Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.

Device Description

The Elefix V Paste for EEG & EMG is the electroconductive media used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. The Elefix V Paste for EEG & EMG is an aqueous based material with Sodium Chloride as the conductive material combined with emulsifiers, humectants and preservatives. The Elefix V Paste for EEG & EMG has been designed to have increased stiffness and improved temperature resistance compared to its predecessor, the predicate device. These changes allow the paste to stay in place better as desired by its users. The Elefix V Paste for EEG & EMG has a neutral pH compared to the slightly alkaline pH of the predicate.

The Elefix V Paste for EEG & EMG is available in two models: ZV-401E and ZV-181E. ZV-401E is a container filled with 400 g of the paste. ZV-181E is a tube filled with 180g of the paste.

The Elefix V Paste for EEG & EMG is intended to be used by qualified medical personnel within a medical facility. It can be used with electrodes for electroencephalography (EEG) and electromyography (EMG) examination.

AI/ML Overview

The document provided details for the Elefix V Paste for EEG & EMG, an electroconductive media. While the document discusses performance data and various tests conducted, it does not contain information typically associated with studies demonstrating the performance of AI/ML-driven medical devices, such as those related to effect size, human readers with or without AI assistance, or details on ground truth establishment for training sets.

Here's the information that could be extracted from the provided text, primarily related to bench testing of the device's physical properties:

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Elefix V Paste)
Impedance (at 50Hz)	1 kΩ or less	1 kΩ or less
pH	8.5 to 9.5	6.5 to 8.5
Conductivity	1.08 S/m	1.04 S/m
Stiffness (using curdmeter)	25 to 50	35 to 50
Temperature Resistance	NA	Yes

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "performance testing" and "design verification and validation testing," but does not specify the sample size for these tests for pH, impedance, stiffness, or temperature resistance. The data provenance is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the tests conducted were for physical and chemical properties of a conductive paste, not for diagnostic accuracy or interpretation requiring expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the tests conducted were for physical and chemical properties and did not involve human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is an electroconductive paste, not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is an electroconductive paste, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the physical property tests, the "ground truth" or reference was based on established physical and chemical measurement standards for impedance, pH, conductivity, and stiffness. For biocompatibility, it was based on ISO 10993 standards.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set."

Summary

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February 7, 2020

Nihon Kohden Corporation % Natalie Kennel Quality & Regulatory Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129

Re: K191975

Trade/Device Name: Elefix V Paste for EEG & EMG Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: January 6, 2020 Received: January 8, 2020

Dear Natalie Kennel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191975

Device Name Elefix V Paste for EEG & EMG

Indications for Use (Describe)

Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary – K191975

Sponsor:	Nihon Kohden Corporation1-31-4 Nishiochiai, Shinjuku-KuTokyo, Japan 161-8560
Initial Importer:	Nihon Kohden America15353 Barranca ParkwayIrvine, CA
Contact:	Natalie KennelConsultantNJK & Associates, Inc.13721 Via Tres VistaSan Diego, CA 92129Phone: (858) 705-0350Fax: (858) 764-9739Email: nkennel@njkconsulting.com

Date Prepared: February 6, 2020

DEVICE INFORMATION:

Proprietary Name:	Elefix V Paste for EEG & EMG
Common Name:	Electroconductive Media
Classification:	Class II
Product Code:	GYB
Regulations:	21 CFR 882.1275
Classification Panel:	Neurology

PRODUCT DESCRIPTION:

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predicate device. These changes allow the paste to stay in place better as desired by its users. The Elefix V Paste for EEG & EMG has a neutral pH compared to the slightly alkaline pH of the predicate.

The Elefix V Paste for EEG & EMG is available in two models: ZV-401E and ZV-181E. ZV-401E is a container filled with 400 g of the paste. ZV-181E is a tube filled with 180g of the paste.

INDICATIONS FOR USE:

Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.

For prescription use only

PREDICATE DEVICES:

Table 1 contains information about the predicate device.

Table 1 Predicate Device Information

510(k)	Product	510(k) Holder	Clearance Date
K860210	Elefix EEG Electrode Cream	Nihon Kohden Corporation	07/01/1986

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Table 2 is a detailed comparison of the Elefix V Paste for EEG & EMG and its predicate Nihon Kohden Elefix EEG Electrode Cream (K860210). The Elefix V Paste for EEG & EMG has the same intended use, same intended population, and is the same or similar in most physical and chemical attributes. The chemical composition differences are primarily to remove some ingredients to increase the subject device's performance by increasing stiffness and temperature resistance. The subject device has more neutral pH than the predicate device. All other attributes are the same as the predicate device.

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Table 2 Comparison of the Elefix V Paste for EEG & EMG and its predicate
Characteristics	Elefix V Paste for EEG & EMG(this submission)	Nihon Kohden Elefix EEGElectrode Cream (K860210)	Comparison
Classification Panel	Neurology	Neurology	Same
Classification Name	Electroconductive media(21 CFR 882.1275)	Electroconductive media(21 CFR 882.1275)	Same
Regulatory Class	II	II	Same
Product Code	GYB	GYB	Same
Intended Use	ElefixV Paste for EEG & EMG is theelectroconductive media used with externalelectrode to reduce the impedance (resistanceto alternating current) of the contact betweenthe electrode surface and the skin.	Elefix is the electroconductive mediaused with external electrode to reducethe impedance (resistance toalternating current) of the contactbetween the electrode surface and theskin.	Same intended use.
Indications for Use	Elefix V Paste for EEG & EMG is aconductive paste used with surface electrodesto lower skin-electrode impedance. It can beused with electrodes for EEG and EMGexamination.	The Elefix EEG Cream is designed forattaching Nihon Kohden electrodes inEEG measuring.	Substantially equivalent.The subject device has the same intendeduse as the predicate device. There is nodifference in functionality required ofelectroconductive media between EEG andEMG. Therefore, this difference does notraise different issue of safety oreffectiveness.
Patient population	Adults and pediatrics	Adults and pediatrics	Same
	Elefix V Paste for EEG & EMG	Nihon Kohden Elefix EEG
Characteristics	(this submission)	Electrode Cream (K860210)	Comparison
Composition(function ofingredient)	Water (solvent)Oleth-30 (emulsifier)PEG-60 hydrogenated castor oil(emulsifier)Calcium carbonate (opacifier)Petrolatum (base)Glycerin (humectant)Sodium chloride (conductive material)Propylene glycol (humectant)PEG-40 hydrogenated castor oil(emulsifier)Cetyl alcohol (emollient)BHT (antioxidant)Methylparaben (preservative)Propylparaben (preservative)	Water (solvent)Polyoxyethylene oleyletherphosphate (emulsifier)Glycerin (humectant)Calcium carbonate (opacifier)Liquid petrolatum (base)Propylene glycol (humectant)Lanolin alcohol (emollient)Sodium chloride (conductivematerial)Sodium hydroxide (pH control)Polyoxyethylene hydrogenatedlanolin (emulsifier)Coconut fatty aciddiethanolamide (emulsifier)Polyoxyethylene stearylether(emulsifier)Oleth-30 (emulsifier)BHT (antioxidant)Methylparaben (preservative)Propylparaben (preservative)	Substantially equivalent.Although the subject device and thepredicate device have some difference incomposition, the subject device includesthe same or substantially equivalentingredients as the predicate Theingredients included in the subject devicehave functionality same as the ingredientsincluded in the predicate. Thesedifferences do not raise different issue ofsafety or effectiveness.
Patient Contact	Intact Skin	Intact Skin	Same
Single-use	Yes	Yes	Same
Sterile	Non-Sterile	Non-Sterile	Same
Biocompatibility	Complies with ISO 10993-1	Complies with ISO 10993-1	Same
Shelf Life	24 Months	24 Months	Same
Impedance	1 kΩ or less at 50Hz	1 kΩ or less at 50Hz	Same
pH	6.5 to 8.5	8.5 to 9.5	DifferentAlthough the subject device and thepredicate device have the difference in pH,the subject device is closer to neutral pH.This difference does not raise differentissue of safety or effectiveness.
Conductivity	1.04 S/m	1.08 S/m	Substantially equivalent
Characteristics	Elefix V Paste for EEG & EMG(this submission)	Nihon Kohden Elefix EEGElectrode Cream (K860210)	Comparison
Stiffness (usingcurdmeter)	35 to 50	25 to 50	DifferentBy design, the subject device is stiffer thanthe predicate device. The stiffness rangefor the subject device is tighter than thepredicate. This difference does not raisedifferent issue of safety or effectiveness.
TemperatureResistance	Yes	NA	DifferentBy design, the subject device is stiffer thanthe predicate device to provide increasedtemperature resistance compared to thepredicate device. This difference does notraise different issue of safety oreffectiveness.

Table 2, Comparison of the Elefix V Paste for FFG & FMG and its predicate

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PERFORMANCE DATA

The safety and effectiveness of the Elefix V were established and the substantial equivalence determination was supported by a series of performance testing, including biocompatibility testing, shelf life testing, and physical property testing. The physical properties testing included impedance testing, pH testing, stiffness testing and temperature resistance testing were conducted across the environmental operating range for the Elefix V Paste for EEG & EMG. The subject device met all acceptance criteria which were informed by the predicate device. There are minor differences in pH, stiffness, and temperature resistance of the Elefix V Paste for EEG & EMG compared to the predicate device. These differences are by design to improve product performance and do not raise different issues of safety or effectiveness.

BIOCOMPATIBILITY

The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards. This evaluation of the device included relevant data sources related to biological safety of finished device testing, component material history of safe biological use and testing, and where applicable, safe previous use in previously cleared product. This biocompatibility evaluation establishes the biological safety for the Elefix V Paste for EEG & EMG.

SHELF LIFE TESTING

The Elefix V Paste is a single use, non-sterile material.

The Elefix V Paste for EEG & EMG has been validated for product shelf life. In use stability has been validated for the product's ability to withstand an open container condition for an extended time at worst case operating environmental conditions of high temperature and low humidity.

BENCH TESTING

The Elefix V Paste for EEG & EMG has been subjected to design verification and validation testing for operational performance for pH, impedance, stiffness, and temperature resistance across its stated environmental operating and storage range.

CONCLUSION

The device comparison and the results of the above listed performance testing indicate that the Nihon Kohden Elefix V Paste for EEG & EMG is substantially equivalent to the predicate device, Nihon Kohden Elefix EEG Electrode Cream (K860210), and the minor differences raises no different issues of safety or effectiveness.

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).