NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Device Facts
| Record ID | K213543 |
|---|---|
| Device Name | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health |
| Applicant | Neuronetics, Inc. |
| Product Code | OBP · Neurology |
| Decision Date | Dec 10, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5805 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The NeuroStar Advanced Therapy system is indicated for the treatment of Major Depressive Disorder in adult patients who failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Device Story
NeuroStar Advanced Therapy System is a computerized, electromechanical device for Transcranial Magnetic Stimulation (TMS). It delivers brief, pulsed magnetic fields to induce electrical currents in the cerebral cortex. Used in inpatient/outpatient settings (clinics, hospitals, physician offices) by trained clinicians. The system includes a mobile console, ferromagnetic coil, head support system, and TrakStar data management. The new MT Cap accessory is a single-use wearable grid used during the Motor Threshold (MT) Hunt process to guide coil positioning. The physician monitors the patient's hand for involuntary movement during pulse delivery to determine the MT. The system allows for anatomically focused stimulation of the left dorsolateral prefrontal cortex. By delivering targeted electrical currents, the device provides a non-invasive therapeutic option for patients with treatment-resistant Major Depressive Disorder.
Clinical Evidence
Bench testing only. No clinical data required for this submission. Usability testing was conducted in accordance with IEC 60601-1-6:2010 and FDA human factors guidance.
Technological Characteristics
Electromechanical TMS system; ferromagnetic iron core coil with internal cooling fan. Laser-guided coil positioning. Connectivity via TrakStar data management system. Compliant with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10993-1:2018 (biocompatibility). Single-use MT Cap accessory for positioning. Biphasic sinusoid pulse type; 185µS nominal pulse width.
Indications for Use
Indicated for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- NeuroStar Advanced Therapy System (K201158)
Submission Summary (Full Text)
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December 10, 2021
Neuronetics, Inc Fred Cowdery Director, Regulatory Affairs and Qulaity Assurance 3222 Phoenixville Pike Malvern, Pennsylvania 19355
### Re: K213543
Trade/Device Name: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: November 2, 2021 Received: November 8, 2021
Dear Fred Cowdery:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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### Indications for Use
510(k) Number (if known)
#### K213543
Device Name NeuroStar Advanced Therapy System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a teal and purple graphic of three people holding hands in a circle.
# 510(k) Summary (As required by Section 807.92)
| Date Prepared: | November 2, 2021 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Neuronetics, Inc.<br>3222 Phoenixville Pike<br>Malvern, PA. 19355 |
| Contact Person: | Fred Cowdery<br>Director – Regulatory Affairs and Quality Assurance<br>Ph 610.981-4138<br>Email: fred.cowdery@neurostar.com |
| Device Trade Name: | NeuroStar<br>NeuroStar TMS Therapy System<br>NeuroStar Advanced Therapy System<br>NeuroStar Advanced Therapy for Mental Health |
| Device Name: Common: | Transcranial Magnetic Stimulation System |
| Classification: | 21 CFR 882.5802, Transcranial Magnetic Stimulation<br>System for Neurological and Psychiatric Disorders<br>and Conditions |
| Regulatory Class: | Class II Medical Device |
| Product Code: | OBP |
| Predicate Device(s): | NeuroStar Advanced Therapy System, K201158, |
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Image /page/4/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the words is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "Star" is a teal and purple graphic of three people holding hands in a circle.
## Device Description / Technological Characteristics:
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
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Image /page/5/Picture/0 description: The image is a logo for NeuroStar, a company that provides advanced therapy for mental health. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a teal and purple star-shaped design with two people figures. Below the words "NeuroStar" is the phrase "Advanced Therapy for Mental Health".
Proposed Change:
The proposed change to the NeuroStar Advanced Therapy System is the addition of the a single use wearable device, namely the MT Cap Accessory, which provides an optional method to aid in the Motor Threshold Hunt process (MT Hunt).
lt is only worn during the MT Hunt (prior to the patient's first treatment session) as a quide to facilitate the hunt for the MT location.
The MT Cap outer surface contains a symmetrical grid printed with alternating colors, and includes two intersecting lines which indicate the MT Hunt starting point for coil positioning. The seam on the cap is aligned the patient's nasion and the edge of the cap is positioned above the patient's eyebrows.
The symmetrical grid printed on the outer surface of the MT Cap enables the physician to easily move the coil incrementally in the anterior and posterior directions without having to adjust the A/P Bar.
As pulses are delivered to the patient during the MT Hunt process, the treating physician monitors the patient hand for involuntary movement in exactly the same manner as the current method.
The SOA grid lines are then used to align the coil to deliver pulses in the SOA angle (i.e. medial/lateral directions). When each pulse is delivered, the treating physician is observing the patient hand for involuntary movement in exactly the same manner as the current method.
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Image /page/6/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a graphic of three people holding hands in a star shape, with the people in teal and purple. Below the words is the phrase "Advanced Therapy for Mental Health".
## Intended Use:
The NeuroStar Advanced Therapy system is indicated for the treatment of Major Depressive Disorder in adult patients who failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
## Performance Standards:
The NeuroStar Advanced Therapy system has been tested and conforms with the following recognized consensus standards:
- IEC60601-1
- IEC60601-1-2 .
- ISO 10993-1:2018 .
- IEC 60601-1-6:2010, Edition 3.1 .
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Image /page/7/Picture/0 description: The image shows the logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Above and to the right of the word "Star" is a star-shaped graphic made of three figures holding hands. Below the words "NeuroStar" is the phrase "Advanced Therapy for Mental Health".
## Non-Clinical Testing:
The contents of this 510(k) complies with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff". The non-clinical performance testing of the MT Cap was conducted according to ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
Additionally, Usability testing was completed in accordance with IEC 60601-1-6:2010, Edition 3.1 and also following the FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices".
## Clinical Testing:
There is no clinical testing required to support this submission.
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Image /page/8/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the words is the phrase "Advanced Therapy for Mental Health".
#### Technical Comparison:
| Device Feature | Subject Device, NeuroStar<br>Advanced Therapy System | Predicate Device, NeuroStar<br>Advanced Therapy System<br>K201158 | Substantial EquivalenceRationale |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended Use | Major Depressive Disorder | Major Depressive Disorder | Same |
| Indications for<br>Use | Treatment of Major Depressive Disorder<br>in adult patients who have failed to<br>receive satisfactory improvement from<br>prior antidepressant medication in<br>the current episode | Treatment of Major Depressive Disorder<br>in adult patients who have failed to<br>receive satisfactory improvement from<br>prior antidepressant medication in<br>the current episode | Same |
| Population | Adult patients | Adult patients | Same |
| Materials | Standard materials commonly<br>used in the manufacture of<br>electrical medical devices. | Standard materials commonly<br>used in the manufacture of<br>electrical medical devices. | Same |
| Device Feature | Subject Device, NeuroStar<br>Advanced Therapy System | Predicate Device, NeuroStar<br>Advanced Therapy System<br>K201158 | Substantial Equivalence Rationale |
| Design | Computerized, electromechanical<br>medical devices that use integrated<br>systems to deliver TMS<br>therapy | Computerized, electromechanical<br>medical devices that use integrated<br>systems to deliver TMS<br>therapy | Same |
| Energy Source | Power console with magnetic<br>coil for delivery of magnetic<br>energy | Power console with magnetic<br>coil for delivery of magnetic<br>energy | Same |
| Biocompatibility | Patient-contacting device components<br>use standard materials compliant with<br>ISO10993-1:2018 that are commonly<br>used in consumer products and medical<br>device<br>applications. | Patient-contacting device components use<br>standard materials compliant with ISO<br>10993-1:2018 that are commonly used in<br>consumer products and medical device<br>applications | Same |
| Electrical Safety<br>EMC | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | Same |
| Device Feature | Subject Device, NeuroStar<br>AdvancedTherapy System | Predicate Device, NeuroStar<br>AdvancedTherapy System<br>K201158 | Substantial Equivalence Rationale |
| Sterility | No parts of the device, accessories, or components are required to be sterilized | No parts of the device, accessories, or components are required to be sterilized | Same |
| Coil Type | Ferromagnetic<br>Iron Core<br>Internal Cooling Fan | Ferromagnetic<br>Iron Core<br>Internal Cooling Fan | Same |
| Coil Positioning System | Integrated into Head SupportSystem<br>Laser-Aided Coil Placement | Integrated into Head SupportSystem<br>Laser-Aided Coil Placement | Same |
| Treatment Quality Features | Magnetic Field Level<br>Detection Coil Contact<br>Sensing | Magnetic Field Level<br>Detection Coil Contact<br>Sensing | Same |
| Anatomical Sites | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | Same |
| Device Feature | Subject Device, NeuroStar<br>Advanced Therapy System | Predicate Device, NeuroStar<br>Advanced Therapy System<br>K201158 | Substantial Equivalence Rationale |
| Treatment<br>Requirements | TMS Treatments<br>5 days per week for 4 to 6weeks<br>Total of 20 to 30 treatment<br>sessions | TMS Treatments<br>5 days per week for 4 to 6weeks<br>Total of 20 to 30 treatment<br>sessions | Same |
| Device<br>Components | Mobile Console<br>Ferromagnetic Coil for delivering treatment.<br>Head Support System for coil positioning.<br>MT Cap for coil positioning<br>Multi-use disposable for contact sensing<br>and magnetic field quality control.<br>TrakStar System for recording patient data | Mobile Console Ferromagnetic Coil<br>for delivering treatment.<br>Head Support System for coil positioning.<br>Multi-use disposable for contact sensing<br>and magnetic field quality control.<br>TrakStar System for recording patient data. | Different<br>The addition of the MT Cap accessory is the subject of this special 510K |
| %MT Range | 25% to 140% MT | 25% to 140% MT | Same |
| Device Feature | Subject Device, NeuroStar<br>Advanced Therapy System | Predicate Device, NeuroStar<br>Advanced Therapy System<br>K201158 | Substantial Equivalence Rationale |
| Pulses per Second<br>(PPS)Range | For Treatment: 1 to 30 PPS For MT<br>Determination: 0.1 to<br>0.3 PPS | For Treatment: 1 to 30 PPS For MT<br>Determination: 0.1 to<br>0.3 PPS | Same |
| Induced Electric<br>Field at 2 cm at<br>1.0 SMT | 135 V/m (Nominal) | 135 V/m (Nominal) | Same |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid | Same |
| Pulse Width | 185µS (Nominal) | 185µS (Nominal) | Same |
| Treatment<br>Protocols | Standard Treatment Level: 120% MT<br>with allowable adjustments<br>Repetition Rate: 10 PPS Stimulation<br>Time: 4 sec.<br>Inter-train Interval: As low as11 sec.<br>Session Duration: As low as<br>18.75 min.<br>Pulses per Session: 3000<br>Sessions per Week: 5 | Standard Treatment Level: 120% MT<br>with allowable adjustments<br>Repetition Rate: 10 PPS Stimulation<br>Time: 4 sec.<br>Inter-train Interval: As low as11 sec.<br>Session Duration: As low as<br>18.75 min.<br>Pulses per Session: 3000<br>Sessions per Week: 5 | Same |
| Device Feature | Subject Device, NeuroStar<br>Advanced Therapy System | Predicate Device, NeuroStar<br>Advanced Therapy System<br>K201158 | Substantial Equivalence Rationale |
| | NeuroBurst Treatment Level: 80 -<br>120% MT with allowable adjustments<br>Stimulation Time: 2 sec. Inter-train<br>Interval: 8 sec. Pulses per Burst: 3<br>pulses<br>Interpulse Interval: 20 ms<br>Pulses per Session: 600 Session<br>Duration: 3.3 min Bursts per Second: 5<br>burstsAmplitude:<br>0.22-2.08 SMT (≤ 5% drop) | NeuroBurst Treatment Level: 80 -120%<br>MT with allowable adjustments<br>Stimulation Time: 2 sec. Inter-train<br>Interval: 8 sec. Pulses per Burst: 3<br>pulses<br>Interpulse Interval: 20 ms<br>Pulses per Session: 600 Session Duration:<br>3.3 min Bursts per Second: 5 bursts<br>Amplitude:<br>0.22-2.08 SMT (≤ 5% drop) | Same |
| Treatment Level<br>Range | Standard Treatment<br>0.22 SMT to 2.08 SMTCalibrated linear<br>output | Standard Treatment<br>0.22 SMT to 2.08 SMTCalibrated linear<br>output | Same |
| | NeuroBurst Treatment<br>0.22 to 1.9 SMT<br><br>80-120% MT<br><br>≤ 5% drop | NeuroBurst Treatment<br>0.22 to 1.9 SMT<br><br>80-120% MT<br><br>≤ 5% drop | Same |
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Image /page/9/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a star shape with human figures at the points. Below the words is the phrase "Advanced Therapy for Mental Health."
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Image /page/10/Picture/0 description: The image is a logo for NeuroStar Advanced Therapy for Mental Health. The word "Neuro" is in purple, and the word "Star" is in teal. To the right of the word "Star" is a star-shaped figure with a person in the middle.
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Image /page/11/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. The tagline "Advanced Therapy for Mental Health" is in a smaller font below the words NeuroStar. To the right of the word "Star" is a teal and purple star-shaped design.
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Image /page/12/Picture/0 description: The image shows the logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. To the right of the word "Star" is a teal star with a purple person figure at the top. Below the words "NeuroStar" is the phrase "Advanced Therapy for Mental Health".
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Image /page/13/Picture/0 description: The image is a logo for NeuroStar Advanced Therapy for Mental Health. The word "Neuro" is in purple, and the word "Star" is in teal. Above the word "Star" is a teal and purple star-shaped figure with a person in the middle.
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Image /page/14/Picture/0 description: The image is a logo for NeuroStar. The word "Neuro" is in purple, and the word "Star" is in teal. Below the words is the phrase "Advanced Therapy for Mental Health". To the right of the words is a teal and purple star-shaped design.
## Conclusion:
The NeuroStar Advanced Therapy System and the primary predicate device have the same indications for use and the same technological characteristics. The use of the optional MT Cap accessory does not raise any new questions of safety or effectiveness.
