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    K Number
    K211219
    Device Name
    LASSOSTAR NAV Circular Mapping Catheter
    Manufacturer
    Biosense Webster, Inc.
    Date Cleared
    2022-01-26

    (278 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K193632
    Why did this record match?
    Device Name :

    LASSOSTAR NAV Circular Mapping Catheter

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

    The LASSOSTAR™ NAV Circular Mapping Catheter is indicated for multiple electrode electrophysiology recording and stimulation of the atrial region of the heart. The catheter can be used with a compatible CARTO™ 3 System to provide location information and to create three-dimensional electroanatomic maps. (The catheter is not compatible with CARTO™ 3 Systems prior to Version 7.)

    Device Description

    The Biosense Webster LASSOSTAR™ NAV Circular Mapping Catheter is a 3.5 Fr, multielectrode electrophysiological circular mapping catheter designed to provide location information and to create three-dimensional electroanatomic maps of the heart. On its distal tip, the catheter has a loop with platinum electrodes that can be used for recording and stimulation. The tip has an embedded sensor that allows the catheter to provide location information and create threedimensional electroanatomic maps when used with a compatible Biosense Webster Inc. CARTO™ 3 System. The catheter is available in three loop diameters: 15 mm, 20 mm and 25 mm to allow for use in pulmonary veins of differing size. The catheter can be visualized using conventional systems (such as fluoroscopy or ultrasound imaging), or with a compatible CARTO™ 3 System via interface cables with the appropriate connectors. The LASSOSTAR™ NAV Circular Mapping catheter has three product configurations (D-1404-01-S, D-1404-02-S, D-1404-03-S).

    AI/ML Overview

    This document describes the FDA clearance for the LASSOSTAR™ NAV Circular Mapping Catheter. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm-based medical device.

    The provided text pertains to a physical medical device (a circular mapping catheter) and its substantial equivalence to a predicate device. The performance data section refers to bench and animal testing of the physical catheter, not a study evaluating an AI algorithm's performance.

    Therefore, I cannot populate the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, etc.) for an AI/algorithm device based on the provided text.

    The closest relevant information is:

    • Device Type: Physical Medical Device (LASSOSTAR™ NAV Circular Mapping Catheter)
    • Purpose: Electrophysiology recording and stimulation, and providing location information/creating 3D electroanatomic maps when used with a compatible CARTO™ 3 System.
    • Performance Data: Mentions "bench and animal testing using similar pre-determined acceptance criteria as the predicate device" to support modifications (decreased outer diameter, change in shaft material). Specific tests listed include Visual Inspections, Electrical, EEPROM Burn Checks, Buckle Force, Insertion, Torque, Tensile Strength, Impedance and resistance, Visualization, Packaging Sterile Barrier Gross Leak, Transportation, Sterilization, Simulated Use, Electrical Compatibility.

    Without information on an AI/algorithm component and its associated performance study, I cannot fulfill the request as specified.

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