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510(k) Data Aggregation

    K Number
    K222889
    Device Name
    FlowArt® Needle-Free Split Septum Valve
    Manufacturer
    Asset Medikal Tasarim San Tic As.
    Date Cleared
    2023-01-20

    (119 days)

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

    FlowArt® Needle-Free Split Septum Valve: Needle-free valve is intended for use as an accessory to a vascular access device used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein.

    Device Description

    FlowArt® Needle-Free Split Septum Valve

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "FlowArt® Needle-Free Split Septum Valve" and its indications for use. It briefly describes the device's purpose as an accessory for vascular access devices in hemodialysis or for administering/withdrawing fluids via an intravascular administration set.

    This document does not include information about:

    • Acceptance criteria or reported device performance in a table format.
    • Details of a study proving the device meets acceptance criteria.
    • Sample sizes, data provenance, number of experts, adjudication methods, or ground truth details for any test or training sets.
    • Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot provide a detailed response to your request based on the given input. The document is solely an FDA clearance letter confirming substantial equivalence to predicate devices, not a study report.

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