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    K Number
    K201422
    Device Name
    Arisure Closed System Drug Transfer Device (CSTD)
    Manufacturer
    Yukon Medical, LLC
    Date Cleared
    2021-03-02

    (277 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K141448
    Why did this record match?
    Device Name :

    Arisure Closed System Drug Transfer Device (CSTD)

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

    Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

    Device Description

    Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.

    AI/ML Overview

    The Yukon Medical, LLC Arisure Closed System Drug Transfer Device (CSTD) (K201422) demonstrates substantial equivalence to its predicate device (TEVADAPTOR® Closed Drug Reconstitution and Transfer System, K141448) based on a comprehensive set of non-clinical performance data.

    1. Acceptance Criteria and Reported Device Performance:

    The document provides a table of various tests conducted to support the substantial equivalence of the Arisure CSTD. The reported device performance is indicated by its compliance with the specified standards or by direct statements of outcome (e.g., "Non-pyrogenic," "Single use"). Where acceptance criteria are implicitly stated through comparison with standards, the device is reported to have met these. Explicit performance metrics are provided for certain aspects.

    Test NameAcceptance Criteria (Implicit/Explicit from provided text)Reported Device Performance
    CytotoxicityISO 10993-5 compliantMet
    HemocompatibilityISO 10993-4 compliantMet
    SensitizationISO 10993-10 compliantMet
    Systemic Toxicity (Acute)ISO 10993-11 compliantMet
    IrritationISO 10993-10 compliantMet
    Material-Mediated PyrogenicityISO 10993-11 compliantMet
    LAL EndotoxinANSI/AAMI ST72:2002, USP 24 compliantMet
    Luer AccessISO 594-2 compliantMet
    Liquid Leakage (back pressure)ISO 594-2 compliantMet
    Liquid Leakage (connected pressure)ISO 594-2 compliantMet
    Ease of AssemblyISO 594-2 compliantMet
    Resistance to OverridingISO 594-2 compliantMet
    Stress CrackingISO 594-2 compliantMet
    Separation ForceISO 594-2 compliantMet
    Gloved HandsUsable with nitrile gloved handsUsable with nitrile gloved hands
    Valve Removal Torque and Bond Strength>4.5 in-lbsMet (>4.5 in-lbs)
    Vial Pressure(Not explicitly stated in provided document, but implicitly met for CSTD function)Met
    Attachment Force4.5 in-lbs", "
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