(42 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a simple electrode, with no mention of data processing or algorithmic analysis that would suggest AI/ML.
No
The device is described as an accessory for recording biopotential signals (EMG) and does not inherently provide therapy.
Yes
Explanation: The device is used with recording and monitoring equipment of Electromyography (EMG), which is a diagnostic procedure used to assess the health of muscles and the nerve cells that control them. The device records biopotential signals, which are then interpreted to diagnose conditions.
No
The device description explicitly details physical components (stainless steel dome electrode, nuts, washers) and describes it as an accessory for recording biopotential signals from the skin surface, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for non-invasive use with recording and monitoring equipment of Electromyography (EMG). This involves measuring electrical signals from muscles, which is a physiological measurement from the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as an accessory for recording biopotential signals from the surface of the skin. This aligns with in-vivo measurements, not in-vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in-vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to acquire electrical signals directly from the body's surface.
N/A
Intended Use / Indications for Use
The Dome Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).
Product codes
GXY
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Performance Data:
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:
- Mechanical Fit Test: Pass
- Voltage Continuity Test: Pass
- Signal Detection Test: Pass
- Validation – Compatible Device – Coapt COMPLETE CONTROL System: Pass
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 years with proven safety and efficacy. The non clinical testing detailed in this submission supports substantial safety and efficacy when used for its intended purposes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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, LLC
222 W. Ontario St., Suite 300
Chicago, IL 60654 |
|----------------------|------------------------------------------------------------------|
| Contact Person: | Blair Lock, MScE, Peng
Chief Executive Officer |
| Contact Information: | (844)262-7800 x700
Blair.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 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 .
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 for | |||
| Use | The Dome Electrodes are | ||
| intended for non-invasive | |||
| use with recording and | |||
| monitoring equipment of | |||
| Electromyography (EMG). | The Cup Electrodes are intended | ||
| for non-invasive use with | |||
| recording and monitoring | |||
| equipment, (active and reference), | |||
| of Electromyography (EMG), | |||
| Electroencephalograph (EEG) | |||
| and Evoked Potentials (EP). | Similar | ||
| Mechanism of | |||
| Action | Non-invasive transfer of | ||
| biopotential signals | Non-invasive transfer of | ||
| biopotential signals | Same | ||
| Electrode | |||
| Dimensions | Diameter - 9.525 mm | ||
| Surface Area – 2.80 cm² | Diameter - 10 mm | ||
| Surface Area – 1.87 cm² | Similar | ||
| Electrode Contact | |||
| Material | 316L Stainless Steel | Gold or Silver | Similar |
| Electrode | |||
| resistivity as a % | |||
| of typical skin | |||
| impedance | $3.57 \times 10^{-12}%$ | $1.12 \times 10^{-13}%$ | Similar - both |
| negligible | |||
| compared to | |||
| skin resistance | |||
| of 1000 ohms | |||
| Electrode | |||
| Connection | |||
| Thread | Common thread stud | N/A - Permanently adhered to an | |
| electrode lead wire | Different, but | ||
| achieve the | |||
| same purpose | |||
| Biocompatibility | |||
| Testing Passed | ISO 10993-5: Cytotoxicity | ||
| ISO 10993-10: | |||
| Sensitization | |||
| ISO 10993-10: Irritation | Product datasheet says | ||
| "Technomed electrodes are ISO | |||
| 10993 Biocompatibility certified" | Assumed | ||
| Same |
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 – Coapt | |
| COMPLETE 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.