GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE

K071118 · Ives Eeg Solutions, Inc. · GXY · Sep 7, 2007 · Neurology

Device Facts

• Record ID: K071118
• Device Name: GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE
• Applicant: Ives Eeg Solutions, Inc.
• Product Code: GXY · Neurology
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The cutaneous, surface cup electrode system is intended for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

Device Story

Non-invasive cutaneous surface electrodes; used for recording EEG and EP signals. Input: bioelectric signals from patient skin surface. Device consists of gold, silver, conductive plastic, or Ag-Ag/Cl discs/cups; permanently connected to lead wires with Teflon insulation; heat-shrink tubing provides strain relief. Output: electrical signals transmitted via lead wires to EEG recording instruments. Connectors conform to DIN 42-802 for electrical safety; mate with harness systems. Used in clinical settings by healthcare professionals for neurodiagnostic monitoring. Benefits: provides reliable signal acquisition for clinical assessment of brain activity and evoked potentials.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and intended use similarity to legally marketed predicate devices.

Technological Characteristics

Materials: gold, silver, conductive plastic, Ag-Ag/Cl. Form factor: disc or cup electrodes with lead wires. Connectivity: wired connection to EEG recording instruments via DIN 42-802 compliant connectors. Non-invasive, passive sensing. No energy source.

Indications for Use

Indicated for general recording and monitoring of EEG and EP signals, including ground and reference electrodes, in patients requiring neurodiagnostic monitoring. Prescription use only.

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

• Grass Instruments Surface EEG Electrode (pre-1974)
• AMBU, Inc. EEG/EP Cup Electrode (K032278)
• The Electrode Store Cutaneous Electrode (K022197)

Reference Devices

• Ives EEG Solutions Subdermal Wire Electrode System (K062880)

Submission Summary (Full Text)

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K071118

# 5. 510(k) Summary

## EEG Surface Electrode System

| | | | SEP - 7 2007 | |
|--------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------|--|
| Company Name: | Ives EEG Solutions, Inc. | | | |
| Contact:<br>Phone:<br>Fax:<br>Email: | Mr. John Ives<br>613-692-1567<br>613-692-1567<br>[e-mail] | | | |
| Summary Date: | April 12, 2007 | | | |
| Trade Name: | EEG Surface Electrode System | | | |
| Model Number: | GCE, SCES, SCES and CPES | | | |
| Common Name: | Surface Electrode, Cutaneous electrode | | | |
| | Classification Name: 21 CFR 882.1350, Cutaneous Electrode GXY | | | |
| Main Predicate<br>Device: | 510(k) Number:<br>Manufacture:<br>Trade Name:<br>Product Code: | marketed before 1974 (see note below)<br>Grass Instruments, Inc, Quincy, MA<br>Surface EEG Electrode<br>GXY | | |
| Other Predicate<br>Devices: | 510(k) Number:<br>Manufacture:<br>Trade Name:<br>Product Code: | K032278<br>AMBU, Inc.<br>EEG/EP Cup Electrode<br>GXY | | |
| | 510(k) Number:<br>Manufacture:<br>Trade Name:<br>Product Code: | K022197<br>The Electrode Store<br>Cutaneous Electrode<br>GXY | | |

#### Description of Electrodes

The cutaneous surface electrode (GCE, SCE, SCE, SCE' and CPES) are electrodes that are all applied to the surface of the patient's skin, they are non-invasive. These electrodes are used for the recording of electroencephalography (EEG), evoked potential (EP) as well as the ground and reference associated with the recording. They consist of a disc or cup made from a variety of materials, which include, gold, silver, conductive plastic, Ag-Ag/Cl, that have long been used for this intended purpose throughout the industry. The recording disc is permanently connected to a lead wire. This joint is then covered in a heat-shrink tube so as not to allow exposed lead wires and also to provide a strain relief. The lead wires are insulated with a Teflon insulation or equivalent. The lead wires are

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short and terminate in a small mass connector than conforms to DIN 42-802 for electrical safety. This small mass connector mates with a harness system as per K062880 (an Ives EEG Solutions 510K describing a Subdermal Wire Electrode System) which connects to the EEG recording instrument using molded "touch-proof" connectors which also conform to DIN 42-802.

### Intended Use of Electrodes

The cutaneous, surface electrode system is intended for use for the recording and monitoring of the electroencephalography (EEG), evoked potential (EP) and the ground and reference associated with these recordings.

NOTE: Mr. Albert Grass began marketing EEG electrodes for general use when he established his company (Grass Instruments, Inc. Quincy, MA) in 1935. These cutaneous, surface cup electrodes have been continuously marketed under the Grass name by Astro-Med, Inc., West Warwick, RI. Advertising for these electrodes can be seen in copies of the Journal of Clinical Neurophysiology from 1949 to 1974 as well as in the early publications of the American Journal of Electroneurodiagnostic Technology.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ives EEG Solutions, Inc % Mr. John Ives President 6325 Rideau Valley Drive Manotick, Ontario Canada, K4M 1B3

SEP - 7 2007

Re: K071118

Trade/Device Name: EEG Surface Electrode System Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 28, 2007 Received: September 4, 2007

Dear Mr. Ives:

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. John Ives

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely you

sincerely yours,

for Pete D. Rumm

OEP
8/7/07

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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# 4. Indications for Use

510(k) Number:

Device Name:

EEG Surface Electrode System

The cutaneous, surface cup electrode system is intended Indications for Use: for use in the general recording and monitoring of the electroencephalography (EEG), evoked potential (EP) as well as ground and reference related to the EEG and EP recording.

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Pedro Lumino mo

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

**510(k) Number** 4071118