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510(k) Data Aggregation

    K Number
    K993379
    Device Name
    PALL SUPOR AEF FILTER
    Manufacturer
    PALL CORP.
    Date Cleared
    1999-12-16

    (70 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K143583
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Removal by in-line filtration of inadvertent contaminants (including bacteria, particulates, and entrained air) from infused intravenous fluids.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "Pall Supor AEF™ Filter." This type of document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

    The 510(k) clearance process is primarily about demonstrating substantial equivalence to a predicate device already on the market, not about establishing specific performance metrics through detailed studies as would be required for an AI/ML diagnostic or assistive device.

    Therefore, I cannot provide the requested information from the given text.

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