(32 days)
The NeuroStar Advanced Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
The NeuroStar Advanced Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration 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 Maqnetic Stimulation (TMS). NeuroStar Advanced Therapy 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 in the current episode. NeuroStar Advanced Therapy is used for patient treatment by prescription only under the supervision of a licensed physician and can be used in both inpatient and outpatient settings including physician's offices, clinics, and hospitals. NeuroStar Advanced Therapy uses a well-understood property of physics regarding the law of electromagnetic induction, which states that a time-varying or moving magnetic field will induce an electric current in an adjacent conductive substance with the electric current traveling in a direction perpendicular to the motion of the magnetic field. NeuroStar Advanced Therapy uses a generated magnetic field as a vector for delivering an electrical current to a tarqet conductor of interest, which in therapeutic application, is the brain. By using this method of delivering electrical current to the brain the electrical current produced in the brain can be delivered in an anatomically focused manner at discrete cortical areas of interest and can avoid areas of the brain that are not relevant for its therapeutic actions.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console for housing the electronics and includes a software . controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil.
- Ferromagnetic Coil for delivering treatment. .
- . Head Support System for positioning the treatment coil and includes a laser-guided alignment system
- . Optional MT Cap for
- Multi-use consumable SenStar Treatment Link for contact sensing of the ● treatment coil with the patient's head and maqnetic field quality control.
- TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software
Here's a breakdown of the acceptance criteria and study information for the NeuroStar Advanced Therapy System, based on the provided FDA 510(k) summary:
The primary purpose of this 510(k) submission is for the addition of the MT Cap accessory. The document explicitly states that the NeuroStar Advanced Therapy System (the subject device) has the same indications for use and technological characteristics as the predicate device, implying that the core system's performance metrics have already been established in previous submissions. This K213543 submission focuses on the safety and effectiveness of the new accessory.
Therefore, the "acceptance criteria" and "device performance" in the context of this specific submission revolve around demonstrating that the MT Cap accessory does not negatively impact the existing performance or introduce new risks, and that it functions as intended to aid in the Motor Threshold Hunt process.
Acceptance Criteria and Reported Device Performance
Given that this 510(k) is an update for an accessory (MT Cap) to an already cleared device, the acceptance criteria are focused on demonstrating that the accessory does not compromise the device's safety or efficacy. The document does not provide specific quantitative performance metrics tied to sensitivity, specificity, accuracy, or similar measures typically found in standalone diagnostic AI/ML device acceptances. Instead, the "performance" demonstrated is compliance with relevant standards and successful usability.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (for MT Cap) | MT Cap material compliant with ISO 10993-1:2018; uses standard materials commonly used in consumer products and medical device applications. |
| Usability (for MT Cap integration) | Usability testing completed in accordance with IEC 60601-1-6:2010, Edition 3.1 and FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices." The MT Cap enables physicians to easily move the coil incrementally without adjusting the A/P Bar. |
| Safety - Electrical/EMC (overall system) | IEC 60601-1 compliant; IEC 60601-1-2 compliant (inherited from predicate device, not re-evaluated for MT Cap specifically as it's a passive accessory). |
| No New Questions of Safety or Effectiveness | The use of the optional MT Cap accessory "does not raise any new questions of safety or effectiveness." This is the overarching acceptance. |
| Functional Aiding of MT Hunt | MT Cap provides symmetrical grid for incremental coil movement and includes intersecting lines for starting point; aids in facilitating the hunt for the MT location. |
| No change to core treatment parameters | All core treatment parameters (%MT Range, PPS Range, Induced Electric Field, Pulse Type, Pulse Width, Treatment Protocols, Treatment Level Range) remain identical to the predicate device. |
Study Information Specific to the MT Cap Accessory
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Sample Size used for the test set and the data provenance:
- The document states, "There is no clinical testing required to support this submission."
- For Usability testing, the sample size is not explicitly stated in the provided text. Usability studies typically involve a small number of representative users (e.g., 8-15) as per human factors guidance, but the exact number is not here.
- The provenance for usability testing would typically be prospective, involving healthcare professionals interacting with the device/accessory. The document does not specify country of origin for usability test participants.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As no clinical testing was required, there was no "ground truth" to establish in the traditional sense of disease diagnosis or outcome for the MT Cap.
- For usability testing, "experts" would be the healthcare professionals participating in the test. Their qualifications would typically involve experience with TMS procedures. The document does not specify the number or detailed qualifications of these individuals.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there was no clinical study with a diagnostic endpoint requiring adjudication. Usability studies use qualitative and quantitative measures of user performance, error rates, and satisfaction rather than adjudication of findings.
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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:
- No MRMC or comparative effectiveness study was done. This device is a hardware accessory (MT Cap) for a TMS system, not an AI/ML diagnostic or assistive algorithm. The MT Cap is a physical guide to assist in a manual process (Motor Threshold Hunt), not an AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The MT Cap is a passive physical accessory, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for the MT Cap accessory. For the overall NeuroStar system (established in prior submissions), ground truth for Major Depressive Disorder (MDD) efficacy would have been based on clinical assessments (e.g., Hamilton Depression Rating Scale, Montgomery-Åsberg Depression Rating Scale) and clinical outcomes, but this is not part of this submission.
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The sample size for the training set:
- Not applicable as this is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device requiring a training set.
§ 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.