(132 days)
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.
The Horizon® 3.0 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. ("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 antidepressant medication in the current episode. 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.
The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It is important to note that this document primarily focuses on non-clinical testing for substantial equivalence to predicate devices, rather than a clinical effectiveness study against a gold standard.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes non-clinical testing conducted to validate the performance of the Horizon® 3.0 TMS Therapy System and to ensure it meets design specifications and relevant FDA guidance. The "acceptance criteria" here are generally compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is the outcome of these compliance tests.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Electrical Safety (Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) | A sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+) was tested by independent test laboratory BSI Appliances and found to be compliant with the requirements of ANSI/AAMI ES 60601-1, demonstrating safety and effectiveness following incorporation of new/different characteristics compared to the predicate device. |
| Mechanical Safety (Implicit in ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012) | (Covered by Electrical Safety compliance above) |
| Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1-2: 2014) | A sample of the Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+) was tested by independent test laboratory Eurofins Hursley and found to be compliant with the requirements of IEC 60601-1-2, demonstrating safety and effectiveness following incorporation of new/different characteristics compared to the predicate device. |
| Alarm Systems (Compliance with IEC 60601-1-8) | A sample Horizon® 3.0 TMS Therapy System was tested by independent test laboratory BSI Appliances and found to be compliant with the requirements of IEC 60601-1-8, demonstrating substantial equivalence to the legally marketed predicate device. |
| Biocompatibility (Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010) | Patient-contacting components (Enclosure of Horizon® MT Coil, Enclosure of Horizon® E-z Cool Coil 3.0, Enclosure of Horizon® E-z Cool Coil (Nav) 3.0) were tested by an independent test laboratory and found, for materials with limited skin contact duration (surface contacting, less than 24-hour duration), to be compliant with the requirements of ISO 10993-1, ISO 10993-5, and ISO 10993-10, demonstrating substantial equivalence to the legally marketed predicate devices. |
| Human Factors Testing (Compliance with AAMI/ANSI HE75 and IEC 62366-1) | Usability testing was performed on the Horizon® 3.0 TMS Therapy System. The Human Factors Engineering report verifies the system is safe and effective for the intended users, uses, and use environments, demonstrating substantial equivalence to the legally marketed predicate devices. |
| Software Lifecycle Process (Verification & Validation, ISO 14971, AAMI TIR57:2016/(R)2019 for Cybersecurity) | The software lifecycle process, including verification and validation testing, assures that the software performs as intended and in accordance with specifications. Potential risks were identified and evaluated in compliance with ISO 14971 (Ed 2.0) and determined acceptable or addressed with risk control measures. AAMI TIR57:2016/(R)2019 was applied to evaluate and control cybersecurity risks, which were determined acceptable. |
| Substantial Equivalence to Predicate Devices | The Horizon® 3.0 TMS Therapy System was found substantially equivalent to the Horizon® TMS Therapy System (K182853) and Horizon® TMS Therapy System with Navigation (K183376) in terms of intended use, indications for use, basic design, mechanism of action, coil head geometry, magnetic field characteristics, and treatment protocols (standard rTMS and iTBS). Minor differences (upgraded mainframe, PSU design change, new interface unit, improved touch panels/GUI, upgraded cart/arm, StimGuide+ updates, Magstim Connect integration) were evaluated through the non-clinical testing listed above, demonstrating that the Horizon® 3.0 is as safe and effective as the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical bench testing and verification/validation activities on the device itself.
- For tests like Electrical Safety, EMC, and Alarm Systems, a "sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+)" was used.
- For Biocompatibility, "samples of these materials" (patient-contacting components) were tested.
- For Human Factors, "Usability testing was performed to Horizon® 3.0 TMS Therapy System."
Data Provenance: This is not applicable to the non-clinical testing described, as it does not involve patient data. The tests were performed by independent test laboratories (BSI Appliances, Eurofins Hursley) and internally by Magstim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as the study involves non-clinical engineering and systems testing, not the establishment of a medical 'ground truth' based on expert consensus for diagnostic or prognostic purposes. Compliance with standards and direct measurement against specifications serve as the "ground truth."
4. Adjudication Method for the Test Set
This is not applicable, as the study does not involve expert adjudication of medical cases. The tests are objective measurements and compliance checks performed by qualified testing laboratories and the manufacturer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical trial of effectiveness. There is no mention of human readers or AI assistance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical system (Transcranial Magnetic Stimulation Therapy System), not primarily an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical sense of AI diagnostics. However, the software components of the device were a subject of extensive verification and validation testing, including assessing cybersecurity risks, as part of the overall system. This can be seen as an evaluation of the system's inherent performance, albeit for a complex electro-mechanical system rather than a purely diagnostic algorithm.
7. The Type of Ground Truth Used
For this submission, the "ground truth" for the non-clinical testing is:
- Recognized International and National Standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 10993 series, AAMI/ANSI HE75, IEC 62366-1.
- Design Specifications and Intended Performance: The device was tested to ensure it performs as intended and meets its internal design specifications.
- FDA Guidance: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS)."
- Predicate Device Characteristics: Comparison of the new device's technical specifications and performance to legally marketed predicate devices to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. The document describes a 510(k) submission based on non-clinical testing for substantial equivalence. It does not involve machine learning models that require training sets of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as no machine learning training set is described in the document.
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September 14. 2021
Magstim Company Ltd. Tom Campbell Chief Quality and Regulatory Affairs Officer and UK Site Director Spring Gardens Whitland, Carmarthenshire SA34 0HR United Kingdom
Re: K211389
Trade/Device Name: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0. Horizon 3.0 with Navigation Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: May 5, 2021 Received: May 5, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K211389
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.
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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Image /page/3/Picture/0 description: The image shows the word "magstim" in a bold, sans-serif font. The word is dark blue, and there is a light blue circle above the "i" in "magstim". There is a registered trademark symbol to the right of the word.
K211389 Traditional 510(k) SUMMARY Maqstim's Horizon® 3.0 TMS Therapy System
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 OHR, United Kingdom
Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061
Contact Person: Tom Campbell, Chief Quality & Regulatory Affairs Officer and UK Site Director
Date Prepared: September 14, 2021
Trade Name of Device
Horizon® 3.0 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
K182853 Horizon® TMS Therapy System, The Maqstim® Company Limited (Primary Predicate Device), 21 C.F.R § 882.5805, OBP K183376 Horizon® TMS Therapy System with Navigation, The Magstim® Company Limited (Secondary Predicate Device), 21 C.F.R § 882.5805, OBP K201158 NeuroStar Advanced Therapy, Neuronetics Inc. (Reference Predicate Device), 21 C.F.R & 882.5805, OBP
Device Description
The Horizon® 3.0 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. ("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
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achieve satisfactory improvement from antidepressant medication in the current episode. 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.
Intended Use
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.
Technological Characteristics
Horizon® 3.0 TMS Therapy System is offered in two system configurations: Horizon® 3.0 and Horizon® 3.0 with StimGuide+. These system configurations are comprised of the following physical components:
| Horizon® 3.0 | Horizon® 3.0 with StimGuide+ |
|---|---|
| 1. Horizon® 3.0 Stimulatora. Horizon® 3.0 Mainframe;b. Horizon® 3.0 PSU (Power Supply Unit);c. Horizon® 3.0 Interface Unit;d. Horizon® 3.0 User Interface.2. Horizon® 3.0 Coil for MT Determinationa. Horizon® MT Coil;3. Horizon® 3.0 Coil for Treatmenta. Horizon® 3.0 E-z Cool Coil.4. Horizon® 3.0 Cart and Coil Holdera. Horizon® 3.0 E-z Cart;b. Horizon® 3.0 Coil Holder.5. Horizon® 3.0 Camera Stand6. Accessoriesa. Horizon® 3.0 Accessory Kit. | 1. Horizon® 3.0 Stimulatora. Horizon® 3.0 Mainframe;b. Horizon® 3.0 PSU (Power Supply Unit);c. Horizon® 3.0 Interface Unit (Nav);d. Horizon® 3.0 User Interface;e. StimGuide+ User Interface.2. Horizon® 3.0 Coil for MT Determinationa. Horizon® MT Coil.3. Horizon® 3.0 Coil for Treatmenta. Horizon® E-z Cool Coil (Nav).4. Horizon® 3.0 Cart and Coil Holdera. Horizon® 3.0 E-z Cart;b. Horizon® 3.0 Coil Holder.5. Horizon® 3.0 Camera Stand6. Accessoriesa. Horizon® 3.0 Accessory Kit;b. StimGuide+ Accessory Kit. |
The technological differences between Horizon® 3.0 TMS Therapy System and its primary and secondary predicate devices (K182853 & K183376) includes:
- . An upgraded mainframe to address component obsolescence including component upgrades to improve reliability, whilst also enabling remote upgradeability.
- . A minor design change to the Power Supply Unit to facilitate the introduction of the Horizon® 3.0 Interface Unit.
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- . The introduction of the Horizon® 3.0 Interface Unit that runs the graphical user interface (Horizon® and StimGuide+), houses the StimGuide+ accessories for full system integration, whilst also enabling wireless network connectivity.
- . Improved touch panels and graphical user interface to improve the user experience.
- . An upgraded cart and arm to refine and improve the user experience for coil positioning for treatment.
- An update to StimGuide to allow users to place additional helper landmarks at any . position on the patient's head. StimGuide+ can display distances to the selected landmarks.
Horizon® 3.0 TMS Therapy System also enables patients to be treated in multi-site clinics through its integration with a Patient Data Management (PDM) system, Magstim Connect. Integration of Horizon® 3.0 and Magstim Connect includes the following three functions:
-
- Authentication Service
-
- Synchronization Service
-
- Remote Update Service
Software documentation for a "moderate" level of concern has been provided.
Non-Clinical Testing
Non-clinical testing was conducted to validate the performance of the Horizon® 3.0 TMS Therapy System and to ensure that the device performs as intended and meets the design specifications, consistent with FDA's guidance "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS).
Electrical safety and electromagnetic compatibility ("EMC") testing were conducted on the Horizon® 3.0 TMS Therapy System to demonstrate that the device is compliant with IEC 60601-1 (Ed. 3.1.) and IEC 60601-1-2 (Ed. 4.). Environmental testing and acoustic output measurements has been conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance.
Biocompatibility evaluation has demonstrated that patient-contacting components of Horizon® 3.0 TMS Therapy System meet the requirements of ISO 10993-1 (Ed. 4.) standards. In addition, acoustic output measurements have been conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance.
A summary of the non-clinical testing performed on the Horizon® 3.0 TMS Therapy System is provided in Table 1.
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Table 1: Summary of Non-Clinical Testing
| Test | Method | Results/ Comment |
|---|---|---|
| Electrical SafetyMechanical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012-Medical electrical equipment - Part 1:General requirements forbasic safety and essential performance;FDA Recognition Number: 19-4 | A sample Horizon® 3.0 TMS TherapySystem (specifically Horizon® 3.0 withStimGuide+) has been tested and foundto be compliant to the requirements ofANSI/AAMI ES 60601-1 by independenttest laboratory BSI Appliances, todemonstrate safety and effectiveness ofthe system following incorporation ofnew/ different characteristics ascompared to the predicate device. |
| ElectromagneticCompatibility | IEC 60601-1-2: 2014 -Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance -Collateral standard: Electromagneticcompatibility -Requirements and tests;FDA recognition number: 19-8 | A sample of the Horizon® 3.0 TMSTherapy System (specifically Horizon®3.0 with StimGuide+) has been testedand found to be compliant to therequirements of IEC 60601-1-2 byindependent test laboratory EurofinsHursley, to demonstrate safety andeffectiveness of the system followingincorporation of new/ differentcharacteristics as compared to thepredicate device. |
| Alarm Systems | IEC 60601-1-8 -Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - CollateralStandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems; FDA Recognition Number: 5-76 | A sample Horizon® 3.0 TMS TherapySystem has been tested and found to becompliant to the requirements of IEC60601-1-8 by independent testlaboratory BSI Appliances, thusdemonstrating the Horizon® 3.0 TMSTherapy System is substantiallyequivalent to the legally marketedpredicate device. |
| Biocompatibility | ISO 10993-1:2009 - Biological Evaluationof Medical Devices - Part 1: Evaluation andtesting within a risk management processISO 10993-5:2009 - Biological evaluationof medical devices -- Part 5: Tests for invitro cytotoxicity; FDA RecognitionNumber: 2-245 | Patient-contacting components of theHorizon® 3.0 TMS Therapy Systeminclude:• Enclosure of the Horizon® MT Coil;• Enclosure of the Horizon® E-z CoolCoil 3.0:• Enclosure of Horizon® E-z Cool Coil(Nav) 3.0, |
| ISO 10993-10:2010 - Biological evaluationof medical devices - Part 10: Tests forirritation and skin sensitization; FDARecognition Number: 2-174 | All these have limited contact durationwith skin (surface contacting, less than24-hour duration).Samples of these materials have beentested and found to be compliant to therequirements of ISO 10993-1, ISO10993-5 and ISO 10993-10 by anindependent test laboratory, thusdemonstrating the Horizon® TMSTherapy System is substantiallyequivalent to the legally marketedpredicate devices. | |
| Human Factors Testing | AAMI/ANSI HE75 - Human FactorsEngineering - Design of Medical Devices;FDA Recognition Number: 5-57 | Usability testing was performed toHorizon® 3.0 TMS Therapy System.The Human Factors Engineering reportverifies the Horizon® 3.0 TMS TherapySystem, to be safe and effective for theintended users, uses, and useenvironments thus demonstrating theHorizon® 3.0 TMS Therapy System issubstantially equivalent to the legallymarketed predicate devices. |
| IEC 62366-1 - Medical Devices - Part 1:Application of Usability Engineering ToMedical Devices; FDA RecognitionNumber: 5-114 | intended users, uses, and useenvironments thus demonstrating theHorizon® 3.0 TMS Therapy System issubstantially equivalent to the legallymarketed predicate devices. |
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The Software lifecycle process, which includes verification and validation testing assures that the software performs as intended and in accordance with specifications. The potential risks of Horizon 3.0 have been identified and evaluated in compliance with ISO 14971 (Ed 2.0), and the risks were determined to be acceptable, or have been addressed with risk control measures. In addition to ISO 14971, AAMI TIR57:2016/(R)2019 – Principles for Medical Device Security – Risk Manaqement was also applied to evaluate and control cyber security risks associated with the Horizon 3.0 device and the risks were determined to be acceptable.
Substantial Equivalence Discussion
The Horizon® 3.0 TMS Therapy System is substantially equivalent to the primary and secondary predicate devices, the Horizon® TMS Therapy System (K182853) and the Horizon® TMS Therapy System with Navigation (K183376).
The intended use and indications for use of the Horizon® 3.0 TMS Therapy System and the primary and secondary predicate devices is identical: all devices are intended to treat Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
The basic design of Horizon® 3.0 TMS Therapy System is substantially equivalent to the design of the predicate devices (K182853 and K183376), as all systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. All 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.
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The coil head geometry of the Horizon® 3.0 E-z Cool Coil and Horizon® 3.0 E-z Cool Coil (Nav) are identical to the predicate devices, the Horizon® E-z Cool Coil and Horizon® E-z Cool Coil (SG), cleared under K182853 and K183376. For this reason, the magnetic field characteristics of the system are identical to the predicate devices, therefore equivalent safety and performance is assured. Consequently, no additional testing of the magnetic field characteristics of the system is necessary to meet the requirement of FDA's quidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" in order to demonstrate safety and performance.
The remaining technological characteristics of the Horizon® 3.0 TMS Therapy System, the Horizon® TMS Therapy System (K182853) and the Horizon® TMS Therapy System with Navigation®, including mechanism of action, specifications, treatment procedure, are very similar, and in most cases, identical.
The integration of Magstim Connect that could adversely affect the device (Authentication and Synchronization) have been evaluated, controlled and validated. Magstim has concluded that these functions do not compromise the established safety and effectiveness of the device and that the benefit of introducing these networked functions to enable greater patient management, and the ability for patient information to be persisted across multiple clinics/sites, outweighs the identified risk and the risk has been controlled to an acceptable level. The ability for Horizon® to integrate with Magstim Connect is supported by the FDAs clearance of the Neurostar Advanced Therapy (K201158) which includes the integration of TrakStar (MDDS) with their NeuroStar Advanced Therapy System for patient data manaqement.
The principles of operation of the Horizon® 3.0 TMS Therapy System is equivalent to the primary and secondary predicate devices. The methods for determining Motor Threshold both with and without EMG and determining the coil position for treatment in both navigated and non-navigated device configurations remain unchanged compared to the predicate devices. The the FDA cleared standard rTMS protocol and the FDA cleared iTBS protocol are identical to those of the predicate devices.
A summary of the similarities and minor differences between the Horizon® 3.0 TMS Therapy System and its primary and secondary predicate devices; the Horizon TMS Therapy System (K182853) and the Horizon TMS Therapy System with Navigation (K183376) are described in Table 2.
Conclusions
The intended use and indications for use are identical between the Horizon® 3.0 TMS Therapy System (subject of this submission) and the primary and secondary predicate devices (K182853 and K183376).
Although the technological characteristics of the Horizon® 3.0 TMS Therapy System differ slightly following the introduction of product improvements and patient data management integration, non-clinical testing demonstrates that the Horizon® 3.0 is as safe and effective compared to its primary and secondary predicate devices, the Horizon® TMS Therapy System (K182853) and the Horizon® TMS Therapy System with Navigation (K183376).
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Furthermore, the principles of operation remain unchanged between the Horizon® 3.0 TMS Therapy System and its primary and secondary predicates. The labeling for both the Horizon® 3.0 TMS Therapy System and its primary and secondary predicates instruct users that the FDA cleared Standard Treatment Protocol and FDA cleared iTBS Treatment Protocol are the only stimulation parameters that have been established to be safe and effective for treating MDD in clinical trials and should be set as the default treatment parameters for treating adult patients with MDD who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Thus, the information and data provided in this 510(k) premarket notification submission support a finding of substantial equivalence for the Horizon® 3.0 TMS Therapy System.
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Table 2: Substantial Equivalence Summary
| Criteria | Horizon® 3.0 TMS Therapy System(Subject of this submission) | Horizon® TMS TherapySystem with Navigation(K182853)(Primary Predicate) | Horizon® TMS TherapySystem(K183376(Secondary Predicate) |
|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Magstim Company Limited |
| Device Name | Horizon® 3.0 TMS Therapy System | Horizon® TMS Therapy Systemwith Navigation | Horizon® Therapy System |
| Clearance date | 04/03/2019 | 03/15/2019 | |
| 510(k) number | K211389 | K183376 | K182853 |
| Device code | OBP | OBP | OBP |
| Intended Use/Indications for Use | The Horizon® 3.0 TMS Therapy System is indicated for the treatment ofMajor Depressive Disorder in adult patients who have failed to achievesatisfactory improvement from prior antidepressant medication in thecurrent episode. | The Horizon® TMS Therapy System isindicated for the treatment of MajorDepressive Disorder in adult patientswho have failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode. | The Horizon® Therapy System isindicated for the treatment of MajorDepressive Disorder in adult patientswho have failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode. |
| Standard Treatment Protocol | |||
| Magnetic Field Intensity | 120% of the MT | 120% of the MT | 120% of the MT |
| Stimulus Frequency | 10 Hz | 10 Hz | 10 Hz |
| Stimulus Train duration | 4 sec | 4 sec | 4 sec |
| Inter-train interval | 11-26 sec | 11-26 sec | 11-26 sec |
| Number of trains | 75 | 75 | 75 |
| Magnetic Pulses perSession | 3000 | 3000 | 3000 |
| Treatment SessionDuration | 18.8 min-37.5 min | 18.8 min-37.5 min | 18.8 min-37.5 min |
| Sessions/week | 5 | 5 | 5 |
| Treatment Schedule | 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 |
| iTBS Treatment Protocol | |||
| Stimulation Intensity | 120% of the MT | 120% of the MT | N/A |
| Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | N/A |
| Train Duration | 2 sec | 2 sec | N/A |
| Inter-train Interval | 8 sec | 8 sec | N/A |
| Burst Pulses | 3 | 3 | N/A |
| Bursts | 200 | 200 | N/A |
| Inter Pulse interval | 20 msec | 20 msec | N/A |
| Number of trains | 20 | 20 | N/A |
| Number of Pulses per Session | 600 | 600 | N/A |
| Treatment Session Duration | 3 minutes 9 seconds | 3 minutes 9 seconds | N/A |
| Sessions/week | 5 | 5 | N/A |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | N/A |
| Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | N/A |
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| Stimulating Coils | ||||||||
|---|---|---|---|---|---|---|---|---|
| Coil Reference | Horizon®MT Coil | Horizon®3.0 E-z Cool Coil | Horizon®3.0 E-z Cool Coil(Nav) | Horizon®MT Remote Coil | Horizon®E-z Cool Coil(SG) | Horizon®MT Remote Coil | Horizon®E-z Cool Coil | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Configuration | Figure of 8 | Figure of 8 | Figure of 8 | Figure of 8 | Figure of 8 | Figure of 8 | Figure of 8 | |
| Core Material | Air | Air | Air | Air | Air | Air | Air | |
| Inductance (nominal) | 15μH | 16.5μH | 16.5μH | 15μH | 16.5μH | 15μH | 16.5μH | |
| Pulse Width | 330μs | 340μs | 340μs | 330μs | 340μs | 330μs | 340μs | |
| Horizon 3.0 Specifications | ||||||||
| Amplitude in SMT units(Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 | 0.28 - 1.9 | |||||
| Frequency range (Hz) at100% | 1 - 20 | 1 - 20 | 1 - 20 | |||||
| Maximum outputamplitude (V/m) at adepth of 2cm below thecoil surface | 150 V/m | 150 V/m | 150 V/m | |||||
| Maximum magnetic fieldstrength (T) at coilsurface | 1.0T | 1.0T | 1.0T | |||||
| Maximum magnetic fieldstrength (T) at a depth of2cm | 0.4T | 0.4T | 0.4T | |||||
| Maximum magnetic fieldgradient (dB/dt) (kT/s) atcoil surface | 18 kT/s | 18 kT/s | 18 kT/s | |||||
| Coil Positioning and MT Determination Principle | ||||||||
| System Configuration | Horizon® 3.0 | Horizon® 3.0 withStimGuide+ | Horizon® Performance | Horizon® Performance withStimGuide |
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| Coil Position Principle | Indirect targeting of treatmenttarget through measureddistance and direction (5.5cm)from MT Hotspot. Measurederived from statisticaldistance of DLPFC from MThotspot. | Indirect targeting of treatmenttarget through measureddistance and direction (5.5cm)from MT Hotspot usingstereotactic navigation.Measure derived fromstatistical distance of DLPFCfrom MT hotspot. | Indirect targeting of treatmenttarget through measured distanceand direction (5.5cm) from MTHotspot. Measure derived fromstatistical distance of DLPFC fromMT hotspot. | Indirect targeting of treatmenttarget through measured distanceand direction (5.5cm) from MTHotspot using stereotacticnavigation. Measure derived fromstatistical distance of DLPFC fromMT hotspot. |
|---|---|---|---|---|
| MT Response Detection | Visual qualitative monitoringfor APB response | Option 1. EMG providesquantitative data based onwhich user defines MT.Option 2. Visual qualitativemonitoring for APB response | Visual qualitative monitoring forAPB response | Option 1. EMG providesquantitative data based on whichuser defines MT.Option 2. Visual qualitativemonitoring for APB response |
§ 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.