CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE

K072016 · Technomed Europe · GXY · Oct 19, 2007 · Neurology

Device Facts

• Record ID: K072016
• Device Name: CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE
• Applicant: Technomed Europe
• Product Code: GXY · Neurology
• Decision Date: Oct 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).

Device Story

Cutaneous cup electrodes applied to patient skin; acquire physiological signals for EEG, EMG, and EP monitoring. Reusable versions (silver, Ag/AgCl, or gold-plated discs) and disposable versions (molded ABS, Ag/AgCl plated discs) available. Electrodes feature lead wires with DIN 42-802 touch-proof connectors for electrical safety. Used by clinicians in clinical settings to record signals via external monitoring equipment. Non-invasive application allows repeated use on adults and children. Reusable electrodes are steam-autoclavable. Output is raw physiological signal transmitted to recording equipment for clinical interpretation and diagnostic decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cutaneous electrodes; reusable (silver, Ag/AgCl, or gold-plated discs) or disposable (molded ABS, Ag/AgCl plated discs). DIN 42-802 touch-proof connectors. Non-sterile delivery. Reusable versions compatible with steam autoclave sterilization. Passive sensing components.

Indications for Use

Indicated for non-invasive acquisition of physiological signals (EMG, EEG, EP) for monitoring and recording in adults and children.

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

• Rhythmlink Disc Electrodes (K061148)

Submission Summary (Full Text)

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| Attachment C: | 510(k) Summary | K072016 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Manufacturer: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands | OCT 19 2007 |
| 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: | 07 September, 2007 | |
| Proprietary Name: | Cutaneous Electrodes | |
| Common/usual Name: | Cup Electrodes | |
| Classification Name: | Cutaneous Electrode is classified as class II per<br>21 CFR section 882.1320. Product code GXY. | |
| Substantial Equivalence: | K061148: Rhythmlink Disc Electrodes | |
| Device description: | A cutaneous electrode is an electrode that is applied directly to<br>a patient's skin to record physiological signals. In other words<br>cutaneous devices are used in the acquisition of signals for the<br>purpose of monitoring and recording Electroencephalograph<br>(EEG), Electroencephalography (EEG), and Evoked<br>Potentials (EP) and the electroencephalographic/evoked<br>potentials reading is a completely non-invasive procedure that<br>can be applied repeatedly to patients, normal adults, and<br>children with virtually no risk or limitation. The electrodes are<br>delivered non sterile and are available in reusable and<br>disposable versions. | |
| Reusable: | Reusable Cup Electrodes have a disc manufactured with a<br>variety of materials which include: silver, Ag/AgCl, Gold<br>Plated. The disc is permanently adhered to a lead wire. The<br>insulated lead wires terminate using a molded touch proof<br>connector (DIN 42-802) for electrical safety. The cup<br>electrode may be sterilized using steam autoclave. The cup<br>electrodes are available in an adult version and a pediatric<br>version. | |
| Disposable: | These electrode are for single patient use only. Disposable<br>Cup Electrodes have a disc manufactured of molded ABS,<br>Ag/AgCl Plated. The disc is permanently adhered to a lead<br>wire. The insulated lead wires terminate using a molded touch<br>proof connector (DIN 42-802) for electrical safety. | |

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| Intended Use: | The Cup Electrodes are intended for non-invasive use with<br>recording and monitoring equipment, (active and reference),<br>of Electromyography (EMG), Electroencephalograph (EEG)<br>and Evoked Potentials (EP). |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Cup Electrode<br>to confirm performance characteristics of this device. |
| Conclusion: | The comparison to the predicate devices demonstrate that the<br>cup electrodes are safe and effective and are substantially<br>equivalent to the predicate devices. |

:

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the image.

OCT 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Technomed Europe c/o Mr. Maurice Roost, Manager Research & Development Amerikalaan 71 6199 AE Maastricht Airport The Netherlands

Re: K072016

Trade/Device Name: Cup Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode. Regulatory Class: Class II Product Code: GXY Dated: July 20, 2007 Received: July 23, 2007

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

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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. 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 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):

Device Name: Cup Electrodes

Indications For Use:

The Cup Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

| 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)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | K012014 |
|---------------|---------|
|---------------|---------|

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