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510(k) Data Aggregation

    K Number
    K193197
    Device Name
    QuickClear Mechanical Thrombectomy System
    Manufacturer
    Volcano AtheroMed Inc.
    Date Cleared
    2020-04-20

    (152 days)

    Product Code
    QEZ,DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K070403,K181877,K180939
    Why did this record match?
    Reference Devices :

    K070403, K181877

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

    The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

    Device Description

    The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories:

    • QuickClear Aspiration Pump
    • A 60cc Syringe
    • QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip.
    • An Obturator is supplied with the 8F and 10F catheters.
    • A Waste Collection Bag
    AI/ML Overview

    This document is a 510(k) summary for the QuickClear Mechanical Thrombectomy System, seeking substantial equivalence to a predicate device. It primarily details the device's design, intended use, and a comparison to existing devices. It does not describe the acceptance criteria or a study proving the device meets performance criteria for a diagnostic tool (e.g., an AI-powered one).

    Instead, this device is a mechanical thrombectomy system, meaning it physically removes thrombus (blood clots). The testing described is for the physical performance and safety of a medical device, not the diagnostic performance of an AI algorithm.

    Therefore, I cannot extract the requested information (acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications for ground truth, MRMC study, etc.) from this document. This document pertains to the regulatory clearance of a mechanical medical device, not a diagnostic AI system.

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