MagPro R20

K160280 · Tonica Elektronik A/S · GWF · May 16, 2016 · Neurology

Device Facts

• Record ID: K160280
• Device Name: MagPro R20
• Applicant: Tonica Elektronik A/S
• Product Code: GWF · Neurology
• Decision Date: May 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The MagPro R20 is intended for stimulation of peripheral nerves for diagnostic purposes.

Device Story

MagPro R20 is a magnetic stimulator for non-invasive peripheral nerve stimulation. Device comprises power electronics, processor module, and two displays; connects to external magnetic coil to generate magnetic fields. Operator controls stimulation parameters (intensity, frequency, pulse sequences) via user interface. Biphasic magnetic pulses (280 µsec) are delivered to tissue at frequencies up to 20 pulses per second. Used in clinical settings for diagnostic purposes; healthcare provider monitors stimulation parameters and coil status via front panel displays. Device facilitates nerve conduction studies or similar diagnostic assessments by inducing electrical currents in neural tissue.

Clinical Evidence

Bench testing only. Compliance with electrical safety (IEC 60601-1 v3.1) and electromagnetic compatibility (IEC 60601-1-2) standards verified by certified test centers (UL Demko and Delta). No clinical data provided.

Technological Characteristics

Magnetic stimulator; biphasic waveform (280 µsec); max frequency 20 pps. Power supply via isolation transformer (120V, 50/60 Hz). Dimensions: 150x390x440mm; weight 20kg. User interface includes two displays for intensity, coil temperature, and stimulus parameters. Developed per EN13485 quality management standards. Connectivity: standalone unit with manual controls.

Indications for Use

Indicated for stimulation of peripheral nerves for diagnostic purposes in patients requiring such diagnostic procedures.

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

• MagPro R30 (K061645)

Submission Summary (Full Text)

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

May 16, 2016

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

Re: K160280

Trade/Device Name: MagPro R20 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: February 1, 2016 Received: February 2, 2016

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 [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 yours, William J. Heetderks -A cn=William J. Heetderks -A
Date: 2016.05.16 16:55:59 -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) K160280

Device Name MagPro R20

Indications for Use (Describe)

MagPro R20 is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

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

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/S<br>Lucernemarken 15<br>DK-3520 Farum, Denmark |
|-------------------------------------|---------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact person: | Lise Terkelsen |
| Preparation date: | May 13th, 2016 |
| Trade name: | MagPro R20 |
| Common name: | MagPro R20 |
| Classification name: | Evoked Response Electrical Stimulator |
| Classification: | Class II Medical Device |
| Product Code: | GWF |
| Regulation number: | 21 CFR 882.1870 |
| Identification of predicate device: | MagPro R30, K061645 |

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## Device description

MagPro R20 is a Magnetic stimulator used for Magnetic stimulation. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation.

The MagPro R20 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.

The MagPro R20 consists of power electronics to generate the magnetic field in the Magnetic Coil. The MagPro R20 is controlled via a user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The MagPro R20 has a built-in computer and 2 small displays.

The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 20 pulses per second (pps).

## Intended Use:

The MagPro R20 is intended for stimulation of peripheral nerves for diagnostic purposes.

## Substantial Equivalence:

The MagPro R20 in this submission has the same characteristics as the predicate device, MagPro R30 (K061645). Stimulation of peripheral nerves is the intended application which applies to both devices.

They consist of a unit comprising power electronic to generate the magnetic fields in a Magnetic Coil. All includes a user interface to control the device via knobs and a display on the front panel.

The waveforms for the MagPro R20 and the MagPro R30 are biphasic. The maximum stimuli frequency is 30 pulses per second for MagPro R30 while 20 pulses per second for MagPro R20.

The MagPro R20 is CE-marked and complies with the Medical Device Directive 93/42/EEC. The MagPro R20 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 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| MagPro R20 | MagPro R30 | | |
| Tonica Elektronik A/S | Tonica Elektronik A/S | | |
| Is intended to be used for stimulation of<br>peripheral nerves for diagnostic purposes. | Is intended to be used for stimulation of<br>peripheral nerves for diagnostic purposes. | Identical | |
| Power Supply via Isolation Transformer<br>Power Supply: 120V~, 50/60 Hz.<br>Power consumption: Maximum 800VA | Power Supply via Isolation Transformer<br>Power Supply: 120V~, 50/60Hz<br>Power consumption: Maximum 2300VA | Identical<br>Lower power consumption | |
| Dimensions (HxWxD):<br>150 x 390 x 440mm<br>Weight: 20 kg / 44 lbs | Dimensions (HxWxD):<br>210 x 530 x 400mm<br>Weight: 36kg / 79 lbs | R30 bigger and heavier than R20. | |
| 280 µsec Biphasic | 280 µsec Biphasic | Identical | |
| MagPro R20 consists of a power module, a<br>processor module and built in displays. The<br>optional trolley supports the R20 and makes it<br>moveable. The complete system is powered from<br>an Isolation Transformer. | MagPro R30 consists of a power module, a<br>processor module and a built in display. The<br>optional trolley supports the R30 and makes it<br>moveable. The complete system is powered from<br>an Isolation Transformer. | Identical | |
| MagPro R20 has 2 displays<br>• Intensity display<br>• Coil temperature<br>• Intensity<br>• Menu display and indicators can show<br>• Repetition rate<br>• Pulses in train<br>• Number of trains<br>• Inter train interval<br>• Start delay | MagPro R30 has 1 display<br>All parameter settings can be shown on the<br>display.<br>• Intensity<br>• Repetition rate<br>• Pulses in train<br>• Number of trains<br>• Inter train interval<br>• Start delay<br>• Amplitude | Primary readout equivalent.<br>MagPro R30 has a more complex interface. MagPro R20<br>is meant for everyday diagnostic purposes<br>Same level of safety. | |
| Area | New Device | Predicate Device | Conclusion |
| | MagPro R20 | MagPro R30 | |
| | Tonica Elektronik A/S | Tonica Elektronik A/S | |
| | • Status: enable/disable | • Status: enable/disable | |
| | • Coil type | • Coil temperature | |
| | | • Coil type | |
| | | • Available stimuli | |
| | | • Event log information and date/time | |
| | | • Treatment sequence can be stored and<br>reused. Event log and Amplitude log can be<br>exported. | |
| | | • Continuously readout of di/dt controlling the<br>stability of the produced magnetic<br>stimulation | |

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# Testing

The MagPro R20 complies with the standard for electrical safety standard, IEC 60601-1 v3.1, and has been tested at a certified test center, UL Demko. EMC testing has been performed for compliance with the EMC standard, IEC 60601-1-2.

#### List of latest test reports:

| Electrical Safety reports | | Electromagnetic Compatibility Reports |
|----------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------|
| Tests performed by: | | Tests performed by: |
| UL International Demko A/S | | Delta (Danish Electronics, Light & Acoustics) |
| www.ul-europe.com | | www.delta.dk |
| Test report no. | Test report name | Test report no. Test report name |
| E360406-D1-CB | UL IEC 60601-1 Medical<br>electrical equipment<br>ANSI/AAMI ES60601-<br>1:2005/A2:2010 | T206073-1<br>DANAK-<br>19/13416<br>Rev. A |
| DK-38637-UL | CB certificate | DELTA Test Report:<br>EMC test of MagPro R20 |

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## Conclusion:

The MagPro R20 has the same intended use as the predicate device and the same technological features. The MagPro R20 does not raise new issues of safety and effectiveness and is substantially equivalent to the predicate device.