HORIZON TMS Therapy System

K182853 · Magstim Company, Ltd. · OBP · Mar 15, 2019 · Neurology

Device Facts

• Record ID: K182853
• Device Name: HORIZON TMS Therapy System
• Applicant: Magstim Company, Ltd.
• Product Code: OBP · Neurology
• Decision Date: Mar 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Computerized, electromechanical rTMS system; delivers non-invasive, pulsed magnetic fields to induce electrical currents in cerebral cortex. Used in inpatient/outpatient settings (clinics, hospitals, offices) by licensed physicians. System comprises stimulator, user interface, power supply, and electromagnetic coils. Operator uses touchscreen interface to control stimulation parameters; coil positioned over left dorsolateral prefrontal cortex. Device determines motor threshold (MT) via remote coil; delivers treatment via AFC or E-z Cool coils. Modification adds iTBS (intermittent Theta Burst Stimulation) protocol, matching primary predicate. Benefits patients with treatment-resistant depression by providing non-invasive cortical stimulation.

Clinical Evidence

Bench testing only. Verification testing confirmed iTBS stimuli intensity is equal and constant throughout treatment delivery. No new clinical data provided; reliance on predicate device performance data.

Technological Characteristics

Class II rTMS system. Components: stimulator, LCD touchscreen interface, high-voltage capacitor, air-core figure-of-eight coils (MT Remote, AFC, E-z Cool). Biphasic waveform. Standards: IEC 60601-1 (electrical/mechanical safety), EN 60601-1-2 (EMC). Connectivity: standalone system. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for treatment of Major Depressive Disorder in adults who failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Regulatory Classification

Identification

A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

Predicate Devices

• Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620)
• HORIZON TMS Therapy System (K180907)

Submission Summary (Full Text)

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March 15, 2019

Magstim Company Ltd. Tom Campbell Regulatory Manager Spring Gardens, Whitland, Carmarthenshire SA34 OHR. United Kingdom

Re: K182853

Trade/Device Name: HORIZON TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: February 5, 2019 Received: February 11, 2019

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/cdrl/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Pamela D. Scott -S

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

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# Indications for Use

510(k) Number (if known) K182853

Device Name HORIZON TMS Therapy System

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY Magstim's HORIZON®TMS 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: [phone] Facsimile: [phone]

Contact Person: Tom Campbell

Date Prepared: March 15, 2019

#### Name of Device

HORIZON® 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 Device

Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S. (K173620) (Primary Predicate)

HORIZON® TMS Therapy System, The Magstim Company Limited. (K180907) (Secondary Predicate)

#### Device Description

The HORIZON® 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.

The HORIZON® 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® 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 and outpatient settings, including physicians' offices, clinics, and hospitals.

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The HORIZON® 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 / Indications for Use

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.

## Technological Characteristics

The HORIZON® TMS Therapy System is comprised of the following components:

- 1. HORIZON® Stimulator
- a. HORIZON® User Interface;
- b. HORIZON® Mainframe;
- c. HORIZON® Power Supply;
- d. Accessory Cables;
- e. Accessory Footswitch.
- 2. Coil for MT Determination
- a. HORIZON® MT Remote Coil.
- 3. Coil(s) for Treatment
- a. HORIZON® AFC:
- b. HORIZON® E-z Cool Coil.
- 4. Accessory Cart(s) and Coil Holding Mechanism(s)
- a. Magstim®Trollev:
- b. Magstim® Coil Stand(s);
- c. HORIZON® E-z Cart;
- d. HORIZON® E-z Arm.
- 5. Accessory Marking Apparatus
- a. TMS Patient Caps.

The operator controls the HORIZON® TMS 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 either the HORIZON® AFC or the HORIZON® E-z Cool Coil, which is positioned above the treatment area. Positioning, and fixation, of the coil over the treatment area is accomplished using the Coil Holding Mechanism(s). The HORIZON® Power Supply provides power to charge the high voltage capacitor in the HORIZON® Mainframe.

#### Non-Clinical Performance Testing

The non-clinical performance testing of the HORIZON® TMS Therapy System including electrical safety, electromagnetic compatibility, biocompatibility, human factors and magnetic field characteristics has been tested as required and cleared by the FDA earlier in K180907.

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Additional verification testing has demonstrated that the intensity of the individual stimuli in iTBS is equal and kept constant throughout the delivery of the full treatment. As stated by the primary predicate device (K173620), the clinical performance of iTBS is dependent on the stimuli being delivered at equal intensity, to ensure that a constant dose of stimuli is delivered during treatment.

This demonstrates that the HORIZON® TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder.

#### Substantial Equivalence

The HORIZON® TMS Therapy System is substantially equivalent to its predicate devices, the HORIZON® TMS Therapy System (K180907) and the Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620).

The intended use and indications for use for the HORIZON® TMS Therapy System and the secondary predicate device, the HORIZON® TMS Therapy System (K180907) are identical.

The key technological characteristics including basic design, mechanism of action, specifications are also identical for both the HORIZON® TMS Therapy System and the secondary predicate device (K180907).

The principles of operation of the HORIZON® TMS Therapy System is equivalent to the secondary predicate device, the HORIZON® TMS Therapy System (K180907). The only change to the HORIZON® TMS Therapy System is a modification to the labelling to include a recommendation for an additional treatment protocol known as iTBS. This treatment protocol, is identical to the treatment protocol recommended by the primary predicate device, the Maq Vita TMS Therapy System w/Theta Burst Stimulation (K173620). The design of the HORIZON® TMS Therapy System is unchanged from that previously cleared under K180907.

Transcranial magnetic stimulation is enabled in the HORIZON® TMS Therapy System and in the predicate devices, as all have the same key system components, consisting of electromagnetic coils, a coil holding mechanism, a TMS stimulator and software. The operation procedure consisting of system setup, patient preparation, determination of patients' motor threshold, coil position, and administration of treatment at pre-defined treatment stimulation parameters is unchanged in the HORIZON® TMS Therapy System to that cleared earlier in (K180907).

The basic software capabilities related to treatment administration are the same as the secondary predicate (K180907)

The HORIZON® TMS Therapy System meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (EN 60601-1-2).

The similarities and minor differences between the HORIZON® TMS Therapy System, the Mag Vita TMS Therapy System w/Theta Burst Stimulation (K173620) (Primary Predicate) and the HORIZON® TMS Therapy System (K180907) (Secondary Predicate) are described in Table 1.

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#### Conclusions

In summary, the intended use and indications for use for the HORIZON® TMS Therapy System and the secondary predicate device, the HORIZON® TMS Therapy System (K180907) are identical.

Furthermore, the key technological characteristics including basic design, mechanism of action, specifications are also identical for both the HORIZON® TMS Therapy System and the secondary predicate device (K180907).

The principles of operation, including the method for determining coil position, the treatment procedure and the relevant protocol parameters are substantially equivalent to the predicate devices.

Non-clinical performance testing has demonstrated that the change to the HORIZON® TMS Therapy System labelling to add a recommendation for an additional treatment protocol known as iTBS, raises no new issues of safety or effectiveness. Furthermore, the intended use, as described in the labeling, has not changed as a result of this modification.

Thus, the HORIZON® TMS Therapy System is considered to be substantially equivalent.

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# Table 1: Substantial Equivalence Summary

| Criteria | HORIZON® TMS Therapy System<br>(Subject of this submission) | Mag Vita TMS Therapy System<br>w/Theta Burst Stimulation<br>(K173620)<br>(Primary Predicate) | HORIZON® TMS Therapy System<br>(K180907)<br>(Secondary Predicate) | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Manufacturer | Magstim Company Limited | Tonica Elektronik A/S | Magstim Company Limited | |
| Device Name | HORIZON® TMS Therapy System | Mag Vita TMS Therapy System<br>w/Theta Burst Stimulation | HORIZON® TMS Therapy System | |
| Clearance date | | 08/14/2018 | 08/03/2018 | |
| 510(k) number | | K173620 | K180907 | |
| Device code | OBP | OBP | OBP | |
| Intended Use/<br>Indications for Use | The HORIZON® TMS Therapy System is indicated for<br>the treatment of Major Depressive Disorder in adult<br>patients who have failed to achieve satisfactory<br>improvement from prior antidepressant medication in<br>the current episode. | The Mag Vita TMS Therapy System w/Theta<br>Burst Stimulation is indicated for the<br>treatment of Major Depressive Disorder in<br>adult patients who have failed to receive<br>satisfactory improvement from prior<br>antidepressant medication in the current<br>episode. | The HORIZON® TMS Therapy System is indicated for the<br>treatment of Major Depressive Disorder in adult<br>patients who have failed to achieve satisfactory<br>improvement from prior antidepressant medication in<br>the current episode. | |
| | Standard Treatment Protocol | | | |
| Magnetic Field<br>Intensity | 120% of the MT | - | 120% of the MT | |
| Stimulus Frequency | 10 Hz | - | 10 Hz | |
| Stimulus Train<br>duration | 4 sec | - | 4 sec | |
| Inter-train interval | 11-26 sec | - | 11-26 sec | |
| Number of trains | 75 | - | 75 | |
| Magnetic Pulses per<br>Session | 3000 | - | 3000 | |
| Treatment Session<br>Duration | 18.8 min–37.5 min | - | 18.8 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 be<br>stimulated | Left Dorsolateral Prefrontal Cortex | - | Left Dorsolateral Prefrontal Cortex | |
| iTBS Treatment Protocol | | | | |
| Stimulation Intensity | 120% of the MT | 120% of the MT | - | |
| Repetition Rate | 50 Hz (5 pulses per sec) | 50 Hz (5 pulses per sec) | - | |
| Train Duration | 2 sec | 2 sec | - | |
| Inter-train Interval | 8 sec | 8 sec | - | |
| Burst Pulses | 3 | 3 | - | |
| Bursts | 200 | 200 | - | |
| Inter Pulse interval | 20 msec | 20 msec | - | |
| Number of trains | 20 | 20 | - | |
| Number of Pulses per<br>Session | 600 | 600 | - | |
| Treatment Session<br>Duration | 3.09 min | 3.09 min | - | |
| Sessions/week | 5 | 5 | - | |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | - | |
| Area of brain to be<br>stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | - | |

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| | HORIZON®<br>MT Remote<br>Coil | HORIZON®<br>E-z Cool Coil | HORIZON®<br>AFC | Cool-B70 Coil | HORIZON®<br>MT Remote<br>Coil | HORIZON®<br>E-z Cool Coil | HORIZON®<br>AFC | |
|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------|-------------------------------------------------|---------------------------------------------|-------------------------------------------|---------------------------------------------------|-------------------------------------------------|--|
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Core Material | Air | Air | Air | Air | Air | Air | Air | |
| Shape | Figure-of-<br>eight | Figure-of-<br>eight | Figure-of-<br>eight | Figure-of-eight | Figure-of-<br>eight | Figure-of-<br>eight | Figure-of-<br>eight | |
| Coil Winding<br>Configuration<br>Inner Diameter (ID)<br>Outer Diameter (OD)<br>Winding Height (H)<br>Number of Windings (NW) | ID: 55mm<br>OD: 92mm<br>H: 6mm<br>NW: 2x9 | ID: 37.5mm<br>OD: 97mm<br>H: 11mm<br>NW: 2x(3x23) | ID: 43mm<br>OD: 92mm<br>H: 11mm<br>NW: 2x(3x19) | ID: 23mm<br>OD: 96mm<br>H: 12mm<br>NW: 2x11 | ID: 55mm<br>OD: 92mm<br>H: 6mm<br>NW: 2x9 | ID: 37.5mm<br>OD: 97mm<br>H: 11mm<br>NW: 2x(3x23) | ID: 43mm<br>OD: 92mm<br>H: 11mm<br>NW: 2x(3x19) | |
| Pulse Width | 330μs | 340μs | 300μs | 280μs | 330μs | 340μs | 300μs | |
| Amplitude in SMT<br>units<br>(Standard Motor Threshold) | | 0.28 - 1.9 | | 0 - 1.7 | | 0.28 - 1.9 | | |
| Frequency range (Hz)<br>at 100% | 1 - 20 | | | | 1 - 20 | | | |