The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

Device Description

The NeuroStar TMS System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (~200 usec) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. The peak magnetic field strength achieved with each pulse is approximately 1.5 Tesla.

The NeuroStar TMS System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, mechanically supports the ferromagnetic Treatment Coil and includes a software controlled graphical user interface, a ferromagnetic Treatment Coil to deliver TMS Therapy, a Head Support System for accurate coil positioning, and a single use device (SenStar® Treatment Link) placed on the face of the coil to reduce local scalp stimulation, to provide feedback to the operator regarding contact of the coil with the patient's head, and to verify the applied field strength. A separate Practice Data Management System (PDMS) allows and facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS System units.

AI/ML Overview

Here's an analysis of the provided text regarding the Neurometnics NeuroStar TMS Therapy System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on a 510(k) summary for a modification to an existing device (adding a Class 1 laser positioning aid). As such, it primarily discusses the equivalence of the modified device to the predicate device, rather than establishing de novo acceptance criteria for the core therapeutic efficacy of TMS for Major Depressive Disorder. The core efficacy would have been established during the predicate device's clearance (K061053).

However, specific acceptance criteria for the new feature (the Class 1 laser positioning aid) were mentioned.

Acceptance Criteria (for Class 1 laser positioning aid)	Reported Device Performance
Meet design specifications (accuracy)	Verified to meet design specifications (Test Report 80-80095-001)
Equivalence to predicate device in MT determination	Demonstrated (Test Report 80-80095-000)
Equivalence to predicate device in TMS treatment locations	Demonstrated (Test Report 80-80095-000)
Raise no new questions of safety and efficacy	Based on risk analysis and performance testing, raises no new questions of safety and efficacy.
Comply with IEC 60825-1 (Class 1 laser)	Complies with IEC 60825-1
Comply with FDA Laser Notice No. 50 (June 24, 2007)	Complies with FDA Laser Notice No. 50
Comply with UL/CSA/EN60601-1	Complies with all applicable sections of UL/CSA/EN60601-1 for electrical safety.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for the test sets in the context of the laser positioning aid. It refers to "design verification tests" and "performance testing."

Test Set Sample Size: Not specified quantitatively.
Data Provenance: The studies mentioned ("Test Report 80-80095-001" and "Test Report 80-80095-000") are internal verification and validation studies conducted by Neuronetics, Inc. The country of origin for the data is implicitly the United States, given the company's location and FDA submission. The studies are prospective in nature, as they are verification and validation tests for a new design feature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. The types of tests described (accuracy of positioning, equivalence in MT determination) suggest a technical evaluation rather than a clinical expert panel review for the laser component.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned for this 510(k) submission. This submission is for a device modification (adding a laser positioning aid) to a previously cleared device. The focus is on demonstrating that the new feature maintains the established safety and effectiveness, not on a new comparative effectiveness study of the TMS therapy itself. Therefore, no effect size of human reader improvement with/without AI assistance is relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device, the NeuroStar TMS Therapy System, is a medical device for treatment, not an AI or algorithm-only diagnostic tool. The "Class 1 laser positioning aid" is a hardware component with integrated circuitry and software to facilitate human operation; it is not a standalone algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device or its new feature.

7. The Type of Ground Truth Used

For the laser positioning aid's performance, the ground truth would be based on:

Design Specifications: For accuracy (e.g., how precisely the laser indicates a position compared to mechanical measurements or engineering requirements).
Established Methods: For equivalence in Motor Threshold (MT) determination and TMS treatment locations. This implies comparison against the results obtained using the predicate device's existing positioning method.

8. The Sample Size for the Training Set

This information is not provided. The laser positioning aid involves embedded software and control logic, but the document does not describe it in terms of a "training set" in the machine learning context. It refers to design verification and validation, which typically involves testing against specifications and comparison to an existing standard.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is explicitly described, this question is not directly applicable. For the engineering verification of the laser positioning aid, the "ground truth" would be the predefined engineering specifications and criteria for accuracy and equivalence, which are established during the device design and development process.

Summary

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K043538

DEC 1 6 2008

NEURONETICS

510(k) SUMMARY

NEUROSTAR TMS THERAPY® SYSTEM

510(k) Owner:

Neuronetics, Inc. 1 Great Valley Parkway, Suite 2 Malvern, PA 19355 Phone: 610-640-4202 610-640-4206 Fax:

Company Contact:

Judy P. Ways, Ph.D. Vice-President Regulatory Affairs and Quality Assurance Neuronetics, Inc. 1 Great Valley Parkway, Suite 2 Malvern, PA 19355 Phone: 610-640-4202, ext. 1006 Fax: 610-640-4206

Date Prepared:

28 November 2008

Proprietary Name:

Common Name:

Transcranial Magnetic Stimulator

NeuroStar TMS Therapy System2 [K061053]

NeuroStar® TMS Therapy System

Transcranial Magnetic Stimulator for Treatment of Major Depressive Disorder [21 CFR 882.5805, Product Code OBP]

Predicate Device:

Classification Name:

Device Description:

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NEURONETICS

510(k) SUMMARY NEUROSTAR TMS THERAPY® SYSTEM¹

	The NeuroStar TMS System is a non-invasive tool for thestimulation of cortical neurons for the treatment of adult patientswith Major Depressive Disorder (MDD) who have failed to receivesatisfactory improvement from prior antidepressant medication. TheNeuroStar TMS System is used for patient treatment by prescriptiononly under the supervision of a licensed psychiatrist. It can be usedin both inpatient and outpatient settings including psychiatrist'soffices and clinics, psychiatric hospitals, and generalmedical/surgical hospitals with psychiatric units.
	The NeuroStar TMS System is an integrated system consisting of acombination of hardware, software, accessories and consumablesupplies. It includes a Mobile Console which houses the electronics,mechanically supports the ferromagnetic Treatment Coil andincludes a software controlled graphical user interface, aferromagnetic Treatment Coil to deliver TMS Therapy, a HeadSupport System for accurate coil positioning, and a single use device(SenStar® Treatment Link) placed on the face of the coil to reducelocal scalp stimulation, to provide feedback to the operator regardingcontact of the coil with the patient's head, and to verify the appliedfield strength. A separate Practice Data Management System(PDMS) allows and facilitates recording and retrieval of patient andtreatment information and communication of data among multipleNeuroStar TMS System units.
Intended Use	NeuroStar TMS Therapy is indicated for the treatment of MajorDepressive Disorder in adult patients who have failed to achievesatisfactory improvement from one prior antidepressant medicationat or above the minimal effective dose and duration in the currentepisode.
TechnologicalCharacteristicsand SubstantialEquivalence	The NeuroStar TMS Therapy System with Class 1 laser positioningaid utilizes a Class 1 laser for positioning and registration of thepatient's head in the Head Support System prior to coil positioningfor Motor Threshold (MT) determination and TMS treatment. TheClass 1 laser positioning aid provides for ease of use during headpositioning and registration as compared to the use of plasticpositioning pointers in the predicate device. The use of the Class 1laser positioning aid does not substantially change the process ofpatient positioning for NeuroStar TMS Therapy and providesequivalent accuracy in coil placement for MT determination andTMS treatment as shown by verification and validation testing.
	The Class 1 laser positioning aid consists of a laser diode, linegenerating lens, printed circuit board and 1.5V AA battery. The

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NEURONETICS

510(k) SUMMARY NEUROSTAR TMS THERAPY® SYSTEM?

optical components are cemented in place and mechanically captured with a non-removable bezel. The circuitry regulates the laser diode current based on measured output and incorporates a timing circuit that ensures that the laser diode is turned off after a maximum of 45 seconds. There are no user or service adjustable components; the only required maintenance is replacement of the battery on an annual basis during the required system preventative maintenance visit which is performed by a trained service technician. The only laser radiation that is accessible during use or service is the primary output beam which meets Class 1 requirements.

Laser certification and identification labels and additional Instructions for Use are provided as required for a Class 1 laser.

Based on risk analysis and performance testing, the NeuroStar TMS Therapy System with Class 1 laser positioning aid raises no new questions of safety and efficacy and is substantially equivalent to the predicate device.

The NeuroStar TMS Therapy System with Class 1 laser positioning aid was designed in conformity with design controls. Design verification tests were performed as based on a Failure Modes and Effects Analysis (FMEA). The accuracy of the Class 1 laser positioning aid was verified to meet design specifications (Test Report 80-80095-001). Its utility in treatment coil positioning and equivalence to the predicate device in determination of MT and TMS treatment locations was demonstrated (Test Report 80-80095-000).

The laser is Class 1 according to IEC 60825-1 and complies with FDA Laser Notice No. 50 (issued 24 June 2007). The NeuroStar TMS Therapy System including the laser assembly complies with all applicable sections of UL/CSA/EN60601-1 for electrical safety.

Based on performance testing, the NeuroStar TMS Therapy System with Class 1 laser positioning aid is as safe, as effective, and performs as well as the predicate device with enhanced ease of use in patient positioning.

0031

The NeuroStar TMS Therapy and SenStar® are registered trademarks of Neuronetics, Inc.

2 Any statement made in conjunction with this submission regarding substantial equivalence to any relates to whether the product can be lawfully market without premarket approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation [42 Fed. Reg. 42,520 et seq. (1977].

Performance Testing

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, intertwined with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three intertwined snakes and a staff. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neuronetics, Inc. % Judy P. Ways, Ph.D. Vice President Regulatory Affairs and Quality Assurance One Great Valley Parkway, Suite 2 Malvern, Pennsylvania 19355

Re: K083538

Trade/Device Name: NeuroStar TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulator for treatment of major depressive disorder Regulatory Class: II Product Code: OBP Dated: November 28, 2008 Received: November 28, 2008

DEC 1 6 2008

Dear Dr. Ways:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Judy P. Ways, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800).638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulhern

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __

Device Name: NeuroStar TMS Therapy System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

S. Number.

Regulation Number and Section

§ 882.5805 Repetitive transcranial magnetic stimulation system.

(a)
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.(b)
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.