(199 days)
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.
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 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.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the Electro-Gel device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Electro-Gel are primarily based on its physical properties and biocompatibility. The reported device performance demonstrates compliance with these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties | pH range | 4.5 to 6.0 pH |
| Viscosity range | 575 to 615 cp. | |
| Impedance | 0.5K/Ohms or less | |
| Shelf life | 1 year (if stored properly: containers tightly closed, room temperature) | |
| Composition | Conductive material | Salt (NaCl) |
| Thickening agent | Aragum, Glycerine (note: changed from Tragacanth, Glycerine in prior version) | |
| Preservative | Methylparaben and Propylparaben | |
| Biocompatibility | Cytotoxicity (ISO 10993-5, -12) | Passed (Agar Diffusion Test) |
| Primary Skin Irritation (ISO 10993-10, -12) | Passed (Primary Skin Irritation Test-ISO Direct Contact) | |
| Sensitization (ISO 10993-10, -12) | Passed (Buehler Sensitization Test) | |
| Sterilization Status | Provided Non-Sterile | Provided Non-Sterile |
| Chemical Safety | No OSHA PEL (Permissible Exposure Limit) requirements | No OSHA PEL* |
| Intended Use | Use with external electrodes as conductor between scalp and electrodes, reducing impedance for EEG/EP recordings in humans. | The device's stated intended use aligns with the functional performance (conductivity and impedance reduction) and safety (biocompatibility) demonstrated. The device is used with external electrodes as the conductor between skin and electrode to reduce impedance between the electrode surface and the skin. Test results for pH, viscosity and impedance are regularly monitored internally. The non-clinical tests (biocompatibility tests) confirmed its safety and effectiveness relative to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" in the traditional sense of a clinical or performance study with patient data. The testing described for the device is primarily non-clinical:
- Biocompatibility Tests: These tests (Agar Diffusion Test for cytotoxicity, Primary Skin Irritation Test, Buehler Sensitization Test) were conducted by Toxikon Corporation, an FDA/USDA Registered lab, in compliance with 21CFR, Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies). The document does not specify the number of samples or subjects (e.g., animals for irritation/sensitization, cell cultures for cytotoxicity) used in these tests. These are standard laboratory tests, so the "provenance" is a certified testing facility adhering to GLP.
- Internal Testing: pH, impedance, and viscosity are tested internally on a regular basis. No sample sizes are provided for these internal quality control checks. The data provenance is internal quality control.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The submission is for an electrode gel, and the "test set" described consists of non-clinical, laboratory-based evaluations of physical properties and biocompatibility. There is no mention of a clinical study or a need for expert consensus on a "ground truth" derived from patient data for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable. Since there's no clinical "test set" involving human interpretation or subjective assessment, an adjudication method like 2+1 or 3+1 is not relevant. The biocompatibility tests have objective outcomes (pass/fail based on established assay criteria) and are interpreted by the testing laboratory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic algorithms or imaging interpretation devices where human performance is significantly impacted by and compared with AI assistance. The Electro-Gel is a medical device (electrode gel) and not an AI-powered diagnostic tool. Therefore, there's no "AI" component, no human readers, and no effect size on how human readers improve with AI vs. without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The device is an electrode gel, not an algorithm or software. Its performance is measured through its physical and chemical properties and biocompatibility, not as an "algorithm" operating independently.
7. Type of Ground Truth Used
The "ground truth" for evaluating Electro-Gel is based on:
- Established physical and chemical standards: The pH, viscosity, and impedance ranges are established specifications for such gels, likely derived from industry standards and functional requirements.
- Biocompatibility standards: ISO 10993 standards define the acceptable "ground truth" for cytotoxicity, irritation, and sensitization. The device's performance is compared against these internationally recognized biological evaluation criteria for medical devices.
- Comparison to predicate devices: The primary method for demonstrating safety and effectiveness is substantial equivalence to legally marketed predicate devices. The "ground truth" here is the established safety and efficacy profile of these comparable products.
8. Sample Size for the Training Set
This information is not applicable. The Electro-Gel is a physical product (an electrode gel), not a machine learning model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
{0}------------------------------------------------
K111717
510K summary
| Company Name: | Electro-Cap International, Inc.1011 West Lexington RoadP.O. Box 87Eaton, 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.
{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-GELAfter July 2008 | ELECTRO-GELPrior 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 BaseNon-irritatingNon Toxic | Salt BaseNon-irritatingNon 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-GELAfter July 2008 | MAVIDON ELECTRODEJELLY | QUIK GEL | SubstantialEquivalence Comments | |
| FeatureNo. | K111717 | K003924 | K033052 | |
| Indication for Use | Use with external electrodes as theconductor between skin and electrode andto reduce impedance between theelectrode surface and the skin | A thixotropic conductive gel foruse with silver, gold or tinelectrodes. | The Quik Gel is intended foruse when a reduction of skinimpedance would enhance atest result. It also helps theQuik Cap electrodes adhere tothe patient. | Electro-Gel is used in thesame environments andis substantiallyequivalent to thepredicates |
| Environment of Use | Electrophysiological | Electrophysiological | Electrophysiological | Used in the same clinicalenvironments. |
| 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 sterilizationstatus |
| 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 predicatesﺮ | ame as predicates | ame as predicates | ame as predicates | ame as predicates | |
|---|---|---|---|---|---|
| Test in accordance with ISO1 0993 | Y es- | Yes | Yes | Salt Base Non-irritatingNon Toxic | |
| Yes | Yes | Yes | Yes | Non-irritatingNon ToxicSalt 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
§ 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).