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 Description

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

AI/ML Overview

The provided text describes the OCD MT Cap, a single-use wearable device intended to be used as an optional aid during the Obsessive-Compulsive Disorder (OCD) Motor Threshold (MT) determination process for the NeuroStar Advanced Therapy System.

However, the document specifies that no clinical testing was required to support this submission, as the proposed change (addition of the OCD MT Cap) is considered to not raise any different questions regarding safety or effectiveness compared to the predicate device. Therefore, a study proving the device meets specific performance acceptance criteria for diagnostic performance is not detailed in this document.

Instead, the document focuses on non-clinical testing and a technological comparison to establish substantial equivalence to a predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical performance study was conducted to establish diagnostic accuracy metrics, a table showing acceptance criteria for such metrics cannot be provided. The reported "performance" is primarily related to compliance with recognized standards and usability.

Category	Acceptance Criteria	Reported Device Performance
Non-Clinical Testing
Biocompatibility	Conforms to ISO 10993-1 and 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'".	A biocompatibility risk assessment was performed and "revealed no biocompatibility concerns."
Usability	Conforms to FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a guide.	"Usability testing was completed" and the results "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."
K231350 (Subject Device) vs. Predicate Device (K212289, K230029) Equivalence
Indications for Use	Same as predicate device (adjunct for the treatment of adult patients suffering from OCD).	No Difference
Intended Use	Same as predicate device (Obsessive Compulsive Disorder).	No Difference
Anatomical Sites	Same as predicate device (Bilateral dorsomedial prefrontal cortex).	No Difference
Target Population	Same as predicate device (Adult patients (ages 22-70) with Obsessive-Compulsive Disorder).	No Difference
Clinical Setting	Same as predicate device (Inpatient and outpatient settings including physician's offices and clinics, hospitals, and general medical/surgical hospitals).	No Difference
Materials	Standard materials compliant with ISO 10993-1, commonly used in consumer and medical devices.	No Difference (Patient-contacting device components use standard materials compliant with ISO 10993-1 that are commonly used in consumer products and medical device applications)
Energy Source	Power console with magnetic coil for delivery for magnetic energy (same as predicate).	No Difference
Electrical Safety & EMC	IEC 60601-1 compliant; IEC 60601-1-2 compliant (same as predicate).	No Difference
Communication with TrakStar	Wireless (Wi-fi) and Ethernet cable (same as predicate).	No Difference
Sterility	No parts required to be sterilized (same as predicate).	No Difference
Coil Type	Ferromagnetic, Iron core, Internal cooling fan (same as predicate).	No Difference
Coil Positioning System	Integrated into Head Support System, Laser-aided coil placement (same as predicate).	No Difference
Treatment Schedule	Weeks 1-5: 1 treatment session per day for 5 days; Week 6: 1 treatment session per day for 4 days; Total of 29 treatment sessions (same as predicate).	No Difference
Device Components	The addition of the OCD MT Cap. (The predicate device did not include the OCD MT Cap.)	Different. The addition of the OCD MT Cap is the subject of this 510(k). Note: The MT Cap, D-Tect™ MT Accessory, and Beam F3 Treatment Pack are not intended to be used as part of the OCD treatment protocol.
%MT Range	25% to 140% MT (same as predicate).	No Difference
Pulses per Second (PPS) Range	For treatment: 1 to 30 PPS; For MT determination: 0.1-0.3 PPS (same as predicate).	No Difference
Induced Electrical field at 2 cm at 1.0 SMT	135 V/m (Nominal) (same as predicate).	No Difference
Pulse Type	Biphasic Sinusoid (same as predicate).	No Difference
Pulse Width	185 µS (Nominal) (same as predicate).	No Difference
Treatment Protocols	Level: 100% foot motor threshold level, Repetition Rate: 20 PPS, Stimulation Time: 2 s, Inter-train Interval: 20 s, Session Duration: As low as 18.3 min, Pulses per Session: 2000, Sessions Per Week: 5 for Weeks 1-5 and 4 for Week 6 (same as predicate).	No Difference
Treatment Level Range	0.22 to 2.08 SMT, Calibrated linear output (same as predicate).	No Difference
Stimulation Time Pulse Train Duration Range	1 PPS: 1 to 600 s; > 1 PPS: 1 to 20 s (same as predicate).	No Difference
Inter-train Interval Range	1 PPS: 0 to 600 s; > 1 PPS: 10 to 60 s (same as predicate).	No Difference
Pulse per Treatment Session	Nominal: 2000; Maximum: 5000 (same as predicate).	No Difference

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable. The document explicitly states: "There is no clinical testing required to support this submission." The testing described is non-clinical (biocompatibility, usability) and a technological comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The OCD MT Cap is an aid for a physical procedure (MT determination), not an AI diagnostic tool used by human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The OCD MT Cap is described as 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 a tool to facilitate a human clinician's action, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for clinical performance. For the usability testing, the "ground truth" would be the successful aid to clinicians in determining the patient's unique MT location, as confirmed by the usability study results. However, the exact methodology for establishing this success (e.g., expert observation, user feedback metrics) is not detailed.

8. The sample size for the training set:

Not applicable. No machine learning algorithm or AI component requiring a "training set" is described for the OCD MT Cap.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.3222 Phoenixville PikeMalvern, PA 19355
Contact Person:	Amanda Pentecost, PhDSr. Regulatory Affairs SpecialistPhone: 610-640-4202, ext. 1132Email: amanda.pentecost@neurostar.com
Secondary Contact:	Robin FatzingerSr. Director, Regulatory and Medical AffairsPhone: 610-640-4202, ext. 1064Email: robin.fatzinger@neurostar.com
Device Trade Name:	NeuroStarNeuroStar TMS Therapy SystemNeuroStar Advanced Therapy SystemNeuroStar 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)(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 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

Image /page/6/Picture/6 description: The image shows a logo with the letters "NS" in bold, purple font. The letters are slightly overlapping, with the "S" positioned behind the "N". Above the letters is a stylized star shape, also in purple, with curved lines extending from the center to form the points of the star. The overall design is simple and modern, with a focus on the letters and the star symbol.

Page 4 of 6

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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.

t 610 640 4202 / ƒ 610 640 4206

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.

Regulation Number and Section

§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.

(a)
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.(b)
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.