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510(k) Data Aggregation

    K Number
    K250635
    Device Name
    FEops HEARTguide Simulation Application
    Manufacturer
    Feops Nv
    Date Cleared
    2025-11-25

    (267 days)

    Product Code
    QQI
    Regulation Number
    870.1405
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K223855,K214066
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K223855

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

    FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.

    The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.

    FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.

    FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.

    FEops HEARTguide™ Simulation Application is prescription use only.

    Device Description

    FEops HEARTguide™ Simulation Application predicts implant frame deformation after percutaneous LAAO device implantation through computer simulation. The predicted deformation provides additional information during LAAO procedural planning.

    The information provided by FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.

    The customer (clinician) does not interact with the simulation software directly. The simulations are performed by trained FEops case analysts through an established workflow. Based on a patient-specific 3D model of the anatomy, a computational model of the anatomy is generated and combined with a predefined computational model of the device.

    The simulation results are delivered to the customer through the medical device FEops HEARTguide™ ALPACA (FEops - K223855) in the form of 3D model visualizations and a PDF report. All results are accessible through a standard web browser. The customer cannot modify the simulation results nor run additional simulations.

    AI/ML Overview

    N/A

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