NeuroStar Advanced Therapy System (Version 3.7)

K230029 · Neuronetics · OBP · Apr 4, 2023 · Neurology

Device Facts

• Record ID: K230029
• Device Name: NeuroStar Advanced Therapy System (Version 3.7)
• Applicant: Neuronetics
• Product Code: OBP · Neurology
• Decision Date: Apr 4, 2023
• Decision: SESE
• Submission Type: Traditional
• 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 is a computerized, electromechanical transcranial magnetic stimulation (TMS) device. It delivers non-invasive magnetic pulses to the cerebral cortex via an electromagnetic coil placed near the scalp; pulses induce electric fields that depolarize axons and activate neurons. Used in clinical settings (hospitals, clinics) by trained operators. The system includes a mobile console, treatment chair, ferromagnetic coil, head support, and TrakStar data management system. This submission adds wireless (Wi-Fi) communication for data transfer to TrakStar and an alternative 'Beam F3' method for determining treatment location within the dorsolateral prefrontal cortex (DLPFC). The Beam F3 method uses skull measurements and embedded software calculations to guide coil placement. Healthcare providers use the system to deliver standardized treatment protocols; output is magnetic stimulation. Benefits include non-invasive treatment for MDD and OCD patients who have not responded to medication.

Clinical Evidence

No clinical data required for this submission. Performance is supported by non-clinical bench testing and usability engineering.

Technological Characteristics

Transcranial magnetic stimulation system; ferromagnetic iron-core coil with internal cooling. Energy source: power console delivering biphasic sinusoidal magnetic pulses (185 µS nominal width). Connectivity: Ethernet and wireless (Wi-Fi). Standards: ISO 10993-1 (biocompatibility), ANSI AAMI ES60601-1/IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability). Software developed per IEC 62304 and ISO 14971.

Indications for Use

Indicated for adult patients with Major Depressive Disorder (MDD) who failed to achieve satisfactory improvement from previous antidepressant medication in the current episode, for treatment of depressive episodes and 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)
• NeuroStar Advanced Therapy System (K212289)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

April 4, 2023

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

Re: K230029

Trade/Device Name: NeuroStar Advanced Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: January 4, 2023 Received: January 4, 2023

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

# Pamela D. Scott -S

Pamela D. 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

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## Indications for Use

510(k) Number (if known) K230029

Device Name NeuroStar Advanced Therapy System (Version 3.7)

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) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 stylized star shape.

| 510(k) Summary | | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Date Prepared: | April 4, 2023 | | |
| 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<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 | | |
| Classifications: | 21 CFR 882.5805, 21 CFR 882.5802 | | |
| Product Codes: | OBP, QCI | | |
| Primary Predicate Device: | NeuroStar Advanced Therapy System (K083538, K130233,<br>K133408, K160703, K161519, K201158, and K220127)<br>(Product Code: OBP) | | |
| Secondary Predicate Device: | NeuroStar Advanced Therapy System (K212289) (Product<br>Code: OCI) | | |

Image /page/3/Picture/5 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. Above the letters, there are three stylized figures that appear to be dancing or reaching upwards, also in purple. The figures are arranged in a semi-circular fashion, suggesting movement and energy. The logo has a clean and modern design, likely representing a company or organization with a focus on people or community.

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### 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 magnetic 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 .
- . Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MT Cap
- TrakStar™ Patient Data Management System .
- . D-Tect™ MT Accessory
- . Beam F3 Treatment Pack

There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.

#### 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 Page 2 of 12

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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" written in smaller font below. To the right of the word "NeuroStar" is a stylized star with three people at the top of the star.

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).

#### Performance Standards:

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
- 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 and also following FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices." Software was designed, developed, and tested in accordance with relevant FDA quidance documents, IEC 62304, and ISO 14971.

#### Clinical Testing:

There is no clinical testing required to support this submission.

Image /page/5/Picture/17 description: The image shows a logo with the letters "NS" in bold, purple font. Above the letters is a stylized graphic of three figures with outstretched arms, also in purple. The figures are arranged in a line, suggesting unity or collaboration. The logo has a clean and modern design.

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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 logo features the word "NeuroStar" in a bold, sans-serif font, with the words "Advanced Therapy for Mental Health" in a smaller font underneath. To the right of the word "NeuroStar" is a stylized star shape with human figures incorporated into the design. The overall design is clean and modern, and the use of purple gives the logo a sense of calm and sophistication.

NeuroStar.com

## 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 | Ethernet cable | Different<br>The addition of the<br>wireless capability is<br>part of the subject of<br>this 510(k). |
| Sterility | No parts of the device, accessories or<br>components are required to be sterilized | No parts of the device, accessories or components<br>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 6 weeks with taper over 3<br>weeks (3 sessions first week, 2 sessions second<br>week and 1 session third week) for total of 36<br>treatment sessions. | 5 days per week for 6 weeks with taper over 3 weeks<br>(3 sessions first week, 2 sessions second week and 1<br>session third week) for total of 36 treatment<br>sessions. | No Difference |
| Device Components | Mobile Console Ferromagnetic Coil for delivering treatment Head Support System for coil positioning MT Cap for coil positioning D-Tect™ MT Accessory for MT location and level determination Multi-use disposable for contact sensing and magnetic field quality control Single-use treatment pack including disposable hygienic barriers and coil positioning head strap for use with the standard 5 cm method Single-use treatment pack including disposable hygienic barriers and head strap for use with the Beam F3 method for determining treatment location and coil positioning TrakStar System for recording patient data | Mobile Console Ferromagnetic Coil for delivering treatment Head Support System for coil positioning MT Cap for coil positioning D-Tect™ MT Accessory for MT location and level determination Multi-use disposable for contact sensing and magnetic field quality control Single-use treatment pack including disposable hygienic barriers and coil positioning head strap for use with the standard 5 cm method TrakStar System for recording patient data | Different<br>The addition of the<br>Beam F3 Treatment<br>Pack is part of the<br>subject of this<br>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 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: | |
| | 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 | Level: 80-120% MT with allowable | No Difference |
| | adjustments | adjustments | |
| | Stimulation Time: 2 s | Stimulation Time: 2 s | |
| | Inter-train Interval: 8 s | Inter-train Interval: 8 s | |
| | Pulses per Burst: 3 | Pulses per Burst: 3 | |
| | Interpulse Interval: 20 ms | Interpulse Interval: 20 ms | |
| | Session Duration: 3.3 min | Session Duration: 3.3 min | |
| | Pulses per Session: 600 | Pulses per Session: 600 | |
| | Bursts per Second: 5 | Bursts per Second: 5 | |
| | Amplitude: 0.22-2.08 SMT (<5% drop) | Amplitude: 0.22-2.08 SMT (<5% drop) | |
| Treatment Level Range | Standard Treatment: | Standard Treatment: | |
| | 0.22 to 2.08 SMT | 0.22 to 2.08 SMT | |
| | Calibrated linear output | Calibrated linear output | |
| | NeuroBurst Treatment: | NeuroBurst Treatment: | No Difference |
| | 0.22 to 1.9 SMT | 0.22 to 1.9 SMT | |
| | 80-120% MT | 80-120% MT | |
| | <5% drop | <5% drop…