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510(k) Data Aggregation

    K Number
    K041517
    Device Name
    INFUSIONCATH
    Manufacturer
    ID LLC
    Date Cleared
    2004-08-05

    (59 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K013635,K992940,K913517
    Predicate For
    K052738,K052844,K073400
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

    Device Description

    The VeinRx InfusionCath is used to temporarily occlude a vessel in the peripheral vasculature and then deliver a predetermined dose of a physician specified fluid proximally along the inner lumen of the vessel. The VeinRx InfusionCath is comprised of a distal occlusion balloon, a variable treatment length catheter body with elution holes, and a proximal trifurcated Luer connection hub. The Trifurcated hub allows connections for to the following three main systems of the device. The Luer Lock connections for balloon inflation, infusion valve operation and fluid infusion. The device is provided sterile and for single patient use.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

    The documents are FDA substantial equivalence letters related to the "InfusionCath" device, primarily focused on administrative changes to product codes and the initial 510(k) clearance process. While they mention "product testing was conducted to evaluate conformance to product specification," they do not detail what those specifications or acceptance criteria are, nor do they provide the results or methodologies of such testing in a way that would allow me to answer your specific questions.

    The only "testing" mentioned is:

    • "mechanical strength testing, bond strength, balloon inflation / deflation and fluid infusion."
    • "In vivo animal testing comparing the InfusionCath to a commercially available predicate product was conducted." with the result "The results showed the InfusionCath was equivalent to the predicate device."

    However, this is not sufficient to construct the table or answer the detailed questions you've posed regarding acceptance criteria, study design, sample sizes, ground truth, or expert involvement.

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