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510(k) Data Aggregation

    K Number
    K252593
    Device Name
    LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-09-12

    (28 days)

    Product Code
    MXD
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K231328
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia, such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath. The LUX-Dx ICM is indicated for atrial fibrillation monitoring in patients that have been previously diagnosed or treated for atrial fibrillation.

    Device Description

    The LUX-Dx II and LUX-Dx II+ ICM devices evaluate S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation and evaluation when the algorithm criteria are met. The ICM device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The ICM device is powered by an integrated battery. The LUX-Dx system includes the following main components:

    • ICM device - a subcutaneously-implanted cardiac monitor device for cardiac arrhythmia event data collection and transmission. In addition, symptom events are collected and transmitted from the device.
    • Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the ICM device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
    • LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
    • System Accessories - for insertion of the ICM device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate ICM/MM app communication.
    AI/ML Overview

    N/A

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