NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health

K222230 · Neuronetics, Inc. · OBP · Aug 24, 2022 · Neurology

Device Facts

• Record ID: K222230
• Device Name: NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
• Applicant: Neuronetics, Inc.
• Product Code: OBP · Neurology
• Decision Date: Aug 24, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

NeuroStar Advanced Therapy System is a computerized, electromechanical transcranial magnetic stimulation (TMS) device. It delivers non-invasive magnetic pulses to the cerebral cortex to induce electrical currents, activating neurons in targeted brain regions. The system includes a mobile console, treatment chair, ferromagnetic coil, and head support. The new D-Tect MT Accessory is an optional, standalone, multi-use device used during the initial Motor Threshold (MT) determination process. It features a user display and hand interface with sensors to measure thumb and finger movements, providing a quantitative alternative to the standard qualitative visual assessment. The accessory receives pulse signals from the system to sync data collection but does not otherwise interact with the therapy system. The device is operated by clinicians in inpatient or outpatient settings. By facilitating accurate MT determination, the accessory assists in calibrating the TMS therapy, which benefits patients by ensuring appropriate stimulation levels for treating MDD and comorbid anxiety.

Clinical Evidence

No clinical testing required to support this submission. Bench testing and usability engineering were performed in accordance with FDA guidance and recognized consensus standards.

Technological Characteristics

Computerized electromechanical TMS system. Components: mobile console, ferromagnetic treatment coil, head support, MT Cap, and D-Tect MT Accessory. Materials compliant with ISO 10993-1. Energy source: power console with magnetic coil. Connectivity: D-Tect accessory receives pulse signals for data sync. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6.

Indications for Use

Indicated for adult patients with Major Depressive Disorder (MDD) and comorbid anxiety symptoms who have failed to achieve satisfactory improvement from previous antidepressant medication treatment 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 (K083538, K130233, K133408, K160703, K161519, K201158, K213543, K220127)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 24, 2022

Neuronetics, Inc. Amanda Pentecost, PhD Regulatory Affairs Specialist 3222 Phoenixville Pike Malvern, PA 19355

## Re: K222230

Trade/Device Name: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: July 21, 2022 Received: July 25, 2022

Dear Dr. Pentecost:

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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

Enclosure

{2}------------------------------------------------

## Indications for Use

Submission Number (if known)

K222230

Device Name

NeuroStar D-Tect MT Accessory (81-00241-000)

Indications for Use (Describe)

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.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a stylized font. 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 graphic of a star with a person in the middle.

# 510(k) Summary

| Date Prepared: | July 19, 2022 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Neuronetics, Inc.<br>3222 Phoenixville Pike<br>Malvern, PA 19355 |
| Contact Person: | Amanda Pentecost, PhD<br>Regulatory Affairs Specialist<br>Phone: [phone], ext. 1132<br>Email: [e-mail] |
| Secondary Contact: | Robin Fatzinger, RAC<br>Sr. Director, Regulatory Affairs<br>Phone: [phone], ext. 1064<br>Email: [e-mail] |
| Device Trade Name: | NeuroStar<br>NeuroStar TMS Therapy System<br>NeuroStar Advanced Therapy System<br>NeuroStar Advanced Therapy System for Mental Health |
| Device Common Name: | Transcranial Magnetic Stimulator |
| Classification: | 21 CFR 882.5805 |
| Product Code: | OBP |
| Predicate Device: | NeuroStar Advanced Therapy System (K083538, K130233,<br>K133408, K160703, K161519, K201158, K213543, and K220127) |

Image /page/3/Picture/6 description: The image shows a logo with the letters 'NS' in a stylized, sans-serif font. The letters are purple. Above the letters is a graphic of three stylized figures with outstretched arms, also in purple. The figures are arranged in a semi-circle, suggesting unity or collaboration. The overall design is simple and modern.

{4}------------------------------------------------

## Device Description / Technological Characteristics:

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.

## Indications for Use:

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.

Image /page/4/Picture/18 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and appear to be connected. Above the letters, there are three abstract figures that resemble people with outstretched arms, arranged in a semi-circle. These figures are also purple and contribute to the overall design of the logo.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. To the right of the word "NeuroStar" is a star-shaped design with human figures at each point.

### Performance Standards:

The use of the D-Tect™ MT Accessory with the NeuroStar Advanced Therapy System has been tested and conforms to the following recognized consensus standards:

- . ISO 10993-1
- ANSI AAMI ES60601-1 ●
- IEC 60601-1-2 ●
- IEC 60601-1-6

#### 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." Non-clinical performance testing was performed according to the standards listed above.

Additionally, usability testing was completed in accordance with IEC 60601-1-6 Edition 3.1 2013-10 and also following FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices."

#### Clinical Testing:

There is no clinical testing required to support this submission.

Image /page/5/Picture/15 description: The image shows a logo with the letters 'NS' in a bold, sans-serif font. The letters are purple. Above the letters, there are three stylized figures that appear to be people holding hands, also in purple. To the right of the letters, there is a curved, swooping line that resembles a stylized star or comet tail, also in purple. The overall design is simple and modern.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a logo for NeuroStar, a company that provides advanced therapy for mental health. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller, sans-serif font. To the right of the word "NeuroStar" is a stylized star shape. The star shape is made up of several curved lines that come together to form a point.

# Technological Comparison:

| | NeuroStar Advanced Therapy System<br>(Subject Device) | NeuroStar Advanced Therapy System<br>(Predicate Device) | Explanation of<br>Differences |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Indications for Use | The NeuroStar Advanced Therapy System<br>is indicated for the treatment of depressive<br>episodes and for decreasing anxiety<br>symptoms for those who may exhibit<br>comorbid anxiety symptoms in adult<br>patients suffering from Major Depressive<br>Disorder (MDD) and who failed to achieve<br>satisfactory improvement from previous<br>antidepressant medication treatment in<br>the current episode. | The NeuroStar Advanced Therapy System<br>is indicated for the treatment of depressive<br>episodes and for decreasing anxiety<br>symptoms for those who may exhibit<br>comorbid anxiety symptoms in adult<br>patients suffering from Major Depressive<br>Disorder (MDD) and who failed to achieve<br>satisfactory improvement from previous<br>antidepressant medication treatment in the<br>current episode. | No Difference |
| Intended Use | Major Depressive Disorder (MDD) and<br>comorbid anxiety symptoms | Major Depressive Disorder (MDD) and<br>comorbid anxiety symptoms | No Difference |
| Anatomical Sites | Left dorsolateral prefrontal cortex | Left dorsolateral prefrontal cortex | No Difference |
| Target Population | Adult patients | Adult patients | No Difference |
| Clinical Setting | Inpatient and outpatient settings,<br>including physician's offices and clinics,<br>hospitals, and general medical/surgical<br>hospitals | Inpatient and outpatient settings, including<br>physician's offices and clinics, hospitals,<br>and general medical/surgical hospitals | No Difference |
| Materials | Standard materials commonly used in the<br>manufacture of electrical medical devices | Standard materials commonly used in the<br>manufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components use<br>standard materials compliant with ISO<br>10993-1 that are commonly used in<br>consumer products and medical device<br>applications | Patient-contacting device components use<br>standard materials compliant with ISO<br>10993-1 that are commonly used in<br>consumer products and medical device<br>applications | No Difference |
| Design | Computerized, electromechanical medical<br>devices that use integrated systems to<br>deliver TMS therapy | Computerized, electromechanical medical<br>devices that use integrated systems to<br>deliver TMS therapy | No Difference |
| Energy Source | Power console with magnetic coil for<br>delivery for magnetic energy | Power console with magnetic coil for<br>delivery for magnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | IEC 60601-1 compliant<br>IEC 60601-1-2 compliant | No Difference |
| Sterility | No parts of the device, accessories or<br>components are required to be sterilized | No parts of the device, accessories or<br>components are required to be sterilized | No Difference |
| Coil Type | Ferromagnetic<br>Iron core<br>Internal cooling fan | Ferromagnetic<br>Iron core<br>Internal cooling fan | No Difference |
| Coil Positioning System | Integrated into Head Support System<br>Laser-aided coil placement | Integrated into Head Support System<br>Laser-aided coil placement | No Difference |
| Treatment Schedule | 5 days per week for 4-6 weeks<br>Total of 20-30 treatment sessions | 5 days per week for 4-6 weeks<br>Total of 20-30 treatment sessions | No Difference |
| Device Components | • Mobile Console<br>• Ferromagnetic Coil for delivering<br>treatment<br>• Head Support System for coil<br>positioning<br>• MT Cap for coil positioning<br>• D-Tect™ MT Accessory for MT<br>location and level determination<br>• Multi-use disposable for contact<br>sensing and magnetic field quality control<br>• TrakStar System for recording patient<br>data | • Mobile Console<br>• Ferromagnetic Coil for delivering<br>treatment<br>• Head Support System for coil<br>positioning<br>• MT Cap for coil positioning<br>• Multi-use disposable for contact<br>sensing and magnetic field quality control<br>• TrakStar System for recording patient<br>data | Different<br>The addition of<br>the D-Tect™ MT<br>Accessory is the<br>subject of this<br>special 510(k). |
| %MT Range | 25% to 140% MT | 25% to 140% MT | No difference |
| Pulses per Second (PPS)<br>Range | For treatment: 1 to 30 PPS<br>For MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPS<br>For MT determination: 0.1-0.3 PPS | No difference |
| Induced Electric Field at<br>2 cm at 1.0 SMT | 135 V/m (Nominal) | 135 V/m (Nominal) | No difference |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid | No difference |
| Pulse Width | 185 µS (Nominal) | 185 µS (Nominal) | No difference |
| | Standard Treatment:<br>Level: 120% MT with allowable<br>adjustments<br>Repetition Rate: 10 PPS<br>Stimulation Time: 4 s<br>Inter-train Interval: As low as 11 s<br>Session Duration: As low as 18.75 min<br>Pulses per Session: 3000<br>Sessions per Week: 5 | Standard Treatment:<br>Level: 120% MT with allowable<br>adjustments<br>Repetition Rate: 10 PPS<br>Stimulation Time: 4 s<br>Inter-train Interval: As low as 11 s<br>Session Duration: As low as 18.75 min<br>Pulses per Session: 3000<br>Sessions per Week: 5 | No difference |
| Treatment Protocols | NeuroBurst Treatment:<br>Level: 80-120% MT with allowable<br>adjustments<br>Stimulation Time: 2 s<br>Inter-train Interval: 8 s<br>Pulses per Burst: 3<br>Interpulse Interval: 20 ms<br>Session Duration: 3.3 min<br>Pulses per Session: 600<br>Bursts per Second: 5<br>Amplitude: 0.22-2.08 SMT (<5% drop) | NeuroBurst Treatment:<br>Level: 80-120% MT with allowable<br>adjustments<br>Stimulation Time: 2 s<br>Inter-train Interval: 8 s<br>Pulses per Burst: 3<br>Interpulse Interval: 20 ms<br>Session Duration: 3.3 min<br>Pulses per Session: 600<br>Bursts per Second: 5<br>Amplitude: 0.22-2.08 SMT (<5% drop) | No difference |
| Treatment Level Range | Standard Treatment:<br>0.22 to 2.08 SMT<br>Calibrated linear output | Standard Treatment:<br>0.22 to 2.08 SMT<br>Calibrated linear output | No difference |
| | NeuroBurst Treatment:<br>0.22 to 1.9 SMT<br>80-120% MT<br><5% drop | NeuroBurst Treatment:<br>0.22 to 1.9 SMT<br>80-120% MT<br><5% drop | No difference |
| Stimulation Time Pulse<br>Train Duration Range | Standard Treatment:<br>1 PPS: 1 to 600 s<br>>1 PPS: 1 to 20 s | Standard Treatment:<br>1 PPS: 1 to 600 s<br>>1 PPS: 1 to 20 s | No difference |
| | NeuroBurst Treatment:<br>1 to 10 s | NeuroBurst Treatment:<br>1 to 10 s | No difference |
| Inter-train Interval Range | Standard Treatment:<br>1 PPS: 0 to 600 s<br>>1 PPS: 10 to 60 s | Standard Treatment:<br>1 PPS: 0 to 600 s<br>>1 PPS: 10 to 60 s | No difference |
| | NeuroBurst Treatment:<br>1 to 60 s | NeuroBurst Treatment:<br>1 to 60 s | No difference |
| Pulses per Treatment<br>Session | Standard Treatment:<br>Nominal: 3000<br>Maximum: 5000 | Standard Treatment:<br>Nominal: 3000<br>Maximum: 5000 | No difference |
| | NeuroBurst Treatment:<br>Nominal: 600<br>Maximum: 2000 | NeuroBurst Treatment:<br>Nominal: 600<br>Maximum: 2000 | No difference |
| Pulses per Burst (PPB) | NeuroBurst Treatment:<br>1 to 5 | NeuroBurst Treatment:<br>1 to 5 | No difference |
| Interpulse Interval | NeuroBurst Treatment:<br>20 to 2000 ms | NeuroBurst Treatment:<br>20 to 2000 ms | No difference |
| Bursts per Second (BPS) | NeuroBurst Treatment:<br>0.1 to 20.0 Hz | NeuroBurst Treatment:<br>0.1 to 20.0 Hz | No difference |

Image /page/6/Picture/6 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned to the left of a star-like symbol. The star symbol is also purple and appears to be formed by abstract human figures with outstretched arms, creating a sense of community or connection. The overall design is simple and modern, suggesting a focus on people and collaboration.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the tagline "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape with small circles at the end of each point.

NeuroStar.com

Image /page/7/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized, purple font. A star-like shape is incorporated into the design, with three abstract figures positioned around the star. The overall design is simple and modern, suggesting a focus on people and achievement.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and consists of the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. To the right of the word "NeuroStar" is a star-shaped design with small circles at the end of each point.

3222 Phoenixville Pike / Malvern, PA 19355

t 610 640 4202 / f 610 640 4206

NeuroStar.com

Image /page/8/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned to the left of a star-like symbol. The star is formed by curved lines that resemble people with outstretched arms, also in purple. The overall design is simple and modern.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a bold, purple font. Below the name is the text "Advanced Therapy for Mental Health" in a smaller font. To the right of the name is a stylized star shape with small figures at the points.

t 610 640 4202 / f 610 640 4206

NeuroStar.com

Image /page/9/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple, and there is a star-like design above them, formed by abstract figures with outstretched arms. The overall design is simple and modern.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the NeuroStar logo. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. 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 stylized star shape with three figures on top of it.

## 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 D-Tect™ MT Accessory does not raise any new questions of safety or effectiveness.

Image /page/10/Picture/6 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned next to each other. Above the letters, there are three abstract figures that appear to be people holding hands, also in purple. To the right of the letters and figures, there are curved lines that resemble a starburst or a comet tail, adding a sense of motion or energy to the logo.