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510(k) Data Aggregation

    K Number
    DEN180041
    Device Name
    Monarch eTNS System
    Manufacturer
    NeuroSigma, Inc
    Date Cleared
    2019-04-19

    (263 days)

    Product Code
    QGL,OGL
    Regulation Number
    882.5898
    Type
    Direct
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Monarch eTNS System

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

    The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

    Device Description

    The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:

    • The Monarch external pulse generator
    • The Monarch NS-2 external (cutaneous) electrical patches, which are single use disposable patches worn on the forehead.

    The device has two primary components A) an external pulse generator approximately the size of a cell phone, and B) the non-invasive electrical patch that patients apply to their forehead to receive therapy.

    AI/ML Overview

    The Monarch eTNS System underwent two clinical studies to establish its effectiveness and safety.

    1. Acceptance Criteria and Reported Device Performance

    The primary acceptance criteria for effectiveness were based on the change in ADHD-IV Rating Scale (ADHD-RS) scores.

    Acceptance Criteria (Implicit from Study 2 Primary Endpoint)Reported Device Performance (Study 2, Active Group vs. Sham)
    Statistically significant improvement in ADHD-IV RS total score in the active group compared to the sham group after 4 weeks of treatment.ADHD-RS Total Score:
    Active Group: Decreased from 34.1 at baseline to 23.4 at Week 4 (mean change of -10.7).
    Sham Group: Decreased from 33.7 at baseline to 27.5 at Week 4 (mean change of -6.2).
    The difference between active and sham groups was clinically meaningful and statistically significant (p
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