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).

AI/ML Overview

The provided text is a 510(k) summary for the MagPro R20 device, comparing it to a predicate device, the MagPro R30. The document focuses on demonstrating substantial equivalence for a medical device rather than proving performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, the requested information about acceptance criteria, study design for AI/algorithm performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for AI devices is NOT available in this document.

The document states:

The intended use of the MagPro R20 is "stimulation of peripheral nerves for diagnostic purposes".
The conclusion is that "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."

The "Testing" section refers to electrical safety and electromagnetic compatibility (EMC) testing, which are standard regulatory requirements for medical devices to ensure they are safe for use and do not interfere with other equipment. These are not performance studies for a diagnostic algorithm.

Here's a breakdown of why the requested information cannot be provided from the given text:

A table of acceptance criteria and the reported device performance: Not applicable. The device is a stimulator, not a diagnostic algorithm with performance metrics like sensitivity/specificity. The document lists physical and functional characteristics for comparison to a predicate, not performance against diagnostic accuracy targets.
Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's diagnostic performance study. The testing mentioned is for electrical safety and EMC.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for diagnostic accuracy is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for diagnostic accuracy.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for diagnostic accuracy.
The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
How the ground truth for the training set was established: Not applicable.

This document describes a device approval process based on demonstrating substantial equivalence to a legally marketed predicate device, focusing on similar intended use and technological characteristics, and compliance with safety and EMC standards. It does not involve the type of performance evaluation typically associated with AI/ML diagnostic devices.

Summary

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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 (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, 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/SLucernemarken 15DK-3520 Farum, Denmark
Phone:	+45 4499 8444
Fax:	+45 4499 1544
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

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 ofperipheral nerves for diagnostic purposes.	Is intended to be used for stimulation ofperipheral nerves for diagnostic purposes.	Identical
Power Supply via Isolation TransformerPower Supply: 120V~, 50/60 Hz.Power consumption: Maximum 800VA	Power Supply via Isolation TransformerPower Supply: 120V~, 50/60HzPower consumption: Maximum 2300VA	IdenticalLower power consumption
Dimensions (HxWxD):150 x 390 x 440mmWeight: 20 kg / 44 lbs	Dimensions (HxWxD):210 x 530 x 400mmWeight: 36kg / 79 lbs	R30 bigger and heavier than R20.
280 µsec Biphasic	280 µsec Biphasic	Identical
MagPro R20 consists of a power module, aprocessor module and built in displays. Theoptional trolley supports the R20 and makes itmoveable. The complete system is powered froman Isolation Transformer.	MagPro R30 consists of a power module, aprocessor module and a built in display. Theoptional trolley supports the R30 and makes itmoveable. The complete system is powered froman Isolation Transformer.	Identical
MagPro R20 has 2 displays• Intensity display• Coil temperature• Intensity• Menu display and indicators can show• Repetition rate• Pulses in train• Number of trains• Inter train interval• Start delay	MagPro R30 has 1 displayAll parameter settings can be shown on thedisplay.• Intensity• Repetition rate• Pulses in train• Number of trains• Inter train interval• Start delay• Amplitude	Primary readout equivalent.MagPro R30 has a more complex interface. MagPro R20is meant for everyday diagnostic purposesSame 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 andreused. Event log and Amplitude log can beexported.
		• Continuously readout of di/dt controlling thestability of the produced magneticstimulation

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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 Medicalelectrical equipmentANSI/AAMI ES60601-1:2005/A2:2010	T206073-1DANAK-19/13416Rev. A
DK-38637-UL	CB certificate	DELTA Test Report:EMC test of MagPro R20

TABLE 1

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.

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).