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510(k) Data Aggregation

    K Number
    K220177
    Device Name
    Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
    Date Cleared
    2022-09-01

    (223 days)

    Product Code
    Regulation Number
    882.5805
    Why did this record match?
    Applicant Name (Manufacturer) :

    Magnus Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Magnus Neuromodulation System with SAINT Technology is indicated for the treatment of Maior Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidenressant medication in the current episode.
    Device Description
    The Magnus Neuromodulation System (MNS) with SAINT Technology is a non-invasive repetitive transcranial magnetic stimulation (rTMS) system that delivers individualized and navigationally directed repetitive magnetic pulses to the left dorsolateral prefrontal cortex (L-DLPFC) to treat Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. The MNS with SAINT Technology is available for prescription use only and is intended for use by trained medical professionals in either an inpatient or outpatient setting. The Magnus Neuromodulation System consists of hardware devices (stimulator with treatment coil and neuronavigation system) intended to deliver SAINT Technology; that is, rTMS (as intermittent theta burst stimulation (iTBS)) to a target area within the L-DLPFC along with proprietary software informed by structural and functional MRI and designed to identify the individualized target within the L-DLPFC for stimulation. Also included in the system are a coil and monitor for motor threshold determination, which is used to inform patient-specific stimulation settings. SAINT Technology is the combination of using the specific individualized target for treatment along with a proprietary accelerated treatment protocol that condenses treatment to five days. The Magnus Neuromodulation System is designed to support successful delivery of SAINT Technology.
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