Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical and electrical properties of a conductive gel, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No.
The device facilitates diagnostic recordings (EEG/EP) by improving electrode conductivity, but it does not directly treat or prevent a medical condition.

Diagnostic

No

This device is a conductive gel used with electrodes to improve the signal quality for EEG/EP recordings. It facilitates the diagnostic process by ensuring proper signal transmission but does not itself perform any diagnostic function (e.g., analysis, interpretation, or diagnosis).

SaMD (Software as a Medical Device)

No

The device description clearly states it is a conductive gel, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "clinical and research EEG/EP recordings from humans." This involves applying the gel to the scalp to facilitate the recording of electrical signals from the brain. This is a direct interaction with the human body for diagnostic purposes, but not in vitro.
Device Description: The description details the composition and function of the gel as a conductor between the scalp and electrodes. It doesn't mention any analysis of biological samples outside the body.
Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.

The device is a medical device used in conjunction with other equipment (EEG/EP recorders and electrodes) for diagnostic procedures performed on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GYB

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

scalp, skin

Indicated Patient Age Range

Adults and Children

Intended User / Care Setting

Neurologists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K780045, K883149, K003924, K033052

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.1275 Electroconductive media.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

K111717

510K summary

| Company Name: | Electro-Cap 1011 West Lexington Road
P.O. Box 87
Eaton, OH 45320 | |----------------------|------------- | Contact: | Amy Swallows | Phone: | 937-456-6099 | Fax: | 937-456-7323 | Summary Date: | June | 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: | | Manufacture: | | Trade Name: | | 510(k) Number: | | Manufacture: | | Trade Name: | | 510(k) Number: | | Manufacture: | | Trade Name: | | 510(k) Number: | | Manufacture: | | Trade Name: International, Inc.
|
----------------------------------------------------------------------------------|---------------------------------|
| |
| |
| |
15, 2011 (Revised December 30, 2011) | |
| |
| |
| |
| |
| |
| |
| K780045 |
| Electro-Cap International, Inc. |
| Electro-Gel |
| K883149 |
| Weaver and Company |
| TEN20 Conductive Paste |
| K003924 |
| Mavidon |
| Mavidon Electrode Jelly |
| K033052 |
| Compumedics USA, Ltd. |
| 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.

1

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).

2

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.

| Feature | ELECTRO-GEL
After July 2008 | ELECTRO-GEL
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 |

.. ...

|

3

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
Non-irritating
Non Toxic		Salt Base
Non-irritating
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

4

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
After July 2008	MAVIDON ELECTRODE
JELLY	QUIK GEL	Substantial
Equivalence Comments
Feature
No.	K111717	K003924	K033052
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	A thixotropic conductive gel for
use with silver, gold or tin
electrodes.	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.	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.
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
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

5

| Same as predicates

ﺮ	ame as predicates	ame as predicates	ame as predicates	ame as predicates
Test in accordance with ISO
1 0993	Y es

                                                                                                                                                                                 | Yes               | Yes               | Salt Base Non-irritating

Non Toxic | |
| Yes | Yes | Yes | Yes | Non-irritating
Non Toxic
Salt Base | |
| Test in accordance with ISO 10993 | Yes | Yes | Yes | Salt Base Non-irritating Non-irritating Non-Toxic | |
| iocompatibility | Cytotoxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 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.

6

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.

7

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.

8

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 (800) 638-2041 or (301) 796-7100 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

9

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