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510(k) Data Aggregation

    K Number
    K980768
    Device Name
    VACUETTE HOLDEX
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1998-04-09

    (41 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K921520
    Predicate For
    K160532
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.

    Device Description

    The VACUETTE® Holdex® Holder is a single-use disposable plastic device to be used in routine venipuncture procedures using butterfly needles or luer needles. Sterile and non-sterile versions are available. The sterile version of VACUETTE® Holdex® is manufactured from polystyrene plastic and is sterilized by electronic beam. The non-sterile version is autoclavable and is manufactured from polycarbonate plastic.

    AI/ML Overview

    The provided text is a 510(k) summary for the Greiner VACUETTE® Holder and the FDA's response letter. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

    The document primarily focuses on establishing substantial equivalence to a predicate device (Becton Dickinson's VACUTAINER® Brand holder). This means it's a regulatory submission to show the new device is as safe and effective as a device already legally marketed, rather than a report on specific performance testing against pre-defined acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text. The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for a test set or data provenance.
    3. Number of experts or their qualifications for establishing ground truth.
    4. Adjudication method.
    5. Information on a multi-reader, multi-case comparative effectiveness study.
    6. Information on standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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