(90 days)
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.
The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 µsec) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS.
The NeuroStar TMS System is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar TMS System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
The NeuroStar TMS System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS TherapyTM. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. A singleuse device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient to patient. The TMS TrakStar (previously known as Practice Data Management System - PDMS) consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
This 510(k) summary (K130233) describes a labeling change to the NeuroStar TMS Therapy System, not a new device requiring performance data. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance is not applicable to this submission.
Here's a breakdown of the relevant information provided and why other sections are not applicable:
-
A table of acceptance criteria and the reported device performance
Not applicable. This 510(k) is for a labeling change to an already cleared device (K061053/K083538). No new performance data or acceptance criteria were required for this specific submission. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set data was generated or required for this labeling change. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment was needed for a labeling change. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used. -
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. This device is a transcranial magnetic stimulator for treatment, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. -
The sample size for the training set
Not applicable. This 510(k) is not for an AI/machine learning device requiring a training set. -
How the ground truth for the training set was established
Not applicable.
Summary of the K130233 Submission:
- Device: NeuroStar® TMS Therapy System
- Submission Type: 510(k) for a labeling change.
- Predicate Device: NeuroStar TMS Therapy® System [K061053/K083538]
- Reason for 510(k): To update the prescribing statement in the labeling to comply with the FDA's Class II Special Controls Guidance for Repetitive Transcranial Magnetic Stimulation (rTMS) Devices (26 July 2011).
- Conclusion: The FDA determined the device with the proposed labeling change is substantially equivalent to the predicate device, as no other changes were made to the device or its intended use. The substantial equivalence was based on similarities in indications for use, principles of operation, design for delivery of TMS, materials, shelf life, and packaging.
§ 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.