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510(k) Data Aggregation

    K Number
    K220866
    Device Name
    EKOS+ Endovascular Device
    Manufacturer
    Boston Scientific
    Date Cleared
    2022-04-20

    (26 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EKOS+ Endovascular Device

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K213422
    Device Name
    EkoSonic Endovascular Device, EKOS+ Endovascular Device
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2021-12-14

    (55 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K191119,K200648
    Why did this record match?
    Device Name :

    EkoSonic Endovascular Device, EKOS+ Endovascular Device

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

    The EkoSonicTM Endovascular System is indicated for the:
    · Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis
    · Controlled and selective infusion of physician-specified fluids, into the pulmonary arteries and or peripheral vasculature.

    The EKOS+ Endovascular System is indicated for the:
    · Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis
    · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/ or peripheral vasculature.

    Device Description

    The sterile, single-use EkoSonic Endovascular Device consists of an Infusion Catheter (IC) and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.

    The sterile, single-use EKQS+ Endovascular Device consists of an Infusion Catheter (IC),and an Ultrasonic Core (USC). The USC fits within the central lumen of the IC. Together, they are used to deliver physician-specified fluids and ultrasound energy to the treatment zone.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance metrics. Instead, it is a 510(k) premarket notification for the EkoSonic Endovascular Device and EKOS+ Endovascular Device, which are medical devices for intravascular infusion, not AI/ML software.

    The document discusses expanding the Indications for Use to include Deep Vein Thrombosis (DVT), stating that this change does not impact the technological characteristics of the device. It references a systematic literature review, including data from the ACCESS-PTS trial and CAVA studies, to support the inclusion of DVT in the indications for use.

    Therefore, I cannot extract the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these are not relevant to the content of this document.

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