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510(k) Data Aggregation

    K Number
    K220270
    Device Name
    Aspirex Thrombectomy System
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2022-06-21

    (141 days)

    Product Code
    QEW,DQX
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K172315,K192833
    Why did this record match?
    Reference Devices :

    K172315

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

    The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.

    Device Description

    The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use.

    The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.

    The Aspirex™ Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated tungsten tip coated with DSM ComfortCoat® hydrophilic coating. The guidewire is used to initially cross through the area to be treated.

    AI/ML Overview

    The provided text describes a medical device, the Aspirex™ Thrombectomy System, and its performance data to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study related to an AI/algorithm-based device's performance, human reader assistance, or ground truth establishment for such a device.

    The study described is a GLP animal study comparing the Aspirex™ catheter (test article) to the Indigo Aspiration Catheter (control article) in healthy veins. This study assesses the physical and biological performance of the catheters, not an AI algorithm.

    Therefore, I cannot provide the requested information regarding AI device acceptance criteria and performance based on the input text. The text does not discuss:

    1. A table of acceptance criteria and the reported device performance for an AI/algorithm.
    2. Sample size for a test set (related to AI data) or data provenance.
    3. Number of experts or their qualifications for establishing ground truth for AI data.
    4. Adjudication method for an AI test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
    6. Standalone performance of an AI algorithm.
    7. Type of ground truth used for AI (e.g., expert consensus, pathology, outcomes data).
    8. Sample size for a training set for an AI algorithm.
    9. How ground truth for a training set for an AI algorithm was established.

    The document focuses on the mechanical and biological performance of a physical medical device (thrombectomy system) through in vitro and animal studies, and its substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

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