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

K232235 · The Magstim Company , Ltd. · OBP · Oct 25, 2023 · Neurology

Device Facts

• Record ID: K232235
• Device Name: 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
• Applicant: The Magstim Company , Ltd.
• Product Code: OBP · Neurology
• Decision Date: Oct 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.

Device Story

Computerized, electromechanical TMS system; delivers pulsed magnetic fields to induce electrical currents in cerebral cortex; treats MDD and OCD. System components: mainframe, power supply, interface unit, user interface, coils, cart, and optional StimGuide Pro navigation. Used in clinics/hospitals by physicians. Navigation uses camera tracking (OptiTrack V120:Duo) and EMG amplifier (MentaLab) to guide coil positioning relative to motor threshold (MT) hotspot. Provides visual/quantitative feedback for MT determination and target navigation. Benefits patients by enabling precise, non-invasive cortical stimulation for treatment-resistant depression and OCD.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm systems (IEC 60601-1-8), human factors (IEC 62366-1), and performance testing of the tracking system and EMG amplifier.

Technological Characteristics

Electromechanical TMS system; air-core coils; biphasic waveform. Components: OptiTrack V120:Duo camera, MentaLab EMG amplifier, Bluetooth HID pointer. Connectivity: Azure infrastructure for data management. Software: integrated UI for stimulation and navigation. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 14971. Biocompatibility: ISO 10993-1/5/10. Sterilization: N/A (surface contact).

Indications for Use

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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Horizon 3.0® TMS Therapy System (K222171)

Submission Summary (Full Text)

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October 25, 2023

The Magstim Company Ltd. Daniel Gregory Principal Systems Engineer Spring Gardens Whitland, Carmarthenshire SA340HR United Kingdom

Re: K232235

Trade/Device Name: 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 Regulation Number: 21 CFR 882.5805. 21 CFR 882.5802 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, QCI Dated: July 27, 2023 Received: July 27, 2023

Dear Daniel Gregory:

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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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 (QS) 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.

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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

### Robert Kang -S

for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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) K232235

Device Name Horizon 3.0 TMS Therapy System

#### Indications for Use (Describe)

Horizon 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

| Type of Use (Select one or both, as applicable) |
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| <span style="font-family: Arial, sans-serif; font-size: 10pt;"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial, sans-serif; font-size: 10pt;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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### K232235 Traditional 510(k) Summary Magstim's Horizon® 3.0 TMS Therapy System

Prepared according to the requirements outlined in 21 CFR 807.92

Prepared according to the requirements outlined in 21 CFR 807.92

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

Magstim® Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 0HR, United Kingdom [phone] Phone: Facsimile: [phone] Contact Person: Daniel Gregory, Principal Systems Engineer ([e-mail])

Date Prepared: October 25, 2023

#### Trade Name of Device

Horizon® 3.0 TMS Therapy System

#### Common or Usual Name

Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions

#### Classification

21 C.F.R. § 882.5805, Class II, primary product code OBP 21 C.F.R. § 882.5802, Class II, subsequent product code QCI

#### Predicate Devices

Primary Predicate Device: Horizon 3.0® TMS Therapy System, The Magstim® Company Limited (K222171)

Product Code: 21 C.F.R. § 882.5805 OBP,

Subsequent Product Code: 21 C.F.R. § 882.5802 QCI

#### 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 well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

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.

Horizon® 3.0 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.

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#### Intended Use & Indications for Use

The Horizon® 3.0 TMS Therapy System is intended to produce and deliver 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.

Horizon® 3.0 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

#### Technological Characteristics

Horizon® 3.0 TMS Therapy Systems are offered in two system configurations: Horizon® 3.0 and Horizon® 3.0 with StimGuide Pro. These system configurations are comprised of the following physical components:

| Horizon® 3.0 | Horizon® 3.0 with StimGuide Pro |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Horizon® 3.0 Stimulator<br>a. Horizon® 3.0 Mainframe;<br>b. Horizon® 3.0 PSU (Power Supply Unit);<br>c. Horizon® 3.0 Interface Unit;<br>d. Horizon® 3.0 User Interface<br>2. Horizon® 3.0 Coil for MT Determination<br>a. Horizon® MT Coil;<br>3. Horizon® 3.0 Coil for Treatment<br>a. Horizon® 3.0 E-z Cool Coil<br>4. Horizon® 3.0 Cart and Coil Holder<br>a. Horizon® 3.0 E-z Cart<br>b. Horizon® 3.0 Coil Holder<br>5. Accessories<br>a. Horizon® 3.0 Accessory Kit | 1. Horizon® 3.0 Stimulator<br>a. Horizon® 3.0 Mainframe;<br>b. Horizon® 3.0 PSU (Power Supply Unit);<br>c. Horizon® 3.0 Interface Unit;<br>d. Horizon® 3.0 User Interface<br>2. Horizon® 3.0 Coil for MT Determination<br>a. Horizon® MT Coil;<br>3. Horizon® 3.0 Coil for Treatment<br>a. Horizon® 3.0 E-z Cool Coil (Nav)<br>4. Horizon® 3.0 Cart and Coil Holder<br>a. Horizon® 3.0 E-z Cart;<br>b. Horizon® 3.0 Coil Holder<br>5. Accessories<br>a. Horizon® 3.0 Accessory Kit;<br>b. StimGuide Pro Camera & Horizon® 3.0<br>Camera Stand<br>c. StimGuide Pro Accessory Kit |

The following technological changes are proposed for the Horizon® 3.0 TMS Therapy System which is the subject of this 510(k):

- 1. The Horizon 3.0 Ul Software and StimGuide+ Navigation software have been combined onto a single screen to give a more integrated feel to the entire device. This has resulted in the minor rebranding of the StimGuide name to "StimGuide Pro".
- 2. The StimGuide® Camera has been replaced, previously using an NDI Polaris Vicra Camera, with an OptiTrack V120:Duo Camera. The new camera has equivalent performance characteristics as the camera used on the predicate device. Testing of the tracking system with the new camera is described in the "Non-Clinical Testing" section below.
- 3. The EMG amplifier used within the predicate device the StimGuide® Eego amplifier has been replaced with an amplifier with equivalent performance characteristics, co-developed between Magstim and MentaLab GmbH. Testing of the EMG device is described in the "Non-Clinical Testing" section below.
- 4. Tracker Tools, which are sets of reflective spheres to help identify objects such as the Patient Head and Applicating Coil, have been modified to have slightly different arrangements to support the new camera system.
- 5. As a result of the Camera and EMG Amplifier changing, it was necessary to make some additional technological changes to support the integration of the above components:

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- a. The Horizon 3.0 UI Software and StimGuide+ Navigation software have been updated to integrate with the new Camera and EMG components. This includes the interpretation of the new Tracker Tools sphere placements to identify tracked rigid bodies. The updated StimGuide software has been rebranded as StimGuide Pro.
- ﻒ Modification to the pointer tool to allow remote interaction with the touchscreen to facilitate the landmarks registration process via Bluetooth, acting as a Human Interface Device (HID).
- i. Previously one hand would need to be placed on a landmark with the pointer tool and the other used to interact with the touchscreen. The remote function allows a user to use both hands for stabilizing the tool and register landmarks without needing to interact with the touchscreen.
- ii. The Bluetooth stack and chips used for communication were analyzed and not found to be vulnerable to exploits such as SweynTooth. This is documented further in Section XVIII.I.
- c. The Camera Stand holding the camera has been slightly modified to support the new OptiTrack camera.
- d. The Interface Unit which previously housed the StimGuide® Eego amplifier now houses the amplifier co-developed by Magstim and MentaLab GmbH.
- Device labels and instructions for use updated to cover modified components. e
- 6. This has resulted in a minor change in rebranding from 'StimGuide+' to 'StimGuide Pro'.
- 7. A Coil winding temperature interlock using solid state temperature sensors has been placed within the Horizon E-z Cool Coil 3.0 and Horizon E-z Cool Coil 3.0 (Nav) variant. This has been implemented due to the previous implementation of thermal fuses which may, under rare circumstances, activate as a result of mechanical shock when the coil is discharged. This addresses the issue whilst still providing the same level of safety as the predicate device. Performance testing has been documented in Appendix 06.C.3.

Please note that the MentaLab EMG Amplifier is manufactured as a component to be used in the manufacture and assembly of the updated Horizon 3.0 device.

#### Non-clinical Testing

Non-clinical testing was conducted to validate the performance of the subject Horizon® 3.0 TMS Therapy System and to ensure that the device performs as intended and meets the design specifications, consistent with the FDA's guidance "Class II Special Control Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."

As part of the update, Electrical Safety and Electromagnetic Compatibility ("EMC") testing were conducted on the subject device to demonstrate that the device remains compliant with IEC 60601-1 (Ed. 3.2), IEC 60601-1-2 (Ed. 4.1) and IEC 60601-1-8 (Ed. 2.2) following its modifications.

Human Factors Usability testing in accordance with IEC 62366-1 (Ed. 1.1) and AAMI/ANSI HE75:2009/(r)2018 was performed on the updated device with modifications to confirm that the subject device with its modifications continue to be safe and effective for the intended users, uses and use environments.

Biocompatibility testing from previous submissions (K222171) is leveraged for this 510(k) as the materials of the patient-contacting components of the system have not been modified and have been found to be compliant to the requirements of ISO 10993-1 (Ed. 5), ISO 10993-5 (Ed. 3) and ISO 10993-10 (Ed. 3). For completeness, the testing from the previous submission and a recent biological evaluation and gap analysis can be found in Appendix 03.

To evaluate the replacement of the Camera Tracking System, performance testing was performed to compare the modified system within the subject device to that used on the currently marketed predicate device. The performance testing included:

- . Stress Testing to ensure maintained system performance and sampling rates under worst-case scenarios.

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- . Positional, Volumetric and Orientational Accuracy for tracked reflective spheres and rigid bodies.
- Evaluation that the new tracking system with a simulated Motor Threshold and Treatment procedure maintains the appropriate level of induced voltage when used to navigate to a treatment target from a Motor Threshold Hotspot.
- Direct Evaluation of Performance when used as a full system. The tracking system used with the currently marketed Horizon® 3.0 TMS Therapy System has previously been evaluated for performance against the manual method. This was repeated on the modified tracking system of the subject device and compared against that of the predicate device.
- Evaluation of EMG Amplifier performance characteristics compared to the predicate device.

A summary of the non-clinical testing performed on the subject Horizon® 3.0 TMS Therapy System is provided in Table 2.

A summary of the non-clinical performance testing used to evaluate the performance characteristics of the modified tracking system can be found in Table 3.

| Test | Method | Results/ Comment |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety<br>Mechanical Safety<br>Thermal Safety | ANSI/AAMI ES60601-1 (incl. AMD2:2021)<br>Medical electrical equipment - Part 1:<br>General requirements for<br>basic safety and essential performance;<br>FDA Recognition Number: 19-46 | A sample Horizon® 3.0 TMS Therapy<br>System (specifically Horizon® 3.0 with<br>StimGuide Pro) has been tested and<br>found to be compliant to the<br>requirements of ANSI/AAMI ES 60601-1<br>by independent test laboratory BSI<br>Appliances, to demonstrate safety and<br>effectiveness of the system following<br>incorporation of new/ different<br>characteristics as compared to the<br>predicate device. |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 (2020) -<br>Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance -<br>Collateral standard: Electromagnetic<br>compatibility -Requirements and tests;<br>FDA recognition number: 19-36 | A sample of the Horizon® 3.0 TMS<br>Therapy System (specifically Horizon®<br>3.0 with StimGuide Pro) has been tested<br>and found to be compliant to the<br>requirements of IEC 60601-1-2 by<br>independent test laboratory Eurofins<br>Hursley, to demonstrate safety and<br>effectiveness of the system following<br>incorporation of new/ different<br>characteristics as compared to the<br>predicate device. |
| Alarm Systems | IEC 60601-1-8 (2020) -<br>Medical electrical equipment - Part 1-8:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: General requirements, tests and<br>guidance for alarm systems in medical<br>electrical equipment and medical electrical<br>systems; FDA Recognition Number: 5-131 | A sample Horizon® 3.0 TMS Therapy System<br>(specifically Horizon® 3.0 with StimGuide Pro)<br>Horizon has been tested and found to be<br>compliant to the requirements of IEC 60601-<br>1-8 by independent test laboratory BSI<br>Appliances, thus demonstrating the subject<br>Horizon® 3.0 TMS Therapy System is<br>substantially equivalent to the legally<br>marketed predicate device. |
| Risk Management | ISO 14971 (2019) - Medical Devices –<br>Application of risk management to medical<br>devices; FDA Recognition Number: 5-125.<br>AAMI TIR57 (2016 reaffirmed 2019) –<br>Principles for medical device security –<br>Risk Management; FDA Recognition<br>Number: 13-83.<br>AAMI TIR97:2019 - Principles for medical<br>device security – Postmarket risk<br>management for device manufacturers;<br>FDA Recognition Number: 13-112 | The potential risks of Horizon 3.0 have<br>been identified and evaluated in<br>compliance with ISO 14971, and the risks<br>were determined to be acceptable, or<br>have been addressed with risk control<br>measures. In addition to ISO<br>14971:2019, AAMI TIR57:2016/(R)2019<br>and AAMI TIR97:2019 were also applied<br>to evaluate and control cyber security<br>risks associated with the Horizon 3.0<br>device and the risks were determined to<br>be acceptable. |
| Software | IEC 62304 (2015) – Medical Device<br>Software – Software life cycle processes;<br>FDA Recognition Number: 13-79 | The Software lifecycle process in<br>accordance with IEC 62304, which<br>includes verification and validation<br>testing assures that the modified<br>software performs as intended and in<br>accordance with specifications. |
| Biocompatibility | ISO 10993-1 (2018) - Biological Evaluation<br>of Medical Devices - Part 1: Evaluation and<br>testing within a risk management process;<br>FDA Recognition Number: 2-258<br>ISO 10993-5 (2009) - Biological evaluation<br>of medical devices -- Part 5: Tests for in<br>vitro cytotoxicity; FDA Recognition<br>Number: 2-245<br>ISO 10993-10 (2010) - Biological<br>evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization;<br>FDA Recognition Number: 2-174 | Patient-contacting components of the<br>Horizon® 3.0 TMS Therapy System<br>include:<br>• Enclosure of the Horizon® MT Coil;<br>• Enclosure of the Horizon® Ez Cool<br>Coil 3.0;<br>• Enclosure of Horizon® Ez Cool Coil<br>(Nav) 3.0,<br>These components are unchanged from<br>the predicate device.<br>All these have limited contact duration<br>with skin (surface contacting, less than<br>24-hour duration).<br>Samples of these materials have been<br>tested and found to be compliant to the<br>requirements of ISO 10993-1, ISO<br>10993-5 and ISO 10993-10 by an<br>independent test laboratory. |
| Cybersecurity Testing | AAMI TIR57 (2016 reaffirmed 2019) –<br>Principles for medical device security –<br>Risk Management; FDA Recognition<br>Number: 13-83.<br><br>AAMI TIR97:2019 - Principles for medical<br>device security - Postmarket risk<br>management for device manufacturers;<br>FDA Recognition Number: 13-112 | AAMI TIR57:2016/(R)2019 and AAMI<br>TIR97:2019 were also applied to<br>evaluate and control cyber security risks<br>associated with the Horizon 3.0 device<br>and the risks were determined to be<br>acceptable.<br><br>Penetration testing has been performed<br>on the Azure Infrastructure and Patient<br>Data Management items the system<br>integrates with.<br><br>Finally, the addition of the Bluetooth<br>clicker tool was analyzed for Bluetooth<br>vulnerabilities such as SweynTooth and<br>was found not to be vulnerable to any<br>known exploits. Off-the-shelf software<br>packages used with the Horizon 3.0<br>devices have been updated to address<br>any known vulnerabilities. |
| Human Factors Testing | AAMI/ANSI HE75 (2018) - Human Factors<br>Engineering - Design of Medical Devices;<br>FDA Recognition Number: 5-57<br><br>IEC 62366-1 (2020) - Medical Devices -<br>Part 1: Application of Usability Engineering<br>To Medical Devices; FDA Recognition<br>Number: 5-129 | Usability testing was performed on the<br>subject Horizon® 3.0 TMS Therapy<br>System.<br><br>The Human Factors Engineering report<br>verifies the subject Horizon® 3.0 TMS<br>Therapy System, to be safe and<br>effective for the intended users, uses,<br>and use environments thus<br>demonstrating the subject Horizon® 3.0<br>TMS Therapy System is substantially<br>equivalent to the legally marketed<br>predicate devices. |

#### Table 2: Summary of Non-Clinical Testing

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#### Non-clinical Testing – Tracking System:

As the updated Horizon® 3.0 TMS Therapy system replaces the tracking camera, EMG, updates the tracking tools and results in modifications to associated software systems – the following performance testing was performed to confirm that the changes in technological characteristics do not raise any new or differing questions of safety or effectiveness.

Expected results to evaluate equivalence were obtained from the tracking system used on the currently marketed Horizon® 3.0 TMS Therapy System (K222171):

#### Table 3: Summary of Non-Clinical Testing for Tracking System Update

| Test | Method | Results/ Comment |
|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stress Testing - Sample<br>Rate | System is set up to continuously sample<br>using the camera while the host PC<br>running the software is put under heavy<br>load.<br>Expected Result: Tracking remains stable<br>under load to support sampling rates of<br>20Hz and 50Hz. 20Hz and 50Hz are<br>chosen as this is the highest rate of | Actual Results:<br>Maintains a constant sample rate above<br>50Hz.<br>50Hz chosen as that is the fastest rate<br>of delivery out of cleared protocols.<br>Under Abnormal PC Load: 52Hz min<br>recorded. |
| Test | Method | Results/ Comment |
| | delivery for an FDA cleared protocol (OCD<br>Protocol and iTBS Protocol). | Average Capture Rate in Normal<br>Conditions: 120Hz/<br><br>Equivalent to Predicate Device. |
| Stress Testing - Data<br>Storage | System is placed in a state for defining<br>motor threshold and treatment delivery.<br>Random points are then injected into the<br>software to identify limits.<br><b>Expected Result:</b> 1000 rMT positions can<br>be stored and 10,000 stimuli positions can<br>be stored. | <b>Actual Results:</b><br>Supports recording of 1000<br>Simultaneous MT Locations for Motor<br>Hotspot procedures and recording of up<br>to 12,000 Stimuli which is sufficient for<br>treatment (Maximum stimuli from FDA<br>protocol is 3000) – Equivalent to<br>Predicate Device. |
| Positional and Volumetric<br>Accuracy - Camera<br>Accuracy | At 25C temperature, A reflective marker is<br>stepped through 1000 different positions<br>(ground truths) with 30 samples taken at<br>each position.<br><b>Expected Result:</b> <= 0.25mm Root Mean<br>Squared (RMS) Positional Accuracy | <b>Actual Results:</b><br>0.16mm RMS Positional Accuracy –<br>Equivalent to Predicate Device. |
| Landmark Registration<br>Accuracy (Rigid Body<br>Testing) | At 25C temperature, A rigid body is defined<br>using sets of reflective markers and are<br>placed at known points (ground truths)<br>where they are sampled.<br><b>Expected Result:</b> <= 1mm RMS Rigid-<br>body Positional Accuracy | <b>Actual Results:</b><br>0.45mm RMS Rigid-body Positional<br>Accuracy - Equivalent to Predicate<br>Device. |
| Orientational Accuracy | At 25C temperature, A rigid body is defined<br>using sets of reflective markers and are<br>moved along rotational axes by known<br>amounts (ground truths) for Yaw, Pitch and<br>Roll where the orientation of the body is<br>then sampled.<br><b>Expected Result:</b> <= 5.5 degrees RMS<br>Orientational Accuracy | <b>Actual Results:</b><br>1.8 degrees RMS Orientational<br>Accuracy<br>Equivalent to Predicate Device,<br>provides an equivalent level of<br>rotational accuracy. |
| Treatment Delivery<br>Performance on Phantom<br>Head. | An MT workflow is performed in a<br>simulated setting with a built-up system<br>and tracker tools attached to the phantom<br>head and coils. A stimuli is delivered at<br>50% machine output at a known position<br>on the phantom head that is defined as the<br>MT hotspot. The induced voltage was<br>detected using a precisely positioned and<br>secured pickup coil within the phantom<br>head. The magnitude of this voltage was<br>recorded.<br>Subsequently, the new software and<br>tracking system is used to navigate 5.5cm<br>forward for MDD, 4cm forward for OCD in<br>accordance with the principles of operation<br>and a stimuli at the same power is<br>delivered at the anticipated treatment<br>target where there is another precisely<br>positioned and secured pickup coil at the<br>ideal location.<br><b>Expected Result:</b> Pickup coil should<br>detect a reading of the same voltage | <b>Actual Results:</b><br>Over 20 samples (repeat of 10 tests for<br>MDD and 10 tests for OCD) there was<br>an average difference of 1.02% for MDD<br>and 1.92% for OCD of the induced<br>voltage when measured at the expected<br>treatment target following the principles<br>of operation.<br>Resulting in a combined average<br>difference of 1.47% from the voltage<br>induced in a search coil at the MT<br>location compared to when it is placed<br>at the treatment location following the<br>Navigation software.<br>The treatment location was determined<br>to be the location presented by<br>Navigation software and when the<br>software indicated it was in the position<br>(green).<br>Equivalent to Predicate Device. When<br>following the same principles of |
| Test | Method | Results/ Comment |
| | induced at the MT hotspot and Treatment<br>Target (+/- 5%). | operation as the predicate device –<br>the new tracking system results in<br>equivalent output. |
| | | <b>Actual Results:</b> |
| | Treatment targets are defined using the<br>manual method as described in the<br>Predicate Device operating manual. | MDD Mean Difference to Manual<br>Method (5.5cm forward from MT<br>Hotspot): |
| | These points are then used as reference to<br>compare to treatment targets generated<br>using the tracking system of the Predicate<br>Device and the tracking system of the | 1.51mm (Std. Dev 1.14mm) |
| Direct Accuracy Comparison<br>to Manual Method and<br>Predicate Device - Overall<br>System Accuracy | Subject Device. | OCD Mean Difference to Manual<br>Method (4cm forward from MT Hotspot): |
| | This test takes into account all sources of<br>error and is completed on a full system set-<br>up. | 1.66mm (Std. Dev 0.76mm) |
| | <b>Expected Result:</b> The mean difference<br>between the manual method and the<br>subject device navigation method is | Compared to the results of the predicate<br>device: |
| | equivalent or better than the predicate<br>device navigation method compared to the<br>same manual method (< 4.0mm). | Predicate – 3.0mm Mean Delta (Std.<br>Dev 1.8mm)<br>Subject – 1.5mm (Std. Dev 1.1mm) |
| | | Equivalent to Predicate Device –<br>subject device offers better<br>approximation/guidance to the<br>treatment target in accordance with<br>the principles of operation. |
| EMG Performance. | Using a function generator, known<br>waveforms are input into the EMG<br>interface on the Horizon 3.0 device. A<br>pulse is then delivered to trigger an EMG | Timing Jitter Measured: Maximum of<br>3.25ms and mean of 1.68ms over<br>samples. |
| | capture. The capture data collected by the<br>amplifier and stored on the system is then | Noise Level Measured: 3.03uV RMS |
| | compared to the known waveforms using<br>the function generator. | Waveform Accuracy Measured:<br>Maximum Amplitude Error - 6.5%, |
| | <b>Expected Result:</b> Timing Jitter between<br>TMS Pulse and EMG Capture: < 5ms. | Maximum Pulse Width Error - 3%,<br>Maximum Frequency Error - 3.16% |
| | Noise Level <5uV RMS. | Equivalent to Predicate Device. All<br>measured values of the system are<br>within tolerance. |
| | EMG Waveform Accuracy: error of < 10%<br>in Amplitude and Time.…