DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES

K073532 · Technomed Europe · GXY · May 1, 2008 · Neurology

Device Facts

• Record ID: K073532
• Device Name: DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
• Applicant: Technomed Europe
• Product Code: GXY · Neurology
• Decision Date: May 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Disposable Adhesive Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single-patient/multiple application use.

Device Story

Disposable adhesive surface electrodes; non-invasive; used for acquisition of biopotential signals (EEG, EMG, EP, nerve conduction). Device consists of flexible electrodes with adhesive gel; available as fixed lead wire (with DIN 42802 connector) or tab style (for alligator clip connection). No external securing material required. Used in clinical settings by healthcare professionals to interface patient skin with recording/monitoring/stimulation equipment. Facilitates signal transmission for diagnostic or monitoring purposes; benefits patient by enabling non-invasive physiological data collection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Flexible, disposable adhesive surface electrodes. Features solid-gel adhesive interface. Available with fixed lead wires (DIN 42802 connector) or tab-style contact strips. Non-sterile. Passive signal acquisition/stimulation interface.

Indications for Use

Indicated for use with recording, monitoring, and stimulation equipment to acquire biopotential signals including EEG, surface EMG, nerve conduction, and EP. Non-invasive, applied to skin via self-adhesive solid-gel. For single-patient use.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• KM-10 Non-Sterile TENS Electrode (K000870)
• TECA NCS Electrode System 2000 (K971914)

Submission Summary (Full Text)

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## 510(k) Summary

| Manufacturer: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands | MAY - 1 2008 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitted by: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands<br>Tel.: [phone]<br>Fax: [phone] | |
| Contact person: | Mr. Maurice Roost<br>Manager Research & Development<br>E-mail: [e-mail] | |
| Date: | December 10, 2007 | |
| Proprietary Name: | Cutaneous Electrodes | |
| Common/usual Name: | Disposable Adhesive Surface Electrodes | |
| Classification Name: | Cutaneous Electrode is classified as class II per<br>21 CFR section 882.1320. Product code GXY. | |
| Substantial Equivalence: | K000870: KM-10 Non-Sterile TENS Electrode<br>K971914: TECA NCS Electrode System 2000 | |
| Device description: | Disposable Adhesive Surface Electrodes are non-invasive.<br>Cutaneous devices are used in the acquisition of signals for the<br>purpose of stimulating, monitoring and recording<br>Electroencephalograph (EEG), surface Electromyography<br>(EMG) and Evoked Potentials (EP). The electrodes are<br>designed for single-patient/multiple application use and are very<br>flexible. Because of the adhesive nature of the gel, no securing<br>material is required for fixating the electrode to the patient's<br>skin.<br>There are two types of electrodes, one with fixed lead wire and<br>the other without lead wire, tab electrodes.<br>The electrodes with lead wire have a safety DIN 42802<br>connector, several lengths and color combinations. Tab<br>electrode can be connected, using a lead wire with alligator clip,<br>to the gel free contact strip at the electrode end. | |
| Intended Use: | The Disposable Adhesive Surface Electrodes are intended for<br>non-invasive use with recording and monitoring equipment,<br>(active and reference), of Electromyography (EMG),<br>Electroencephalograph (EEG) and Evoked Potentials (EP). The<br>electrodes are designed for single-patient/multiple application<br>use. | |
| Comparison to predicates: | The design, materials, chemical composition, packaging and<br>other technological characteristics of the subject device is<br>equivalent to those of the predicate devices. | |
| Non-clinical data: | Technomed Europe has been bench testing the Cutaneous<br>Electrodes to confirm performance characteristics of this<br>device. | |
| Conclusion: | The comparison to the predicate devices demonstrate that the<br>Disposable Adhesive Surface Electrodes are safe and effective<br>and are substantially equivalent to the predicate devices. | |

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Technomed Europe % Mr. Maurice Roost Manager Research & Development Amerikalaan 71 6199 AE Maastricht-Airport Limburg The Netherlands

MAY - 1 2008

Re: K073532

> Trade/Device Name: Disposable Adhesive Surface Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode. Regulatory Class: Class II Product Code: GXY Dated: April 17, 2008 Received: April 21, 2008

Dear Mr. Roost:

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

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Page 2 - Mr. Maurice Roost

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.

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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Murk N Millerson

Mark N. 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): K073532

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Device Name:

Disposable Adhesive Surface Electrodes

Indications For Use:

The Disposable Adhesive Surface Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating/recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction and Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes are non-sterile and for single patient use only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nelbo Cyd for 383

(Divis Division of and Neurological Devi

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**510(k) Number** K073532