ELECTRO-GEL

K111717 · Electro-Cap Intl., Inc. · GYB · Jan 5, 2012 · Neurology

Device Facts

• Record ID: K111717
• Device Name: ELECTRO-GEL
• Applicant: Electro-Cap Intl., Inc.
• Product Code: GYB · Neurology
• Decision Date: Jan 5, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Electro-Gel is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin.

Device Story

Electro-Gel is a water-miscible, conductive gel applied topically to intact skin. It serves as an interface between the scalp and external (recessed) electrodes during EEG/EP recordings. By reducing impedance between the electrode surface and the skin, it facilitates the transfer of electrical brain activity to EEG or computer equipment. The gel is used by neurologists in clinical and research settings. It is a non-sterile, salt-based (NaCl) formulation containing thickening agents, emulsifiers, humectants, and preservatives. The device is intended for single recording sessions not exceeding 8 hours. It provides a stable conductive path, ensuring signal quality for diagnostic neurophysiological procedures.

Clinical Evidence

Bench testing only. Device underwent biocompatibility testing per ISO 10993, including Agar Diffusion (ISO 10993-5, -12), Primary Skin Irritation (ISO 10993-10, -12), and Buehler Sensitization (ISO 10993-10, -12). Device passed all tests. Internal quality control testing performed for pH (4.5-6.0), viscosity (575-615 cp), and impedance (≤0.5K/Ohms).

Technological Characteristics

Water-miscible conductive gel. Composition: Water, Aragum T-1998, Methylparaben, Glycerin, Potassium Bitartrate, Sodium Chloride, Propylparaben. Physical specs: pH 4.5-6.0; viscosity 575-615 cp; impedance ≤0.5K/Ohms. Non-sterile. Topical application. No electronic components or software.

Indications for Use

Indicated for use in clinical and research EEG/EP recordings in adults and children. Used as a conductive medium between scalp and external electrodes to reduce skin-electrode impedance. Contraindicated for contact exceeding 8 hours per session.

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

• Electro-Gel (K780045)
• TEN20 Conductive Paste (K883149)
• Mavidon Electrode Jelly (K003924)
• QuikGel (K033052)

Submission Summary (Full Text)

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## K111717

## 510K summary

| Company Name: | Electro-Cap International, Inc.<br>1011 West Lexington Road<br>P.O. Box 87<br>Eaton, OH 45320 | |
|----------------------|-----------------------------------------------------------------------------------------------|---------------------------------|
| Contact: | Amy Swallows | |
| Phone: | 937-456-6099 | |
| Fax: | 937-456-7323 | |
| Summary Date: | June 15, 2011 (Revised December 30, 2011) | |
| Trade Name: | Electro-Gel | |
| Common Name: | Electrode Gel | |
| Classification Name: | Media, Electroconductive | |
| Regulation Number: | 21 CFR 882.1275 | |
| Product Code: | GYB | |
| Predicate Device(s): | | |
| | 510(k) Number: | K780045 |
| | Manufacture: | Electro-Cap International, Inc. |
| | Trade Name: | Electro-Gel |
| | 510(k) Number: | K883149 |
| | Manufacture: | Weaver and Company |
| | Trade Name: | TEN20 Conductive Paste |
| | 510(k) Number: | K003924 |
| | Manufacture: | Mavidon |
| | Trade Name: | Mavidon Electrode Jelly |
| | 510(k) Number: | K033052 |
| | Manufacture: | Compumedics USA, Ltd. |
| | Trade Name: | QuikGel |

## 1.0 Description of Device

Electro-Gel is the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to the EEG or computer equipment. Electro-Gel is for use with external electrodes only.

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Electro-Gel is an off white color, water-miscible conductive gel consisting of Sodium Chloride as the conductor combined with thickening agents, emulsifiers, humectants and preservatives all in an aqueous solvent.

The formula is as follows:

Water Aragum T-1998 Methylparaben Glycerin

Potassium Bitartrate Sodium Chloride Propylparaben

The pH range is 4.5 to 6.0 pH, Viscosity range is 575 to 615 cp. and Impedance 0.5K/Ohms or less. Direct contact with the Electro-Gel should not exceed 8 hours in any single recording session. The Electro-Gel is available in the following jar sizes: 16 ounce and 128 ounce. Shelf life is 1 year if stored properly, i.e. kept with containers tightly closed and at room temperature.

## 2.0 Intended Use of Device

This device is intended for use in clinical and research EEG/EP recordings from humans. The Electro-Gel is used with external electrodes as the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin.

## 3.0 Predicate Comparison

The Electro-Gel has the same technological characteristics as the predicate devices. It is the conductor between the scalp and electrodes and reduces impedance between the electrode and the scalp.

(Please refer to the comparison tables on the following four pages).

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Table 1 1 compares features and specifications of the current (After July 2008) Electro-Gel under review to the predicates (Prior July 2008) and TEN20 Conductive Paste.

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| Feature | ELECTRO-GEL<br>After July 2008 | ELECTRO-GEL<br>Prior July 2008 | TEN20 Conductive Paste | Substantial Equivalence Comments |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510K No. | K111717 | K780045 | K883149 | |
| Indication for Use | Use with external electrodes as the conductor between skin and electrode and to reduce impedance between the electrode surface and the skin | Use with external electrodes as the conductor between skin and electrode and to reduce impedance between the electrode surface and the skin | Use with non-disposable neurodiagnostic electrodes during EEG exams, EP procedures, ENG exams, brainmapping andMSLT procedures | Electro-Gel is used in the same environments and is substantially equivalent to the predicates. |
| Environment of Use | Electrophysiological | Electrophysiological | Electrophysiological | Used in the same clinical environments as predicates. |
| Intended user | Neurologists | Neurologists | Neurologists | Same as predicates |
| Target Patient | Adults and Children | Adults and Children | Adults and Children | Same as predicates |
| Where Used | Topically on intact skin | Topically on intact skin | Topically on intact skin | Same as predicates |
| Conductive material | Salt (NaCl) | Salt (NaCl) | Salt (NaCl) | Same as predicates |
| Thickening agent | Aragum, Glycerine | Tragacanth, Glycerine | Glycerine | Equivalent to predicates |
| Sterilization Method | Provided Non-Sterile | Provided Non Sterile | Provided Non Sterile | Identical sterilization status |
| Chemical Safety | No OSHA PEL* | No OSHA PEL* | No OSHA PEL* | Same as predicates |
| Preservative | Methylparaben and Propylparaben | Methylparaben and Propylparaben | Methylparaben and Propylparaben | Same as predicates |

.. ...

|

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| Biocompatibility | Test in accordance with ISO 10993 | | Test in accordance with ISO 10993 | Same as predicates |
|------------------|------------------------------------------|--|------------------------------------------|--------------------------|
| Cytotoxicity | Yes | | No | Same as predicates |
| Irritation | Yes | | No | Same as predicates |
| Sensitization | Yes | | No | Same as predicates |
| Characteristics | Salt Base<br>Non-irritating<br>Non Toxic | | Salt Base<br>Non-irritating<br>Non Toxic | Equivalent to predicates |

# Comparison Summary 4.1

.

As shown above in Table 4.0, the "July 2008 Electro-Gel brand EEG conductive gel" included in the submission, is identical in all aspects to the predicate "Prior July 2008 Electro-Gel brand EEG conductive gel" except for the thickening agent Aragum, which replaced a like gum, Tragacanth

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Table 24. Compares features and specifications of the current (After July 2008) Electro-Gel under review to the predicates Mavidon Electrode Jelly and Compumedics Quik Gel

| | 2: Comparison to Predicate Devices | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | ELECTRO-GEL<br>After July 2008 | MAVIDON ELECTRODE<br>JELLY | QUIK GEL | Substantial<br>Equivalence Comments |
| Feature<br>No. | K111717 | K003924 | K033052 | |
| Indication for Use | Use with external electrodes as the<br>conductor between skin and electrode and<br>to reduce impedance between the<br>electrode surface and the skin | A thixotropic conductive gel for<br>use with silver, gold or tin<br>electrodes. | The Quik Gel is intended for<br>use when a reduction of skin<br>impedance would enhance a<br>test result. It also helps the<br>Quik Cap electrodes adhere to<br>the patient. | Electro-Gel is used in the<br>same environments and<br>is substantially<br>equivalent to the<br>predicates |
| Environment of Use | Electrophysiological | Electrophysiological | Electrophysiological | Used in the same clinical<br>environments. |
| Intended user | Neurologists | Neurologists | Neurologists | Same as predicates |
| Target Patient | Adults and Children | Adults and Children | Adults and Children | Same as predicates |
| Where Used | Topically on intact skin | Topically on intact skin | Topically on intact skin | Same as predicates |
| Conductive material | Salt (NaCl) | Salt (NaCl) | Salt (NaCl) | Same as predicates |
| Thickening agent | Aragum, Glycerine | Hydroxyethyl Cellulose | Glycerine | Equivalent to predicates |
| Sterilization Method | Provided Non-Sterile | Provided Non Sterile | Provided Non-Sterile | Identical sterilization<br>status |
| Chemical Safety | No OSHA PEL | No OSHA PEL | No OSHA PEL | Same as predicates |
| Preservative | Methylparaben and Propylparaben | Phenol | Anti-fungal Agents | Similar to predicates |

------

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| Same as predicates<br>ﺮ | ame as predicates | ame as predicates | ame as predicates | ame as predicates | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|---------------------------------------------------|--|
| Test in accordance with ISO<br>1 0993 | Y es<br>- | Yes | Yes | Salt Base Non-irritating<br>Non Toxic | |
| Yes | Yes | Yes | Yes | Non-irritating<br>Non Toxic<br>Salt Base | |
| Test in accordance with ISO 10993 | Yes | Yes | Yes | Salt Base Non-irritating Non-irritating Non-Toxic | |
| iocompatibility | Cytotoxicity<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Irritation | ensitization | naracteristics | |

## Comparison Summary 4.1

identical in all aspects to the predicate "Prior July 2008 Electro-Gel brand EEG conductive gel" except for the thickering agent As shown above in Table 4.0 Add., the "July 2008 Electro-Gel" included in the submission, Aragum, which replaced a like gum, Tragacanth.

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## 4.0 Device Testing

The Electro-Gel has been tested by Toxikon Corporation, FDA/USDA Registered, in compliance with 21CFR, Part 58, Good Laboratory Practice for Non-Clinical Laboratory Studies, for the following test: Agar Diffusion Test, ISO 10993-5,-12, Primary Skin Irritation Test-ISO Direct Contact, ISO 10993-10,- 12 and Buehler Sensitization Test, ISO 10993-10, - 12. The Electro-Gel passed all tests.

Electro-Gel is tested internally for pH, impedance and viscosity on a regular basis.

### 4.0 Conclusions

- Based on the results of the non-clinical tests (that demonstrate that the device is as safe, as effective and performs as well as the other legal marketed devices) we conclude that the intended use and technology of the Electro-Gel is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN - 5 2012

Electro-Cap International, Inc. c/o Ms. Amy Swallows Director of Marketing 1011 West Lexington Road Eaton, OH 45320

Re: K111717

Trade/Device Name: Electro-Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: December 19, 2011 Received: December 20, 2011

Dear Ms. Swallows:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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- -

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Page 2 - Ms. Amy Swallows

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ettan m for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment B

Indications for Use

510(k) Number (if known): K 11 | 719

Device Name: Electro-Gel

Indications for Use:

Electro-Gel is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin.

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)

John Grimes

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111717