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510(k) Data Aggregation

    K Number
    K162804
    Device Name
    Q2 Low Pressure Power Injection Extension Set
    Manufacturer
    QUEST MEDICAL, INC.
    Date Cleared
    2017-03-08

    (154 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K162304,K140831
    Why did this record match?
    Device Name :

    Q2 Low Pressure Power Injection Extension Set

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

    Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

    Device Description

    Sterile, single use non-pyrogenic intravenous administration extension set comprised of 7 inch tubing bonded to a male luer on one end and a female luer on the other end with a clamp in between. A swabable, needle-free port is connected to the female luer. This device is not made with the plasticizer Diethylhexylphthalate (DEHP).

    AI/ML Overview

    The provided text describes information for the Q2® Low Pressure Power Injection Extension Set, which is a medical device, and does not contain information about an AI/ML powered device. Therefore, I cannot extract information pertaining to AI/ML acceptance criteria or studies.

    However, I can provide available information regarding the device's performance as described in the document in a table format:

    1. A table of acceptance criteria and the reported device performance

    Test ParameterAcceptance Criteria / Predicate PerformanceReported Device Performance (Q2 Low Pressure Power Injection Extension Set)
    Particulate TestingPer ISO 8536-4:2010Successfully demonstrated device performs as intended and meets manufacturer specification.
    Simulated Shipping(Not explicitly stated but implied to meet functional requirements)Successfully demonstrated device performs as intended and meets manufacturer specification.
    Package Burst(Not explicitly stated but implied to meet functional requirements)Successfully demonstrated device performs as intended and meets manufacturer specification.
    Priming VolumePredicate:
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