Rapid2 Therapy System

K162935 · Magstim Company, Ltd. · OBP · Mar 10, 2017 · Neurology

Device Facts

• Record ID: K162935
• Device Name: Rapid2 Therapy System
• Applicant: Magstim Company, Ltd.
• Product Code: OBP · Neurology
• Decision Date: Mar 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rapid2 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

Rapid2 Therapy System is a computerized, electromechanical rTMS device; 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 mainframe, power supply, user interface, and stimulating coils (Air Film Coil for treatment; optional D70mm MT Remote Coil for motor threshold determination). Operator uses touchscreen interface to control high-voltage capacitor charging/discharging; coil positioned over treatment area via accessory stand. Output is magnetic stimulation; clinical benefit is treatment of refractory Major Depressive Disorder. Device provides non-invasive cortical neuron stimulation; physician monitors patient response to adjust treatment parameters.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility) demonstrated. Magnetic field and acoustic output measurements performed. Software verification and validation confirmed performance per specifications.

Technological Characteristics

rTMS system; Class II (21 CFR 882.5805). Components: mainframe, power supply, touchscreen UI, Air Film Coil, optional D70mm MT Remote Coil. Energy: high-voltage capacitor discharge. Waveform: biphasic. Configuration: Figure 8 coil. Connectivity: standalone. Software: moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for adult patients with Major Depressive Disorder who have 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

• Magstim Rapid2 Therapy System (K143531)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2017

Magstim Company Ltd. Kevyn Beard, Regulatory Affairs Manager Spring Gardens Whitland, SA34 0HR Carmarthenshire, GB

Re: K162935

Trade/Device Name: Rapid2 Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: February 2, 2017 Received: February 6, 2017

Dear Kevyn Beard:

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 devicerelated 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.

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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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, William J. Heetderks -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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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

### Device Name

Rapid2 Therapy System

## Indications for Use (Describe)

The Rapid2 Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients The Rape failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

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

2 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)

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# 510(k) SUMMARY Magstim's Rapid2 Therapy System

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Magstim Company Limited Spring Gardens, Whitland, Carmathenshire SA34 OHR, United Kingdom

Phone: [phone] Facsimile: [phone]

Contact Person: Kevyn Beard

Date Prepared: February 2, 2017

### Name of Device

Magstim Rapid2 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)

## Device Description

The Rapid2 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 Rapid2 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 Rapid2 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 Rapid2 Therapy System is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.

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#### Intended Use / Indications for Use

The Rapid2 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 Rapid Therapy System is comprised of five principal components. These include:

- 1) User Interface;
- 2) Mainframe:
- 3) Power supply;
- 4) Air Film Coil;
- 5) Optional D70mm MT Remote Coil
- 6) Accessory coil stand
- 7) Accessory footswitch and
- 8) Accessory cables

The proposed change which is the subject of this 510(k), is to introduce a new optional hand held remote coil that is intended to be used for determining the motor threshold level.

The operator controls the Rapid2 Therapy System via the User Interface, using a graphic LCD panel with touchscreen technology. The operator instructions, given through the User Interface, direct the Rapid2 Stimulator 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 either the Air Film Coil or the optional D70mm MT Remote Coil. Treatment is delivered to the treatment area via the 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 stand. The Rapid2 power supply provides power to charge the high voltage capacitor in the Rapid2 Stimulator.

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, magnetic field measurements and acoustic output measurements have been conducted to demonstrate safety and performance.

Software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. The potential risks of Rapid2 have been identified and evaluated in compliance with ISO14971, and the risks were determined to be acceptable, or have been addressed with risk control measures.

The non-clinical testing with the Rapid2 Therapy System included testing of the magnetic field characteristics of the system, as required by FDA's guidance document "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems", was demonstrated under K143531

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The addition of the optional D70mm MT Remote Coil to the Rapid2 Therapy System (predicate device) does not change the intended use and indications for use nor does it change the technological characteristics and principles of operation. The addition of the optional D70mm MT Remote Coil raises no new issues of safety or effectiveness.
Performance data demonstrate that the Rapid Therapy System is as safe and effective as the predicate.

The similarities and minor differences between the Air Film Coil and optional D70mm MT Remote Coil are described in the table below:

| Criteria | Rapid² System<br>(Subject of this submission) | Rapid² Therapy System<br>(Predicate System) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | |
| Device Name | Rapid² System | Rapid² System | |
| Clearance date | | 08/05/2015 | |
| 510(k) number | | K143531 | |
| Device code | OBP | OBP | |
| Intended Use/<br>Indications for Use | The Rapid² 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<br>medication in the current episode. | The Rapid² 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<br>medication 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 per<br>Session | 3000 | 3000 | |
| Treatment Session<br>Duration | 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 be<br>stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | |
| Applicator (Coil) Parameters | | | |
| | D70 MT Remote Coil<br>(Optional for MT<br>Determination only) | Air Film Coil<br>(Treatment Delivery and<br>MT Determination) | |
| Waveform | Biphasic | Biphasic | |
| Configuration | Figure 8 | Figure 8 | |
| | Rapid2 System | | Rapid2 Therapy System |
| Criteria | (Subject of this submission) | | (Predicate System) |
| Core Material | Air | | Air |
| Coil Winding<br>Parameters | Flat spiral winding<br>9 turns/wing<br>$1.75 \u00d7 6$ mm wire | | Flat spiral winding<br>19 turns/wing, 3 layers<br>$1.0 \u00d7 3.5$ mm wire |
| Inductance (nominal) | $15\u03bc$ H | | $12\u03bc$ H |
| Pulse Width | $330\u03bcs$ | | $300\u03bcs$ |
| | Stimulator Output Parameters | | |
| Amplitude in SMT units<br>(Standard Motor Threshold) | 0.28 - 1.9 | | 0.28 - 1.9 |
| Frequency range (Hz) | 0.1 - 30 | | 0.1 - 30 |
| Pulse train duration<br>range (sec) | 1 - 20 | | 1 - 20 |
| Inter-train interval range<br>(sec) | 10 - 60 | | 10 - 60 |
| Maximum trains per<br>session | ~ 140 | | ~ 140 |
| Maximum # of pulses<br>per session<br>(cumulative exposure) | 5000 | | 5000 |
| Method for determining<br>Motor Threshold | • Place device over the left motor region<br>• Determine patient sensitivity<br>• Adjust coil position to identify region of<br>maximal response in contra-lateral<br>hand.<br>• Reduce output amplitude to determine<br>threshold of stimulation | | • Place device over the left motor region<br>• Determine patient sensitivity<br>• Adjust coil position to identify region of<br>maximal response in contra-lateral<br>hand.<br>• Reduce output amplitude to determine<br>threshold of stimulation |
| Method for determining<br>coil treatment position | 5.5cm anterior to motor hotspot | | 5.5cm anterior to motor hotspot |
| Maximum output<br>amplitude (V/m) at a<br>depth of 2cm below the<br>coil surface | 150 V/m | | 150 V/m |
| Maximum magnetic field<br>strength (T) at coil<br>surface | 1.0T | | 1.0T |
| Maximum magnetic field<br>strength (T) at a depth<br>of 2cm | 0.4T | | 0.4T |
| Maximum magnetic field<br>gradient (dB/dt) (kT/s) at<br>coil surface | 18 kT/s | | 18 kT/s |
| Maximum magnetic field<br>gradient (dB/dt) (kT/s) at<br>a depth of 2cm | 10 kT/s | | 10 kT/s |
| Magnetic field strength<br>gradient ratio | 1.8 | | 1.8 |

Table 1: Substantial Equivalence Summary

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The basic software capabilities related to treatment administration are unchanged from
the predicate device.

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The Rapid Therapy System meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (IEC 60601-1-2), with or without the optional D70mm MT Remote Coil.

#### Conclusions

In summary, the addition of the D70mm MT Remote Coil does not change the intended use and indications for use for the Rapid2 Therapy System, nor does it change the technological characteristics and principles of operation, including basic design, mechanism of action, specifications and treatment procedure. The addition of the optional D70mm MT Remote Coil raises no new issues of safety and effectiveness. Performance data demonstrate that the Rapid2 Therapy System is as safe and effective as the predicate.

Thus, the Rapid2 Therapy System, with the addition of the D70mm MT Remote Coil, is substantially equivalent to the predicate device.