(30 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 a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive maqnetic 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 ●
- . MT Cap
- TrakStar™ Patient Data Management System ●
- D-Tect™ MT Accessory ●
The proposed change to the NeuroStar Advanced Therapy System that is the subject of this 510(k) is the addition of the NeuroStar D-Tect™ MT Accessory, which is a non-sterile, multi-use device that provides an optional method to aid in the Motor Threshold (MT) hunt process. This device is used to provide indication and amplitude of hand movement during this process. The D-Tect™ MT Accessory includes a user display interface and a human hand interface with builtin sensors for measuring thumb and finger movements. The device is a standalone accessory that does not communicate or interact with the NeuroStar Advanced Therapy System, except for receiving pulse signals in order to sync data collection. Use of the device is optional, and provides an alternative, quantitative method to determine the MT compared to the standard of care, which includes a qualitative, visual assessment. The D-Tect™ MT Accessory is only used during the Motor Threshold (MT) determination process, which is only performed the first time a patient is seen by the doctor and is performed prior to the first treatment session.
This document describes a 510(k) premarket notification for the NeuroStar D-Tect™ MT Accessory, an addition to the NeuroStar Advanced Therapy System. The accessory is designed to aid in the Motor Threshold (MT) hunt process by providing an optional, quantitative method to determine the MT, as an alternative to the standard qualitative, visual assessment.
Acceptance Criteria and Device Performance:
The document does not specify quantified acceptance criteria or reported device performance metrics in the format of a table for the D-Tect™ MT Accessory itself. Instead, it relies on demonstrating that the D-Tect™ MT Accessory does not introduce new questions of safety or effectiveness and that the overall NeuroStar Advanced Therapy System, with the addition of this accessory, continues to conform to established performance standards.
The closest information related to performance is the statement that the device provides an "indication and amplitude of hand movement" during the MT hunt process.
Study Information:
The document explicitly states: "There is no clinical testing required to support this submission."
Therefore, the following points associated with clinical studies are not applicable or provided:
- Sample size used for the test set and the data provenance: Not applicable as no clinical testing was performed for this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical testing was performed for this submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical testing was performed for this submission.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical testing was performed for this submission. The D-Tect™ MT Accessory is a physical device that provides quantitative data to aid a human operator, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical testing was performed for this submission.
- The sample size for the training set: Not applicable as no clinical testing was performed for this submission.
- How the ground truth for the training set was established: Not applicable as no clinical testing was performed for this submission.
Non-clinical Testing:
The device's acceptance is primarily based on non-clinical performance and usability testing. These tests conform to the following recognized consensus standards:
- ISO 10993-1
- ANSI AAMI ES60601-1
- IEC 60601-1-2
- IEC 60601-1-6
Additionally, usability testing was completed in accordance with IEC 60601-1-6 Edition 3.1 2013-10 and the FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices."
The overarching conclusion is that the addition of the D-Tect™ MT Accessory, while providing an optional quantitative method for MT determination, does not alter the fundamental safety or effectiveness of the NeuroStar Advanced Therapy System, which has existing regulatory clearances (predicate devices listed: K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127). The accessory's function is to aid in a process, not to independently make diagnostic or treatment decisions.
§ 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.