The MEP Monitor is an accessory for the MagPro stimulators (MagPro R30, MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.

Device Description

The MEP Monitor is a small accessory device which is connected to the rear side of a MagPro magnetic stimulator. The MagPro magnetic stimulators are FDA cleared in K061645 and K091940. The device in this submission is not used alone but is connected to the MagPro stimulators on the rear side of either of the 4 cleared stimulators. The setup of the MEP Monitor is done in the MEP menu on the stimulator. The display on the stimulator shows a curve with the MEP response. The Motor Evoked Potential (MEP) Monitor is an optional component which allows the user to capture EMG signals and display them on the MagPro UI. Device with 1 channel input. Isolated input DIN-connector (Body Floating). Directly connected to the rear panel of the magnetic stimulator device. The MEP Monitor is designed to be used with surface electrodes only. Supports connections of standard electrode cables and surface electrodes.

AI/ML Overview

The provided text is a 510(k) summary for the MEP Monitor, a medical device accessory. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria through clinical or algorithmic testing.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in an AI/algorithm context, a specific study proving it meets those criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth for training was established.

This is a regulatory submission based on substantial equivalence, which means the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, rather than providing novel performance data against predefined acceptance criteria from a new study. The "Testing" section primarily refers to compliance with electrical safety and EMC standards, not clinical performance metrics for an AI/algorithm.

In summary, none of the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI-specific performance metrics is present in the provided text.

Summary

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

March 31, 2017

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

Re: K162873

Trade/Device Name: MEP Monitor Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: February 27, 2017 Received: March 1, 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 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,

Michael J. Hoffmann -S

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) K162873

Device Name MEP Monitor

Indications for Use (Describe)

The MEP Monitor is an accessory for the MagPro stimulators (MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.

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:Fax:	+45 4499 8444+45 4499 1544
Contact person:	Lise Terkelsen
Preparation date:	March 22, 2017
Trade name:	MEP Monitor
Common name:	MEP Monitor
Classification name:	Evoked Response Electrical Stimulator
Classification:	Class II Medical Device
Product Code:	GWF
Regulation number:	21 CFR 882.1870
Identification of predicate device:	MEP POD, Magstim Rapid2 in K051864,MagPro magnetic stimulators in K061645 /K091940

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Device description

The MEP Monitor is a small accessory device which is connected to the rear side of a MagPro magnetic stimulator. The MagPro magnetic stimulators are FDA cleared in K061645 and K091940.

The device in this submission is not used alone but is connected to the MagPro stimulators on the rear side of either of the 4 cleared stimulators.

The setup of the MEP Monitor is done in the MEP menu on the stimulator. The display on the stimulator shows a curve with the MEP response.

Indications for Use:

The MEP Monitor is an accessory for the MagPro stimulators (MagPro R30, MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.

Substantial Equivalence:

The MEP Monitor in this submission has the same characteristics as the predicate device, MEP Pod (K051864). The magnetic stimulators, to which the MEP Monitor is an accessory, have the same characteristics as the predicate stimulator and are substantial equivalent to this.

The MEP Monitor is CE-marked and complies with the Medical Device Directive 93/42/EEC. The MEP Monitor is developed and manufactured according to EN13485, "Medical devices - Quality management systems - Requirement for regulatory purposes".

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Area	New Device	Predicate Device	Conclusion
	MEP Monitoraccessory to MagPro Stimulators (K061645and K091940)Tonica Elektronik A/S	MEP POD (K051864)Included with Magstim Rapid2Magstim Company Ltd.
Indications foruse	MEP Monitor:The MEP Monitor is an accessory for the MagProstimulators (MagPro R30, MagPro R30 includingMagOption, MagPro X100, and MagPro X100 includingMagOption) and is intended to monitor evoked potentials.Magnetic Stimulator:The MagPro family is intended to be used formagnetic stimulation of peripheral nerves fordiagnostic purposes.	MEP Pod:The device will when connected to a stimulatormonitor the MEP response in peripheral nerves anddisplay this on the stimulator.Magnetic StimulatorThe Magstim Rapid2 magnetic nerve stimulatorsystems are intended for the stimulation of peripheralnerves.	Identical
Energy used	MEP Monitor:Power supported from the magnetic stimulatorMagnetic stimulator:Power Supply: 100-120V Mains.Pulses, max energy 280J	MEP Pod:Power supported from the magnetic stimulatorMagnetic stimulator:Power Supply: 115V Mains.Pulses, max energy 225J	MEP:Identical.Magnetic stimulator:Similar energy system used.Similar.
Mechanical data	MEP Monitor:Dimensions: (HxWxD:) 7.2 x 3.7 x 1.6 inWeight: 1.5 lbMagnetic stimulators:33 kg/72 lbs58 kg/128 lbs35 kg/ 77 lbs60 kg/ 132 lbs	MEP Pod:The MEP Pod has smaller dimensions than MEPMonitor.Magnetic stimulator:27 kg / 60 lbs	Differences are of no importance.
Design	MEP Monitor:The Motor Evoked Potential (MEP) Monitor is anoptional component which allows the user to captureEMG signals and display them on the MagPro UI.Device with 1 channel input.Isolated input DIN-connector (Body Floating).Directly connected to the rear panel of the magneticstimulator device	MEP Pod:The Motor Evoked Potential (MEP) Pod is an optionalcomponent which allows the user to capture EMGsignals and display them on the Magstim Rapid2 UI.Device with 2 channel input.Isolated input connectors (Body Floating).Connected via a long cable to the magnetic stimulatordevice	MEP:Identical.MEP Monitor has only 1 channel.
Area	New Device	Predicate Device	Conclusion
	MEP Monitoraccessory to MagPro Stimulators (K061645and K091940)Tonica Elektronik A/S	MEP POD (K051864)Included with Magstim Rapid2Magstim Company Ltd.
	The MEP Monitor is designed to be used with surfaceelectrodes only.Supports connections of standard electrode cables andsurface electrodes.	The MEP Pod is designed to be used with surfaceelectrodes only.Supports connections of standard electrode cables andsurface electrodes.
	Magnetic stimulator:Magnetic stimulation is equivalent to currentstimulation. The principle of magnetic stimulation isimplicit in Faraday's law, which describes that a time-varying magnetic field induces a current in aconductor (tissue). Application areas of magneticstimulation are a sub-set of the application areas forcurrent stimulation.The device consist of a unit comprising power supply,capacitor bank, high voltage electronics, controlelectronics and user interface (controls) with knobsand display on the front panel.User interface is menu-driven and computercontrolled.A magnetic coil is connected to the device to generatea magnetic field.	Magnetic stimulator:Magnetic stimulation is equivalent to currentstimulation. The principle of magnetic stimulation isimplicit in Faraday's law, which describes that a time-varying magnetic field induces a current in aconductor (tissue). Application areas of magneticstimulation are a sub-set of the application areas forcurrent stimulation.The device consist of a unit comprising power supply,capacitor bank, high voltage electronics, controlelectronics and user interface (controls) with knobsand a display with touch screen control.User interface is menu-driven and computercontrolled.A magnetic coil is connected to the device to generatea magnetic field.	Magnetic stimulator:Identical.The design of the devices is basically the same, with use of acapacitor bank and high voltage electronics to generate amagnetic field in a magnetic coil.
Performance	MEP Monitor:Time base max.: 100msSensitivity: 50μV/Div – 10mV/DivFilters: 1Hz-20kHzMagnetic stimulator:MagPro R30Waveforms: Biphasic.Single pulses, train pulses.Max. stim. Frequency: 30 pulses per second.	MEP Pod:Time base max.: 500msSensitivity: 50μV/Div – 10mV/DivFilters: 2Hz-10kHzMagnetic stimulator:Waveforms: Biphasic and Biphasic Burst.Single pulses, train pulses.Max. stim. Frequency: 60 pulses per second.	MEP:Similar characteristicsMagnetic stimulator:MagPro R30:Similar
Area	New Device	Predicate Device	Conclusion
	MEP Monitor	MEP POD (K051864)
	accessory to MagPro Stimulators (K061645and K091940)	Included with Magstim Rapid2
	Tonica Elektronik A/S	Magstim Company Ltd.
	MagPro R30 incl. MagOption:Waveforms: Biphasic, Monophasic.Single pulses, train pulses, dual/twin pulses.Max. stim. Frequency: 30 pulses per second		MagPro R30 incl. MagOption:Waveforms identical.Single and train pulses identical.Dual/twin pulses are where 2 pulses is given as a double pulse.This is equivalent with the setup in Biphasic Burst mode wherethe Super Rapid2 is able to stimulate with up to 10 pulses. Thismode is also called Theta Burst.The use of double pulses is also well known for currentstimulation.Max. stim. Frequency identical or lower
	MagPro X100:Waveforms: Biphasic, Biphasic Burst, Monophasic.Single pulses, train pulses.Max. stim. Frequency: 100 pulses per second		MagPro X100:Waveforms identical with predicate devices.Single and train pulses identical.Max. stim. Frequency of 100 pulses per second is higher thanthe Magstim Super Rapid2 with 60pps.The output power from the MagPro is very limited at highrepetition rates because the charging of the power electronic isnot capable building up the full power between the pulses. At100 pps the output power from MagPro is only 30% of fullpower at 15pps.High stimulation frequency is normal for current stimulatordevices. E.g. the current stimulator for the Neuro diagnosticdevice Keypoint (K944547) with max. stim. frequency of200Hz (pps) and Digitimer DS7A (K051357) with max.1000pps.Stimulation at high frequency up to 100 pps is within thealready accepted range for current stimulators on the USmarked.
	MagPro X100 incl. MagOption:Waveforms: Biphasic, Halfsine, Biphasic Burst,Monophasic		MagPro X100 incl. MagOption:Waveforms identical. The Halfsine waveform is based on thenormal Biphasic waveform. But the Halfsine waveform is not
Area	New DeviceMEP Monitoraccessory to MagPro Stimulators (K061645and K091940)Tonica Elektronik A/S	Predicate DeviceMEP POD (K051864)Included with Magstim Rapid2Magstim Company Ltd.	Conclusion
	Single pulses, train pulses, dual pulses.Max. stim. Frequency: 100 pulses per second		as powerful as the Biphasic waveform. Halfsine waveform isalso similar to the Monophasic waveform.Single and train pulses identical.Dual/twin pulses are where 2 pulses is given as a double pulse.This is equivalent with the setup in Biphasic Burst mode wherethe Super Rapid2 is able to stimulate with up to 10 pulses. Thismode is also called Theta Burst.The use of double pulses is also well known for currentstimulation.Max. stim. Frequency of 100 pulses per second is higher thanthe Magstim Super Rapid2 with 60pps.The output power from the MagPro is very limited at highrepetition rates because the charging of the power electronic isnot capable building up the full power between the pulses. At100 pps the output power from MagPro is only 30% of fullpower at 15pps.High stimulation frequency is normal for current stimulatordevices. E.g. the current stimulator for the Neuro diagnosticdevice Keypoint (K944547) with max. stim. frequency of200Hz (pps) and Digitimer DS7A (K051357) with max.1000pps.Stimulation at high frequency up to 100 pps is within thealready accepted range for current stimulators on the USmarked.

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Testing

The MEP Monitor together with the MagPro magnetic stimulators comply with the standard for electrical safety standard, IEC 60601-1 v3.1, and have been tested at a certified test center, UL Demko. EMC testing has been performed for compliance with the EMC standard, IEC 60601-1-2:2007 (3rd edition), Clause 6.1 Emission and Clause 6.2 Immunity.

List of latest test reports:

Electrical Safety reports
Tests performed by:
UL International Demko A/S
www.ul-europe.com
Test report no.	Test report name
E360406-D1002-1	UL IEC 60601-1 Medicalelectrical equipmentANSI/AAMI ES60601-1:2005/A2:2010

TABLE 1

Conclusion:

The MEP Monitor device, as well as the MagPro magnetic stimulators, has the same intended use as the predicate device and the same technological features. The MEP Monitor does not raise new issues of safety and effectiveness and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).