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510(k) Data Aggregation

    K Number
    K231926
    Device Name
    NeuroStar Advanced Therapy System (All previously cleared models)
    Manufacturer
    Neuronetics, Inc.
    Date Cleared
    2024-03-22

    (266 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K083538,K130233,K133408,K160703,K161519,K201158,K213543,K222230,K230029
    Why did this record match?
    Reference Devices :

    K083538, K130233, K133408, K160703, K161519, K201158, K213543, K222230

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

    NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).

    Device Description

    The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.

    The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components:

    • Mobile Console
    • System Software
    • Treatment Chair
    • Head Support System
    • MT Cap
    • . D-Tect MT Accessory
    • TrakStar Data Management
    AI/ML Overview

    The NeuroStar Advanced Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Success Criteria)Reported Device Performance
    A minimum of 50% of the primary per protocol analysis population meet the Individual Subject Success Criteria (defined as a meaningful reduction in depression symptoms based on PHQ-9 scores over a pre-post TMS treatment interval of 6 weeks and achieving remission of MDD symptoms).77.8% (95% CI: 72.8%, 83.0%) of the primary per protocol population met the criteria.
    The lower limit of the 95% confidence interval for individual success rate should exceed the pre-established Overall Study Success Criteria of a minimum 50%.The lower limit (72.8%) exceeded 50% by 22.79%.
    Proportion of responders (defined as a meaningful reduction in depression symptoms based on PHQ-9 scores) is statistically significant.This proportion was found to be statistically significant at p
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