The HORIZON™ TMS Therapy System is indicated 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.

Device Description

The HORIZON® TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration 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. The HORIZON® 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 antidepressant medication in the current episode. The HORIZON® 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.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, approving the Magstim HORIZON™ TMS Therapy System. It states that the device is substantially equivalent to a predicate device and therefore does not contain all the detailed information typically found in a full clinical study report. Specifically, it focuses on non-clinical testing for substantial equivalence rather than a comparative clinical effectiveness study (MRMC) or standalone algorithm performance.

However, based on the provided text, we can extract details about the acceptance criteria (implicitly defined by the substantial equivalence argument), the study proving it meets these, and some related information:

Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present explicit quantitative acceptance criteria as one might find for a novel device, but rather frames "acceptance" as demonstration of substantial equivalence to a previously cleared predicate device. The performance is assessed by comparing technical characteristics.

Criteria	HORIZON® TMS Therapy System (Subject Device)	HORIZON® Therapy System (K171051) (Primary Predicate)	NeuroStar TMS Therapy System (K160703) (Secondary Predicate)	Neurosoft TMS (K173441) (Secondary Predicate)
Intended Use/Indications for Use	Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.	Identical	Identical	Identical
Sessions/week	5	5	5	5
Treatment Schedule	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks	5 daily sessions for 6 weeks
Area of brain to be stimulated	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex	Left Dorsolateral Prefrontal Cortex
Waveform	Biphasic	Biphasic	Biphasic	Biphasic
Core Material	Air	Air	Ferromagnetic core	Air
Pulse Width	330μs (range given as 0.28-1.9)	340μs (range given as 0.28-1.9)	300μs	185μs
Magnetic Field Intensity	120% of the MT	120% of the MT	120% of the MT	120% of the MT
Stimulus Frequency	10 Hz	10 Hz	10 Hz	10 Hz
Stimulus Train duration	4 sec	4 sec	4 sec	4 sec
Inter-train interval	11-26 sec	26 sec	11-26 sec	11-26 sec
Number of trains	75	75	75	75
Magnetic Pulses per Session	3000	3000	3000	3000
Treatment Session Duration	18.8 min-37.5 min	37.5 min	18.8 min – 37.5 min	18.8 min-37.5 min
Maximum # of pulses per session (cumulative exposure)	60,000	6,000	5,000	72,000 (stand-alone), 240,000 (with PC)
Maximum output amplitude (V/m) at 2cm	150 V/m	150 V/m	135V/m nominal	Not disclosed by Manufacturer
Electrical Safety Standards	IEC 60601-1 (Ed. 3.1.)	IEC 60601-1	Not explicitly stated for predicate in table, but general statement of meeting standards applies.	Not explicitly stated for predicate in table, but general statement of meeting standards applies.
EMC Standards	EN 60601-1-2 (2007)	EN 60601-1-2	Not explicitly stated for predicate in table.	Not explicitly stated for predicate in table.

Note: Bolded values highlight the parameters where the subject device differs from its primary predicate but aligns with secondary predicates, demonstrating substantial equivalence through a combination of existing cleared devices.

Sample size used for the test set and the data provenance:

The document does not describe a test set in the context of a clinical trial with human subjects for performance evaluation like an AI/algorithm-based diagnostic device would. This is a premarket notification for a medical device (TMS system) based on substantial equivalence to predicates.

The "testing" mentioned is primarily non-clinical:
- Electrical safety and electromagnetic compatibility (EMC) testing: Done on the system itself to demonstrate compliance with standards (IEC 60601-1, EN 60601-1-2).
- Biocompatibility evaluation: Demonstrated adherence to ISO 10993-1.
- Acoustic output measurements: Conducted during IEC 60601-1 testing.
- Software verification and validation testing: To ensure software performs as intended.
- Magnetic field characteristics testing: To show substantial equivalence to the primary predicate.
There's no mention of a "test set" of patient data or clinical retrospective/prospective studies demonstrating diagnostic or treatment efficacy in the context of an algorithm's performance on patient data. This is a physical therapy device, not a diagnostic AI.
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" with ground truth established by experts is described in this 510(k) summary for a TMS therapy system.
Adjudication method for the test set:

Not applicable. See point 3.
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 device is a Transcranial Magnetic Stimulation (TMS) system for treating Major Depressive Disorder. It is not an AI diagnostic tool designed to assist human readers (e.g., radiologists) in interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of diagnostic AI. This is a therapeutic device. The "standalone" mention in the table under Neurosoft TMS refers to its ability to deliver pulses independent of a PC connection, not an algorithm's diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for a clinical test set. The "ground truth" for the non-clinical testing relates to engineering and safety standards (e.g., whether the device output is within specified ranges, whether it meets electrical safety requirements).
The sample size for the training set:

Not applicable. No machine learning training set is mentioned or relevant for this type of device submission.
How the ground truth for the training set was established:

Not applicable. No machine learning training set is mentioned.

Summary

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August 3, 2018

Magstim Company Ltd. Tom Campbell Regulatory Affairs Manager Spring Gardens Whitland, Camarthenshire Wales, UK SA34 0HR

Re: K180907

Trade/Device Name: HORIZON TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: July 2, 2018 Received: July 5, 2018

Dear Tom Campbell:

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

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Sincerelv.

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for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180907

Device Name HORIZON™ TMS Therapy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Residential Use (Part 21 CFR 601 Subpart D) OTC Cosmetic Use (21 CFR 331)	Residential Use (Part 21 CFR 601 Subpart D)	Residential Use (Part 21 CFR 601 Subpart D)	Residential Use (Part 21 CFR 601 Subpart D)		Residential Use (Part 21 CFR 601 Subpart D)	OTC Cosmetic Use (21 CFR 331)	OTC Cosmetic Use (21 CFR 331)
Residential Use (Part 21 CFR 601 Subpart D)	Residential Use (Part 21 CFR 601 Subpart D)	Residential Use (Part 21 CFR 601 Subpart D)		Residential Use (Part 21 CFR 601 Subpart D)	OTC Cosmetic Use (21 CFR 331)	OTC Cosmetic Use (21 CFR 331)	OTC Cosmetic Use (21 CFR 331)	OTC Cosmetic Use (21 CFR 331)
Residential Use (Part 21 CFR 601 Subpart D)	Residential Use (Part 21 CFR 601 Subpart D)		Residential Use (Part 21 CFR 601 Subpart D)
Residential Use (Part 21 CFR 601 Subpart D)		Residential Use (Part 21 CFR 601 Subpart D)
	Residential Use (Part 21 CFR 601 Subpart D)
OTC Cosmetic Use (21 CFR 331)	OTC Cosmetic Use (21 CFR 331)		OTC Cosmetic Use (21 CFR 331)
OTC Cosmetic Use (21 CFR 331)		OTC Cosmetic Use (21 CFR 331)
	OTC Cosmetic Use (21 CFR 331)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY Magstim's HORIZON®TMS Therapy System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Magstim Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 0HR, United Kingdom

Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061

Contact Person: Tom Campbell

Date Prepared: July 30, 2018

Name of Device

HORIZON® TMS Therapy System

Common or Usual Name/

Repetitive Transcranial Magnetic Stimulation (rTMS) System

Classification

Repetitive Transcranial Magnetic Stimulation (rTMS) System

21 C.F.R. § 882.5805, Class II, product code OBP

Predicate Devices

HORIZON® Therapy System, The Magstim Company Limited. (K171051) (Primary Predicate) NeuroStar TMS Therapy System, Neuronetics, Inc. (K160703) (Secondary Predicate) Neurosoft TMS, TeleEMG, LLC. (K173441) (Secondary Predicate)

Device Description

The HORIZON® 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 antidepressant medication in the current episode. The HORIZON® 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.

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The HORIZON® TMS Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.

Intended Use / Indications for Use

The HORIZON® TMS Therapy System is indicated 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.

Technological Characteristics

The HORIZON® TMS Therapy System is comprised of the following components:

1. HORIZON® Stimulator
- a. HORIZON® User Interface:
- b. HORIZON® Mainframe;
- c. HORIZON® Power Supply:
- d. Accessory Cables;
- e. Accessory Footswitch.
1. Coil for MT Determination
- a. HORIZON® MT Remote Coil.
1. Coil(s) for Treatment
- a. HORIZON® AFC;
- b. HORIZON® E-z Cool Coil.
1. Accessory Cart(s) and Coil Holding Mechanism(s)
- a. Magstim® Trolley;
- b. Magstim® Coil Stand(s):
- c. HORIZON® E-z Cart;
- d. HORIZON® E-z Arm.
1. Accessory Marking Apparatus
- a. TMS Patient Caps.

The operator controls the HORIZON® TMS Therapy System via the HORIZON® User Interface, using a graphic LCD panel with touchscreen technology. The operator instructions, given through the HORIZON® User Interface, direct the HORIZON® Mainframe in charging and discharging the device's high voltage discharge capacitor. The discharge is delivered to the patient via the stimulating coil. Motor threshold level can be determined using the HORIZON® MT Remote Coil. Treatment is delivered to the treatment area via either the HORIZON® AFC or the HORIZON® E-z Cool Coil, which is positioned above the treatment area. Positioning, and fixation, of the coil over the treatment area is accomplished using the Coil Holding Mechanism(s). The HORIZON® Power Supply provides power to charge the high voltage capacitor in the HORIZON® Mainframe.

Software documentation for a "moderate" level of concern has been provided.

Non-Clinical Testing

Electrical safety and electromagnetic compatibility ("EMC") testing was conducted on the system to demonstrate that the device is compliant with IEC 60601-1 (Ed. 3.1.) and EN 60601-1-2 (2007). Environmental testing also demonstrated compliance with IEC 60601-1.

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EN 60601-1-2 (2007) is not an FDA recognized standard and hence a justification of its equivalence to the appropriate FDA recognized standard for its acceptance has been provided.

The biocompatibility evaluation demonstrated that the stimulation coils meet ISO 10993-1 (2009) standards. In addition, acoustic output measurements have been conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance.

The software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of HORIZON® TMS Therapy System have been identified and evaluated in compliance with ISO14971, and the risks were determined to be acceptable, or have been addressed with risk control measures.

As required by FDA's Guidance Document titled "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems", non-clinical testing of the HORIZON® TMS Therapy System included testing of the magnetic field characteristics of the system. The results of this testing demonstrate that the magnetic field characteristics of the HORIZON® TMS Therapy System is substantially equivalent to the primary predicate device, the HORIZON® Therapy System (K171051).

Substantial Equivalence

The HORIZON® TMS Therapy System is substantially equivalent to the primary predicate device, the HORIZON® Therapy System (K171051).

The HORIZON® TMS Therapy System and the primary predicate device (K171051) have identical intended use and indications for use, equivalent principles of operation, as well as the same key technological characteristics.

The technological difference between the HORIZON® TMS Therapy System and the HORIZON® Therapy System (K171051), includes the addition of the HORIZON® E-z Cool Coil, HORIZON® E-z Cart and HORIZON® E-z Arm. These changes raise no new issues of safety or effectiveness. Performance data demonstrates that the HORIZON® TMS Therapy System is as safe and effective as the primary predicate device.

The design of the HORIZON® TMS Therapy System is substantially equivalent to the design of the primary predicate device (K171051), as both systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. Both systems 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.

The principles of operation of the HORIZON® TMS Therapy System is equivalent to the HORIZON® Therapy System (K171051). The modification to the device allows a range of inter-train intervals from 11 to 26 seconds, rather than the fixed 26 second duration, which allows a reduction in treatment time from 37.5 minutes to a minimum of 18.8 minutes. The change to this output stimulation parameter is identical to the secondary predicate device, the NeuroStar TMS Therapy System (K160703).

Transcranial magnetic stimulation is enabled in the HORIZON® TMS Therapy System and in the HORIZON® Therapy System (K171051), as both have the same key system

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components, consisting of electromagnetic coils, a coil holding mechanism, a TMS stimulator and software. The operation procedure is the same in both the HORIZON® TMS Therapy System and the HORIZON® Therapy System (K171051), consisting of system setup, patient preparation, determination of patients' motor threshold, coil position, and administration of treatment at pre-defined treatment stimulation parameters.

The basic software capabilities related to treatment administration are the same as the primary predicate, the HORIZON® Therapy System (K171051). A notable difference is that the arbitrary upper limit imposed by software for the maximum number of pulses per session (cumulative exposure) has been increased from 6000 to 60,000 in the HORIZON® TMS Therapy System. This is supported by TeleEMG, LLC's Neurosoft TMS (K173441) that is capable of delivering a maximum of 72,000.

The HORIZON® TMS Therapy System meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (EN 60601-1-2).

The similarities and minor differences between the HORIZON® TMS Therapy System, the HORIZON® Therapy System (Primary Predicate), the NeuroStar TMS Therapy System (Secondary Predicate) and the Neurosoft TMS (Secondary Predicate) are described in Table 1.

Conclusions

In summary, the intended use and indications for use for the HORIZON® TMS Therapy System and primary predicate device, The HORIZON® Therapy System (K171051) are identical.

Furthermore, the key technological characteristics and principles of operation, including basic design, mechanism of action, specifications and treatment procedure are substantially equivalent.

Non-clinical test data demonstrates that the HORIZON® TMS Therapy System is as safe and effective as the HORIZON® Therapy System (K171051).

Thus, the HORIZON® TMS Therapy System is considered substantially equivalent to the primary predicate device, the HORIZON® Therapy System (K171051).

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Table 1: Substantial Equivalence Summary

Criteria	HORIZON® TMS Therapy System(Subject of this submission)	HORIZON® TherapySystem(K171051)(Primary Predicate)	NeuroStar TMSTherapy System(K160703)(SecondaryPredicate)	Neurosoft TMS(K173441)(Secondary Predicate)	Sessions/week	5		5		5	5
Manufacturer	Magstim Company Limited	Magstim Company Limited	Neuronetics Inc.	TeleEMG, LLC	Treatment Schedule	5 daily sessions for 6 weeks		5 daily sessions for 6 weeks		5 daily sessions for 6weeks	5 daily sessions for 6weeks
Device Name	HORIZON® Therapy System	HORIZON® Therapy System	NeuroStar TMSTherapy System	Neurosoft TMS	Area of brain to bestimulated	Left Dorsolateral Prefrontal Cortex		Left Dorsolateral PrefrontalCortex		Left DorsolateralPrefrontal Cortex	Left DorsolateralPrefrontal Cortex
Clearance date		09/13/2017	06/10/2016	12/13/2017		HORIZON®MT RemoteCoil	HORIZON®E-z Cool Coil	HORIZON®AFC	HORIZON®MT Remote Coil	HORIZON®AFC	NeuroStar StimulatingCoil	FEC-02-100-C, AFEC-02-100-CFEC-02-100 (optional),AFEC-02-100 (optional)
510(k) number		K171051	K160703	K173441	Waveform	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic	Biphasic
Device code	OBP	OBP	OBP	OBP	Core Material	Air	Air	Air	Air	Air	Ferromagnetic core	Air
Intended Use/Indications for Use	The HORIZON® TMS Therapy System is indicated for thetreatment of Major Depressive Disorder in adultpatients who have failed to achieve satisfactoryimprovement from prior antidepressant medication inthe current episode.	The HORIZON® Therapy System isindicated for the treatment of MajorDepressive Disorder in adultpatients who have failed to achievesatisfactory improvement from priorantidepressant medication in thecurrent episode.	The NeuroStar TMSTherapy System is indicatedfor the treatment of MajorDepressive Disorder inadult patients who havefailed to achievesatisfactory improvementfrom prior antidepressantmedication in the currentepisode.	The Neurosoft TMS is indicatedfor the treatment of MajorDepressive Disorder in adultpatients who have failed toachieve satisfactoryimprovement from priorantidepressant medication inthe current episode.	Pulse Width	330μs	340μs	300μs	330μs	300μs	185μs	280μs
Magnetic FieldIntensity	120% of the MT	120% of the MT	120% of the MT	120% of the MT	Amplitude in SMT units(Standard Motor Threshold)	0.28 - 1.9		0.28 - 1.9		0.22 - 1.6		FEC-02-100-C 0-1.89AFEC-02-100-C 0-2.38FEC-02-100 0-1.92AFEC-02-100 0-2.33
Stimulus Frequency	10 Hz	10 Hz	10 Hz	10 Hz	Frequency range (Hz)at 100%		1 - 20		1 - 20		0.1-30	0.1-30 (stand-alone)0.1-100 (with PC)
Stimulus Train duration	4 sec	4 sec	4 sec	4 sec	Pulse train durationrange (sec)		0.1 - 600		0.1 - 600		1-20	0.5 - 100
Inter-train interval	11-26 sec	26 sec	11-26 sec	11-26 sec	Inter-train interval range(sec)		1 - 540		1 - 540		10-60	0 - 300
Number of trains	75	75	75	75	Maximum # of pulsesper session(cumulative exposure)		60000		6000		5000	72000 (Stand-alone) =2400 s [max session]30Hz240000 (with PC) =2400 s [max session] 100Hz
Magnetic Pulses perSession	3000	3000	3000	3000	Maximum outputamplitude (V/m) at adepth of 2cm below thecoil surface		150 V/m		150 V/m		135V/m nominal	Not disclosed byManufacturer
Treatment SessionDuration	18.8 min-37.5 min	37.5 min	18.8 min – 37.5 min	18.8 min-37.5 min

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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.