MEP Monitor

K162873 · Tonica Elektronik A/S · GWF · Mar 31, 2017 · Neurology

Device Facts

• Record ID: K162873
• Device Name: MEP Monitor
• Applicant: Tonica Elektronik A/S
• Product Code: GWF · Neurology
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended 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.

Device Story

MEP Monitor is an accessory device for MagPro magnetic stimulators; captures EMG signals via surface electrodes; connects to rear panel of stimulator; displays MEP response curves on stimulator UI; used by clinicians for diagnostic monitoring of peripheral nerves; provides visual feedback of evoked potentials to assist in clinical assessment; benefits include integrated monitoring of nerve response during magnetic stimulation procedures.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 v3.1 (electrical safety) and IEC 60601-1-2:2007 (EMC) verified by UL Demko.

Technological Characteristics

Accessory device with 1-channel isolated input (DIN-connector, Body Floating); powered by host magnetic stimulator; dimensions 7.2 x 3.7 x 1.6 in; weight 1.5 lb; supports surface electrodes; filters 1Hz-20kHz; sensitivity 50μV/Div – 10mV/Div; manufactured per EN13485.

Indications for Use

Indicated for monitoring evoked potentials in peripheral nerves when used as an accessory to MagPro magnetic stimulators for diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• MEP POD (K051864)

Reference Devices

• MagPro magnetic stimulators (K061645)
• MagPro magnetic stimulators (K091940)
• Keypoint (K944547)
• Digitimer DS7A (K051357)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right and are connected by a flowing line.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

# Submitter's Information

| Name of 510(k) owner: | Tonica Elektronik A/S<br>Lucernemarken 15<br>DK-3520 Farum, Denmark |
|-------------------------------------|--------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | [phone]<br>[phone] |
| 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,<br>MagPro magnetic stimulators in K061645 /<br>K091940 |

{4}------------------------------------------------

#### 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".

{5}------------------------------------------------

| Area | New Device | Predicate Device | Conclusion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MEP Monitor<br>accessory to MagPro Stimulators (K061645<br>and K091940)<br>Tonica Elektronik A/S | MEP POD (K051864)<br>Included with Magstim Rapid2<br>Magstim Company Ltd. | |
| Indications for<br>use | MEP Monitor:<br>The MEP Monitor is an accessory for the MagPro<br>stimulators (MagPro R30, MagPro R30 including<br>MagOption, MagPro X100, and MagPro X100 including<br>MagOption) and is intended to monitor evoked potentials.<br><br>Magnetic Stimulator:<br>The MagPro family is intended to be used for<br>magnetic stimulation of peripheral nerves for<br>diagnostic purposes. | MEP Pod:<br>The device will when connected to a stimulator<br>monitor the MEP response in peripheral nerves and<br>display this on the stimulator.<br><br>Magnetic Stimulator<br>The Magstim Rapid2 magnetic nerve stimulator<br>systems are intended for the stimulation of peripheral<br>nerves. | Identical |
| Energy used | MEP Monitor:<br>Power supported from the magnetic stimulator<br><br>Magnetic stimulator:<br>Power Supply: 100-120V Mains.<br>Pulses, max energy 280J | MEP Pod:<br>Power supported from the magnetic stimulator<br><br>Magnetic stimulator:<br>Power Supply: 115V Mains.<br>Pulses, max energy 225J | MEP:<br>Identical.<br><br>Magnetic stimulator:<br>Similar energy system used.<br>Similar. |
| Mechanical data | MEP Monitor:<br>Dimensions: (HxWxD:) 7.2 x 3.7 x 1.6 in<br>Weight: 1.5 lb<br><br>Magnetic stimulators:<br>33 kg/72 lbs<br>58 kg/128 lbs<br>35 kg/ 77 lbs<br>60 kg/ 132 lbs | MEP Pod:<br>The MEP Pod has smaller dimensions than MEP<br>Monitor.<br><br>Magnetic stimulator:<br>27 kg / 60 lbs | Differences are of no importance. |
| Design | MEP Monitor:<br>The Motor Evoked Potential (MEP) Monitor is an<br>optional component which allows the user to capture<br>EMG signals and display them on the MagPro UI.<br><br>Device with 1 channel input.<br>Isolated input DIN-connector (Body Floating).<br>Directly connected to the rear panel of the magnetic<br>stimulator device | MEP Pod:<br>The Motor Evoked Potential (MEP) Pod is an optional<br>component which allows the user to capture EMG<br>signals and display them on the Magstim Rapid2 UI.<br><br>Device with 2 channel input.<br>Isolated input connectors (Body Floating).<br>Connected via a long cable to the magnetic stimulator<br>device | MEP:<br>Identical.<br><br>MEP Monitor has only 1 channel. |
| Area | New Device | Predicate Device | Conclusion |
| | MEP Monitor<br>accessory to MagPro Stimulators (K061645<br>and K091940)<br>Tonica Elektronik A/S | MEP POD (K051864)<br>Included with Magstim Rapid2<br>Magstim Company Ltd. | |
| | The MEP Monitor is designed to be used with surface<br>electrodes only.<br>Supports connections of standard electrode cables and<br>surface electrodes. | The MEP Pod is designed to be used with surface<br>electrodes only.<br>Supports connections of standard electrode cables and<br>surface electrodes. | |
| | Magnetic stimulator:<br>Magnetic stimulation is equivalent to current<br>stimulation. The principle of magnetic stimulation is<br>implicit in Faraday's law, which describes that a time-<br>varying magnetic field induces a current in a<br>conductor (tissue). Application areas of magnetic<br>stimulation are a sub-set of the application areas for<br>current stimulation.<br>The device consist of a unit comprising power supply,<br>capacitor bank, high voltage electronics, control<br>electronics and user interface (controls) with knobs<br>and display on the front panel.<br>User interface is menu-driven and computer<br>controlled.<br>A magnetic coil is connected to the device to generate<br>a magnetic field. | Magnetic stimulator:<br>Magnetic stimulation is equivalent to current<br>stimulation. The principle of magnetic stimulation is<br>implicit in Faraday's law, which describes that a time-<br>varying magnetic field induces a current in a<br>conductor (tissue). Application areas of magnetic<br>stimulation are a sub-set of the application areas for<br>current stimulation.<br>The device consist of a unit comprising power supply,<br>capacitor bank, high voltage electronics, control<br>electronics and user interface (controls) with knobs<br>and a display with touch screen control.<br>User interface is menu-driven and computer<br>controlled.<br>A magnetic coil is connected to the device to generate<br>a magnetic field. | Magnetic stimulator:<br>Identical.<br>The design of the devices is basically the same, with use of a<br>capacitor bank and high voltage electronics to generate a<br>magnetic field in a magnetic coil. |
| Performance | MEP Monitor:<br>Time base max.: 100ms<br>Sensitivity: 50μV/Div – 10mV/Div<br>Filters: 1Hz-20kHz<br><br>Magnetic stimulator:<br>MagPro R30<br>Waveforms: Biphasic.<br>Single pulses, train pulses.<br><br>Max. stim. Frequency: 30 pulses per second. | MEP Pod:<br>Time base max.: 500ms<br>Sensitivity: 50μV/Div – 10mV/Div<br>Filters: 2Hz-10kHz<br><br>Magnetic stimulator:<br>Waveforms: Biphasic and Biphasic Burst.<br>Single pulses, train pulses.<br><br>Max. stim. Frequency: 60 pulses per second. | MEP:<br>Similar characteristics<br><br>Magnetic stimulator:<br>MagPro R30:<br>Similar |
| Area | New Device | Predicate Device | Conclusion |
| | MEP Monitor | MEP POD (K051864) | |
| | accessory to MagPro Stimulators (K061645<br>and K091940) | Included with Magstim Rapid2 | |
| | Tonica Elektronik A/S | Magstim Company Ltd. | |
| | MagPro R30 incl. MagOption:<br>Waveforms: Biphasic, Monophasic.<br>Single pulses, train pulses, dual/twin pulses.<br>Max. stim. Frequency: 30 pulses per second | | MagPro R30 incl. MagOption:<br>Waveforms identical.<br>Single and train pulses identical.<br>Dual/twin pulses are where 2 pulses is given as a double pulse.<br>This is equivalent with the setup in Biphasic Burst mode where<br>the Super Rapid2 is able to stimulate with up to 10 pulses. This<br>mode is also called Theta Burst.<br>The use of double pulses is also well known for current<br>stimulation.<br>Max. stim. Frequency identical or lower |
| | MagPro X100:<br>Waveforms: Biphasic, Biphasic Burst, Monophasic.<br>Single pulses, train pulses.<br>Max. stim. Frequency: 100 pulses per second | | MagPro X100:<br>Waveforms identical with predicate devices.<br>Single and train pulses identical.<br>Max. stim. Frequency of 100 pulses per second is higher than<br>the Magstim Super Rapid2 with 60pps.<br>The output power from the MagPro is very limited at high<br>repetition rates because the charging of the power electronic is<br>not capable building up the full power between the pulses. At<br>100 pps the output power from MagPro is only 30% of full<br>power at 15pps.<br>High stimulation frequency is normal for current stimulator<br>devices. E.g. the current stimulator for the Neuro diagnostic<br>device Keypoint (K944547) with max. stim. frequency of<br>200Hz (pps) and Digitimer DS7A (K051357) with max.<br>1000pps.<br>Stimulation at high frequency up to 100 pps is within the<br>already accepted range for current stimulators on the US<br>marked. |
| | MagPro X100 incl. MagOption:<br>Waveforms: Biphasic, Halfsine, Biphasic Burst,<br>Monophasic | | MagPro X100 incl. MagOption:<br>Waveforms identical. The Halfsine waveform is based on the<br>normal Biphasic waveform. But the Halfsine waveform is not |
| Area | New Device<br>MEP Monitor<br>accessory to MagPro Stimulators (K061645<br>and K091940)<br>Tonica Elektronik A/S | Predicate Device<br>MEP POD (K051864)<br>Included with Magstim Rapid2<br>Magstim Company Ltd. | Conclusion |
| | Single pulses, train pulses, dual pulses.<br>Max. stim. Frequency: 100 pulses per second | | as powerful as the Biphasic waveform. Halfsine waveform is<br>also similar to the Monophasic waveform.<br>Single and train pulses identical.<br>Dual/twin pulses are where 2 pulses is given as a double pulse.<br>This is equivalent with the setup in Biphasic Burst mode where<br>the Super Rapid2 is able to stimulate with up to 10 pulses. This<br>mode is also called Theta Burst.<br>The use of double pulses is also well known for current<br>stimulation.<br><br>Max. stim. Frequency of 100 pulses per second is higher than<br>the Magstim Super Rapid2 with 60pps.<br>The output power from the MagPro is very limited at high<br>repetition rates because the charging of the power electronic is<br>not capable building up the full power between the pulses. At<br>100 pps the output power from MagPro is only 30% of full<br>power at 15pps.<br><br>High stimulation frequency is normal for current stimulator<br>devices. E.g. the current stimulator for the Neuro diagnostic<br>device Keypoint (K944547) with max. stim. frequency of<br>200Hz (pps) and Digitimer DS7A (K051357) with max.<br>1000pps.<br><br>Stimulation at high frequency up to 100 pps is within the<br>already accepted range for current stimulators on the US<br>marked. |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

## 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 Medical<br>electrical equipment<br>ANSI/AAMI ES60601-<br>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.