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K Number
K172667
Device Name
MagVita TMS Therapy w/MagPro R20
Manufacturer
Tonica Elektronik A/S
Date Cleared
2017-10-05

(30 days)

Product Code
OBP
Regulation Number
882.5805
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MagVita TMS Therapy - w/MagPro R20 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 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 Mag Vita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC). The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components: - MagPro Stimulator and Trolley . - Coils for MT determination and Depression Treatment . - Marking apparatus for locating treatment area - Patient head fixation . - Isolation Transformer . The difference between the cleared MagVita TMS Therapy w/MagPro R20 and the modified MagVita TMS Therapy w/MagPro R20 (this submission) is the replacement of the two MCF-B65 coils with one MCF-B70 coil.
More Information

K170114

K170114

No
The description focuses on the electromechanical and magnetic stimulation aspects of the device, with no mention of AI or ML in the device description, intended use, or performance studies.

Yes
The device is indicated for the "treatment of Major Depressive Disorder," which explicitly states a therapeutic purpose for a medical condition.

No

The device is indicated for the treatment of Major Depressive Disorder, and its description details a therapeutic mechanism (non-invasive magnetic fields to induce electrical currents for modulation of cortical excitability), not a diagnostic one.

No

The device description explicitly states it is a "computerized, electromechanical medical device" and lists several hardware components (Stimulator, Trolley, Coils, Marking apparatus, Patient head fixation, Isolation Transformer). While it is computerized, it is not solely software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The MagVita TMS Therapy System is described as a device that produces and delivers magnetic fields to induce electrical currents in the brain. It directly interacts with the patient's body.
  • Intended Use: The intended use is for the treatment of Major Depressive Disorder, not for the diagnosis or analysis of specimens.
  • Mechanism of Action: The device works by stimulating brain tissue, not by analyzing biological samples.

Therefore, the MagVita TMS Therapy System is a therapeutic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The MagVita TMS Therapy - w/MagPro R20 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.

Product codes

OBP

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 Mag Vita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:

  • MagPro Stimulator and Trolley .
    • MagPro R20 o
    • Trolley with holding arrangements o
  • Coils for MT determination and Depression Treatment .
    • Coil MCF-B70 o
  • . Marking apparatus for locating treatment area
    • Marking plate for Coil MCF-B70 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
  • Isolation Transformer .

The difference between the cleared MagVita TMS Therapy w/MagPro R20 and the modified MagVita TMS Therapy w/MagPro R20 (this submission) is the replacement of the two MCF-B65 coils with one MCF-B70 coil.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

left dorsolateral prefrontal cortex (DLPFC)

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 K170114. These tests demonstrate that the MagVita TMS Therapy System is safe and effective for use in treatment of Major Depressive Disorder.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170114

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

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

October 5, 2017

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

Re: K172667

Trade/Device Name: MagVita TMS Therapy w/MagPro R20 Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: August 30, 2017 Received: September 5, 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 (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 2017.10.05 13:52:32 -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) K172667

Device Name MagVita TMS Therapy w/MagPro R20

Indications for Use (Describe)

The MagVita TMS Therapy - w/MagPro R20 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.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary

Submitter's Information

| Name of 510(k) owner: | Tonica Elektronik A/S
Lucernemarken 15
DK-3520 Farum, Denmark | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Phone: | +45 4499 8444 | |
| Fax: | +45 4499 1544 | |
| Contact person: | Lise Terkelsen
Email: lise.terkelsen@tonica.dk | |
| Preparation date: | August 30, 2017 | |
| Trade name: | MagVita TMS Therapy w/MagPro R20 | |
| Common name: | Transcranial Magnetic Stimulator | |
| Classification name: | Repetitive Transcranial Magnetic Stimulator for treatment of
Major Depressive Disorder [21 CFR 882.5805, Product Code
OBP] | |
| Classification: | Class II Medical Device | |
| Predicate Devices: | MagVita TMS Therapy w/MagPro R20, K170114 | |
| Special Controls: | The 510k submission addressed the special controls required
by regulation and specified in the FDA guidance document
titled "Class II Special Controls Guidance
Document: Repetitive Transcranial Magnetic Stimulation
(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 Mag Vita TMS therapy system is applied to the human brain on the left dorsolateral prefrontal cortex (DLPFC).

The MagVita TMS Therapy w/MagPro R20 is an integrated system consisting of the following components:

  • MagPro Stimulator and Trolley .
    • MagPro R20 o
    • Trolley with holding arrangements o
  • Coils for MT determination and Depression Treatment .
    • Coil MCF-B70 o
  • . Marking apparatus for locating treatment area
    • Marking plate for Coil MCF-B70 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
  • Isolation Transformer .

The Modification

The difference between the cleared MagVita TMS Therapy w/MagPro R20 and the modified MagVita TMS Therapy w/MagPro R20 (this submission) is the replacement of the two MCF-B65 coils with one MCF-B70 coil.

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 w/MagPro R20 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 Mag Vita TMS Therapy System has been tested as required, and cleared by the FDA earlier on K170114.

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 w/MagPro R20 is substantially equivalent to the predicate device (our own MagVita TMS Therapy w/MagPro R20 before the modification). The MagVita TMS Therapy w/MagPro R20 and the predicate device have identical intended use /indication for use, and the technological characteristics are similar such that they in our view can be considered equivalent.

The MagVita TMS Therapy w/MagPro R20 and the predicate device are both 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 w/MagPro R20 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 and the predicate device 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 identical.

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| Criteria | MagVita TMS Therapy
w/MagPro R20 modification | MagVita TMS Therapy
w/MagPro R20
K170114 | Conclusion |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Performance | Waveforms: Biphasic
Frequency: 0.1 -20 pulses per
second. | Waveforms: Biphasic
Frequency: 0.1 -20 pulses per
second. | Identical |
| | Preset range of % MT: 50%-140%
Recommended standard treatment:
Stimulation Intensity: 120% MT
(MT=Motor Threshold intensity)
Repetition rate: 10 Hz
Train duration: 4 sec
Interval between pulses: 26 sec
Numbers of pulses/session: 3000
Output Stimulation Parameters:
Available Stimulation Amplitude
in Standard Motor Threshold
(SMT) units
Amplitude Range: 0 - 1.2 SMT | Preset range of % MT: 50%-140%
Recommended standard treatment:
Stimulation Intensity: 120% MT
(MT=Motor Threshold intensity)
Repetition rate: 10 Hz
Train duration: 4 sec
Interval between pulses: 26 sec
Numbers of pulses/session: 3000
Output Stimulation Parameters:
Available Stimulation Amplitude in
Standard Motor Threshold (SMT)
units
Amplitude Range: 0 - 1.2 SMT | Identical |
| | Pulse width:
290 $\mu$ s (±5%), Biphasic sinusoid
waveform. | Pulse width:
290 $\mu$ s (±5%), Biphasic sinusoid
waveform. | |
| | Frequency Range:
0.1-20 pps (±2%) | Frequency Range:
0.1-20 pps (±2%) | |
| Coil
Configuration
Cooling | Figure-of-eight coil
Coil MCF-B70
Liquid cooling | Figure-of-eight coil
Coil MCF-B65
Liquid cooling | Substantial equivalence
of magnetic field
properties is
documented in
Appendix A enclosed
in section 12. |
| Design | The system consists of:

  1. Mobile console
  2. System software with GUI
  3. Coil positioning system
  4. Coil for MT and coil for
    treatment
  5. Coil Fixture
  6. Treatment chair
  7. Head support system | The system consists of:
  8. Mobile console
  9. System software with GUI
  10. Coil positioning system
  11. Coil for MT and coil for
    treatment
  12. Coil Fixture
  13. Treatment chair
  14. Head support system | |
    | Standards met | Company complies with ISO
    13485:2012. | Company complies with ISO
    13485:2012 | Identical |
    | Electrical
    safety | Complies with IEC60601-1,
    IEC60601-1-1 and IEC60601-1-2. | Complies with IEC60601-1,
    IEC60601-1-1 and IEC60601-1-2. | Identical |

Characteristics of the Device as Compared to Predicate Device

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Conclusion:

The SE comparison as documented in the Substantial Equivalence section together with the Appendix 1 regarding the coil properties demonstrates and supports the substantial equivalency of the modified MagVita TMS Therapy w/MagPro R20 to our own notmodified MagVita TMS Therapy w/MagPro R20.

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 modified MagVita TMS Therapy w/MagPro R20 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 MagVita TMS Therapy w/MagPro R20 does not introduce any new safety considerations in comparison to the predicate device.