OCD MT Cap (85-00397-000)

K231350 · Neuronetics · QCI · Jun 8, 2023 · Neurology

Device Facts

• Record ID: K231350
• Device Name: OCD MT Cap (85-00397-000)
• Applicant: Neuronetics
• Product Code: QCI · Neurology
• Decision Date: Jun 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5802
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 patient's scalp. These pulses induce electric fields that depolarize neurons in targeted brain regions. The system includes a mobile console, treatment chair, ferromagnetic coil, head support, and TrakStar data management system. The new OCD MT Cap is a single-use wearable accessory used during the Motor Threshold (MT) determination process. It features symmetrical gridlines centered on the back of the head, allowing clinicians to move the treatment coil incrementally without manually adjusting A/P and SOA indicators. Clinicians operate the system in inpatient or outpatient settings, monitoring the patient for involuntary foot movement to determine the unique MT location. The device provides a non-invasive treatment option for OCD, potentially benefiting patients by facilitating precise coil positioning during the setup phase of therapy.

Clinical Evidence

No clinical testing was required to support this submission. Evidence consists of non-clinical verification and validation testing, including biocompatibility assessments per ISO 10993-1 and usability engineering per IEC 62366-1.

Technological Characteristics

Computerized, electromechanical TMS system. Components: mobile console, ferromagnetic iron-core coil, head support, TrakStar data management. Energy: magnetic pulses (biphasic sinusoid, 185 µS pulse width). Connectivity: Wi-Fi and Ethernet. Materials: standard medical-grade materials compliant with ISO 10993-1. Accessory: OCD MT Cap (single-use, wearable grid). Electrical safety: IEC 60601-1 and IEC 60601-1-2 compliant. No sterilization required.

Indications for Use

Indicated for adult patients (ages 22-70) suffering from Obsessive-Compulsive Disorder (OCD) as an adjunct treatment.

Regulatory Classification

Identification

A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.

Special Controls

In combination with the general controls of the FD&C Act, the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic pulse output testing; (ii) Magnetic and electrical field testing; (iii) Testing of the safety features built into the device; and (iv) Testing of the sound levels patients are exposed to during device use. (5) The physician and patient labeling must include the following: (i) The risks and benefits associated with use of the device; (ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and (iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.

Predicate Devices

• NeuroStar Advanced Therapy System (K212289, K230029)

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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 8, 2023

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

Re: K231350

Trade/Device Name: OCD MT Cap (85-00397-000) Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions Regulatory Class: Class II Product Code: QCI Dated: May 1, 2023 Received: May 9, 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

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

Sincerely,

# Robert Kang -S

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

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# Indications for Use

510(k) Number (if known) K231350

Device Name OCD MT Cap (85-00397-000)

Indications for Use (Describe)

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 is a 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. Above the word "NeuroStar" is a graphic of a star made up of people holding hands. The logo is purple and white.

| 510(k) Summary | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 7, 2023 |
| Applicant: | Neuronetics, Inc.<br>3222 Phoenixville Pike<br>Malvern, PA 19355 |
| Contact Person: | Amanda Pentecost, PhD<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone], ext. 1132<br>Email: [e-mail] |
| Secondary Contact: | Robin Fatzinger<br>Sr. Director, Regulatory and Medical 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 882.5802 |
| Product Codes: | QCI |
| Predicate Device: | NeuroStar Advanced Therapy System (K212289, K230029)<br>(Product Code: QCI) |

Image /page/3/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 shape. The star shape is also purple and appears to be formed by stylized figures with outstretched arms, giving the impression of people reaching towards the center of the star. The overall design is simple and modern.

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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 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
- OCD MT Cap

## Proposed Change:

The only proposed change to the NeuroStar Advanced Therapy System is the addition the OCD MT Cap, a single-use wearable device that is intended to be used as an optional aid during the OCD Motor Threshold (MT) determination process. It is only worn by the patient during the MT determination process as a quide to facilitate determination of the patient's unique MT location. The OCD MT Cap outer surface contains a symmetrical gridlines that are centered on the back of the head and stem from a single point. These gridlines enable the clinician to easily move the coil incrementally without the need for manually moving the Anterior/Posterior (A/P) and Superior Oblique Anqle (SOA) indicators to incrementally move the Treatment Coil between MT pulses. As the MT pulses are delivered to the patient during this process, the clinician monitors the patient for involuntary movement in the foot/feet in exactly the same manner as the current method.

There are no changes to the NeuroStar Advanced Therapy System nor to any other accessory to the system.

Image /page/4/Picture/22 description: The image shows a logo with the letters 'NS' in bold, purple font. Above and around the letters are stylized figures that resemble people with outstretched arms, also in purple. These figures are arranged to create a star-like shape, adding a sense of dynamism and energy to the logo. The overall design is simple yet eye-catching, suggesting a focus on people and community.

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Image /page/5/Picture/0 description: The image is a logo for NeuroStar. 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 with two figures at the top.

### Indications for Use:

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 OCD MT Cap has been tested and conforms to the following recognized consensus standards:

- . 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 quide.

To summarize, the results of verification and validation testing confirmed that the OCD MT Cap can be successfully used to aid clinicians in the MT determination process to determine the patient's unique MT location.

#### 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 optional OCD MT Cap accessory 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 bold, sans-serif font, colored in purple. The letters are stylized and integrated with a graphic element that resembles stylized human figures or abstract shapes, also in purple. The overall design is modern and suggests a sense of community or connection.

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Image /page/6/Picture/0 description: The image shows the NeuroStar logo. The logo features the word "NeuroStar" in a bold, purple font. Below the word is the text "Advanced Therapy for Mental Health" in a smaller font. To the right of the word is a star-shaped graphic with stylized figures.

NeuroStar.com

## Technological Comparison

| | NeuroStar Advanced Therapy System<br>(Subject Device) | NeuroStar Advanced Therapy System<br>(Predicate Device – K212289, K230029) | Explanation of<br>Differences |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The NeuroStar Advanced Therapy System is<br>intended to be used as an adjunct for the<br>treatment of adult patients suffering from<br>Obsessive-Compulsive Disorder (OCD) | The NeuroStar Advanced Therapy System is<br>intended to be used as an adjunct for the treatment<br>of adult patients suffering from Obsessive-<br>Compulsive Disorder (OCD) | No Difference |
| Intended Use | Obsessive Compulsive Disorder | Obsessive Compulsive Disorder | No Difference |
| Anatomical Sites | Bilateral dorsomedial prefrontal cortex | Bilateral dorsomedial prefrontal cortex | No Difference |
| Target Population | Adult patients (ages 22-70) with Obsessive-<br>Compulsive Disorder | Adult patients (ages 22-70) with Obsessive-<br>Compulsive Disorder | 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 components<br>are required to be sterilized | No Difference |
| Coil Type | Ferromagnetic<br>Iron core | Ferromagnetic<br>Iron core | No Difference |
| | Internal cooling fan | Internal cooling fan | |
| 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 | Weeks 1-5: 1 treatment session per day for 5<br>days<br>Week 6: 1 treatment session per day for 4 days<br>Total of 29 treatment sessions | Weeks 1-5: 1 treatment session per day for 5 days<br>Week 6: 1 treatment session per day for 4 days<br>Total of 29 treatment sessions | No Difference |
| Device Components | Mobile Console<br>Ferromagnetic Coil for delivering<br>treatment<br>Head Support System for coil positioning<br>MT Cap for coil positioning*<br>D-Tect™ MT Accessory for MT location<br>and level determination*<br>Multi-use disposable for contact sensing<br>and magnetic field quality control<br>Single-use treatment pack including<br>disposable hygienic barriers and coil<br>positioning head strap for use with the<br>standard 5 cm method<br>Single-use treatment pack including<br>disposable hygienic barriers and head<br>strap for use with the Beam F3 method for<br>determining treatment location and coil<br>positioning*<br>OCD MT Cap for Coil positioning<br>TrakStar System for recording patient data | Mobile Console<br>Ferromagnetic Coil for delivering treatment<br>Head Support System for coil positioning<br>MT Cap for coil positioning*<br>D-Tect™ MT Accessory for MT location and<br>level determination*<br>Multi-use disposable for contact sensing and<br>magnetic field quality control<br>Single-use treatment pack including disposable<br>hygienic barriers and coil positioning head strap<br>for use with the standard 5 cm method<br>Single-use treatment pack including disposable<br>hygienic barriers and head strap for use with<br>the Beam F3 method for determining treatment<br>location and coil positioning*<br>TrakStar System for recording patient data | Different<br>The addition of the<br>OCD MT Cap is the<br>subject of this<br>510(k).<br>*Note: The MT Cap,<br>D-Tect™ MT<br>Accessory, and Beam<br>F3 Treatment Pack<br>are not intended to<br>be used as part of<br>the OCD treatment<br>protocol. |
| %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 | Level: 100% foot motor threshold level<br>Repetition Rate: 20 PPS<br>Stimulation Time: 2 s<br>Inter-train Interval: 20 s<br>Session Duration: As low as 18.3 min<br>Pulses per Session: 2000<br>Sessions Per Week: 5 for Weeks 1-5 and 4 for<br>Week 6 | Level: 100% foot motor threshold level<br>Repetition Rate: 20 PPS<br>Stimulation Time: 2 s<br>Inter-train Interval: 20 s<br>Session Duration: As low as 18.3 min<br>Pulses per Session: 2000<br>Sessions Per Week: 5 for Weeks 1-5 and 4 for<br>Week 6 | No Difference |
| Treatment Level Range | 0.22 to 2.08 SMT<br>Calibrated linear output | 0.22 to 2.08 SMT<br>Calibrated linear output | No Difference |
| Stimulation Time Pulse Train<br>Duration Range | 1 PPS: 1 to 600 s<br>> 1 PPS: 1 to 20 s | 1 PPS: 1 to 600 s<br>> 1 PPS: 1 to 20 s | No Difference |
| Inter-train Interval Range | 1 PPS: 0 to 600 s<br>> 1 PPS: 10 to 60 s | 1 PPS: 0 to 600 s<br>> 1 PPS: 10 to 60 s | No Difference |
| Pulse per Treatment Session | Nominal: 2000<br>Maximum: 5000 | Nominal: 2000<br>Maximum: 5000 | No Difference |

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Image /page/7/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 graphic of a star made up of people.

NeuroStar.com

Image /page/7/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 shape. The star shape is also purple and has two figures with outstretched arms at the top, suggesting a sense of community or achievement. The overall design is simple and modern, likely representing an organization or brand with the initials "NS".

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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 bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller, lighter font. To the right of the word "NeuroStar" is a stylized star shape with small circles at the end of each point.

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NeuroStar.com

Image /page/8/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 is a stylized star-like shape formed by three abstract figures with outstretched arms, also in purple. The figures are arranged in a semi-circle, creating the impression of a starburst or a group of people reaching upwards. The overall design is simple and modern, suggesting themes of community, achievement, or aspiration.