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510(k) Data Aggregation

    K Number
    K081725
    Device Name
    ENTERAL PUMP SET, MODEL 20-1010
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2008-11-07

    (142 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENTERAL PUMP SET, MODEL 20-1010

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

    The Enteral Pump Set is intended to dispense liquid nutrients from enteral formula containers with SpikeRight™ port via VIASYS MedSystems Enteral Pumps.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Enteral Pump Set Model 20-1010AIV." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

    However, the provided document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications. The document is solely a regulatory approval letter and an indications for use statement.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input, as this information is not present in the provided text.

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