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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (MagVita TMS Therapy w/MagPro R20) and does not describe a study involving an AI/algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested fields related to AI/algorithm performance and study design cannot be extracted.

The document primarily discusses the device's technical specifications and a comparison to an earlier version of the same device. The "performance" mentioned in the acceptance criteria refers to the physical output characteristics of the transcranial magnetic stimulation (TMS) device, not the performance of an AI algorithm in clinical tasks like diagnosis or image interpretation.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria (Predicate Device)	Reported Device Performance (Modified Device)	Conclusion
Performance	Waveforms: BiphasicFrequency: 0.1 - 20 pulses per second.Preset range of % MT: 50%-140%Recommended standard treatment: Stimulation Intensity: 120% MTRepetition rate: 10 HzTrain duration: 4 secInterval between pulses: 26 secNumbers of pulses/session: 3000Output Stimulation Parameters: Available Stimulation Amplitude in Standard Motor Threshold (SMT) unitsAmplitude Range: 0 - 1.2 SMT	Waveforms: BiphasicFrequency: 0.1 - 20 pulses per second.Preset range of % MT: 50%-140%Recommended standard treatment: Stimulation Intensity: 120% MTRepetition rate: 10 HzTrain duration: 4 secInterval between pulses: 26 secNumbers of pulses/session: 3000Output Stimulation Parameters: Available Stimulation Amplitude in Standard Motor Threshold (SMT) unitsAmplitude Range: 0 - 1.2 SMT	Identical
	Pulse width: 290 µs (±5%), Biphasic sinusoid waveform.	Pulse width: 290 µs (±5%), Biphasic sinusoid waveform.	(Identical implies within acceptance criteria)
	Frequency Range: 0.1-20 pps (±2%)	Frequency Range: 0.1-20 pps (±2%)	(Identical implies within acceptance criteria)
Coil Configuration & Cooling	Figure-of-eight coilCoil MCF-B65Liquid cooling	Figure-of-eight coilCoil MCF-B70Liquid cooling	Substantial equivalence of magnetic field properties is documented in Appendix A.
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: 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	(Implied identical for other components)
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

Study that proves the device meets the acceptance criteria:

The document describes a "Non-Clinical performance data" section, stating: "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."

For the modified device (this submission, K172667), the study primarily focused on demonstrating substantial equivalence to its predicate device (K170114), specifically concerning the change from the MCF-B65 coil to the MCF-B70 coil. The document indicates that "Substantial equivalence of magnetic field properties is documented in Appendix A enclosed in section 12." This suggests that the study involved comparative testing of the magnetic field properties of the new coil against the previous coil to ensure they are substantially equivalent.

Regarding AI/Algorithm-specific information:

Since this document pertains to a hardware medical device (Transcranial Magnetic Stimulator) and its modification, there is no mention of an AI/algorithm being tested or evaluated in this context. Therefore, the following points cannot be addressed from the provided text:

Sample size used for the test set and the data provenance: Not applicable, as no AI algorithm is being evaluated. The "test set" would refer to performance data for the physical device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For regulatory approval of a physical device, ground truth relates to meeting technical standards and functional performance specification. For substantial equivalence, it's about matching the predicate device's established safety and effectiveness.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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 (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

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Indications for Use

510(k) Number (if known) K172667

Device Name MagVita TMS Therapy w/MagPro R20

Indications for Use (Describe)

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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510(k) Summary

Submitter's Information

Name of 510(k) owner:	Tonica Elektronik A/SLucernemarken 15DK-3520 Farum, Denmark
Phone:	+45 4499 8444
Fax:	+45 4499 1544
Contact person:	Lise TerkelsenEmail: 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 ofMajor Depressive Disorder [21 CFR 882.5805, Product CodeOBP]
Classification:	Class II Medical Device
Predicate Devices:	MagVita TMS Therapy w/MagPro R20, K170114
Special Controls:	The 510k submission addressed the special controls requiredby regulation and specified in the FDA guidance documenttitled "Class II Special Controls GuidanceDocument: Repetitive Transcranial Magnetic Stimulation(rTMS) Systems

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Device description

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

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

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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 Therapyw/MagPro R20 modification	MagVita TMS Therapyw/MagPro R20K170114	Conclusion
Performance	Waveforms: BiphasicFrequency: 0.1 -20 pulses persecond.	Waveforms: BiphasicFrequency: 0.1 -20 pulses persecond.	Identical
	Preset range of % MT: 50%-140%Recommended standard treatment:Stimulation Intensity: 120% MT(MT=Motor Threshold intensity)Repetition rate: 10 HzTrain duration: 4 secInterval between pulses: 26 secNumbers of pulses/session: 3000Output Stimulation Parameters:Available Stimulation Amplitudein Standard Motor Threshold(SMT) unitsAmplitude 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 HzTrain duration: 4 secInterval between pulses: 26 secNumbers of pulses/session: 3000Output Stimulation Parameters:Available Stimulation Amplitude inStandard Motor Threshold (SMT)unitsAmplitude Range: 0 - 1.2 SMT	Identical
	Pulse width:290 $\mu$ s (±5%), Biphasic sinusoidwaveform.	Pulse width:290 $\mu$ s (±5%), Biphasic sinusoidwaveform.
	Frequency Range:0.1-20 pps (±2%)	Frequency Range:0.1-20 pps (±2%)
CoilConfigurationCooling	Figure-of-eight coilCoil MCF-B70Liquid cooling	Figure-of-eight coilCoil MCF-B65Liquid cooling	Substantial equivalenceof magnetic fieldproperties isdocumented inAppendix A enclosedin section 12.
Design	The system consists of:1. Mobile console2. System software with GUI3. Coil positioning system4. Coil for MT and coil fortreatment5. Coil Fixture6. Treatment chair7. Head support system	The system consists of:1. Mobile console2. System software with GUI3. Coil positioning system4. Coil for MT and coil fortreatment5. Coil Fixture6. Treatment chair7. Head support system
Standards met	Company complies with ISO13485:2012.	Company complies with ISO13485:2012	Identical
Electricalsafety	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.

Regulation Number and Section

§ 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.