COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65

K071821 · Tonica Elektronik A/S · GWF · Jul 27, 2007 · Neurology

Device Facts

• Record ID: K071821
• Device Name: COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
• Applicant: Tonica Elektronik A/S
• Product Code: GWF · Neurology
• Decision Date: Jul 27, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

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

Device Story

Magnetic stimulation coils (MCF-B65, MCF-75, MCF-125, Cool-B65) function as accessories to magnetic stimulators. Coils transfer magnetic stimulation to peripheral nerves. Construction consists of coil winding elements encapsulated in plastic housings, surrounded by liquid cooling media to dissipate heat. Cool-B65 model includes external Coil Cooler unit for active circulation of cooling media, enabling extended operation. Coils are circular or butterfly-shaped, 65-125 mm diameter. Integrated thermo sensors monitor surface temperature to prevent patient or operator burns. Used in clinical settings by healthcare professionals for diagnostic nerve stimulation. Benefits include effective peripheral nerve stimulation with improved thermal management compared to previous molding-based designs.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) verified by UL Demko. Thermal safety validated via integrated thermo sensors.

Technological Characteristics

Coil winding elements in plastic housing; liquid cooling media; circular or butterfly form factor (65-125 mm diameter); integrated thermo sensors; active external cooling unit (Cool-B65 model); manufactured per EN13485; electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for stimulation of peripheral nerves 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

• MC-125, MC-B70, C-100, C-B60, MMC-140-II (K061645)

Submission Summary (Full Text)

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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:

[phone] [phone]

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 [phone]. 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 [phone] or [phone] 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