MagVita TMS Therapy System

K171481 · Tonica Elektronik A/S · OBP · Jun 16, 2017 · Neurology

Device Facts

• Record ID: K171481
• Device Name: MagVita TMS Therapy System
• Applicant: Tonica Elektronik A/S
• Product Code: OBP · Neurology
• Decision Date: Jun 16, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Device Story

MagVita TMS Therapy System is a computerized, electromechanical device delivering non-invasive magnetic fields to induce electrical currents in the cerebral cortex. System components include a MagPro stimulator, trolley, figure-of-eight cooling coil (Cool-B65), patient chair, vacuum pillow, and articulated arm. Operation involves charging a capacitor and discharging it through the coil to generate rapid magnetic field changes, inducing neuronal excitation. Used in clinical settings by trained operators to treat the left dorsolateral prefrontal cortex (DLPFC). The device modulates cortical excitability via repetitive 10Hz pulse trains. The modification allows adjustable inter-train intervals (11-26 seconds), reducing treatment time to 18.8 minutes. Healthcare providers use the system to deliver standardized stimulation protocols (120% motor threshold intensity) to improve depressive symptoms in patients resistant to medication.

Clinical Evidence

Bench testing only. The submission relies on non-clinical performance data previously cleared under K091940 and K150641, demonstrating compliance with ISO 13485, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Electromechanical TMS system; figure-of-eight air-core coil with liquid cooling; biphasic waveform; 10Hz stimulation frequency; 120% motor threshold intensity. Complies with ISO 13485:2012, IEC 60601-1, and IEC 60601-1-2. System includes stimulator, trolley, articulated arm, and patient fixation (vacuum pillow).

Indications for Use

Indicated for adult patients with Major Depressive Disorder who have failed to receive 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

• Neurostar TMS Therapy System (K160703)
• MagVita TMS Therapy System (K150641)

Submission Summary (Full Text)

{0}------------------------------------------------

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

June 16, 2017

Tonica Elektronik A/S Lise Terkelsen QA/RA Manager Lucernemarken 15 Farum, 3520 Dk

Re: K171481

Trade/Device Name: MagVita TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: May 17, 2017 Received: May 19, 2017

Dear Lise Terkelsen:

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 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 2017.06.16 12:07:00 -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}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171481

Device Name MagVita TMS Therapy System

Indications for Use (Describe)

The Mag Vita TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to recieve 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) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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

## Submitter's Information

| Name of 510(k) owner: | Tonica Elektronik A/S<br>Lucernemarken 15<br>DK-3520 Farum, Denmark | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Phone: | [phone] | | |
| Fax: | [phone] | | |
| Contact person: | Lise Terkelsen<br>Email: [e-mail] | | |
| Preparation date: | May 15, 2017 | | |
| Trade name: | MagVita TMS Therapy System | | |
| Common name: | Transcranial Magnetic Stimulator | | |
| Classification name: | Repetitive Transcranial Magnetic Stimulator for treatment of<br>Major Depressive Disorder [21 CFR 882.5805, Product Code<br>OBP] | | |
| Classification: | Class II Medical Device | | |
| Predicate Devices: | Neurostar TMS Therapy System, K160703<br>MagVita TMS Therapy System, K150641 | | |
| Special Controls: | The 510k submission addressed the special controls required<br>by regulation and specified in the FDA guidance document<br>titled "Class II Special Controls Guidance<br>Document: Repetitive Transcranial Magnetic Stimulation<br>(rTMS) Systems | | |

{4}------------------------------------------------

## Device description

The MagVita TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents directed at regions of the cerebral cortex. The Mag Vita TMS Therapy System is indicated for

### Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode

Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons.

In the MagVita TMS therapy system TMS pulses are applied repetitively at a frequency of 10Hz. Such stimulation has been shown to be effective in modulating cortical excitability. The observed and documented increase in cortical excitability after high frequency (10Hz) repetitive transcranial magnetic stimulation has been shown to persist beyond the duration of the train of stimulation. Repetitive Magnetic stimulation with the MagVita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

- MagPro Stimulator and Trolley .
- MagPro family o
- Trolley with holding arrangements o
- Coil for MT determination .
- Coil C-B60 o
- Marking apparatus for locating treatment area .
- Marking plate for Coil C-B60 o
- Pen for marking. Cap, Ruler o
- Patient head fixation .
- Treatment Chair o
- Vacuum Pump and Vacuum pillow o
- Super Flexible Arm mounted on the trolley o
- Coil for Depression Treatment .
- Coil Cool-B65 with Coil Cooler unit o
- Isolation Transformer •

{5}------------------------------------------------

### Intended Use/Indication for Use:

Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

#### Standards:

The MagVita TMS Therapy System has been tested and complies with the following standards

- ISO 13485:2012 .
- IEC60601-1 •
- IEC60601-1-1 .
- IEC60601-1-2 .

#### Non-Clinical performance data:

The non-clinical performance testing of the components of the Mag Vita TMS Therapy System has been tested as required, and cleared by the FDA earlier on K091940 and K150641.

These tests demonstrate that the Mag Vita TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder.

#### Substantial equivalence:

The MagVita TMS Therapy System is substantially equivalent to the predicate devices (our own MagVita TMS Therapy System and Neurostar TMS). The MagVita TMS Therapy System and the predicate devices have identical intended use /indication for use, and technological characteristics. The principles of operation, the output stimulation parameters and the materials are equivalent to the predicates. The modification to the device allows a range of inter-train intervals from 11 to 26 seconds, rather than the fixed 26 second duration, which will allow a reduction in treatment time from 37.5 minutes to a minimum of 18.8 minutes.

The MagVita TMS Therapy System and the predicate devices are all indicated for

## Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Design of the MagVita TMS Therapy System is similar to the predicate device as both systems apply Transcranial Magnetic Stimulation as repetitive pulse trains at 10Hz delivered as brief rapidly alternating magnetic fields to induce electrical currents over the prefrontal cortex.

Both the MagVita TMS Therapy System and the predicate devices have the same components consisting of TMS stimulator with software, electromagnetic coil and an articulated arm for positioning of the treatment coil. The operational procedures including system setup, patient preparations, motor threshold determination, coil

{6}------------------------------------------------

positioning and treatment with predefined treatment stimulation parameters are essentially the same.

| Criteria | MagVita TMS Therapy<br>System | MagVita TMS Therapy<br>System (K150641) | NeuroStar TMS Therapy<br>System (K160703) | |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Performance | Waveforms: Biphasic.<br>Frequency: 0.1 -30 pulses per<br>second or 0.1 -100 pulses,<br>depending on model | Waveforms: Biphasic.<br>Frequency: 0.1 -30 pulses per<br>second or 0.1 -100 pulses,<br>depending on model | Waveforms: Biphasic<br>Frequency: 0.1 -30 pulses per<br>second. | |
| | Recommended standard<br>treatment:<br>Stimulation Intensity: 120% MT<br>Repetition rate:10 Hz<br>Train duration: 4 sec<br>Inter-train interval: 11-26 sec<br>Pulses/session: 3000<br>Treatment duration: 18.8 min. | Recommended standard<br>treatment:<br>Stimulation Intensity: 120% MT<br>Repetition rate: 10 Hz<br>Train duration: 4 sec<br>Inter-train interval: 26 sec<br>Pulses/session: 3000<br>Treatment duration: 37 min. | Recommended standard<br>treatment:<br>Stimulation Intensity: 120% MT<br>Repetition rate: 10 Hz<br>Train duration: 4 sec<br>Inter-train interval: 11-26 sec<br>Pulses/session: 3000<br>Treatment duration: 18.8 min. | |
| | Output Stimulation Parameters:<br>Amplitude in Standard Motor<br>Threshold (SMT) units :<br>0 - 1.7 | Output Stimulation Parameters:<br>Amplitude in Standard Motor<br>Threshold (SMT) units:<br>0 - 1.7 | Output Stimulation Parameters:<br>Amplitude in Standard Motor<br>Threshold (SMT) units:<br>0.22 - 1.6 | |
| | Pulse width:<br>290 μs, Biphasic sinusoid<br>waveform. | Pulse width:<br>290 μs, Biphasic sinusoid<br>waveform. | Pulse width:<br>185 μs (±10%), Biphasic<br>sinusoid waveform.. | |
| | Frequency Range:<br>0.1-30 pps or 0.1-100 pps,<br>depending on model | Frequency Range:<br>0.1-30 pps or 0.1-100 pps,<br>depending on model | Frequency Range:<br>0.1-30 pps | |
| | Coil<br>Configuration | Figure-of-eight coil<br>Air core | Figure-of-eight coil<br>Air core | Figure-of-eight coil<br>Ferromagnetic core |
| | Cooling | Liquid cooling | Liquid cooling | Ferrofluidic cooling |
| | Standards met | Company complies with ISO<br>13485:2012. | Company complies with ISO<br>13485:2012 | Company complies with ISO<br>13485:2003 |
| | Electrical safety | Complies with IEC60601-1 3rd<br>edition, and IEC60601-1-2. | Complies with IEC60601-1 3rd<br>edition, and IEC60601-1-2. | Complies with IEC60601-1 and<br>IEC60601-1-2. |

#### Characteristics of the Device as Compared to Predicate Devices

## Conclusion:

The above comparison, demonstrates and supports the substantial equivalency of the MagVita TMS Therapy System to our own MagVita TMS Therapy System and the NeuroStar TMS Therapy System.

The indication for use, the target population, the dosage, the treatment procedure, the treatment position and all relevant protocol parameters (intensity, repetition rate, number of pulses in a train, numbers of trains, number of treatment sessions) are identical for the MagVita TMS Therapy System and the predicate devices.

{7}------------------------------------------------

The transducer design (figure-of-eight) are equivalent and the realized magnetic properties of the MagVita TMS Therapy System and the predicate devices are substantial equivalent.

The reliability of the positioning method used by the MagVita TMS Therapy System is, based on the direct relationship of the underlying cortical brain anatomy to the patient's scalp, as is the method used in the predicate devices. The method for identifying the correct treatment position in the Mag Vita TMS Therapy System is at least as effective as the method employed by the predicate devices.

On the basis of the only modification of the treatment parameter, the MagVita TMS Therapy System does not introduce any new safety considerations in comparison to the predicate devices

All other identified differences between the three systems are minor and without impact on safety or efficacy.