(90 days)
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
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 Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console
- System Software
- Treatment Chair
- Ferromagnetic Treatment Coil
- Head Support System
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MT Cap
- TrakStar™ Patient Data Management System
- D-Tect™ MT Accessory
- Beam F3 Treatment Pack
There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.
This document does not contain an acceptance criteria table or a detailed study proving the device meets specific performance criteria through clinical testing. Instead, it is a 510(k) premarket notification summary from the FDA, asserting substantial equivalence to previously cleared predicate devices.
The key statement is on page 5: "Clinical Testing: There is no clinical testing required to support this submission."
Therefore, I cannot provide the full response as requested, as the necessary information regarding acceptance criteria, reported performance, test set details, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in the provided document.
The document focuses on demonstrating that the proposed changes (wireless communication and the Beam F3 treatment location method) to the NeuroStar Advanced Therapy System do not raise new questions of safety or effectiveness when compared to its predicate devices. The "Performance Standards" section lists recognized consensus standards (ISO 10993-1, ANSI AAMI ES60601-1 / IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6) and mentions non-clinical performance testing and usability testing were performed according to relevant guidance documents. However, this is related to safety and electrical performance, not clinical efficacy or device performance against specific metrics as would be found in a detailed clinical study report proving accuracy or effectiveness.
§ 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.