Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and electrical performance of the electrodes, with no mention of AI or ML for data analysis or interpretation.

Therapeutic

No.
The device is described as electrodes for recording and monitoring equipment (EEG, EMG, EP), which are diagnostic tools, not therapeutic.

Diagnostic

Yes
Explanation: The device is used with recording and monitoring equipment for Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP), all of which are diagnostic procedures to assess neurological and muscular function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a set of physical electrodes, which are hardware components. The performance studies also focus on the physical and electrical properties of these electrodes.

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 clearly states the electrodes are for "non-invasive use with recording and monitoring equipment" for EEG, EMG, and EP. These are physiological measurements taken directly from the body's electrical activity.
Device Description: The description details electrodes that are applied to the scalp to pick up electrical signals.
Lack of In Vitro Activity: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not involve the analysis of such specimens.

The device is a medical device used for physiological monitoring, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable Gold Cup EEG Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).

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

GXY

Device Description

The EEG electrodes are provided to the healthcare provider in either a set of 10 which are typically used for sleep studies or a set of 15 which are used for EEG monitoring. Each set of electrodes are the same length, however, sets can be ordered in lengths varying from 1.0 to 3.0 meters. Each electrode within a set has a different color to aid in placement.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Scalp

Indicated Patient Age Range

Adults and children

Intended User / Care Setting

health care setting

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)

Non-Clinical Testing Summary -

Biocompatibility
Biocompatibility testing has been performed to the applicable ISO 10993 standards for an external communicating device with a limited duration surface contact of use. The testing supports the patient contacting materials as non-cytotoxic, non-sensitizers, non-irritants, and non-toxic.

Bench testing
We have performed electrical performance testing to the ANSI/AAMI EC12:2000/(R)2015 standard which show the electrodes meet the standard.

Performance bench testing has verified the electrodes will perform adequately through the duration of use of the device. Mechanical bond testing, surface adhesive testing demonstrates the device integrity exceeds requirements for the intended use.

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.

K180232, K072016

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

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2020

Dymedix Diagnostics, Inc. Todd Eiken Vice President of Product Development 5985 Rice Creek Parkway Shoreview, Minnesota 55126

Re: K192564

Trade/Device Name: Disposable Gold Cup EEG Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: September 12, 2019 Received: September 18, 2019

Dear Todd Eiken:

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 (QS) 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.

Heather Dean, Ph.D. Acting Assistant Director, Acute Injury Devices Team 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) K192564

Device Name Disposable Gold Cup EEG Electrodes

Indications for Use (Describe)

The Disposable Gold Cup EEG Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5 510(k) Summary

| Table 5.1

510(k) Summary (As required by section 21 CFR 807.92(c))
Submitter:	Dymedix Diagnostics
	5985 Rice Creek Parkway
	Shoreview, MN 55126
	1-888-212-1100
Contact Person:	Todd Eiken
	Email: teiken@dymedix.com
Date Prepared	09-12-2019
Type of 510(k)
Submission	Traditional
Reason for Submission	New Device
Multiple Devices	This is the only device in this submission
Trade Name:	Disposable Gold Cup EEG Electrodes
Common / Usual Name	Cutaneous electrodes
Classification Name	Electrode, cutaneous
Regulation Number	21 CFR §882.1320
Product Code	GXY, Cutaneous electrode
Establishment
Registration:	3009351773
Predicate Devices:	DAEHAN: Disposable CUP Electrodes
	Technomed Europe: Cup electrodes
Device Description	The EEG electrodes are provided to the healthcare provider in either a
	set of 10 which are typically used for sleep studies or a set of 15 which
	are used for EEG monitoring. Each set of electrodes are the same
	length, however, sets can be ordered in lengths varying from 1.0 to 3.0
	meters. Each electrode within a set has a different color to aid in
placement.
Intended Use	The Disposable Gold Cup EEG Electrodes are intended for non-
	invasive use with recording and monitoring equipment, (active and
	reference), of Electroencephalograph (EEG), electromyography
	(EMG), and Evoked Potentials (EP)
Technology and
Construction:	The technology and construction are similar to predicate in that
we are utilizing
Environment of Use	The environments of use are similar -clinical settings where sleep
studies may be performed.
Patient Population	The patient population is similar to the predicate namely, adults
and children

4

The Disposable Gold Cup EEG Electrodes are based on technical features. A comparison with regard to these characteristics were found to be substantially equivalent to predicate devices.

| Table 5.2
Device

Comparison	Proposed device	Predicate	Secondary Predicate
K Number
Model	K192564
Disposable Gold cup EEG
Electrodes	K180232
DAEHAN Disposable CUP
Electrode	K072016
Cup Electrodes
Manufacturer	Dymedix Diagnostics, Inc.	Daehan Medical Systems
Co., Ltd.	Technomed Europe
Classification	GXY
Neurology
21 CFR 882.1320	GXY
Neurology
21 CFR 882.1320	GXY
Neurology
21 CFR 882.1320
Device Class	Class II	Class II	Class II
Indications for
Use	The Disposable Gold Cup
EEG Electrodes are intended
for non-invasive used with
recording and monitoring
equipment, (active and
reference), of
Electroencephalograph
(EEG), Electromyography
(EMG), and Evoked
Potentials (EP)	The CUP Electrodes are
intended for non-invasive
use with recording and
monitoring equipment,
(active and reference), of
Electroencephalograph
(EEG), electromyography
(EMG), and Evoked
Potentials (EP)	The Cup Electrodes are
intended for non-invasive
use with recording and
monitoring equipment,
(active and reference), of
Electroencephalograph
(EEG), electromyography
(EMG), Evoked Potentials
(EP)
Anatomical
sites	Scalp	Scalp	Scalp
Cup
Diameter	10 mm	10 mm	10 mm
Leadwire
Length	1.0, 1.5, 2.0, 2.5	1.0, 1.5, 2.0, 2.5, 3.0M	1.0, 1.5, 2.0M
Cup material	Gold Plated brass	Ag/AgCl plated ABS	Gold Plated brass
Lead wire	PVC insulated tin plated
copper	PVC insulated tin plated
copper	PVC insulated tin plated
copper
Connectors	Molded touch proof 1.5 mm
DIN connector (DIN 42-802)	Molded touch proof 1.5 mm
DIN connector (DIN 42-

                                                                                                                                                                 | Molded touch proof 1.5 mm

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Table 5.2 compares the key features of the proposed Disposable Gold Cup EEG Electrodes with the identified predicates; K180232 – Daehan Disposable CUP Electrodes, and K072016 Technomed Europe Cutaneous Electrodes, which demonstrate that this proposed device can be found substantially equivalent.

In summary, one can conclude that substantial equivalence is met based upon the following:

Indications for Use -

The Indications for Use are identical. The electrodes can be used with Electroencephalograph (EEG), Electromyography (EMG), and Evoked Potentials (EP) monitoring equipment.

Technoloqy and construction -

The technology and construction are similar to predicate in that we are utilizing an electrode of similar shape and size to collect and transmit signals through the connection wires to the monitoring device. The electrode materials are different from Daehan siver/silver chloride, compared to the gold plated cups used in the Dymedix electrodes which provide equal or better signal sensitivity. However, the Diposable Gold Cup EEG Electrodes are identical to Technomed Europe Gold Cup Electrodes.

Environment of Use -

The environments of use are similar - healthcare settings where monitoring studies may be performed.

Patient Population -

The patient population is similar to the predicate namely, adults and children.

Non-Clinical Testing Summary -

Biocompatibility

Biocompatibility testing has been performed to the applicable ISO 10993 standards for an external communicating device with a limited duration surface contact of use. The testing supports the patient contacting materials as non-cytotoxic, non-sensitizers, non-irritants, and non-toxic.

Bench testing

We have performed electrical performance testing to the ANSI/AAMI EC12:2000/(R)2015 standard which show the electrodes meet the standard.

Performance bench testing has verified the electrodes will perform adequately through the duration of use of the device. Mechanical bond testing, surface adhesive testing demonstrates the device integrity exceeds requirements for the intended use.

Conclusion

As discussed. the indications for use, patient population, environment of use, and performance are substantially equivalent.