(266 days)
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).
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
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 |
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.