Disposable Gold Cup EEG Electrodes

K192564 · Dymedix Diagnostics, Inc. · GXY · Jan 21, 2020 · Neurology

Device Facts

• Record ID: K192564
• Device Name: Disposable Gold Cup EEG Electrodes
• Applicant: Dymedix Diagnostics, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jan 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric

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).

Device Story

Disposable Gold Cup EEG Electrodes function as cutaneous sensors for physiological signal acquisition. Device consists of gold-plated brass cup electrodes with PVC-insulated tin-plated copper lead wires terminating in 1.5 mm DIN connectors. Electrodes are applied to patient scalp by clinician using user-supplied conductive paste and optional adhesive tape. Electrodes collect electrical signals (EEG, EMG, EP) and transmit them to external recording/monitoring equipment. Used in clinical settings for sleep studies and neurological monitoring. Provides healthcare providers with raw signal data for diagnostic interpretation. Benefits include reliable signal transmission for non-invasive patient monitoring.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 confirmed materials are non-cytotoxic, non-sensitizing, non-irritating, and non-toxic. Electrical performance testing verified compliance with ANSI/AAMI EC12:2000/(R)2015. Mechanical bond and surface adhesive testing confirmed device integrity.

Technological Characteristics

Gold-plated brass cup electrodes (10 mm diameter); PVC-insulated tin-plated copper lead wires; 1.5 mm DIN connectors (DIN 42-802). Passive sensing principle. Non-sterile. Biocompatibility per ISO 10993. Electrical performance per ANSI/AAMI EC12:2000/(R)2015.

Indications for Use

Indicated for non-invasive use in adults and children for recording and monitoring EEG, EMG, and Evoked Potentials in clinical settings.

Regulatory Classification

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.

Predicate Devices

• DAEHAN: Disposable CUP Electrodes (K180232)
• Technomed Europe: Cup electrodes (K072016)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 5 510(k) Summary

| Table 5.1<br>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: [e-mail] |
| Date Prepared | 09-12-2019 |
| Type of 510(k)<br>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<br>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<br>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<br>Construction: | The technology and construction are similar to predicate in that<br>we are utilizing |
| Environment of Use | The environments of use are similar -clinical settings where sleep<br>studies may be performed. |
| Patient Population | The patient population is similar to the predicate namely, adults<br>and 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 5.2<br>Device<br>Comparison | Proposed device | Predicate | Secondary Predicate |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number<br>Model | K192564<br>Disposable Gold cup EEG<br>Electrodes | K180232<br>DAEHAN Disposable CUP<br>Electrode | K072016<br>Cup Electrodes |
| Manufacturer | Dymedix Diagnostics, Inc. | Daehan Medical Systems<br>Co., Ltd. | Technomed Europe |
| Classification | GXY<br>Neurology<br>21 CFR 882.1320 | GXY<br>Neurology<br>21 CFR 882.1320 | GXY<br>Neurology<br>21 CFR 882.1320 |
| Device Class | Class II | Class II | Class II |
| Indications for<br>Use | The Disposable Gold Cup<br>EEG Electrodes are intended<br>for non-invasive used with<br>recording and monitoring<br>equipment, (active and<br>reference), of<br>Electroencephalograph<br>(EEG), Electromyography<br>(EMG), and Evoked<br>Potentials (EP) | The CUP Electrodes are<br>intended for non-invasive<br>use with recording and<br>monitoring equipment,<br>(active and reference), of<br>Electroencephalograph<br>(EEG), electromyography<br>(EMG), and Evoked<br>Potentials (EP) | The Cup Electrodes are<br>intended for non-invasive<br>use with recording and<br>monitoring equipment,<br>(active and reference), of<br>Electroencephalograph<br>(EEG), electromyography<br>(EMG), Evoked Potentials<br>(EP) |
| Anatomical<br>sites | Scalp | Scalp | Scalp |
| Cup<br>Diameter | 10 mm | 10 mm | 10 mm |
| Leadwire<br>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<br>copper | PVC insulated tin plated<br>copper | PVC insulated tin plated<br>copper |
| Connectors | Molded touch proof 1.5 mm<br>DIN connector (DIN 42-802) | Molded touch proof 1.5 mm<br>DIN connector (DIN 42-<br>802) | Molded touch proof 1.5 mm<br>DIN connector (DIN 42-<br>802) |
| Sterilization<br>Method | Non Sterilization | Non Sterilization | Non Sterilization |
| Target<br>Population | Adults and children | Adults and children | Adults and children |
| Environment<br>of Use | health care setting | health care setting | health care setting |
| OTC or Rx | Rx only | Rx only | Rx only |
| Method of<br>Connection to<br>the Patient | Conductive paste (provided<br>by the user) provides<br>electrode adhesive and<br>conductivity. Additional<br>adhesive tapes may be used | Conductive paste (provided<br>by the user) provides<br>electrode adhesive and<br>conductivity. Additional<br>adhesive tapes may be used | Conductive paste provides<br>electrode adhesive and<br>conductivity. |

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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.