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 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 as effective as the predicate device 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).

The MagVita TMS Therapy System is an integrated system consisting of the following components:

MagPro Stimulator and Trolley
Coil for MT determination
Marking apparatus for locating treatment area
Patient head fixation
Coil for Depression Treatment
Isolation Transformer

AI/ML Overview

The provided text is a 510(k) summary for the MagVita TMS Therapy System. It states that the device is substantially equivalent to a predicate device (NeuroStar TMS Therapy System) and therefore does not require new acceptance criteria or a new study to prove its efficacy. Instead, it relies on the established safety and effectiveness of the predicate device.

Therefore, the document does not contain the specific information requested about acceptance criteria and a new study proving the device meets those criteria for the MagVita TMS Therapy System itself. It instead focuses on demonstrating substantial equivalence to a previously cleared device.

However, I can extract information related to the comparison of the two devices and their intended use, which might indirectly address some of your points as they relate to the predicate device's established performance.

Here's an analysis based on the provided text, extrapolated to address your request where possible, but with the critical caveat that this document does not present de novo acceptance criteria or a new study for the MagVita TMS Therapy System.

1. Table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission, there are no new acceptance criteria defined in this document for the MagVita TMS Therapy System. Instead, the performance is compared to the predicate device, aiming to show similar or equivalent performance parameters.

Parameter	MagVita TMS Therapy System Performance (Reported for comparison)	NeuroStar TMS Therapy System Performance (Predicate)
Waveforms	Biphasic	Biphasic
Frequency	0.1 - 30 pulses per second or 0.1 - 100 pulses, depending on model	0.1 - 30 pulses per second
Preset range of % MT	0% - 140%	80% - 140%
Recommended standard treatment: Stimulation Intensity	120% MT	120% MT
Recommended standard treatment: Repetition rate	10 Hz	10 Hz
Recommended standard treatment: Train duration	4 sec	4 sec
Recommended standard treatment: Interval between pulses	26 sec	26 sec
Recommended standard treatment: Numbers of pulses/session	3000	3000
Output Stimulation Parameters: Amplitude Range	0 - 1.7 SMT	0.22 - 1.6 SMT
Output Stimulation Parameters: Pulse width	290 $\mu$s (±5%), Biphasic sinusoid waveform	185 $\mu$s (±10%), Biphasic sinusoid waveform
Output Stimulation Parameters: Frequency Range	0.1-30 pps (±2%) or 0.1-100 pps, depending on model	0.1-30 pps (±2%)
Coil Configuration	Figure-of-eight coil, Air core	Figure-of-eight coil, Ferromagnetic core
Cooling	Liquid cooling	Ferrofluidic cooling

2. Sample size used for the test set and the data provenance:

The document states that "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 K061645, K071821 and K091940." It further mentions that "These tests along with the supportive clinical information from the predicate device demonstrate that the MagVita TMS Therapy System is as safe and effective as the predicate device."

This implies that no new clinical study (test set) for the MagVita TMS Therapy System's efficacy in treating Major Depressive Disorder was conducted for this 510(k) submission. The submission relies on the existing clinical data and regulatory clearance of the predicate device (NeuroStar TMS Therapy System) and previous clearances of MagVita TMS Therapy System components. Therefore, information about sample size, country of origin, and retrospective/prospective nature for a new test set for efficacy is not present in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no new clinical efficacy test set was conducted for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable, as no new clinical efficacy test set was conducted for this 510(k) submission.

5. 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. This device is a Transcranial Magnetic Stimulator, not an AI-powered diagnostic imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a therapeutic device, not an algorithm. Its performance is measured directly by its physical output (magnetic fields) and its therapeutic effect, which is established by clinical trials for the predicate device.

7. The type of ground truth used:

For the predicate device, the ground truth for its efficacy would have been established through clinical trials, likely involving patient outcomes data (e.g., reduction in depression symptom scores as measured by standardized clinical scales) and expert consensus from diagnosing clinicians. This document specifically states the indication for the predicate (and thus the new device) is for "treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode," implying that clinical improvement in depressive symptoms is the primary measure of efficacy.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device. The "training set" for a medical device's performance would refer to the data used to validate its design and manufacturing. The document refers to non-clinical performance testing and previous clearances of components (K061645, K071821, K091940), which would have involved their own testing samples.

9. How the ground truth for the training set was established:

Not applicable for a "training set" in the AI sense. For the non-clinical performance testing mentioned, the "ground truth" would be established by predefined engineering and safety specifications and measurements (e.g., magnetic field strength, pulse width accuracy, frequency control).

Summary

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

July 31, 2015

Tonica Elektronik A/S Lise Terkelsen Regulatory Affairs/ Quality Assurance Specialist Lucernemarken 15 DK-3520 Farum, Denmark

Re: K150641

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: March 10, 2015 Received: March 13, 2015

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 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 (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 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 yours,

Carlos L. Pena -SD/△

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) K150641

Device Name MagVita TMS Therapy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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/SLucernemarken 15DK-3520 Farum, Denmark
Phone:	+45 4499 8444
Fax:	+45 4499 1544
Contact person:	Lise TerkelsenEmail: lise.terkelsen@tonica.dk
Preparation date:	July 24, 2015
Trade name:	MagVita TMS Therapy System
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 Device:	NeuroStar TMS Therapy Systems (K083538, K133408)21 CFR 882.5805, Repetitive Transcranial MagneticStimulationProduct code: OBPDevice Class: II

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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 System is an integrated system consisting of the following components:

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

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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 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 K061645, K071821 and K091940.

These tests along with the supportive clinical information from the predicate device demonstrate that the MagVita TMS Therapy System is as safe and effective as the predicate device for use in treatment of Major Depressive Disorder.

Substantial equivalence:

The MagVita TMS Therapy System is substantially equivalent to the predicate device (Neurostar TMS Therapy® System). The MagVita TMS Therapy System and the predicate device 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 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 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 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 essentially the same.

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Area	MagVita TMS Therapy System	NeuroStar TMS Therapy SystemNeuronetics Inc. (K083538,K133408)
Performance	Waveforms: Biphasic.Frequency: 0.1 -30 pulses persecond or 0.1 -100 pulses,depending on modelPreset range of % MT: 0% -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 - 1.7 SMTPulse width:290 $\mu$ s (±5%), Biphasic sinusoidwaveform.Frequency Range:0.1-30 pps (±2%) or 0.1-100 pps,depending on model	Waveforms: BiphasicFrequency: 0.1 -30 pulses persecond.Preset range of % MT: 80% -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: 0.22 - 1.6 SMTPulse width:185 $\mu$ s (±10%), Biphasic sinusoidwaveform.Frequency Range:0.1-30 pps (±2%)
CoilConfiguration	Figure-of-eight coilAir core	Figure-of-eight coilFerromagnetic core
Cooling	Liquid cooling	Ferrofluidic cooling
Standardsmet	Company complies with ISO13485:2012.	Company complies with ISO13485:2003
Electricalsafety	Complies with IEC60601-1,IEC60601-1-1 and IEC60601-1-2	Complies with UL60601-1 andUL60601-1-2

Characteristics of the Device as Compared to Predicate Device*

*For a more comprehensive comparison of devices please refer to section 12 Substantial Equivalence Comparison

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Conclusion:

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

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

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 device. 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 device.

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

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

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.