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    K Number
    K021293
    Device Name
    ARTERIA BLOOD FILTER
    Manufacturer
    ARTERIA MEDICAL SCIENCE, INC.
    Date Cleared
    2002-08-22

    (121 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K993120
    Why did this record match?
    Device Name :

    ARTERIA BLOOD FILTER

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

    The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.

    Device Description

    The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a medical device called the "ArteriA Blood Filter," which is a blood administration filter. It describes the device, its intended use, and states its substantial equivalence to a predicate device.

    *However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the purpose of demonstrating performance.

    The 510(k) summary provided here focuses on administrative details, device description, intended use, and comparison to a predicate device to establish substantial equivalence based on design, materials, and function, rather than a detailed performance study proving specific acceptance criteria.

    Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document states: "The basic technologies, design and function of ArteriA Medical Science, Inc.'s ArteriA Blood Filter are substantially equivalent in design, materials of construction, and intended us to the predicate device." This indicates that the regulatory submission primarily relied on demonstrating equivalence to an already approved device rather than a de novo performance study against specific acceptance criteria.

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