The Dome Electrode is an accessory designed for recording of biopotential signals. It is a non-invasive electrode that records biopotential signals from the surface of the skin. It has a standard mating thread that enables connection to electrical conductors of compatible devices. The Dome Electrode contains the following components: 316L Stainless Steel Dome Electrode, Stainless Steel Size 4-40 Nut, Stainless Steel Flat Washer, Stainless Steel Split ("Lock") Washer.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to compose the answer in the requested format. The document is an FDA 510(k) premarket notification for a medical device (Dome Electrode) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the text does not contain details about:

Acceptance Criteria Table with Reported Device Performance: No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned, nor are quantitative performance results against such criteria for the Dome Electrode itself in terms of signal processing or diagnostic accuracy. The "Result" column in the Non-Clinical Performance Data section only states "Pass" for various internal mechanical and electrical tests.
Sample Size for Test Set and Data Provenance: While "Signal Detection Test" and "Validation – Compatible Device" are listed, the document does not specify the sample size (number of subjects, number of electrode placements, duration of recording) for these tests, nor the origin of the data (country, retrospective/prospective).
Number of Experts and Qualifications for Ground Truth: There is no mention of experts establishing ground truth for any test set or their qualifications. The device is a cutaneous electrode for EMG, not an AI diagnostic tool requiring expert consensus for interpretation.
Adjudication Method: Not applicable as there's no mention of expert review or consensus.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for AI systems assisting human readers in interpreting images or data. The Dome Electrode is a physical medical device (electrode) and not an AI algorithm. Therefore, no MRMC study was conducted or reported.
Standalone Performance (Algorithm Only): The device is an electrode, not an algorithm. Standalone performance for an algorithm is not applicable.
Type of Ground Truth Used: The ground truth for electrode performance would typically be the physical properties of the electrical signals detected. There's no mention of a "ground truth" in the context of expert consensus, pathology, or outcomes data, as would be common for AI/diagnostic devices. The internal tests (voltage continuity, signal detection) likely assess the electrode's ability to pick up and transmit electrical signals, with "Pass" indicating it meets specifications.
Sample Size for Training Set & How Ground Truth for Training Set was Established: The device is hardware, not a machine learning model. Therefore, there is no "training set" in the context of AI.

The document primarily focuses on:

Biocompatibility Testing: Conformance to ISO 10993 standards (cytotoxicity, sensitization, irritation) with "passing results."
Physical and Electrical Performance: Internal tests for mechanical fit, voltage continuity, and signal detection, all reported as "Pass."
Comparison to a Predicate Device: Detailed comparison of technological characteristics (dimensions, materials, connection type, indications for use, mechanism of action) to establish substantial equivalence.

Given the nature of the device (a cutaneous electrode) and the content of the 510(k) submission, the study design and reporting requirements are very different from those for an AI/ML-based diagnostic device. The document states, "No human clinical testing was required to support the medical device as it was designed to conform to IEEE 2010-2012 Recommended Practice for Neurofeedback Systems. Cutaneous electrodes have been on the market for many years with proven safety and efficacy." This explicitly indicates that complex clinical studies, particularly those involving human interpretation or AI performance metrics, were not part of this submission for this particular device.

Summary

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April 4, 2019

Coapt, LLC Blair Lock Chief Executive Officer 222 W. Ontario Street, Unit #300 Chicago, Illinois 60654

Re: K190416

Trade/Device Name: Dome Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 13, 2019 Received: February 21, 2019

Dear Blair Lock:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190416

Device Name Dome Electrodes

Indications for Use (Describe)

The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

Type of Use (Select one or both, as applicable)
Research Use (Part 21 CFR 361.2, subpart D)
Over-The-Counter Use (21 CFR 361.2, subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for COAPT Complete Control. The word "COAPT" is written in a sans-serif font, with the "C" and "O" in orange and the "A," "P," and "T" in gray. There is an orange dot in the middle of the "A." Below the word "COAPT" is the phrase "COMPLETE CONTROL" in gray sans-serif font.

Abbreviated 510(k) Summary – Dome Electrode

1. Submitter Information

Manufacturer:	Coapt, LLC222 W. Ontario St., Suite 300Chicago, IL 60654
Contact Person:	Blair Lock, MScE, PengChief Executive Officer
Contact Information:	(844)262-7800 x700Blair.lock@coaptengineering.com
Date Prepared:	4/1/2019

2. Device Identification

Trade/Proprietary Name:	Dome Electrode
Common/Usual Name:	Cutaneous Electrode
Classification Name:	Electrode, cutaneous
Regulation Number:	21 CFR §882.1320
Product Code:	GXY, Cutaneous electrode
Device Class:	Class II
Classification Panel:	Neurology

3. Legally Marketed Predicate Device

510(k) Number	Device Name
K072016	Cup Electrodes

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Image /page/4/Picture/1 description: The image shows the logo for COAPT. The letters "COA" are in orange, and the letters "PT" are in gray. There is a small orange dot in the middle of the "A". Below the letters, the words "COMPLETE CONTROL" are written in gray.

4. Device Description

The Dome Electrode contains the following components:

. 316L Stainless Steel Dome Electrode
Stainless Steel Size 4-40 Nut ●
Stainless Steel Flat Washer ●
Stainless Steel Split ("Lock") Washer .

5. Indication for Use Statement

The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

6. Comparison to Predicate Devices

The following table compares the Dome Electrode to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials used, performance, and safety/performance testing. Although the Dome Electrodes were designed with conformance to IEEE 2010-2012 Recommended Practice for Neurofeedback Systems, the comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or efficacy based on the similarities to the predicate device.

Manufacturer:	Coapt, LLC	Technomed Europe	Device Comparison
Trade Name:	Dome Electrode	Cup Electrode
510(k) Number	K190416	K072016	Not applicable
Classification Product Code	GXY	GXY	Same
Regulation Number	21 CFR 882.1320	21 CFR 882.1320	Same
Regulation Name	Cutaneous electrode	Cutaneous electrode	Same

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Coapt, LLC Abbreviated 510(k) Premarket Submission Dome Electrode

Image /page/5/Picture/1 description: The image shows the logo for COAPT Complete Control. The word "COAPT" is written in large, bold letters, with the "C" and "O" in orange and the "A", "P", and "T" in gray. There is an orange dot in the middle of the "A". Below the word "COAPT" is the phrase "COMPLETE CONTROL" in smaller, gray letters.

Manufacturer:	Coapt, LLC	Technomed Europe	Device Comparison
Trade Name:	Dome Electrode	Cup Electrode
Indications forUse	The Dome Electrodes areintended for non-invasiveuse with recording andmonitoring equipment ofElectromyography (EMG).	The Cup Electrodes are intendedfor non-invasive use withrecording and monitoringequipment, (active and reference),of Electromyography (EMG),Electroencephalograph (EEG)and Evoked Potentials (EP).	Similar
Mechanism ofAction	Non-invasive transfer ofbiopotential signals	Non-invasive transfer ofbiopotential signals	Same
ElectrodeDimensions	Diameter - 9.525 mmSurface Area – 2.80 cm²	Diameter - 10 mmSurface Area – 1.87 cm²	Similar
Electrode ContactMaterial	316L Stainless Steel	Gold or Silver	Similar
Electroderesistivity as a %of typical skinimpedance	$3.57 \times 10^{-12}%$	$1.12 \times 10^{-13}%$	Similar - bothnegligiblecompared toskin resistanceof 1000 ohms
ElectrodeConnectionThread	Common thread stud	N/A - Permanently adhered to anelectrode lead wire	Different, butachieve thesame purpose
BiocompatibilityTesting Passed	ISO 10993-5: CytotoxicityISO 10993-10:SensitizationISO 10993-10: Irritation	Product datasheet says"Technomed electrodes are ISO10993 Biocompatibility certified"	AssumedSame

Both the Dome Electrode and listed predicated device are classified as product code: GXY, cutaneous electrodes under 21 CFR 882.1320. Both devices operate in the same manner - the non-invasive transfer of biopotential signals.

Electromyograph and Electroencephalogram operate on the same basic principal of detecting the electrical potentials generated by the body. Both use non-invasive cutaneous electrodes to record these signals. The intended use of the predicate Cup Electrode is for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The intended use of the Dome Electrode is primarily for non-invasive use with recording and monitoring equipment of Electromyography (EMG). The slight difference in the intended use of the subject device compared to the reference device does not raise any concerns of safety or effectiveness. Both the subject device and predicate device can be used to detect EMG signals, but the predicate device has the additional indications for being used for detecting EEG signals and evoked

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Image /page/6/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "COA" are in orange, while the letters "PT" are in gray. Below the letters is the text "COMPLETE CONTROL" in a smaller font size.

potentials. The Dome Electrode and predicate Cup Electrode are both recording the electrical potentials passively. Both the Dome Electrode and Cup Electrode are able to detect these biopotential signals because they create an equipotential surface that conduct the electrical potentials.

The use/field of application for the Dome Electrode and predicate slightly differ. Both the Dome Electrode and the predicate record biopotential signals from cutaneous locations, they have just been optimized for different cutaneous locations. The predicate Cup Electrodes, are optimized for use on the scalp. The Dome Electrodes are optimized for use on the surface of the skin. The difference in target location of the referenced device and predicate device do not raise any concerns of safety, as the Dome Electrodes have also been tested to meet the biocompatibility requirements of ISO 10993-5, and ISO 10993-10.

The Dome Electrode and predicate device share similar physical dimensions and shape. Thev both have a diameter between 9 and 10 mm. Both the Dome Electrode and Cup Electrode share a semi-spherical shape for the contacting surface of the electrodes. The only major difference in the physical dimensions of the Dome Electrode and Cup Electrode are the surface area. This difference in surface area is due to the fact that the semi-spherical contact area of the Cup Electrode is a ring shape with a hollow center. The difference in surface area of the contacting surfaces of the Dome Electrode and predicate do not cause any concerns of safety. The Dome Electrode has also passed performance testing demonstrating the ability to detect quality EMG signals from cutaneous locations on a user.

The Dome Electrode contacting surface is made from 316L Stainless Steel. The material of the contacting surface for the predicate Cup Electrode is made from gold or silver. The goal in designing the Dome Electrodes was to create a surface electrode for recording EMG signals that was reusable, biocompatible, and cost effective. The Dome Electrodes underwent performance testing to assess the conductivity of EMG signals. The Dome Electrodes passed all performance testing for EMG signal detection. Additionally, the Dome Electrode was tested for conformance to the biocompatibility specifications of ISO 10993-5 for cytotoxicity, ISO 10993-10 for skin sensitization, and ISO 10993-10 for irritation. Because of the ISO 10993 biocompatibility testing results, and wide spread use of 316L Stainless Steel in the medical industry, the difference in material used does not raise any concerns of safety for the Dome Electrodes. The 316L Stainless Steel was chosen as the material for the Dome Electrode because it fits the intended application of a reusable, biocompatible, lowcost EMG surface electrode.

As with the predicate, the Dome Electrode is designed to operate with a wide range of compatible devices. The Dome Electrode can be connected to compatible devices through a standard sized threaded stud. It is not permanently connected to any electrode leads. The predicate electrodes are permanently adhered to an electrode lead wire and this wire is what is connected to compatible devices. The differences in electrode connection do not raise any concerns of safety or effectiveness of the Dome Electrode, they are simply alternative means of connection to compatible devices. The method of connection of the Dome Electrode does not have an effect on its ability to detect EMG signals.

The Dome Electrode was tested for conformance to the biocompatibility specifications of ISO 10993-5 for cytotoxicity, ISO 10993-10 for skin sensitization, and ISO 10993-10 for

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Coapt, LLC Abbreviated 510(k) Premarket Submission Dome Electrode

Image /page/7/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "CO" are in orange, while the letters "APT" are in gray. Underneath the logo, the words "COMPLETE CONTROL" are written in gray.

irritation. The Technomed product manual for the predicate Cup Electrodes states that "Technomed electrodes are ISO 10993 Biocompatibility certified." It does not state the exact ISO 10993 tests that the Cup Electrodes have passed, but it can be assumed that it would have undergone the same biocompatibility tests as the Dome Electrodes because it would also be classified as a prolonged (B), skin contact, surface device under ISO 10993-1. Therefore, it would undergo testing for cytotoxicity, skin sensitization, and irritation. The Dome Electrodes underwent biocompatibility testing for these requirements and received passing results.

7. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the Dome Electrode and in showing conformance to the recognized consensus standard IEEE 2010-2012 Recommended Practice for Neurofeedback Systems that are subject to this Abbreviated 510(k) submission, Coapt, LLC completed a number of non-clinical performance tests. The Dome Electrode meets all the requirements for overall design, safety, and biocompatibility results, confirming that the design output meets the design inputs and specifications for the device.

The Dome Electrode passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support safety and efficacy of the subject device:

IEEE 2010-2012 Recommended Practice for Neurofeedback Systems .
. ISO 10993-1: 2009/(R)2013 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process

The Dome Electrodes were also tested internally to ensure that it meets device specifications & requirements and operates as intended. The following validation testing was performed on the finished device:

Test Name	Result
Mechanical Fit Test	Pass
Voltage Continuity Test	Pass
Signal Detection Test	Pass
Validation – Compatible Device – CoaptCOMPLETE CONTROL System	Pass

8. Clinical Performance Data

No human clinical testing was required to support the medical device as it was designed to conform to IEEE 2010-2012 Recommended Practice for Neurofeedback Systems. Cutaneous electrodes have been on the market for many vears with proven safety and efficacy. The non

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Coapt, LLC Abbreviated 510(k) Premarket Submission Dome Electrode

Image /page/8/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "COA" are in orange, while "PT" is in gray. Below the letters is the phrase "COMPLETE CONTROL" in gray.

clinical testing detailed in this submission supports substantial safety and efficacy when used for its intended purposes.

9. Statement of Substantial Equivalence to Predicate Device

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The technological characteristics between the Dome Electrode and predicate are remarkably similar and therefore substantially equivalent. The slight differences between devices do not raise new questions of safety and effectiveness as compared to the predicate as the Dome Electrodes have received passing results for biocompatibility testing for cytotoxicity, irritation, and sensitization; and passing results for performance testing of mechanical fit, voltage continuity, signal detection, and validation testing with a compatible device.

The Dome Electrode, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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).