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510(k) Data Aggregation

    K Number
    K073166
    Device Name
    ENDOWAVE INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2008-04-22

    (165 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K071933,K072507,K062508,K063620,K014054,K003052,K011557,K030589
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EndoWaveTM Infusion System is intended for the infusion of solutions into the pulmonary arteries.

    The safety and effectiveness of the EKOS EndoWaveTM Infusion system for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

    Device Description

    The EndoWaveTM Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.

    AI/ML Overview

    The provided text is a 510(k) summary for the EKOS EndoWave Infusion System. This document focuses on establishing substantial equivalence to predicate devices and detailing the intended use and limitations of the device. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications) related to a new performance study.

    Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

    The closest information available is:

    • "Performance: EKOS has conducted preclinical bench and animal studies with the EndoWave™ Infusion System. These studies demonstrate that the performance of the EndoWave™ Infusion System meets its design specifications for its intended use."

    This statement confirms that studies were done and that the device met its design specifications, but it does not provide any specifics about those specifications (acceptance criteria) or the studies themselves. Without these details, the requested table and accompanying study information cannot be generated.

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