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510(k) Data Aggregation

    K Number
    K033237
    Device Name
    VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Date Cleared
    2003-11-20

    (45 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K023543,K991659
    Why did this record match?
    Device Name :

    VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VARI-LASE is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

    Device Description

    The VARI-LASE Laser is a semiconducter diode laser operating at 810 ± 20 nanometers.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Vari-Lase Laser Console. It primarily focuses on the device's characteristics, intended use, and a declaration of substantial equivalence to predicate devices based on non-clinical testing and technology comparison.

    Based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets acceptance criteria in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, accuracy).

    The "Summary of Non-Clinical Testing" section lists various electrical and safety performance standards (EN60601-1, EN60601-1-1, EN60601-2, EN60601-1-4, EN60601-2-22) that the laser console complies with. These are general safety and performance standards for medical electrical equipment, not specific "acceptance criteria" related to a study on the clinical performance of the device's intended use against a defined ground truth.

    Therefore, I cannot populate the requested table and information points as they pertain to clinical performance studies. The document only references compliance with general electrical and safety standards.

    The document does not contain information on:

    1. A table of acceptance criteria and reported device performance (in terms of clinical metrics).
    2. Sample size used for the test set or data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method for a test set.
    5. A multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone performance of an algorithm.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.
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