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510(k) Data Aggregation

    K Number
    K974227
    Device Name
    HOSPITAL'S CLAMP
    Manufacturer
    GPS
    Date Cleared
    1997-12-12

    (30 days)

    Product Code
    HFW
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DISPOSABLE, STERILE UMBILICAL CORD CLAMP
    TO BE USED FOR OBSTETRICS USE ONLY.
    UMBILICAL CORD CLAMP WITH SIDE FASTENERS
    TO PREVENT THE UMBILICAL CORD FROM GOING
    OUT OF THE BLOCKING COMBS
    IRREVERSIBLE CLOSURE TO PREVENT ACCIDENTAL
    OPENING.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for an Umbilical Cord Clamp, dated December 12, 1997. It primarily confirms the device's substantial equivalence to a pre-amendment device and outlines regulatory requirements. The second page details the device name and its indications for use.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results or effect size.
    6. 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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