MagVita TMS Therapy System

K171967 · Tonica Elektronik A/S · OBP · Jul 25, 2017 · Neurology

Device Facts

• Record ID: K171967
• Device Name: MagVita TMS Therapy System
• Applicant: Tonica Elektronik A/S
• Product Code: OBP · Neurology
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5805
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mag Vita TMS Therapy System is indicated for the 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

Computerized, electromechanical device delivering non-invasive magnetic fields to induce electrical currents in cerebral cortex; operates via Faraday's law using capacitor-driven stimulating coil. System includes MagPro stimulator, trolley, flexible arm, and figure-of-eight coils. Used in clinical settings by trained operators to treat Major Depressive Disorder. Repetitive pulses (10Hz) modulate cortical excitability in left dorsolateral prefrontal cortex (DLPFC). Output consists of magnetic pulse trains; healthcare providers use system to deliver standardized stimulation protocols (120% motor threshold intensity, 3000 pulses/session). Benefits include non-invasive treatment for medication-resistant depression.

Clinical Evidence

No clinical data; substantial equivalence is supported by bench testing and comparison of technological characteristics to previously cleared predicates.

Technological Characteristics

Figure-of-eight electromagnetic coil; air core; liquid cooling. System includes mobile console, GUI software, coil positioning arm, and isolation transformer. Complies with ISO 13485:2012, IEC 60601-1, and IEC 60601-1-2. Biphasic sinusoid waveform; pulse width 290 µs; frequency 0.1-100 pps.

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

• MagVita TMS Therapy System (K150641)

Reference Devices

• Magstim Rapid2 Therapy System (K143531)
• Neurosoft TMS (K160309)

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 July 25, 2017

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

Re: K171967

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: June 26, 2017 Received: June 30, 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

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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 2017.07.25 13:06:39 -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

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## Indications for Use

510(k) Number (if known) K171967

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 who have failed to receive 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

## 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: | June 26, 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<br>21 CFR 882.5805, Product Code OBP | | |
| Classification: | Class II Medical Device | | |
| Predicate Devices: | MagVita TMS Therapy System, K150641 | | |

## Device description:

The Mag Vita 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 MagVita 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)

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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).

The MagVita TMS Therapy System consists of the following components:

- MagPro Stimulator , Trolley and Super Flexible Arm .
- MagPro family o
- Trolley with holding arrangements o
- Super Flexible Arm mounted on the trolley 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
- . Coil for Depression Treatment
- Coil Cool-B65 with Coil Cooler unit o
- . Isolation Transformer

The difference between the cleared MagVita TMS Therapy System and the modified MagVita TMS Therapy System (this submission) is the reduction of the accompanying accessories; the Treatment Chair, Vaccum pillow and pump are removed. The patient is still expected to be seated in a comfortable treatment chair with his head on a neck rest, but the user will use his existing available chair. It is not mandatory that the treatment chair in the cleared K150641 is chosen.

## 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
- IEC60601-1-2 .

## Non-Clinical performance data:

The non-clinical performance testing of the components of the MagVita TMS Therapy System has been tested as required and cleared by the FDA earlier on K091940 and K150641. These tests demonstrate that the MagVita 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 before the modification, Magstim Rapid2 Therapy System and Neurosoft TMS). The MagVita TMS Therapy System and the predicate devices

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have identical intended use /indication for use, and the technological characteristics are very similar such that they in our view can be considered equivalent.

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 Mag Vita TMS Therapy System is similar to the predicate device as all 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 positioning and treatment with predefined treatment stimulation parameters are essentially the same.

| Criteria | MagVita TMS Therapy System | MagVita TMS Therapy System K150641/171481 | Conclusion |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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 | Identical |
| | Recommended standard<br>treatment:<br>Stimulation Intensity: 120%<br>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: 19-37 min.<br>Sessions/week: 5<br>Treatment schedule: 5 daily<br>sessions for 6 weeks | 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: 19-37 min.<br>Sessions/week: 5<br>Treatment schedule: 5 daily<br>sessions for 6 weeks | Identical |
| | Output Stimulation Parameters:<br>Amplitude in Standard Motor<br>Threshold (SMT) units :<br>0 - 1.7<br>Pulse width:<br>290 µs, Biphasic sinusoid<br>waveform.<br>Frequency Range:<br>0.1-30 pps or 0.1-100 pps,<br>depending on model | Output Stimulation Parameters:<br>Amplitude in Standard Motor<br>Threshold (SMT) units :<br>0 – 1.7<br>Pulse width:<br>290 µs, Biphasic sinusoid<br>waveform.<br>Frequency Range:<br>0.1-30 pps or 0.1-100 pps,<br>depending on model | Identical |

## Characteristics of the Device as Compared to Predicate Device

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| Criteria | MagVita TMS Therapy<br>System | MagVita TMS Therapy System<br>K150641/171481 | Conclusion |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Coil<br>Configuration<br>Cooling<br>Design | Figure-of-eight coil<br>Air core<br>Liquid cooling<br>The system consists of:<br>1. Mobile console<br>2. System software with GUI<br>3. Coil positioning system<br>4. Coil for MT and coil for<br>treatment<br>5. Coil Fixture | Figure-of-eight coil<br>Air core<br>Liquid cooling<br>The system consists of:<br>1. Mobile console<br>2. System software with GUI<br>3. Coil positioning system<br>4. Coil for MT and coil for<br>treatment<br>5. Coil Fixture<br>6. Treatment chair<br>7. Head support system | Identical<br>Treatment chair and pillow are<br>not included in the modified<br>system. The MagVita TMS<br>Therapy System without a<br>treatment chair and head support<br>is identical to other predicates on<br>the market; K143531 of company<br>MagStim and K160309 of<br>company Neurosoft. Both thses<br>TMS Therapy systems require<br>that the user possesses a<br>treatment chair of their own and<br>describes in the user manual that<br>the patient must be seated<br>comfortable with the head fixed<br>before the treatment is initiated |
| Standards met | Company complies with ISO<br>13485:2012. | Company complies with ISO<br>13485:2012 | Identical |
| Electrical<br>safety | Complies with IEC60601-1,<br>IEC60601-1-1 and IEC60601-<br>1-2 | Complies with IEC60601-1,<br>IEC60601-1-1 and IEC60601-1-<br>2 | Identical |

# MagVita TMS Therapy System

## Conclusion:

The SE comparison as documented in the Substantial Equivalence section, demonstrates and supports the substantial equivalency of the modified MagVita TMS Therapy System to our own not-modified MagVita TMS Therapy System as well as the Neurosoft TMS and the Magstim Rapid? Therapy System, the two latter regarding the conditions of the treatment chair and head support.

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 device.

The transducer design (figure-of-eight) is equivalent and the realized magnetic properties of the MagVita TMS Therapy System and the predicate device are substantial equivalent for the treatment coils.

The positioning method used by the modified MagVita TMS Therapy System is identical to the cleared MagVIta TMS Therapy System.

The MagVita TMS Therapy System does not introduce any new safety considerations in comparison to the predicate devices.