(156 days)
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.
The HORIZON™ Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.
The HORIZON™ 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™ Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
The HORIZON™ Therapy System is an integrated system consisting of a combination of hardware, software, and accessories.
This document is a 510(k) Pre-market Notification for the Magstim HORIZON™ Therapy System, a medical device used for the treatment of Major Depressive Disorder. The core of the submission is to demonstrate the substantial equivalence of the HORIZON™ system to a legally marketed predicate device, the Magstim Rapid² Therapy System.
Therefore, the "acceptance criteria" and "device performance" in this context are evaluated against the predicate device's performance and established safety standards, rather than generating new clinical efficacy data for the new device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the acceptance criteria are largely defined by equivalence to the predicate device and compliance with relevant safety and performance standards. No novel acceptance criteria for clinical effectiveness are presented for the HORIZON™ system itself.
| Acceptance Criteria (Demonstration of Equivalence/Compliance) | Reported Device Performance (HORIZON™ Therapy System) |
|---|---|
| Functional Equivalence to Predicate | |
| Same Intended Use and Indications for Use | Identical: Treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. |
| Same Principle of Operation | Identical: 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. |
| Same Key Technological Characteristics | - Identical coil head geometry for both MT Remote Coil and Air Film Coil as predicate. - Identical Stimulus Frequency (10 Hz), Stimulus Train duration (4 sec), Inter-train interval (26 sec), Number of trains (75), Magnetic Pulses per Session (3000), Treatment Session Duration (37.5 min), Sessions/week (5), and Treatment Schedule (5 daily sessions for 6 weeks). - Same brain area stimulated (Left Dorsolateral Prefrontal Cortex). - Similar Stimulator Output Parameters (Amplitude, Frequency range, Pulse train duration, Inter-train interval, Max trains per session, Max pulses per session, MT Determination Method, Placement for stimulation). - Minor modifications: increased thermal performance/reliability of mainframe/power supply, new coil-to-mainframe connector for reliability/usability. |
| Magnetic Field Characteristics | Identical to predicate device (Air Film Coil and D70mm MT Remote Coil cleared under K143531 and K162935) due to identical coil head geometry. Therefore, equivalent safety and performance is assured (no new testing needed for magnetic field characteristics). Values for Max output amplitude, Max magnetic field strength (at surface and 2cm depth), Max magnetic field gradient (at surface and 2cm depth), and Magnetic field strength gradient ratio are identical to predicate. |
| Basic Software Capabilities | Same as the predicate device related to treatment administration. |
| Safety and Performance Standards Compliance | |
| Electrical Safety | Compliant with IEC 60601-1 (Ed. 3.1.). |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 (2007). |
| Biocompatibility | Both coils meet ISO 10993-1 (2009) standards. |
| Acoustic Output Measurements | Conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance. |
| Software Verification and Validation | Performed, demonstrating that the software performs as intended and in accordance with specifications. "Moderate" level of concern. |
| Risk Management | Potential risks identified and evaluated in compliance with ISO14971; risks determined acceptable or addressed with control measures. |
2. Sample size used for the test set and the data provenance
The document does not report any clinical test set data from human patients for efficacy or performance of the HORIZON™ Therapy System itself. The submission relies on non-clinical testing and substantial equivalence to the predicate device.
For non-clinical testing:
- Electrical safety and EMC testing: Conducted on "the system" (singular, implies one system tested).
- Biocompatibility evaluation: On "both coils."
- Acoustic output measurements: Conducted during IEC 60601-1 testing.
- Software verification and validation testing: Conducted for the software.
Data provenance: Not applicable in the context of clinical studies. The non-clinical testing was performed for the HORIZON™ device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical ground truth or expert evaluation of clinical outcomes for the HORIZON™ Therapy System is mentioned in this document as part of the substantial equivalence submission. The ground truth for the equivalence claim is based on engineering specifications, compliance with standards, and comparison to the predicate device's design.
4. Adjudication method for the test set
Not applicable. As no clinical test set for independent evaluation of the HORIZON™ device is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Transcranial Magnetic Stimulation (TMS) system for treating depression, not an AI diagnostic imaging device. Therefore, MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device with integrated software, not an AI algorithm. Its performance is inherent to its operation, not a separate "algorithm only" evaluation. The software functionality is verified and validated, but this is distinct from standalone AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence are:
- Predicate Device Specifications and Performance: The established, cleared characteristics and performance of the Magstim Rapid² Therapy System serve as the primary ground truth for the comparison.
- International Standards and Regulations: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and ISO14971 provide the "ground truth" for safety, EMC, biocompatibility, and risk management compliance.
- Engineering Specifications: The design parameters, such as coil winding parameters, inductance, pulse width, and physical dimensions, are considered the ground truth for comparing the technological characteristics to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires training data for its core functionality. The "software" in question refers to control software, not an adaptive learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI algorithm. The ground truth for the correctness of the control software (functional specifications) would have been established during software development requirements gathering and design phases.
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2017
Magstim Company Ltd. Tom Campbell Regulatory Affairs Officer Spring Gardens Whitland, SA34 0HR Gb
Re: K171051/S002
Trade/Device Name: HORIZON Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: May 23, 2017 Received: August 10, 2017
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
William J. Heetderks -S 2017.09.13 08:48:43 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known)
Device Name
HORIZON™ Therapy System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
{3}------------------------------------------------
510(k) SUMMARY Magstim's HORIZON™ Therapy System
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
Date Prepared: August 29, 2017
Name of Device
HORIZON™ 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
Magstim Rapid2 Therapy System, The Magstim Company Limited. (K143531 and K162935)
Device Description
The HORIZON™ Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation.
The HORIZON™ 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™ Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings, including physicians' offices, clinics, and hospitals.
{4}------------------------------------------------
The HORIZON™ Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Intended Use / Indications for Use
The HORIZON™ Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Technological Characteristics
The HORIZON™ Therapy System is comprised of five principal components. These include:
-
- HORIZON™ User Interface;
-
- HORIZON™ Mainframe;
-
- HORIZON™ Power supply:
-
- HORIZON™ Air Film Coil;
-
- HORIZON™ MT Remote Coil;
-
- Accessory HORIZON™ Cart;
-
- Accessory Coil Holding Mechanism;
-
- Accessory Footswitch;
-
- Accessory Cables: and
-
- Accessory TMS Patient Caps.
The operator controls the HORIZON™ Therapy System via the HORIZON™ User Interface, using a graphic LCD panel with touchscreen technology. The operator instructions, given through the HORIZON™ User Interface, direct the HORIZON™ Mainframe in charging and discharging the device's high voltage discharge capacitor. The discharge is delivered to the patient via the stimulating coil. Motor threshold level can be determined using the HORIZON™ MT Remote Coil. Treatment is delivered to the treatment area via the HORIZON™ Air Film Coil, which is positioned above the treatment area. Positioning, and fixation, of the coil over the treatment area is accomplished using an Accessory Coil Holding Mechanism. The HORIZON™ Power Supply provides power to charge the high voltage capacitor in the HORIZON™ Mainframe.
Software documentation for a "moderate" level of concern has been provided.
Non-Clinical Testing
Electrical safety and electromagnetic compatibility ("EMC") testing was conducted on the system to demonstrate that the device is compliant with IEC 60601-1 (Ed. 3.1.) and IEC 60601-1-2 (2007). Environmental testing also demonstrated compliance with IEC 60601-1. The biocompatibility evaluation demonstrated that both coils meet ISO 10993-1 (2009) standards. In addition, acoustic output measurements have been conducted during IEC 60601-1 (Ed. 3.1) testing to demonstrate safety and performance.
The software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of HORIZON™ Therapy System have been identified and evaluated in compliance with
{5}------------------------------------------------
ISO14971, and the risks were determined to be acceptable, or have been addressed with risk control measures.
As demonstrated in Section XIV and Appendix 03 the coil head geometry of both the HORIZON™ Air Film Coil and HORIZON™ MT Remote Coil are identical to the predicate devices, the Air Film Coil and D70mm MT Remote Coil, cleared under K143531 and K162935. For this reason, the magnetic field characteristics of the system are identical to the predicate device, 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 guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" in order to demonstrate safety and performance.
In summary, performance testing demonstrates that the HORIZON™ Therapy System is as safe and effective as the predicate.
Substantial Equivalence
The HORIZON™ Therapy System has the same intended use and indications for use, the same principles of operation, as well as the same key technological characteristics as the predicate device.
The design of the HORIZON™ Therapy System is substantially equivalent to the design of the predicate, as both systems are based on applying transcranial magnetic stimulation by means of repetitive pulse trains at a predetermined frequency. Both systems use the same mechanism of action, i.e., an electromechanical instrument that produces and delivers brief duration, rapidly alternating (pulsed) magnetic fields to induce electrical currents in localized regions of the prefrontal cortex.
The modifications from the predicate device include increased thermal performance and reliability of the mainframe and power supply and a new coil to mainframe connector to improve reliability and usability.
Transcranial magnetic stimulation is enabled in the HORIZON™ Therapy System and in the Rapid² Therapy System, as both have the same key system components, consisting of electromagnetic coils, a coil holding mechanism, a TMS stimulator and software. The operation procedure is the same in both the HORIZON™ Therapy System and the Rapid² Therapy System consisting of system setup, patient preparation, determination of patients' motor threshold, coil position, and administration of treatment at pre-defined treatment stimulation parameters. The similarities and minor differences between the HORIZON™ Therapy System and the Rapid2 Therapy System are described in Table 1.
{6}------------------------------------------------
Table 1: Substantial Equivalence Summary
| Criteria | HORIZON™ Therapy System(Subject of this submission) | Rapid² Therapy System | ||
|---|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | ||
| Device Name | HORIZON™ Therapy System | Rapid² Therapy System | ||
| Clearance date | 2017/03/10 | |||
| 510(k) number | K143531 and K162935 | |||
| Device code | OBP | OBP | ||
| Intended Use/ Indicationsfor Use | The HORIZON™ Therapy System is indicatedfor the treatment of Major DepressiveDisorder in adult patients who have failed toachieve satisfactory improvement from priorantidepressant medication in the currentepisode. | The Rapid² Therapy System is indicated for thetreatment of Major Depressive Disorder in adultpatients who have failed to achieve satisfactoryimprovement from prior antidepressantmedication in the current episode. | ||
| Treatment Protocol | ||||
| Magnetic Field Intensity | 120% of the MT | 120% of the MT | ||
| Stimulus Frequency | 10 Hz | 10 Hz | ||
| Stimulus Train duration | 4 sec | 4 sec | ||
| Inter-train interval | 26 sec | 26 sec | ||
| Number of trains | 75 | 75 | ||
| Magnetic Pulses perSession | 3000 | 3000 | ||
| Treatment SessionDuration | 37.5 min | 37.5 min | ||
| Sessions/week | 5 | 5 | ||
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | ||
| Area of brain to bestimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | ||
| MT Determination Coil Parameters | ||||
| HORIZON™ MT Remote CoilPart #: 4990-00 | D70 MT Remote CoilPart #: 4949-00 | |||
| Waveform | Biphasic | Biphasic | ||
| Configuration | Figure 8 | Figure 8 | ||
| Core Material | Air | Air | ||
| Coil Winding Parameters | Flat spiral winding9 turns/wing1.75 × 6mm wireMagstim Part #: 3303-01 | Flat spiral winding9 turns/wing1.75 × 6mm wireMagstim Part #: 3303-01 |
{7}------------------------------------------------
| Criteria | HORIZON TM Therapy System(Subject of this submission) | Rapid2 Therapy System |
|---|---|---|
| Inductance (nominal) | 15μH | 15μH |
| Pulse Width | 330μs | 330μs |
| Coil Connector | Harting Han-Eco Connector | Trident Ringlock Circular Connector |
| Treatment Delivery Coil Parameters | ||
| HORIZON TM Air Film CoilPart #: 4980-00 | Air Film CoilPart #: 3910-00 | |
| Waveform | Biphasic | Biphasic |
| Configuration | Figure 8 | Figure 8 |
| Core Material | Air | Air |
| Coil Winding Parameters | Flat spiral winding19 turns/wing, 3 lyrs1.0 x 3.5mm wireMagstim Part #: 0056-01 | Flat spiral winding19 turns/wing, 3 lyrs1.0 x 3.5mm wireMagstim Part #: 0056-01 |
| Inductance (nominal) | 12μH | 12μH |
| Pulse Width | 300μs | 300μs |
| Coil Connector | Harting Han-Eco Connector | Trident Ringlock Circular Connector |
| Stimulator Output Parameters | ||
| Amplitude in SMT units(Standard Motor Threshold) | 0.28 - 1.9 | 0.28 - 1.9 |
| Frequency range (Hz) at100% | 1 - 20 | 1 - 11 |
| Pulse train duration range(sec) | 0.1 - 600 | 0.1 - 600 |
| Inter-train interval range(sec) | 1 - 540 | 1 - 540 |
| Maximum trains persession | 1 - 999 | 1 - 999 |
| Maximum # of pulses persession(cumulative exposure) | 6000 | 65000 |
| Method for determiningMotor Threshold | • Place device over the left motorregion• Determine patient sensitivity• Adjust coil position to identifyregion of maximal response incontra-lateral hand.• Reduce output amplitude todetermine threshold of stimulation | • Place device over the left motor region• Determine patient sensitivity• Adjust coil position to identify region ofmaximal response in contra-lateralhand.• Reduce output amplitude to determinethreshold of stimulation |
| Method for determining | 5.5cm anterior to motor hotspot | 5.5cm anterior to motor hotspot |
| Criteria | HORIZON™ Therapy System(Subject of this submission) | Rapid2 Therapy System |
| Maximum outputamplitude (V/m) at adepth of 2cm below thecoil surface | 150 V/m | 150 V/m |
| Maximum magnetic fieldstrength (T) at coilsurface | 1.0T | 1.0T |
| Maximum magnetic fieldstrength (T) at a depth of2cm | 0.4T | 0.4T |
| Maximum magnetic fieldgradient (dB/dt) (kT/s) atcoil surface | 18 kT/s | 18 kT/s |
| Maximum magnetic fieldgradient (dB/dt) (kT/s) ata depth of 2cm | 10 kT/s | 10 kT/s |
| Magnetic field strengthgradient ratio | 1.8 | 1.8 |
{8}------------------------------------------------
The basic software capabilities related to treatment administration are the same as the predicate device.
The HORIZON™ Therapy System meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (IEC 60601-1-2).
Conclusions
In summary, the intended use and indications for use for the HORIZON™ Therapy System and the Rapid² Therapy System are identical. Furthermore, the key technological characteristics and principles of operation, including basic design, mechanism of action, specifications and treatment procedure are the same. Non-clinical test data demonstrates that the HORIZON™ Therapy System is as safe and effective as the predicate.
Thus, the HORIZON™ Therapy System is substantially equivalent to the Rapid? Therapy System.
§ 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.