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    K Number
    K061325
    Device Name
    BODYGAURD PAIN MANAGER INFUSION SYSTEM
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Date Cleared
    2006-08-24

    (105 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BODYGAURD PAIN MANAGER INFUSION SYSTEM

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

    The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "BodyGuard Pain Management Infusion System," indicating that the device has been found substantially equivalent to a predicate device.

    The document discusses:

    • The device name and regulation number.
    • The indications for use of the device.
    • Regulatory information regarding marketing the device.

    However, it does not include any details about:

    • Acceptance criteria and reported device performance.
    • Sample sizes, data provenance, ground truth establishment, or expert qualifications for any studies.
    • Adjudication methods.
    • Comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

    Therefore, I cannot fulfill your request for this specific device based on the information provided.

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