The coils MCF-B65, MCF-75, MCF-125 and Cool-B65 are used as an accessory together with a Magnetic stimulator used for magnetic stimulation. The coils transfer the magnetic stimulation to the tissue. All four coils are constructed the same way. A coil winding element encapsulated in a plastic housing. The coil winding element is inside the housing surrounded by a liquid cooling media. The cooling media absorb the heat built up during use. The coil Cool-B65 is furthermore connected to an external Coil Cooler unit that generates an active circulation of the cooling media, which allows the coil to operate for an even longer period. They are either circular or butterfly shaped. They are from 65 to 125 mm in diameter.

AI/ML Overview

The provided text is a 510(k) summary for magnetic stimulation coils (MCF-B65, MCF-75, MCF-125, Cool-B65). This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information (such as acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth methodologies) is not typically found in these types of submissions, as the device is not a new algorithm or diagnostic AI.

However, I can extract the relevant information regarding the equivalence asserted in the document.

Acceptance Criteria and Device Performance:

Since this is a 510(k) special submission, the acceptance criteria are implicitly met by demonstrating substantial equivalence to existing predicate devices. The "performance" is therefore the assertion that the new coils function similarly and safely to the predicate devices.

Acceptance Criteria Category	Reported Device Performance (Assertion)
Intended Use	Stimulation of peripheral nerves (same as predicate)
Technological Features	Same as predicate, with a modification to the cooling system (liquid cooling media vs. molding material). Magnetic field is not affected. Built-in thermo sensor.
Safety	No new issues of safety raised (implied by design and testing). Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). CE-marked, complies with MDD 93/42/EEC.
Effectiveness	No new issues of effectiveness raised (implied by design and testing).
Physical Characteristics	Similar in size, shape, and application (circular or butterfly shaped, 65 to 125 mm diameter).

Study Information (Based on a 510(k) Special Submission):

Sample size used for the test set and the data provenance: Not applicable. A test set in the traditional sense of a clinical or performance study is not described. Substantial equivalence is demonstrated through comparative analysis of features and adherence to standards.
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 by experts for a test set is described.
Adjudication method for the test set: Not applicable. No adjudication method is described.
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 device is a magnetic stimulation coil, not an AI or imaging device requiring MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of typical device performance studies. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the assertion that the modified device maintains those characteristics.
The sample size for the training set: Not applicable. No training set is described as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary of Device Equivalence:

The submission asserts that the new coils (MCF-B65, MCF-75, MCF-125, Cool-B65) are substantially equivalent to the predicate devices (K061645: MC-125, MC-B70, C-100, C-B60, MMC-140-II) based on the following:

Same intended use: Stimulation of peripheral nerves.
Same technological features: Similar construction with a coil winding element, and all coils have a built-in thermo sensor.
Physical comparability: Similar in size, shape, and application (circular or butterfly, 65 to 125 mm diameter).
Minor modification: The only significant difference is the cooling media (liquid for new coils vs. molding material for predicate coils). The submission explicitly states that "The magnetic field is not affected by the modification."
Safety and regulatory compliance: The coils are CE-marked, comply with the Medical Device Directive 93/42/EEC, are developed and manufactured according to EN13485, and comply with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC), as tested by a certified center (UL Demko).

The FDA reviewed these claims and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The acceptance criteria for this type of submission are therefore met by demonstrating this equivalence through documentation of design, intended use, and adherence to relevant standards, rather than through a traditional clinical study with detailed performance metrics against a defined ground truth.

Summary

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510(k) special

510(k) Summary

07182

JUL 2 7 2007

the first for the first of the

Name of 510(k) owner:

Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum Denmark

Phone: Fax:

+45 4499 8444 +45 4499 1544

Contact:

Lise Terkelsen

Preparation date:

June 25, 2007

Trade name: Common name: Classification name: MCF-B65, MCF-75, MCF-125, Cool-B65 MCF-B65, MCF-75, MCF-125, Cool-B65 Evoked Response Electrical Stimulator

Identification of predicate devices:

K061645: MC-125, MC-B70, C-100, C-B60, MMC-140-II

Summary.doc

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Device description

The coils MCF-B65, MCF-75, MCF-125 and Cool-B65 are used as an accessory together with a Magnetic stimulator used for magnetic stimulation. The coils transfer the magnetic stimulation to the tissue.

All four coils are constructed the same way. A coil winding element encapsulated in a plastic housing. The coil winding element is inside the housing surrounded by a liquid cooling media. The cooling media absorb the heat built up during use. The coil Cool-B65 is furthermore connected to an external Coil Cooler unit that generates an active circulation of the cooling media, which allows the coil to operate for an even longer period.

They are either circular or butterfly shaped. They are from 65 to 125 mm in diameter.

Intended Use:

The coils are intended for stimulation of peripheral nerves.

Substantial Equivalence:

The coils in this submission has the same characteristics as the predicate coils (K061645), Stimulation of peripheral nerves is the intended application which applies for the 5 cleared coils as well as the 4 modified coils. In size, shape and application they are all comparable.

All coils (both cleared and modified) have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the patient skin or operator.

The coil winding element of the predicate coils are surrounded by molding material. where as the modified coils are surrounded by a liquid cooling media. The magnetic field is not affected by the modification.

The coils are CE-marked and comply with the Medical Device Directive 93/42/EEC. The coils are developed and manufactured according to EN13485, "Medical devices -Quality management systems - Requirement for regulatory purposes". The coils comply with the standard for electrical safety standard, IEC 60601-1, and have been tested at a certified test center, UL Demko. The coils comply with the standard for EMC, IEC 60601-1-2.

Conclusion:

The MCF-B65, MCF-75, MCF-125 and Cool-B65 have the same intended use as the predicate coils and the same technological features. The modified coils do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate coils.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol composed of three curved lines that resemble a person embracing another person. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tonica Elektronik A/S % Ms. Lise Terkelsen Lucernemarken 15 DK-3520 Farum Denmark

JUL 2 7 2007

Re: K071821 Trade/Device Name: Coils, Models MCF-B65, MCF-75, MCF-125, Cool-B65 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF Dated: June 28, 2007 Received: July 3, 2007

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 -- Ms. Tonica Elektronik

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A Millhess

Mark Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

Coils: MCF-B65, MCF-75, MCF-125, Cool-B65

The device is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

Mule H. Millen

(Division Sign-Off) Division of General, Re-marative, and Neurological Devices

510(k) Number

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).