K Number
    K063590
    Device Name
    V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
    Manufacturer
    KCI USA, INC.
    Date Cleared
    2007-01-25

    (55 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K032310
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    The V.A.C. ATS® and V.A.C. Freedom® canisters are provided with a sterile fluid path for single use with the V.A.C. ATS® and V.A.C. Freedom® therapy units.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K063590 device:

    The provided text describes a 510(k) summary for V.A.C. Freedom® and V.A.C. ATS® Therapy Device Canisters. It focuses on the manufacturing change to maintain sterility of the fluid path in these canisters compared to predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated Goal)Reported Device Performance (Study Conclusion)
    Maintain integrity of the fluid path sterile barriersVerification through accelerated aging, distribution simulation, and microbial aerosol challenge testing.
    Ensure sterility assurance level (SAL) of 10^-6 for the fluid pathThe sterility assurance level of the sterile fluid path of the canisters can be assured to a level of 10^-6.
    Device is as safe and effective as the predicate deviceThe modified V.A.C. ATS® and V.A.C. Freedom® canisters with the sterile fluid path are safe and effective for their intended use.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify sample sizes for the "accelerated aging, distribution simulation, and microbial aerosol challenge testing." It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This information is not provided in the document. The studies performed (accelerated aging, distribution simulation, microbial aerosol challenge testing) are generally laboratory-based performance tests rather than studies requiring expert clinical assessment for ground truth.

    4. Adjudication Method

    This information is not applicable and therefore not provided. The studies conducted are performance tests, not clinical evaluations requiring adjudication from experts.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and therefore, there is no information on the effect size of human readers improving with or without AI assistance. This device is a medical device accessory and its evaluation did not involve AI or human interpretation in that context.

    6. Standalone (Algorithm Only) Performance

    A standalone performance study was not conducted. This device is not an algorithm or AI-based system, so this type of study is not relevant.

    7. Type of Ground Truth Used

    The ground truth used for these tests would be based on objective performance measurements of the physical and microbiological integrity of the sterile fluid path. For example:

    • Accelerated aging: Measuring the package integrity and sterility after simulated aging.
    • Distribution simulation: Assessing package integrity after simulating shipping and handling stress.
    • Microbial aerosol challenge testing: Direct measurement of the ability of the sterile barrier to prevent microbial ingress, verifying the 10^-6 SAL.

    8. Sample Size for the Training Set

    This information is not applicable and therefore not provided. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is not relevant to the nonclinical tests described for this physical device.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable as there is no training set for this device.

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