(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on electromechanical and software components for magnetic stimulation, not AI/ML algorithms.
Yes
Explanation: The device is indicated for the treatment of Major Depressive Disorder and Obsessive-Compulsive Disorder, which are therapeutic uses.
No
Explanation: The device description and intended use clearly state that the Horizon 3.0 TMS Therapy System produces and delivers magnetic stimulation for the treatment of Major Depressive Disorder and Obsessive-Compulsive Disorder. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the Horizon® 3.0 TMS Therapy System is an "integrated system consisting of a combination of hardware, software, and accessories." It also describes the device as a "computerized, electromechanical medical device" that produces and delivers magnetic stimulation, which involves hardware components.
Based on the provided information, the Horizon 3.0 TMS Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The device is indicated for the treatment of Major Depressive Disorder and Obsessive-Compulsive Disorder. This is a therapeutic use, not a diagnostic one.
- Device Description: The description clearly states it's a "computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation... to induce electrical currents directed at spatially discrete regions of the cerebral cortex." This describes a physical intervention on the patient's body, not a test performed on a sample taken from the body.
- Mechanism of Action: Transcranial Magnetic Stimulation (TMS) involves applying magnetic pulses to the head to stimulate the brain. This is a direct interaction with the patient, not an analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the Horizon 3.0 TMS Therapy System is a therapeutic medical device used for treating specific neurological conditions through non-invasive brain stimulation. It does not perform diagnostic tests on samples outside of the body, which is the defining characteristic of an IVD.
N/A
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).
Product codes (comma separated list FDA assigned to the subject device)
OBP, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebral cortex
Dorsomedial Prefrontal Cortex
Left Dorsolateral Prefrontal Cortex
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Licensed physician
Inpatient settings, including physicians' offices, clinics, and hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)."
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).
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.
- 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.
Non-clinical Testing Summary:
- Electrical Safety, Mechanical Safety, Thermal Safety: Compliant to ANSI/AAMI ES60601-1.
- Electromagnetic Compatibility: Compliant to IEC 60601-1-2.
- Alarm Systems: Compliant to IEC 60601-1-8.
- Risk Management: Identified and evaluated risks in compliance with ISO 14971, AAMI TIR57, and AAMI TIR97; risks determined acceptable.
- Software: Software lifecycle process in accordance with IEC 62304 ensures performance as intended.
- Biocompatibility: Patient-contacting components (coil enclosures) are unchanged from predicate, compliant to ISO 10993-1, ISO 10993-5, and ISO 10993-10.
- Cybersecurity Testing: Compliant to AAMI TIR57 and AAMI TIR97; penetration testing performed; Bluetooth clicker tool not vulnerable to known exploits; off-the-shelf software packages updated.
- Human Factors Testing: Usability testing performed, verifies device as safe and effective, compliant to AAMI/ANSI HE75 and IEC 62366-1.
Non-clinical Testing for Tracking System Update:
- Stress Testing - Sample Rate: Maintains a constant sample rate above 50Hz, average capture rate 120Hz. Equivalent to Predicate Device.
- Stress Testing - Data Storage: Supports recording of 1000 Simultaneous MT Locations and up to 12,000 Stimuli. Equivalent to Predicate Device.
- Positional and Volumetric Accuracy - Camera Accuracy: 0.16mm RMS Positional Accuracy. Equivalent to Predicate Device.
- Landmark Registration Accuracy (Rigid Body Testing): 0.45mm RMS Rigid-body Positional Accuracy. Equivalent to Predicate Device.
- Orientational Accuracy: 1.8 degrees RMS Orientational Accuracy. Equivalent to Predicate Device.
- Treatment Delivery Performance on Phantom Head: Average difference of 1.02% for MDD and 1.92% for OCD of induced voltage. Combined average difference of 1.47%. Equivalent to Predicate Device.
- Direct Accuracy Comparison to Manual Method and Predicate Device - Overall System Accuracy: MDD Mean Difference to Manual Method: 1.51mm (Std. Dev 1.14mm); OCD Mean Difference to Manual Method: 1.66mm (Std. Dev 0.76mm). Subject device offers better approximation/guidance to the treatment target compared to predicate (
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------- |
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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 +44 (0) 1994 240798 Phone: Facsimile: +44 (0) 1994 240061 Contact Person: Daniel Gregory, Principal Systems Engineer (daniel.gregory@magstim.com)
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 | |
| a. Horizon® 3.0 Mainframe; | |
| b. Horizon® 3.0 PSU (Power Supply Unit); | |
| c. Horizon® 3.0 Interface Unit; | |
| d. Horizon® 3.0 User Interface |
- Horizon® 3.0 Coil for MT Determination
a. Horizon® MT Coil; - Horizon® 3.0 Coil for Treatment
a. Horizon® 3.0 E-z Cool Coil - Horizon® 3.0 Cart and Coil Holder
a. Horizon® 3.0 E-z Cart
b. Horizon® 3.0 Coil Holder - Accessories
a. Horizon® 3.0 Accessory Kit | 1. Horizon® 3.0 Stimulator
a. Horizon® 3.0 Mainframe;
b. Horizon® 3.0 PSU (Power Supply Unit);
c. Horizon® 3.0 Interface Unit;
d. Horizon® 3.0 User Interface - Horizon® 3.0 Coil for MT Determination
a. Horizon® MT Coil; - Horizon® 3.0 Coil for Treatment
a. Horizon® 3.0 E-z Cool Coil (Nav) - Horizon® 3.0 Cart and Coil Holder
a. Horizon® 3.0 E-z Cart;
b. Horizon® 3.0 Coil Holder - Accessories
a. Horizon® 3.0 Accessory Kit;
b. StimGuide Pro Camera & Horizon® 3.0
Camera Stand
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):
-
- 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".
-
- 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.
-
- 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.
-
- 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.
-
- 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
-
- This has resulted in a minor change in rebranding from 'StimGuide+' to 'StimGuide Pro'.
-
- 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 | ||
| Mechanical Safety | ||
| Thermal Safety | ANSI/AAMI ES60601-1 (incl. AMD2:2021) | |
| Medical electrical equipment - Part 1: | ||
| General requirements for | ||
| basic safety and essential performance; | ||
| FDA Recognition Number: 19-46 | A sample Horizon® 3.0 TMS Therapy | |
| System (specifically Horizon® 3.0 with | ||
| StimGuide Pro) has been tested and | ||
| found to be compliant to the | ||
| requirements of ANSI/AAMI ES 60601-1 | ||
| by independent test laboratory BSI | ||
| Appliances, to demonstrate safety and | ||
| effectiveness of the system following | ||
| incorporation of new/ different | ||
| characteristics as compared to the | ||
| predicate device. | ||
| Electromagnetic | ||
| Compatibility | IEC 60601-1-2 (2020) - | |
| Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety and | ||
| essential performance - | ||
| Collateral standard: Electromagnetic | ||
| compatibility -Requirements and tests; | ||
| FDA recognition number: 19-36 | A sample of the Horizon® 3.0 TMS | |
| Therapy System (specifically Horizon® | ||
| 3.0 with StimGuide Pro) has been tested | ||
| and found to be compliant to the | ||
| requirements of IEC 60601-1-2 by | ||
| independent test laboratory Eurofins | ||
| Hursley, to demonstrate safety and | ||
| effectiveness of the system following | ||
| incorporation of new/ different | ||
| characteristics as compared to the | ||
| predicate device. | ||
| Alarm Systems | IEC 60601-1-8 (2020) - | |
| Medical electrical equipment - Part 1-8: | ||
| General requirements for basic safety and | ||
| essential performance - Collateral | ||
| Standard: General requirements, tests and | ||
| guidance for alarm systems in medical | ||
| electrical equipment and medical electrical | ||
| systems; FDA Recognition Number: 5-131 | A sample Horizon® 3.0 TMS Therapy System | |
| (specifically Horizon® 3.0 with StimGuide Pro) | ||
| Horizon has been tested and found to be | ||
| compliant to the requirements of IEC 60601- | ||
| 1-8 by independent test laboratory BSI | ||
| Appliances, thus demonstrating the subject | ||
| Horizon® 3.0 TMS Therapy System is | ||
| substantially equivalent to the legally | ||
| marketed predicate device. | ||
| Risk Management | ISO 14971 (2019) - Medical Devices – | |
| Application of risk management to medical | ||
| devices; FDA Recognition Number: 5-125. | ||
| AAMI TIR57 (2016 reaffirmed 2019) – | ||
| Principles for medical device security – | ||
| Risk Management; FDA Recognition | ||
| Number: 13-83. | ||
| AAMI TIR97:2019 - Principles for medical | ||
| device security – Postmarket risk | ||
| management for device manufacturers; | ||
| FDA Recognition Number: 13-112 | The potential risks of Horizon 3.0 have | |
| been identified and evaluated in | ||
| compliance with ISO 14971, and the risks | ||
| were determined to be acceptable, or | ||
| have been addressed with risk control | ||
| measures. In addition to ISO | ||
| 14971:2019, AAMI TIR57:2016/(R)2019 | ||
| and AAMI TIR97:2019 were also applied | ||
| to evaluate and control cyber security | ||
| risks associated with the Horizon 3.0 | ||
| device and the risks were determined to | ||
| be acceptable. | ||
| Software | IEC 62304 (2015) – Medical Device | |
| Software – Software life cycle processes; | ||
| FDA Recognition Number: 13-79 | The Software lifecycle process in | |
| accordance with IEC 62304, which | ||
| includes verification and validation | ||
| testing assures that the modified | ||
| software performs as intended and in | ||
| accordance with specifications. | ||
| Biocompatibility | ISO 10993-1 (2018) - Biological Evaluation | |
| of Medical Devices - Part 1: Evaluation and | ||
| testing within a risk management process; | ||
| FDA Recognition Number: 2-258 | ||
| ISO 10993-5 (2009) - Biological evaluation | ||
| of medical devices -- Part 5: Tests for in | ||
| vitro cytotoxicity; FDA Recognition | ||
| Number: 2-245 | ||
| ISO 10993-10 (2010) - Biological | ||
| evaluation of medical devices - Part 10: | ||
| Tests for irritation and skin sensitization; | ||
| FDA Recognition Number: 2-174 | Patient-contacting components of the | |
| Horizon® 3.0 TMS Therapy System | ||
| include: | ||
| • Enclosure of the Horizon® MT Coil; | ||
| • Enclosure of the Horizon® Ez Cool | ||
| Coil 3.0; | ||
| • Enclosure of Horizon® Ez Cool Coil | ||
| (Nav) 3.0, | ||
| These components are unchanged from | ||
| the predicate device. | ||
| All these have limited contact duration | ||
| with skin (surface contacting, less than | ||
| 24-hour duration). | ||
| Samples of these materials have been | ||
| tested and found to be compliant to the | ||
| requirements of ISO 10993-1, ISO | ||
| 10993-5 and ISO 10993-10 by an | ||
| independent test laboratory. | ||
| Cybersecurity Testing | AAMI TIR57 (2016 reaffirmed 2019) – | |
| Principles for medical device security – | ||
| Risk Management; FDA Recognition | ||
| Number: 13-83. |
AAMI TIR97:2019 - Principles for medical
device security - Postmarket risk
management for device manufacturers;
FDA Recognition Number: 13-112 | AAMI TIR57:2016/(R)2019 and AAMI
TIR97:2019 were also applied to
evaluate and control cyber security risks
associated with the Horizon 3.0 device
and the risks were determined to be
acceptable.
Penetration testing has been performed
on the Azure Infrastructure and Patient
Data Management items the system
integrates with.
Finally, the addition of the Bluetooth
clicker tool was analyzed for Bluetooth
vulnerabilities such as SweynTooth and
was found not to be vulnerable to any
known exploits. Off-the-shelf software
packages used with the Horizon 3.0
devices have been updated to address
any known vulnerabilities. |
| Human Factors Testing | AAMI/ANSI HE75 (2018) - Human Factors
Engineering - Design of Medical Devices;
FDA Recognition Number: 5-57
IEC 62366-1 (2020) - Medical Devices -
Part 1: Application of Usability Engineering
To Medical Devices; FDA Recognition
Number: 5-129 | Usability testing was performed on the
subject Horizon® 3.0 TMS Therapy
System.
The Human Factors Engineering report
verifies the subject Horizon® 3.0 TMS
Therapy System, to be safe and
effective for the intended users, uses,
and use environments thus
demonstrating the subject Horizon® 3.0
TMS Therapy System is substantially
equivalent to the legally marketed
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 | ||
| Rate | System is set up to continuously sample | |
| using the camera while the host PC | ||
| running the software is put under heavy | ||
| load. | ||
| Expected Result: Tracking remains stable | ||
| under load to support sampling rates of | ||
| 20Hz and 50Hz. 20Hz and 50Hz are | ||
| chosen as this is the highest rate of | Actual Results: | |
| Maintains a constant sample rate above | ||
| 50Hz. | ||
| 50Hz chosen as that is the fastest rate | ||
| of delivery out of cleared protocols. | ||
| Under Abnormal PC Load: 52Hz min | ||
| recorded. | ||
| Test | Method | Results/ Comment |
| delivery for an FDA cleared protocol (OCD | ||
| Protocol and iTBS Protocol). | Average Capture Rate in Normal | |
| Conditions: 120Hz/ |
Equivalent to Predicate Device. |
| Stress Testing - Data
Storage | System is placed in a state for defining
motor threshold and treatment delivery.
Random points are then injected into the
software to identify limits.
Expected Result: 1000 rMT positions can
be stored and 10,000 stimuli positions can
be stored. | Actual Results:
Supports recording of 1000
Simultaneous MT Locations for Motor
Hotspot procedures and recording of up
to 12,000 Stimuli which is sufficient for
treatment (Maximum stimuli from FDA
protocol is 3000) – Equivalent to
Predicate Device. |
| Positional and Volumetric
Accuracy - Camera
Accuracy | At 25C temperature, A reflective marker is
stepped through 1000 different positions
(ground truths) with 30 samples taken at
each position.
Expected Result: Actual Results:
0.16mm RMS Positional Accuracy –
Equivalent to Predicate Device. |
| Landmark Registration
Accuracy (Rigid Body
Testing) | At 25C temperature, A rigid body is defined
using sets of reflective markers and are
placed at known points (ground truths)
where they are sampled.
Expected Result: Actual Results:
0.45mm RMS Rigid-body Positional
Accuracy - Equivalent to Predicate
Device. |
| Orientational Accuracy | At 25C temperature, A rigid body is defined
using sets of reflective markers and are
moved along rotational axes by known
amounts (ground truths) for Yaw, Pitch and
Roll where the orientation of the body is
then sampled.
Expected Result: Actual Results:
1.8 degrees RMS Orientational
Accuracy
Equivalent to Predicate Device,
provides an equivalent level of
rotational accuracy. |
| Treatment Delivery
Performance on Phantom
Head. | An MT workflow is performed in a
simulated setting with a built-up system
and tracker tools attached to the phantom
head and coils. A stimuli is delivered at
50% machine output at a known position
on the phantom head that is defined as the
MT hotspot. The induced voltage was
detected using a precisely positioned and
secured pickup coil within the phantom
head. The magnitude of this voltage was
recorded.
Subsequently, the new software and
tracking system is used to navigate 5.5cm
forward for MDD, 4cm forward for OCD in
accordance with the principles of operation
and a stimuli at the same power is
delivered at the anticipated treatment
target where there is another precisely
positioned and secured pickup coil at the
ideal location.
Expected Result: Pickup coil should
detect a reading of the same voltage | Actual Results:
Over 20 samples (repeat of 10 tests for
MDD and 10 tests for OCD) there was
an average difference of 1.02% for MDD
and 1.92% for OCD of the induced
voltage when measured at the expected
treatment target following the principles
of operation.
Resulting in a combined average
difference of 1.47% from the voltage
induced in a search coil at the MT
location compared to when it is placed
at the treatment location following the
Navigation software.
The treatment location was determined
to be the location presented by
Navigation software and when the
software indicated it was in the position
(green).
Equivalent to Predicate Device. When
following the same principles of |
| Test | Method | Results/ Comment |
| | induced at the MT hotspot and Treatment
Target (+/- 5%). | operation as the predicate device –
the new tracking system results in
equivalent output. |
| | | Actual Results: |
| | Treatment targets are defined using the
manual method as described in the
Predicate Device operating manual. | MDD Mean Difference to Manual
Method (5.5cm forward from MT
Hotspot): |
| | These points are then used as reference to
compare to treatment targets generated
using the tracking system of the Predicate
Device and the tracking system of the | 1.51mm (Std. Dev 1.14mm) |
| Direct Accuracy Comparison
to Manual Method and
Predicate Device - Overall
System Accuracy | Subject Device. | OCD Mean Difference to Manual
Method (4cm forward from MT Hotspot): |
| | This test takes into account all sources of
error and is completed on a full system set-
up. | 1.66mm (Std. Dev 0.76mm) |
| | Expected Result: The mean difference
between the manual method and the
subject device navigation method is | Compared to the results of the predicate
device: |
| | equivalent or better than the predicate
device navigation method compared to the
same manual method (Expected Result: Timing Jitter between
TMS Pulse and EMG Capture: