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510(k) Data Aggregation

    K Number
    K980087

    Validate with FDA (Live)

    Device Name
    PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
    Manufacturer
    PRESSURE PRODUCTS, INC.
    Date Cleared
    1998-07-01

    (173 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Pressure Products Pressure Pad is to temporarily occlude the femoral artery when used in conjunction with the appropriate femoral artery clamp.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract the acceptance criteria and the details of a study proving device performance. The document is an FDA letter regarding a 510(k) premarket notification for "Pressure Pads" and primarily discusses the device's substantial equivalence to a predicate device and regulatory compliance. It does not contain information about:

    1. Acceptance criteria or device performance data.
    2. Sample sizes for test or training sets.
    3. Details about expert involvement (number, qualifications, adjudication methods).
    4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    5. Standalone algorithm performance.
    6. Types of ground truth used.

    The letter confirms the device's classification and allows it to be marketed, but does not delve into the technical study results or validation parameters.

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