NeuroStar Advanced Therapy System (Version 3.8)

K233621 · Neuronetics · OBP · Dec 13, 2023 · Neurology

Device Facts

• Record ID: K233621
• Device Name: NeuroStar Advanced Therapy System (Version 3.8)
• Applicant: Neuronetics
• Product Code: OBP · Neurology
• Decision Date: Dec 13, 2023
• 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. The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Device Story

NeuroStar Advanced Therapy System (v3.8) is a computerized, electromechanical transcranial magnetic stimulation (TMS) device; delivers non-invasive magnetic fields to induce electrical currents in cerebral cortex; targets left dorsolateral prefrontal cortex for MDD and bilateral dorsomedial prefrontal cortex for OCD. System components: mobile console, ferromagnetic treatment coil, treatment chair, headrest, NeuroSITE positioning accessory, TrakStar data management system. Physician-operated in inpatient/outpatient clinical settings. NeuroSITE replaces previous laser-aided head support system for navigating/recording motor threshold (MT) and treatment locations. Software v3.8 records, saves, and displays patient-specific MT and treatment coordinates. Output: localized axonal depolarization in targeted brain regions. Clinical benefit: non-invasive treatment for treatment-resistant depression and OCD.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed that the NeuroSITE and Headrest, integrated with updated system software, accurately record, save, and display MT and treatment locations equivalent to the predicate system. Biocompatibility assessment performed per ISO 10993-1. Usability testing conducted per IEC 62366-1.

Technological Characteristics

Transcranial magnetic stimulator; ferromagnetic iron-core coil with internal cooling fan. Energy source: power console delivering biphasic sinusoid magnetic pulses (185 µS nominal width). Connectivity: Wi-Fi and Ethernet to TrakStar system. Materials: standard electrical medical device materials compliant with ISO 10993-1. Software: version 3.8, designed per IEC 62304 and ISO 14971. No sterilization required.

Indications for Use

Indicated for adult patients with Major Depressive Disorder (MDD) who failed previous antidepressant treatment, including those with comorbid anxiety symptoms. Also indicated as an adjunct for adult patients with Obsessive-Compulsive Disorder (OCD).

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, K220127, K230029)
• NeuroStar Advanced Therapy System (K212289, K230029)

Submission Summary (Full Text)

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December 13, 2023

Neuronetics Amanda Pentecost Sr. Regulatory Affairs Specialist 3222 Phoenixville Pike Malvern, Pennsylvania 19355

# Re: K233621

Trade/Device Name: NeuroStar Advanced Therapy System (Version 3.8) Regulation Number: 21 CFR 882.5805, 21 CFR 882.5802 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: November 10, 2023 Received: November 13, 2023

Dear Amanda 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Robert Kang -S

for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K233621

Device Name

NeuroStar Advanced Therapy System (Version 3.8)

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.

The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

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 shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a bold, sans-serif font, with the words "Advanced Therapy for Mental Health" in a smaller font below. To the right of the word "NeuroStar" is a graphic of a star made up of three people holding hands.

| 510(k) Summary | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Prepared: | November 10, 2023 | |
| Applicant: | Neuronetics, Inc.<br>3222 Phoenixville Pike<br>Malvern, PA 19355 | |
| Contact Person: | Amanda Pentecost, PhD<br>Sr. Requlatory Affairs Specialist<br>Email: [e-mail] | |
| Secondary Contact: | Robin Fatzinger, RAC<br>Sr. Director, Requlatory and Medical Affairs<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 | |
| Classifications: | 882.5805, 882.5802 | |
| Product Codes: | OBP, QCI | |
| Primary Predicate Device: | NeuroStar Advanced Therapy System: K083538, K130233,<br>K133408, K160703, K161519, K201158, K220127, and K230029<br>(Product Code: OBP) | |
| Secondary Predicate<br>Device: | NeuroStar Advanced Therapy System: K212289 and K230029<br>(Product Code: QCI) | |

Image /page/3/Picture/5 description: The image shows a logo with the letters "NS" in a bold, sans-serif font. The letters are purple. Above the letters is a stylized star shape, also in purple, with four rounded points that resemble people with their arms raised. The overall design is simple and modern.

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Image /page/4/Picture/1 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Above the word "Star" is a star-shaped design with small figures that appear to be people. Below the logo is the text "Advanced Therapy for Mental Health" in a smaller font.

3222 Phoenixville Pike / Malvern, PA 19355

# 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 maqnetic 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 or Headrest
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- . MDD MT Cap and OCD MT Cap
- . TrakStar™ Patient Data Management System
- . D-Tect™ MT Accessory
- . NeuroSITE

# Proposed Change:

The purpose of this 510(k) submission is to introduce the following new features and accessories of the NeuroStar Advanced Therapy System, version 3.8:

- 1. A simplified Headrest will replace the patient comfort-related features of the current Head Support System.
- 2. The NeuroSITE coil positioning accessory will replace the coil position measuring functions of the current Head Support System. This accessory will be used to navigate to and record the MT and treatment locations.
- 3. The NeuroStar System Software, version 3.8 introduces software allows for recording, saving, and displaying the patient's unique MT and treatment location based on the coil position measurements taken using the NeuroSITE.

## 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

Image /page/4/Picture/26 description: The image shows a logo with the letters 'NS' in a stylized font. Above the letters, there are three abstract figures that resemble people with their arms raised, forming a star-like shape. The color of the logo and figures is a shade of purple. The logo appears to represent a group or organization, possibly related to sports or community involvement.

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Image /page/5/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 stylized star shape with small figures at the points.

episode.

The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

#### Performance Standards:

The NeuroStar Advanced Therapy System and accessories have been tested and conform to the following recognized consensus standard:

- · ISO 10993-1
#### Non-clinical Testing:

The contents of this 510(k) comply 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."

A biocompatibility risk assessment was performed in accordance with ISO 10993-1 and the FDA Guidance Documents "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and revealed no biocompatibility concerns.

Additionally, usability testing was completed in accordance with FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a guide. Software was designed, and tested in accordance with relevant FDA quidance documents, IEC 62304 and ISO 14971.

To summarize, the results of verification and validation testing confirmed that the NeuroSITE and Headrest can successfully be used with the NeuroStar System software to record, save, and display the patient's MT and treatment locations in a manner that is equivalent to the current Head Support System.

#### Clinical Testing:

There is no clinical testing required to support this submission.

#### Conclusion:

The NeuroStar Advanced Therapy System and the predicate device have the same intended uses and technological characteristics. The use of the NeuroSITE, Headrest, or updated NeuroStar System software that supports these features does not raise any different questions regarding safety or effectiveness.

Image /page/5/Picture/18 description: The image shows a logo with the letters 'NS' in a stylized font, colored in purple. Above the letters, there is a star-like shape formed by three figures with raised arms, also in purple. The overall design is simple and modern, suggesting a focus on people or community, possibly related to the organization or brand represented by the logo.

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Image /page/6/Picture/0 description: The image contains the logo for NeuroStar. The logo is purple and consists of 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 stylized star shape.

## Technological Comparison with Primary Predicate (Product Code: OBP)

| | NeuroStar Advanced Therapy System<br>(Subject Device) | NeuroStar Advanced Therapy System<br>(Primary Predicate Device - K083538, K130233,<br>K133408, K160703, K161519, K201158, and<br>K220127) | Explanation of<br>Differences |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The NeuroStar Advanced Therapy System is<br>indicated for the treatment of depressive<br>episodes and for decreasing anxiety symptoms<br>for those who may exhibit comorbid anxiety<br>symptoms in adult patients suffering from<br>Major Depressive Disorder (MDD) and who<br>failed to achieve satisfactory improvement<br>from previous antidepressant medication<br>treatment in the current episode. | The NeuroStar Advanced Therapy System is<br>indicated for the treatment of depressive episodes<br>and for decreasing anxiety symptoms for those who<br>may exhibit comorbid anxiety symptoms in adult<br>patients suffering from Major Depressive Disorder<br>(MDD) and who failed to achieve satisfactory<br>improvement from previous antidepressant<br>medication treatment in the current episode. | No Difference |
| Intended Use | Major Depressive Disorder (MDD) and<br>comorbid anxiety symptoms | Major Depressive Disorder (MDD) and comorbid<br>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, including<br>physician's offices and clinics, hospitals, and<br>general medical/surgical hospitals | Inpatient and outpatient settings, including<br>physician's offices and clinics, hospitals, and general<br>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 10993-1<br>that are commonly used in consumer products<br>and medical device applications | Patient-contacting device components use standard<br>materials compliant with ISO 10993-1 that are<br>commonly used in consumer products and medical<br>device applications | No Difference |
| Energy Source | Power console with magnetic coil for delivery<br>for magnetic energy | Power console with magnetic coil for delivery for<br>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 |
| Communication with<br>TrakStar | Wireless (Wi-fi) and<br>Ethernet cable | Wireless (Wi-fi) and<br>Ethernet cable | 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 | NeuroSITE | Integrated into Head Support System<br>Laser-aided coil placement | Different<br>The replacement of the<br>Head Support System<br>and laser with the<br>Headrest and NeuroSITE<br>as part of the NeuroStar<br>Advanced Therapy<br>System, version 3.8 is<br>the subject of this<br>510(k). This technology<br>change does not<br>introduce any new risks.<br>Engineering and Human<br>Factors testing had<br>demonstrated that the<br>treatment location is<br>equivalent whether<br>using the Head Support<br>System or the NeuroSITE<br>and clinical outcomes<br>will be the same. |
| Treatment Schedule | 5 days per week for 6 weeks with taper over 3<br>weeks (3 sessions first week, 2 sessions second | 5 days per week for 6 weeks with taper over 3<br>weeks (3 sessions first week, 2 sessions second | No Difference |
| | week and 1 session third week) for total of 36<br>treatment sessions. | week and 1 session third week) for total of 36<br>treatment sessions. | Different |
| Device Components | Mobile Console<br>Ferromagnetic Coil for delivering<br>treatment<br>Headrest and NeuroSITE for patient<br>comfort and coil positioning<br>Positioning cushions and Head Side Pad<br>for patient positioning and comfort (MDD) MT Cap and OCD MT Cap for coil<br>positioning* D-Tect™ MT Accessory for MT location<br>and level determination Multi-use disposable for contact sensing<br>and magnetic field quality control Single-use treatment pack including<br>disposable hygienic barriers and coil<br>positioning head strap for use with the<br>standard 5 cm method TrakStar System for recording patient data | Mobile Console<br>Ferromagnetic Coil for delivering<br>treatment<br>Head Support System for patient<br>comfort and coil positioning<br>Positioning cushions and Head Side Pad<br>for patient positioning and comfort (MDD) MT Cap and OCD MT Cap for coil<br>positioning* D-Tect™ MT Accessory for MT location<br>and level determination Multi-use disposable for contact sensing<br>and magnetic field quality control Single-use treatment pack including<br>disposable hygienic barriers and coil<br>positioning head strap for use with the<br>standard 5 cm method TrakStar System for recording patient data | The replacement of the<br>Head Support System<br>and laser with the<br>Headrest and NeuroSITE<br>as part of the NeuroStar<br>Advanced Therapy<br>System, version 3.8 is<br>the subject of this<br>510(k).<br>This technology change<br>does not introduce any<br>new risks. Engineering<br>and Human Factors<br>testing had<br>demonstrated that the<br>treatment location is<br>equivalent whether<br>using the Head Support<br>System or the NeuroSITE<br>and clinical outcomes<br>will be the same.<br>*Note: The OCD MT Cap is<br>not intended to be used in<br>the MDD MT<br>determination process. |
| %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 Electrical field at 2<br>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 |
| Treatment Protocols | Standard Treatment: | Standard Treatment: | No Difference |
| | Level: 120% MT with allowable adjustments | Level: 120% MT with allowable adjustments | |
| | Repetition Rate: 10 PPS | Repetition Rate: 10 PPS | |
| | Stimulation Time: 4 s | Stimulation Time: 4 s | |
| | Inter-train Interval: As low as 11 s | Inter-train Interval: As low as 11 s | |
| | Session Duration: As low as 18.75 min | Session Duration: As low as 18.75 min | |
| | Pulses per Session: 3000 | Pulses per Session: 3000 | |
| | Sessions per Week: 5 (Acute phase) | Sessions per Week: 5 (Acute phase) | |
| | NeuroBurst Treatment: | NeuroBurst Treatment: | |
| | Level: 80-120% MT with allowable<br>adjustments | Level: 80-120% MT with allowable<br>adjustments | |
| | Stimulation Time: 2 s | Stimulation Time: 2 s | |
| | Inter-train Interval: 8 s…