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).

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the Dymedix Diagnostics Disposable Gold Cup EEG Electrodes (K192564), based on the provided document:

This document is a 510(k) clearance letter, which means the device is being cleared based on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to establish its efficacy and safety from scratch. Therefore, the "study" described focuses on bench testing and biocompatibility to show that the new device performs comparably to established devices.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Requirement	Reported Device Performance / Evidence
Indications for Use	Identical to predicate device: Non-invasive use with recording and monitoring equipment for EEG, EMG, and EP.	The device's Indications for Use are identical to the predicate devices. The electrodes can be used with Electroencephalograph (EEG), Electromyography (EMG), and Evoked Potentials (EP) monitoring equipment.
Technology & Construction	Similar to predicate device, with comparable signal collection and transmission.	The technology and construction are similar to the predicate devices, utilizing an electrode of similar shape and size to collect and transmit signals through connection wires to the monitoring device. The electrode materials are different from Daehan (silver/silver chloride vs. gold plated), but the Dymedix electrodes are identical to Technomed Europe Gold Cup Electrodes in material (gold plated brass) indicating equal or better signal sensitivity.
Environment of Use	Similar to predicate device: Healthcare settings where monitoring studies may be performed.	The environments of use are similar to the predicate devices: healthcare settings where monitoring studies may be performed.
Patient Population	Similar to predicate device: Adults and children.	The patient population is similar to the predicate devices: adults and children.
Biocompatibility	Meet applicable ISO 10993 standards for external communicating device with limited duration surface contact.	Biocompatibility testing performed to applicable ISO 10993 standards. Patient contacting materials are reported as non-cytotoxic, non-sensitizers, non-irritants, and non-toxic.
Electrical Performance	Meet the ANSI/AAMI EC12:2000/(R)2015 standard.	Electrical performance testing was performed to the ANSI/AAMI EC12:2000/(R)2015 standard, and the electrodes are reported to meet the standard.
Mechanical Integrity	Adequate performance throughout device use, exceeding requirements.	Performance bench testing verified the electrodes will perform adequately through the duration of use. Mechanical bond testing and surface adhesive testing demonstrate the device integrity exceeds requirements for the intended use.

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or clinical images. The data provenance is from bench testing for electrical, mechanical, and biocompatibility properties. No specific "sample sizes" (e.g., number of electrodes tested for each bench test) are provided in this summary, which is typical for 510(k) summary documents. The testing is prospective in the sense that the manufacturer conducted these tests specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. "Ground truth" in this type of submission refers to established engineering standards (like ISO 10993 and ANSI/AAMI EC12) and the technical specifications of the predicate devices. Experts involved would be those qualified to conduct and interpret the specified standard tests (e.g., test engineers, toxicologists for biocompatibility), but their specific number and qualifications are not detailed here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical trials or image annotation, which are not described here.
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:
- No MRMC study was done. This device is a passive EEG electrode and does not involve AI or human reader interpretation for its function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware component (electrode), not an algorithm or software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence relies on:
  - Industry standards: ISO 10993 for biocompatibility, ANSI/AAMI EC12:2000/(R)2015 for electrical performance.
  - Predicate device specifications: The technical characteristics, indications for use, and performance of the legally marketed predicate devices (K180232 Daehan Disposable CUP Electrodes and K072016 Technomed Europe Cup Electrodes).
The sample size for the training set:
- Not applicable. There is no "training set" as this is a hardware device, not an AI/ML algorithm requiring data for training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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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)

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 5.1510(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
EstablishmentRegistration:	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 inplacement.
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 andConstruction:	The technology and construction are similar to predicate in thatwe are utilizing
Environment of Use	The environments of use are similar -clinical settings where sleepstudies may be performed.
Patient Population	The patient population is similar to the predicate namely, adultsand children

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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 5.2DeviceComparison	Proposed device	Predicate	Secondary Predicate
K NumberModel	K192564Disposable Gold cup EEGElectrodes	K180232DAEHAN Disposable CUPElectrode	K072016Cup Electrodes
Manufacturer	Dymedix Diagnostics, Inc.	Daehan Medical SystemsCo., Ltd.	Technomed Europe
Classification	GXYNeurology21 CFR 882.1320	GXYNeurology21 CFR 882.1320	GXYNeurology21 CFR 882.1320
Device Class	Class II	Class II	Class II
Indications forUse	The Disposable Gold CupEEG Electrodes are intendedfor non-invasive used withrecording and monitoringequipment, (active andreference), ofElectroencephalograph(EEG), Electromyography(EMG), and EvokedPotentials (EP)	The CUP Electrodes areintended for non-invasiveuse with recording andmonitoring equipment,(active and reference), ofElectroencephalograph(EEG), electromyography(EMG), and EvokedPotentials (EP)	The Cup Electrodes areintended for non-invasiveuse with recording andmonitoring equipment,(active and reference), ofElectroencephalograph(EEG), electromyography(EMG), Evoked Potentials(EP)
Anatomicalsites	Scalp	Scalp	Scalp
CupDiameter	10 mm	10 mm	10 mm
LeadwireLength	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 platedcopper	PVC insulated tin platedcopper	PVC insulated tin platedcopper
Connectors	Molded touch proof 1.5 mmDIN connector (DIN 42-802)	Molded touch proof 1.5 mmDIN connector (DIN 42-802)	Molded touch proof 1.5 mmDIN connector (DIN 42-802)
SterilizationMethod	Non Sterilization	Non Sterilization	Non Sterilization
TargetPopulation	Adults and children	Adults and children	Adults and children
Environmentof Use	health care setting	health care setting	health care setting
OTC or Rx	Rx only	Rx only	Rx only
Method ofConnection tothe Patient	Conductive paste (providedby the user) provideselectrode adhesive andconductivity. Additionaladhesive tapes may be used	Conductive paste (providedby the user) provideselectrode adhesive andconductivity. Additionaladhesive tapes may be used	Conductive paste provideselectrode adhesive andconductivity.

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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.

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).