(132 days)
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or algorithms that learn from data. The description focuses on the electromechanical and software components for delivering magnetic stimulation.
Yes.
The device is explicitly indicated for the "treatment of Major Depressive Disorder in adult patients" and is described as a "non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder."
No
Explanation: The device description and intended use clearly state that the Horizon® 3.0 TMS Therapy System is indicated for the "treatment of Major Depressive Disorder" and is a "non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder." It produces and delivers magnetic stimulation for therapy, not for diagnosis.
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" and is a "computerized, electromechanical medical device." It also mentions hardware-related testing like electrical safety, EMC, and biocompatibility.
Based on the provided information, the Horizon® 3.0 TMS Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder by applying magnetic stimulation to the brain. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states it's a system that produces and delivers magnetic stimulation to induce electrical currents in the cerebral cortex. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Mechanism of Action: TMS works by directly stimulating brain activity, not by analyzing biological samples.
Therefore, the Horizon® 3.0 TMS Therapy System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral 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 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.
Electrical Safety: A sample Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+) 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: A sample of the Horizon® 3.0 TMS Therapy System (specifically Horizon® 3.0 with StimGuide+) 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: A sample Horizon® 3.0 TMS Therapy System 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 Horizon® 3.0 TMS Therapy System is substantially equivalent to the legally marketed predicate device.
Biocompatibility: Patient-contacting components of the Horizon® 3.0 TMS Therapy System include: Enclosure of the Horizon® MT Coil; Enclosure of the Horizon® E-z Cool Coil 3.0: Enclosure of Horizon® E-z Cool Coil (Nav) 3.0, (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, thus demonstrating the Horizon® TMS Therapy System is substantially equivalent to the legally marketed predicate devices.
Human Factors Testing: Usability testing was performed to Horizon® 3.0 TMS Therapy System. The Human Factors Engineering report verifies the Horizon® 3.0 TMS Therapy System, to be safe and effective for the intended users, uses, and use environments thus demonstrating the Horizon® 3.0 TMS Therapy System is substantially equivalent to the legally marketed predicate devices.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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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
1
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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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
4
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 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. - Horizon® 3.0 Camera Stand
- 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 (Nav);
d. Horizon® 3.0 User Interface;
e. StimGuide+ User Interface. - Horizon® 3.0 Coil for MT Determination
a. Horizon® MT Coil. - Horizon® 3.0 Coil for Treatment
a. Horizon® 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. - Horizon® 3.0 Camera Stand
- Accessories
a. 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.
5
- . 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.
6
Table 1: Summary of Non-Clinical Testing
| Test | Method | Results/ Comment |
|---|---|---|
| Electrical Safety | ||
| Mechanical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and | |
| A1:2012- | ||
| Medical electrical equipment - Part 1: | ||
| General requirements for | ||
| basic safety and essential performance; | ||
| FDA Recognition Number: 19-4 | A sample Horizon® 3.0 TMS Therapy | |
| System (specifically Horizon® 3.0 with | ||
| StimGuide+) 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: 2014 - | |
| Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety and | ||
| essential performance - | ||
| Collateral standard: Electromagnetic | ||
| compatibility -Requirements and tests; | ||
| FDA recognition number: 19-8 | A sample of the Horizon® 3.0 TMS | |
| Therapy System (specifically Horizon® | ||
| 3.0 with StimGuide+) 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 - | |
| 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: 5-76 | A sample Horizon® 3.0 TMS Therapy | |
| System 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 Horizon® 3.0 TMS | ||
| Therapy System is substantially | ||
| equivalent to the legally marketed | ||
| predicate device. | ||
| Biocompatibility | ISO 10993-1:2009 - Biological Evaluation | |
| of Medical Devices - Part 1: Evaluation and | ||
| testing within a risk management process |
ISO 10993-5:2009 - Biological evaluation
of medical devices -- Part 5: Tests for in
vitro cytotoxicity; FDA Recognition
Number: 2-245 | Patient-contacting components of the
Horizon® 3.0 TMS Therapy System
include:
• Enclosure of the Horizon® MT Coil;
• Enclosure of the Horizon® E-z Cool
Coil 3.0:
• Enclosure of Horizon® E-z Cool Coil
(Nav) 3.0, |
| | | |
| | ISO 10993-10:2010 - Biological evaluation
of medical devices - Part 10: Tests for
irritation and skin sensitization; FDA
Recognition Number: 2-174 | 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, thus
demonstrating the Horizon® TMS
Therapy System is substantially
equivalent to the legally marketed
predicate devices. |
| Human Factors Testing | AAMI/ANSI HE75 - Human Factors
Engineering - Design of Medical Devices;
FDA Recognition Number: 5-57 | Usability testing was performed to
Horizon® 3.0 TMS Therapy System.
The Human Factors Engineering report
verifies the Horizon® 3.0 TMS Therapy
System, to be safe and effective for the
intended users, uses, and use
environments thus demonstrating the
Horizon® 3.0 TMS Therapy System is
substantially equivalent to the legally
marketed predicate devices. |
| | IEC 62366-1 - Medical Devices - Part 1:
Application of Usability Engineering To
Medical Devices; FDA Recognition
Number: 5-114 | intended users, uses, and use
environments thus demonstrating the
Horizon® 3.0 TMS Therapy System is
substantially equivalent to the legally
marketed 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.
8
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).
9
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 Therapy
System with Navigation
(K182853)
(Primary Predicate) | Horizon® TMS Therapy
System
(K183376
(Secondary Predicate) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Magstim Company Limited |
| Device Name | Horizon® 3.0 TMS Therapy System | Horizon® TMS Therapy System
with 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 of
Major Depressive Disorder in adult patients who have failed to achieve
satisfactory improvement from prior antidepressant medication in the
current episode. | The Horizon® TMS Therapy System is
indicated for the treatment of Major
Depressive Disorder in adult patients
who have failed to achieve satisfactory
improvement from prior antidepressant
medication in the current episode. | The Horizon® 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. |
| 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 per
Session | 3000 | 3000 | 3000 |
| Treatment Session
Duration | 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 |
11
12
| 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) at | ||||||||
| 100% | 1 - 20 | 1 - 20 | 1 - 20 | |||||
| Maximum output | ||||||||
| amplitude (V/m) at a | ||||||||
| depth of 2cm below the | ||||||||
| coil surface | 150 V/m | 150 V/m | 150 V/m | |||||
| Maximum magnetic field | ||||||||
| strength (T) at coil | ||||||||
| surface | 1.0T | 1.0T | 1.0T | |||||
| Maximum magnetic field | ||||||||
| strength (T) at a depth of | ||||||||
| 2cm | 0.4T | 0.4T | 0.4T | |||||
| Maximum magnetic field | ||||||||
| gradient (dB/dt) (kT/s) at | ||||||||
| coil surface | 18 kT/s | 18 kT/s | 18 kT/s | |||||
| Coil Positioning and MT Determination Principle | ||||||||
| System Configuration | Horizon® 3.0 | Horizon® 3.0 with | ||||||
| StimGuide+ | Horizon® Performance | Horizon® Performance with | ||||||
| StimGuide |
13
| Coil Position Principle | Indirect targeting of treatment
target through measured
distance and direction (5.5cm)
from MT Hotspot. Measure
derived from statistical
distance of DLPFC from MT
hotspot. | Indirect targeting of treatment
target through measured
distance and direction (5.5cm)
from MT Hotspot using
stereotactic navigation.
Measure derived from
statistical distance of DLPFC
from MT hotspot. | Indirect targeting of treatment
target through measured distance
and direction (5.5cm) from MT
Hotspot. Measure derived from
statistical distance of DLPFC from
MT hotspot. | Indirect targeting of treatment
target through measured distance
and direction (5.5cm) from MT
Hotspot using stereotactic
navigation. Measure derived from
statistical distance of DLPFC from
MT hotspot. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MT Response Detection | Visual qualitative monitoring
for APB response | Option 1. EMG provides
quantitative data based on
which user defines MT.
Option 2. Visual qualitative
monitoring for APB response | Visual qualitative monitoring for
APB response | Option 1. EMG provides
quantitative data based on which
user defines MT.
Option 2. Visual qualitative
monitoring for APB response |