For Adults: Horizon 3.0 TMS Therapy Systems are indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

Device Description

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation 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. ("TMS").

The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of

Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode
as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15--21)

The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals.

The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and accessories.

The Horizon® 3.0 TMS Therapy System is offered in three configurations:

Horizon 3.0 Inspire (Cleared under K241518). -
Horizon 3.0 (Cleared under K232235, K223154, K222171 and K211389), -
Horizon 3.0 with StimGuide Pro (Cleared under K232235).

The three tiers of system offer equivalent safety and effectiveness with the main purpose allowing for physician offices, clinics and hospitals to choose a configuration that suits the organizational needs and provide different entry levels to promote the accessibility of TMS Therapy Treatments to health delivery organizations.

All three configurations have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation.

All configurations are composed from the following main components:

Stimulating Unit & Power Supply -
User Interface
Applicating Coil for Motor Threshold -
-Applicating Coil for Treatment Delivery
-System and Applicating Coil Cart and Holding Arm

The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

AI/ML Overview

Below is a summary of the acceptance criteria and the study that proves the device meets the criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2. Demonstrated equivalent EMC level to the primary predicate device.	The Horizon 3.0 TMS Therapy System was tested and found compliant with IEC 60601-1-2, demonstrating an equivalent level of EMC as the primary predicate device.
Electrical & Mechanical Safety	Compliance with IEC 60601-1 (including IEC 60601-1-6 and IEC 60601-1-8). Demonstrated equivalent electrical and mechanical safety level to the primary predicate device.	The Horizon 3.0 TMS Therapy System was tested and found compliant with IEC 60601-1 standards, demonstrating an equivalent level of electrical and mechanical safety as the primary predicate device.
Thermal Safety	Compliance with IEC 60601-1 (including IEC 60601-1-6 and IEC 60601-1-8). Ability of Horizon Air Film Coil and Horizon 3.0 Ez Cool Coil to execute OCD, iTBS, and rTMS protocols at worst-case ambient conditions without excessive temperatures.	The system was compliant with IEC 60601-1. Additional testing confirmed the Horizon Air Film Coil and Horizon 3.0 Ez Cool Coil could perform protocols safely and effectively, even at worst-case ambient conditions (80%-100% output, 30°C), comparable to the predicate.
Software Verification & Validation	Appropriate function of software, demonstrating it cannot contribute to any unacceptable risk (following IEC 62304 and FDA Software Guidance). Software behavior is consistent and compatible across all configurations and fulfills its intended use, with cybersecurity tested to ensure security equivalent to the primary predicate.	Software development followed IEC 62304. Lifecycle documentation demonstrated appropriate function and no unacceptable risk. Software behavior was consistent, compatible, and passed cybersecurity testing, ensuring security equivalent to the primary predicate.
Usability/Human Factors Engineering	Appropriate human factors and usability for intended use, free from unacceptable use-related risks (following IEC 60601-1-6, IEC 62366-1, ANSI/AAMI HE75). Consistency of workflows, UIs, and components promoting a healthy usability profile.	Human factors evaluation demonstrated appropriate usability and freedom from unacceptable use-related risks. Consistency across configurations promotes a healthy usability profile.
Magnetic Pulse Output & Field Testing	Equivalence of electric field distribution, power outputs, magnetic fields, field spatial distribution, E-field decay, output waveforms, magnetic field strength, and rate of change between subject coils (Ez Cool Coil, Air Film Coil) and predicate coil (Neuronetics Coil) at clinically relevant depths (2-3cm). Compliance with Special Controls: 21 C.F.R. § 882.5802, 21 C.F.R. § 882.5805, and FDA Guidance "Repetitive Transcranial Magnetic Stimulation (rTMS) Systems."	Measurements in a phantom head model showed equivalent power outputs, electric and magnetic fields, and key field characteristics between the subject and predicate coils at clinically relevant depths (2-3cm).
Safety Feature Testing	Maintenance of appropriate safety features, exercising many fault scenarios, and ensuring interlocks with respect to safety features (following IEC 60601-1). Testing includes introducing failure modes to test multiple fault conditions (e.g., disabling software check and ensuring hardware backup interlock is active).	All fault scenarios and safety features were tested and complied with IEC 60601-1, demonstrating substantial equivalence of safety features among all device configurations.
Acoustic Testing	System does not reach excessive/unacceptable noise levels under simulated use scenarios with Horizon Air Film Coil and Horizon 3.0 Ez Cool Coil (following IEC 60601-1).	Acoustic testing under simulated use scenarios (maximum machine output for recommended protocols) demonstrated the system with the specified coils does not reach excessive/unacceptable noise levels.

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

The summary details a series of non-clinical tests. These tests primarily involve physical measurements and simulations, rather than collecting data from human subjects.

Sample Size for Test Set: Not applicable in the traditional sense of human subjects. For the magnetic and electrical field testing, the "test set" was the physical setup involving a phantom head model and specific coils. No numerical sample size for patients is provided.
Data Provenance: The data comes from in-house engineering and laboratory testing performed by The Magstim Company Limited, in accordance with international standards. This is not retrospective or prospective clinical data from human patients, but rather performance data generated from the device itself and its components. The country of origin for the testing is implicitly the United Kingdom, where the applicant is located.

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

Given the nature of the non-clinical tests described, the concept of "experts establishing ground truth" for a test set in a human clinical context is not directly applicable.

Magnetic and Electrical Field Testing: This testing involved physical measurements using a phantom head model and measuring probes. The "ground truth" here is the physical output of the device under controlled conditions, measured against established scientific principles and comparison to a legally marketed predicate device. The expertise involved would be in engineering, physics, and medical device testing, ensuring the test setup, execution, and interpretation of results are scientifically sound and comply with regulatory guidance.
Other Non-Clinical Tests: For areas like Electrical, Mechanical, Thermal Safety, EMC, Software V&V, Usability, Safety Features, and Acoustic Testing, compliance is determined by adherence to specific international standards (e.g., IEC 60601 series, IEC 62304, ISO 10993, AAMI/ANSI HE75) and FDA guidance documents. The "ground truth" is defined by these standards and the expertise lies with the engineers and quality assurance personnel who conduct these tests and verify compliance.

No specific number or qualifications of "experts" are provided in the summary, as this is typically inherent in the regulatory-compliant testing process conducted by the manufacturer.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where ambiguous cases require expert consensus. The tests described here are non-clinical, objective measurements and compliance checks against established standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The summary explicitly states: "Clinical Testing - Not Applicable." The submission relies solely on non-clinical testing to demonstrate substantial equivalence.

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

This question is not entirely applicable as the device in question (Horizon 3.0 TMS Therapy System) is a hardware-based medical device that delivers magnetic stimulation. While it contains software, it is not an AI algorithm that generates diagnostic outputs or interpretations that would typically have a "standalone" performance metric in the absence of human input or a human-in-the-loop. The software functions to control the hardware and deliver therapy protocols, and its performance is validated as part of the overall device system.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is primarily based on:

Compliance with International Standards: The device's performance is measured against established safety, EMC, thermal, electrical, mechanical, and software standards (e.g., IEC 60601 series, IEC 62304).
Scientific Principles and Physical Measurements: For magnetic and electrical field testing, the ground truth is derived from quantitative physical measurements conducted in a controlled phantom head model according to scientific principles.
Comparison to a Legally Marketed Predicate Device: Substantial equivalence is established by demonstrating that the subject device's performance characteristics (e.g., magnetic field output, treatment protocols) are equivalent to those of the predicate device (NeuroStar Advanced Therapy System) and previously cleared Magstim devices.

There is no pathology, expert consensus (in a diagnostic sense), or outcomes data from human patients used as ground truth in this submission, as it focuses on non-clinical performance.

8. The Sample Size for the Training Set

Not applicable. This device is a medical device for therapy, not a machine learning model that requires a distinct "training set" of data in the AI sense. The software embedded in the device is developed and validated through traditional software engineering practices (IEC 62304), not through machine learning training on a dataset.

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

Not applicable, as there is no machine learning "training set" for this device. The software development and validation followed established engineering principles and regulatory standards (IEC 62304), which ensure the software functions as intended and meets safety requirements.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue. The logo includes the words "U.S. FOOD & DRUG ADMINISTRATION".

March 17, 2025

The Magstim Company Limited Alan Yik Senior Regulatory Affairs Specialist Spring Gardens Whitland Carmarthenshire, SA34 0HR United Kingdom

Re: K243869

Trade/Device Name: Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: December 17, 2024 Received: December 17, 2024

Dear Alan Yik:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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changes that may require a new premarket notification are provided in the FDA

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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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, PAMELA D. SCOTT -S

Digitally signed by PAMELA D. scott -S Date: 2025.03.17 22:31:20 -04'00"

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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243869

Device Name

Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire);

Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro);

Horizon® 3.0 TMS Therapy System (Horizon 3.0)

Indications for Use (Describe)

For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Horizon 3.0 TMS Therapy System 510(k) Summary

510(k) Summary

A. Contacts Details

Applicant Name:	The Magstim Company Limited
Applicant Address:	Spring GardensWhitlandCarmarthenshireSA34 0HRUnited Kingdom
Applicant Contact Telephone:	+44 1994240798
Applicant Contact:	Mr. Alan Yik
Applicant Contact Email:	ayik@welcony.com
B. Device Name
Device Trade Name:	Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro);Horizon® 3.0 TMS Therapy System (Horizon 3.0)
Common Name:	Repetitive transcranial magnetic stimulation system

882.5805

Product Code(s):

Classification Name:

Regulation Number:

C. Legally Marketed Predicate Devices

Predicate#	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K231926	NeuroStar Advanced Therapy System	OBP
K241518	Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire);Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuidePro);Horizon® 3.0 TMS Therapy System (Horizon 3.0)	OBP
K232235	Magstim® Horizon® 3.0 TMS Therapy System;Horizon® 3.0 System;Horizon® 3.0; Horizon® 3.0 with Navigation;Horizon® 3.0 with StimGuide Pro	OBP

Transcranial Magnetic Stimulator

OBP, QCI - 21 C.F.R. § 882.5802

Table 1 – List of Predicate Devic

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510(k) Summary

D. Device Description Summary

The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of

Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode
as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15--21)

The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and accessories.

The Horizon® 3.0 TMS Therapy System is offered in three configurations:

Horizon 3.0 Inspire (Cleared under K241518). -
Horizon 3.0 (Cleared under K232235, K223154, K222171 and K211389), -
Horizon 3.0 with StimGuide Pro (Cleared under K232235).

All configurations are composed from the following main components:

Stimulating Unit & Power Supply -
User Interface
Applicating Coil for Motor Threshold -
-Applicating Coil for Treatment Delivery
-System and Applicating Coil Cart and Holding Arm

The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

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510(k) Summary

E. Intended Use/ Indications for Use

For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

F. Indications for Use Comparison

The indications for use for the subject device and the primary predicate device (K231926) are equivalent.

The reference devices K241518 and K232235, which are identical in design, technological features and performance, have been previously cleared for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The subiect device indications for use have been updated to include the additional indication for the treatment, as an adjunct, for the treatment of Major Depressive Disorder (MDD) in adolescent patients (Age 15-21).

The performance data provided within this submission - such as the comparison of device electric and maqnetic field output - demonstrate why the expansion of the indications to include the adjunct treatment of MDD in adolescent patients does not raise any differing questions of safety and effectiveness.

G. Technological Comparison

Introduction:

The Horizon® 3.0 TMS Therapy System is offered in three system configurations: Horizon 3.0, Horizon 3.0 with StimGuide Pro and Horizon 3.0 Inspire.

All system configurations feature the same core components and operating principles that drive the device. All three configurations have identical intended use/indications for use, common specifications and equivalent performance compare with the primary predicate NeuroStar Advanced Therapy System.

Principles of Operation: Horizon 3.0 TMS Therapy System is identical to the primary predicate device in terms of principles of operation. Horizon 3.0 TMS Therapy System is capable of delivering

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510(k) Summary

and provides the same recommended treatment protocols (rTMS and iTBS) as the primary predicate device.

The method for coil positioning is also equivalent to the primary predicate, with the Horizon 3.0 following the same principle of the statistical distance from the Motor Threshold (MT) Hotspot to the target area based on the chosen treatment (5.5cm from MT Hotspot. Left Dorsolateral Prefrontal Cortex, for MDD).

The principles of operation with respect to MT Determination remain identical to the primary predicate device - either by using visual qualitative monitoring for APB response or quantitative data provided by EMG.

In summary, the principles of operation of the subject Horizon 3.0 TMS Therapy System substantially equivalent to the primary predicate device configurations - NeuroStar Advanced Therapy System.

Technological Characteristics:

The subject device remains unchanged compare with the reference devices cleared by FDA under K241518 and K232235. The basic design of the subject device is substantially equivalent to the design of the primary predicate device cleared under K231926, as all configurations are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. Both systems in all configurations use the same mechanism of action, i.e. an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex.

Whilst the treatment coil construction characteristics in the subject device – Ez Cool Coil, Air Film Coil (Cleared in K232235 and K241518) and the primary predicate device - Neuronetics Coil are different, the magnetic field characteristics of the coils are equivalent which is pertinent to treatment delivery effectiveness. Comparison of the magnetic field characteristics, output waveform, magnetic/ electric field spatial distribution and magnetic field strength gradient was conducted between the Ez Cool Coil, Air Film Coil and Neuronetics Coil. The comparison shows that the Horizon Air Film Coil and Horizon 3.0 E-z Cool Coil is equivalent to the predicate device and does not raise any differing questions of safety or effectiveness when used as an adjunct for the treatment of adolescents (age 15 - 21) with MDD.

The performance evaluation measured for all coils in a precise setup, where a measuring probe for measuring the induced voltage was placed inside a phantom head model filled with a physiologic saline solution. The shape of the phantom head model is a representation of the human scalp and the saline solution provided a representation of the conductivity of the human brain. The measurements included magnetic field characteristics, output waveforms, magnetic/electric field spatial distribution and magnetic field strength gradient. Measurements were obtained to a depth of 3cm which was chosen as it encompasses the area and the typical depth required for determining Motor Thresholds as per the principles of operation for MDD treatments (2cm). The results from the evaluation demonstrated that all coils are substantially equivalent at the clinically relevant depth of 2-3cm.

Both the Horizon Air Film Coil and Ez Cool Coil have also been tested and found compliant to

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510(k) Summary

60601-1 and 60601-1-2 testing for Electrical, Electromagnetic Compatibility, Thermal and Mechanical safety. Further, the coils materials of the patient contacting parts are identical to those which have been previously cleared under K241518 and K232235 and are in compliance with 10993 series applicable standards.

As can be seen from the summary above - technologically the Horizon 3.0 TMS Therapy System is very similar, and in some cases identical, to the primary predicate device. Despite of the differences of technological features illustrated above, both the subject device and primary predicate have the same core principles, technology, safety and effectiveness.

The design of all configurations in the subject device have been appropriately verified and conforms to the same safety standards as the primary predicate device such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8. IEC 62366-1. AAMI/ANSI HE75. ISO 10993-1. ISO 14971 for electrical safety. thermal safety, mechanical safety, EMC, human factors, alarm systems and biocompatibility. Including IEC 62304. AAMI TIR57 and AAMI TIR97 for software and security. Security testing of the Horizon 3.0 TMS Therapy System such as Security Requirement. Threat Mitigation and Vulnerability testing was performed and documented in accordance with FDA guidance to demonstrate subject device is as secure as the primary predicate device.

The recommended treatment protocol as an adjunctive treatment for MDD on adolescent patient (age 15 – 21) is equivalent to that of the primary predicate device. This is further described below in Table 2.

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510(k) Summary

Table 2: Horizon® 3.0 TMS Therapy System MDD Treatment Specifications Comparison Against Predicate Device

		Horizon® 3.0 TMSTherapy System(Subject of thissubmission)	NeuroStar AdvancedTherapy System(K231926)(Primary Predicate)	Horizon® 3.0 TMSTherapy System(K232235, K241518)(Reference device)
Standard Treatment Protocol	Magnetic FieldIntensity	120% of the MT	120% of the MT	120% of the MT
		Frequency	10 Hz	10 Pulse per second
		Train duration	4 sec(Note: this duration falls below theMaximum Safe Train DurationLimits for Avoiding Seizures, perthe FDA Guidance for rTMSSystems)	4 sec
		Inter-train interval	11 to 26 sec	As low as 11 s
		Number of trains	75	75
		Magnetic Pulses perSession	3000	3000
		Treatment SessionDuration	18.8 to 37.5 minutes	As low as 18.75 minutes
		Sessions/week	5	5
		Treatment Schedule	5 daily sessions for 6weeks	5 daily sessions for 6weeks
		Area of brain to bestimulated	Left DorsolateralPrefrontal Cortex	Left Dorsolateral PrefrontalCortex
ITBS Treatment Protocol	Stimulation Intensity	120% of the MT	80 - 120% of the MT	120% of the MT
		Repetition Rate	50 Hz (5 pulses per sec)	50 Hz (5 pulses per sec)
		Train Duration	2 sec	2 sec
		Inter-train Interval	8 sec	8 sec
		Burst Pulses	3	3
		Bursts	200	200
		Inter Pulse interval	20 msec	20 msec
		Number of trains	20	/
		Number of Pulsesper Session	600	600
		Treatment SessionDuration*	3 minutes 9 seconds	3.3 minutes
		Sessions/week	5	5
		Treatment Schedule	5 daily sessions for 6weeks	5 daily sessions for 6 weeks
	Area of brain to bestimulated	Left DorsolateralPrefrontal Cortex	Left Dorsolateral PrefrontalCortex	Left DorsolateralPrefrontal Cortex

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510(k) Summary

In conclusion - the Horizon® 3.0 TMS Therapy System with the addition of the patient group for the treatment, as an adjunct, of MDD to adolescent (age 15 - 21) does not raise any new or differing questions of safety or effectiveness and are substantially equivalent to the primary predicate NeuroStar Advanced Therapy System.

H. Non-Clinical and/or Clinical Tests Summary & Conclusions

Performance testing of the Horizon® 3.0 TMS Therapy System demonstrates that the device performs as intended for the safe and effective treatment of MDD, as an adjunct, for adolescent patients (age 15 - 21), and is therefore substantially equivalent to the primary predicate device NeuroStar Advanced Therapy System. The following nonclinical testing within this submission is relied upon for a determination of substantial equivalence:

Electromagnetic Compatibility in accordance with IEC 60601-1-2 - The Horizon 3.0 TMS Therapy System has been tested and found compliant to the requirements of IEC 60601-1-2 to demonstrate an equivalent level of Electromagnetic Compatibility as the primary predicate device. Electrical & Mechanical Safety in accordance with IEC 60601-1 - The Horizon 3.0 TMS Therapy System has been tested and found compliant to the requirements of IEC 60601-1 (including IEC 60601-1-6 and IEC 60601-1-8) to demonstrate an equivalent level of Electrical and Mechanical safety as the primary predicate device.

Thermal Safety in accordance with IEC 60601-1 - The Horizon 3.0 TMS Therapy System has been tested and found compliant to the requirements of IEC 60601-1 (including IEC 60601-1-6 and IEC 60601-1-8). Additional testing was performed to ensure that the Horizon Air Film Coil and Horizon 3.0 Ez Cool Coil can execute OCD, iTBS and rTMS protocols at worst-case ambient conditions without resulting in excessive temperatures.

Software Verification & Validation (IEC 62304, FDA Software Guidance) - Software has been developed in a structured manner following IEC 62304. Software lifecycle documentation demonstrates appropriate function of software and demonstrates the software cannot contribute to any unacceptable risk.

Usability/Human Factors Engineering (IEC 60601-1-6, IEC 62366-1, ANSI/AAMI HE75) - A human factors evaluation demonstrates appropriate human factors and usability of the Horizon® 3.0 TMS Therapy System device configurations for its intended use and demonstrates that the device is free from any unacceptable use related risks.

Magnetic Pulse Output Testing and Magnetic and Electrical Field Testing (Special Controls: 21 C.F.R. § 882.5802, 21 C.F.R. § 882.5805 and FDA Guidance "Repetitive Transcranial Magnetic Stimulation (rTMS) Systems – Class II Special Controls Guidance for Industry and FDA Staff" – July 26, 2011) - The electric field distribution produced by the subject coils and predicate coil in a human head phantom model filled with physiologic saline solution were measured for comparison. Values of the Magnetic and Electric field were obtained by measuring induced voltage into a measuring probe inside a phantom head model filled with a physiologic saline solution. The results demonstrated equivalent Power Outputs, Electric Fields and Magnetic Fields between the subject devices configuration applicating coil and the primary predicate device configuration applicating coil.

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510(k) Summary

Safety Feature Testing (IEC 60601-1) - IEC 60601-1 testing exercises many fault scenarios to ensure appropriate safety features are maintained. System level testing documented as part of the software verification and validation also exercises the various interlocks with respect to safety features. Testing includes deliberately introducing failure modes to test multiple fault conditions, such as disabling a software check and ensuring a hardware backup interlock is active.

Acoustic Testing (IEC 60601-1) - Acoustic testing of the system under a simulated use scenario demonstrates the Horizon 3.0 TMS Therapy System with the Horizon Air Film Coil and Horizon 3.0 Ez Cool Coil do not reach excessive/unacceptable noise levels.

Clinical Testing - Not Applicable

Based on the above nonclinical testing - it can be concluded that the subject Horizon 3.0 TMS Therapy System substantially equivalent to the primary predicate device cleared under K231926. There is no change on the design of the all the configurations since the 510(k) clearance K241518 and K232235, which are the references device in the submission.

Electromagnetic Compatibility was demonstrated to be the same as the primary predicate device through compliance to IEC 60601-1-2. The test plan executed to evaluate the subject devices utilized the standard performance criteria used for EMC testing and therefore demonstrates a substantial equivalence of the subject Horizon 3.0 TMS Therapy System to the primary predicate device.

Electrical. Mechanical and Thermal safety was demonstrated through the application of IEC 60601-1. The subject Horizon 3.0 TMS Therapy System was found to be compliant to the standard. Further, in-house device specific protocol testing determined that for rTMS and iTBS treatment protocols under reasonable worst-case simulated ambient conditions (80% - 100% of machine output, at 30°C ambient room temperature) - the Horizon 3.0 TMS Therapy System with the Horizon Air Film coil and Horizon 3.0 E-z Cool Coil could perform the recommended protocols safely and effectively equivalent to the primary predicate device with the Neuronetics Coil.

Software Verification and Validation was performed on the subject Horizon 3.0 TMS Therapy System to demonstrate the software behaviour is consistent and compatible across all configurations of the Horizon® 3.0 TMS Therapy System and fulfil its intended use. The testing also included cybersecurity testing to ensure the subject device configurations are as secure as the primary predicate device configurations.

Human Factors and Usability Engineering processes demonstrate the Horizon 3.0 TMS Therapy System is substantially equivalent to the primary predicate device configurations for its intended use in terms of human factors and usability, and demonstrates that the device is free from any unacceptable use related risks. The consistency of workflows, User Interfaces and components of known provenance between all configurations of the device promote a healthy usability profile for all system configurations.

Magnetic and Electric Field Testing demonstrated that the applicating coil of the subject device configurations - the Horizon Air Film Coil and Horizon 3.0 E-z Cool Coil, are substantially equivalent

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510(k) Summary

to the applicating coil of the primary predicate device configuration. Values of the Magnetic and Electric field were obtained by measuring induced voltage into a measuring probe inside a phantom head model filled with a physiologic saline solution, with a total volume of 4cm x 3cm and a resolution of 5mm.

Key characteristics of the field output were equivalent between coils; such as the required stimulator output/operating voltage, field spatial distribution, E-Field decay, output waveforms and magnetic field strength and rate of change. This is especially apparent at the clinically relevant depths of stimulation - where the values of the characteristics of coils were virtually identical.

The Air Film Coil and E-z Cool Coils used by the subject have been legally marketed for the treatment of MDD in adults since K143531 and K180907 respectively.

K143531 also used the Neuronetics Device and applicating coil as the primary predicate for the original introduction to market - where substantial equivalence between the Air Film Coil and Neuronetics device was demonstrated. This testing was re-performed and is documented within this submission to re-affirm the determination of substantial equivalence between the output characteristics of the subject device and primary predicate.

Further, the E-z Cool Coil has been recently compared with the Neuronetics and was deemed substantially equivalent in K222171 and K223154.

Finally, the Air Film Coil and E-z Cool Coil were compared first in K180907 and then most recently in the latest submission of the subject device (K241518) to each other and deemed substantially equivalent.

As a result - all three coils have been deemed substantially equivalent to each other for safe and effective stimulation at depths of 2-3cm which is in the clinically relevant area for the proposed indications for use.

This submission collects all this data together to provide a comprehensive comparison and demonstration of substantial equivalence of the subject device (including it's configurations) to the primary predicate device for the proposed indications for use.

Safety Feature Testing ensured all fault scenarios and safety features tested complies to IEC 60601-1. The testing provided within this submission demonstrates that there is substantial equivalence of safety features amongst all device configurations.

Acoustic Testing in simulated use conditions (Recommended Protocols at maximum machine output) for the subject Horizon 3.0 TMS Therapy System demonstrated the system with Horizon Air Film Coil and Horizon 3.0 E-z Cool Coil does not reach excessive/ unacceptable noise levels.

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.