CONDUCTIVE EEG ELECTROLYTE

K033052 · Compumedics USA, Ltd. · GYB · Dec 17, 2003 · Neurology

Device Facts

• Record ID: K033052
• Device Name: CONDUCTIVE EEG ELECTROLYTE
• Applicant: Compumedics USA, Ltd.
• Product Code: GYB · Neurology
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Intended Use

The Quik Gel® is intended for use when a reduction of skin impedance would enhance a test result. It also helps the Quik Cap electrodes adhere to the patient.

Device Story

Quik Gel is an electroconductive medium used to facilitate electrical signal transmission between a patient's skin and diagnostic electrodes. The gel is a jellylike mass composed of salts, a carbohydrate thickening agent, a hypo-allergenic organic emollient, and anti-fungal agents in an aqueous solvent. It is applied to the skin-electrode interface to reduce impedance and improve electrode adhesion. It is intended for use by healthcare professionals in clinical settings during diagnostic procedures requiring surface electrodes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Electroconductive gel consisting of salts, carbohydrate thickening agent, hypo-allergenic organic emollient, and anti-fungal agents in an aqueous solvent. Form factor is a jellylike mass. No electronic components or software.

Indications for Use

Indicated for use in patients undergoing diagnostic testing requiring electrode-to-skin interface to reduce skin impedance and facilitate signal transmission; also serves as an adhesive for electrodes.

Regulatory Classification

Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Predicate Devices

• Conductive Gel (K022006)
• TEN20 Conductive (K883149)

Submission Summary (Full Text)

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K033052 (pg 1 of 1)

## 510(k) SUMMARY V.

| Submitted by: | Compumedics USA, Ltd.<br>7850 Paseo Del Norte<br>El Paso, TX 79912 |
|----------------------|--------------------------------------------------------------------|
| Contact Person: | Elvira Garcia |
| Date Prepared: | September 24, 2003 |
| Proprietary Name: | Quik Gel, EEG Electrodeconductive Gel |
| Common Name: | QuikGel® |
| Classification Name: | Electroconductive Media |
| Predicate Devices: | Conductive Gel<br>K022006<br>TEN20 Conductive<br>K883149 |

A jellylike mass consisting of salts combined with Description of the Device: carbohydrate thickening agent, hypo-allergenic organic emollient, anti-fungal agents all in a aqueous solvent.

Intended Use of the Device: The Quik Gel® is intended for use when a reduction of skin impedance would enhance a test result. It also helps the Quik Cap electrodes adhere to the patient.

Technological Characteristics: The Quik-Gel® has the same technological characteristics as the predicate device.

K022006 Conductive Gel TEN20 Conductive K883149

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2003

Ms. Elvira Garcia Quality Assurance Manager Compumedics USA, Ltd. 7850 Paseo Del Norte El Paso, Texas 79912

Re: K033052 Trade/Device Name: Quik Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: II Product Code: GYB Dated: September 24, 2003 Received: September 29, 2003

Dear Ms. Garcia:

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. Elvira Garcia

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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Cclia M. Witten, Ph.D., M.D. 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

K033052 510(k) Number (if known):

Quik Gel _____________________________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: The Quik gel is intended to enhance electrical conductivity by
the for the first the first the fact and waisance from the natient to the Indications For Use." The Quik get is intention to onlines enom the patient to the facilitating transmission of the electrode-to-skin interface. It also helps the equipmont tectrodes adhere to the patient.

Prescription Use X (Part 21 CFR 801 Subpart D)

:

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

iriam C. Provost

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

510(k) Number k033052