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 w/MagPro R20 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 w/MagPro R20 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 w/MagPro R20 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 Mag Vita TMS therapy w/MagPro R20 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 .
- o Coil MCF-B65
- Marking apparatus for locating treatment area
  - Marking plate for Coil MCF-B65 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

AI/ML Overview

This document is a 510(k) Summary for the MagVita TMS Therapy w/MagPro R20 device, comparing it to a predicate device, the MagVita TMS Therapy System (K150641).

Based on the provided text, there is no acceptance criteria or study outlined to prove the device meets acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device. This means the manufacturer is asserting the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria and a specific study proving it are not present in this type of FDA submission. Here's what can be inferred or explicitly stated based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there are no explicit "acceptance criteria" presented in the document in the format of a performance study with defined thresholds. The document instead presents a comparison of the new device's performance characteristics to those of the predicate device to demonstrate substantial equivalence.

Characteristic	MagVita TMS Therapy w/MagPro R20 (New Device)	MagVita TMS Therapy System (Predicate Device) (K150641)	Comparison Outcome (Implicit Acceptance)
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.	Treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.	Identical
Waveforms	Biphasic	Biphasic	Identical
Frequency Range	0.1 - 20 pulses per second	0.1 - 30 pulses per second or 0.1 - 100 pulses per second, depending on model	Similar (within relevant therapeutic range)
Preset range of % MT	50% - 140%	0% - 140%	Similar (within relevant therapeutic range)
Recommended Standard Treatment Intensity	120% MT	120% MT	Identical
Repetition Rate	10 Hz	10 Hz	Identical
Train Duration	4 sec	4 sec	Identical
Interval between pulses	26 sec	26 sec	Identical
Number of pulses/session	3000	3000	Identical
Output Stimulation Parameters (SMT units)	Available Stimulation Amplitude in Standard Motor Threshold (SMT) units	Available Stimulation Amplitude in Standard Motor Threshold (SMT) units	Identical concept
Amplitude Range	0 - 1.2 SMT	0 - 1.7 SMT	Similar (within relevant therapeutic range)
Pulse Width	290 µs (±5%), Biphasic sinusoid waveform	290 µs (±5%), Biphasic sinusoid waveform	Identical
Coil Configuration	Figure-of-eight coil, Air core	Figure-of-eight coil, Air core	Identical
Cooling	Liquid cooling	Forced liquid cooling	Similar (both involve liquid cooling)
Standards Met	ISO 13485:2012, IEC60601-1, IEC60601-1-2	ISO 13485:2012, IEC60601-1, IEC60601-1-1, IEC60601-1-2	Similar (compliance with key safety and quality standards)

Implicit Acceptance Criteria: The device is "accepted" if it is shown to be substantially equivalent to the predicate device, meaning its differences do not raise new questions of safety or effectiveness. The document asserts that "all other identified differences between the two systems are minor and without any known impact on safety or efficacy."

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical study with a "test set" in the context of diagnostic accuracy, image interpretation, or treatment efficacy data from the new device. The data presented is a technical comparison of device specifications.

The "non-clinical performance data" section refers to previous FDA clearances for components (K160280 for MagPro R20, K150641 for chair/arm/etc., K071821 for Coil MCF-B65). This indicates that the safety and performance of individual components were evaluated and cleared through separate processes, but it does not represent a specific "test set" for the entire integrated system in a clinical performance study.

Data Provenance: The technical specifications are derived from the device's design and engineering. Any clinical data implicitly relied upon would be from trials that supported the original predicate device's clearance and the understanding of rTMS efficacy for Major Depressive Disorder, not new data for this specific 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not a study requiring expert-established ground truth. The comparison is based on technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" or adjudication process described for diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document does not present an MRMC comparative effectiveness study. The submission is for substantial equivalence based on technical and functional comparison to a predicate device. The device is a therapeutic electromagnetic stimulator, not an imaging or diagnostic device typically subject to MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a therapeutic system with human interaction. While it includes software, it is not an "algorithm only" device in the sense of AI for diagnostic interpretation.

7. The Type of Ground Truth Used

Not applicable in the context of a "ground truth" for a diagnostic or AI performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the existing predicate device and the recognized scientific understanding of repetitive transcranial magnetic stimulation (rTMS) for Major Depressive Disorder as supported by clinical evidence for that class of devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm that undergoes a training phase with a labeled dataset in the typical sense. It is a hardware and software system for delivering a physical therapy.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 1, 2017

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

Re: K170114

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: March 31, 2017 Received: April 3, 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 (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,

William J.

Heetderks -S

Digitally signed by William J. Heetderks -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -S
Date: 2017.05.01 13:08:06 -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) K170114

Device Name

MagVita TMS Therapy System with MagPro R20

Indications for Use (Describe)

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

☐ Exported and/or Identified in CITES Article 2, Section 2(a)
☐ Live, To a country outside the U.S.

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:	January 9, 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 Device:	MagVita TMS Therapy System (K150641)21 CFR 882.5805, Repetitive Transcranial MagneticStimulationProduct code: OBPDevice Class: II
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 .
- o Coil MCF-B65
- Marking apparatus for locating treatment area
  - Marking plate for Coil MCF-B65 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

Intended Use/Indication for Use:

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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 w/MagPro R20 has been tested and complies with the following standards

ISO13485:2012 •
IEC60601-1 .
IEC60601-1-2 .

Non-Clinical performance data:

The non-clinical performance testing of the components of the Mag Vita TMS Therapy w/MagPro R20 has been tested as required, and cleared by the FDA earlier in: K160280: MagPro R20 K150641: Chair, flexible arm, vacuum pump and pillow, isolation transformer, marking accessories and caps K071821: Coil MCF-B65.

Substantial equivalence:

The MagVita TMS Therapy w/MagPro R20 is substantially equivalent to the predicate device (MagVita TMS Therapy System). The MagVita TMS Therapy w/MagPro R20 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 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 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. Also the magnetic field/pulses for both devices are identical. Both the MagVita TMS Therapy w/MagPro R20 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 Therapyw/MagPro R20	MagVita TMS Therapy System(K150641)
Performance	Waveforms: BiphasicFrequency: 0.1 -20 pulses persecond.	Waveforms: Biphasic.Frequency: 0.1 -30 pulses persecond or 0.1 -100 pulses persecond, depending on model
	Preset range of % MT: 50%-140%	Preset range of % MT: 0% -140%
	Recommended standard treatment:Stimulation Intensity: 120% MT(MT=Motor Threshold intensity)	Recommended standard treatment:Stimulation Intensity: 120% MT(MT=Motor Threshold intensity)
	Repetition rate: 10 Hz	Repetition rate: 10 Hz
	Train duration: 4 sec	Train duration: 4 sec
	Interval between pulses: 26 sec	Interval between pulses: 26 sec
	Numbers of pulses/session: 3000	Numbers of pulses/ session: 3000
	Output Stimulation Parameters:Available Stimulation Amplitudein Standard Motor Threshold(SMT) units	Output Stimulation Parameters:Available Stimulation Amplitudein Standard Motor Threshold(SMT) units
	Amplitude Range: 0 - 1.2 SMT	Amplitude Range: 0 - 1.7 SMT
	Pulse width:290 μs (±5%), Biphasic sinusoidwaveform.	Pulse width:290 μs (±5%), Biphasic sinusoidwaveform.
	Frequency Range:0.1-20 pps (±2%)	Frequency Range:0.1-30 pps (±2%) or 0.1-100 pps,depending on model
Coil	Figure-of-eight coilAir core	Figure-of-eight coilAir core
Configuration
Cooling	Liquid cooling	Forced liquid cooling
Standards	Company complies with ISO13485:2012	Company complies with ISO13485:2012.
met
Electrical	Complies with IEC60601-1 andIEC60601-1-2	Complies with IEC60601-1,IEC60601-1-1 and IEC60601-1-2
safety

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 summary of the comparison, demonstrates and supports the substantial equivalency of the MagVita TMS Therapy w/MagPro R20 to the MagVita 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 w/MagPro R20 and the predicate device MagVita TMS Therapy System.

The transducer design (figure-of-eight) are equivalent and the realized magnetic properties of the coils used in the MagVita TMS Therapy w/MagPro R20 and the predicate system are substantial equivalent for the two coils.

The reliability of the positioning method used by the MagVita TMS Therapy w/MagPro R20 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 MagVita TMS Therapy w/MagPro R20 is as effective as the method employed by the predicate device, as they are identical.

The MagVita TMS Therapy w/MagPro R20 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.