(28 days)
The ControlSeal Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).
The ControlSeal 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 ControlSeal Electrode contains the following components:
- . 316L Stainless Steel ControlSeal Electrode Dome
- Passivated 18-8 Stainless Steel Phillips Flat Head 2-56 Screw .
- Stainless Steel Tooth Lock Washer .
- . Protective Cap
- Conducting Ring-Terminal .
- Buna-N Rubber O-Ring .
This FDA 510(k) summary describes the ControlSeal Electrode (ELSB), a cutaneous electrode intended for non-invasive use with Electromyography (EMG) recording and monitoring equipment. The submission seeks to demonstrate substantial equivalence to a predicate device, the Dome Electrode (K190416).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Tests | ||
| IEEE 2010-2012 Recommended Practice for Neurofeedback Systems | Conformance to the recommended practices for neurofeedback systems, implying appropriate electrical characteristics for the intended use and safe operation. (Implied from text) | Passed |
| ISO 10993-1: 2009/(R)2013 Biological evaluation of medical devices | Biocompatibility requirements per ISO 10993-1, including evaluation and testing within a risk management process. (Implied from text) | Passed |
| ISO 10993-5 (Cytotoxicity) (Predicate Device) | No cytotoxic effects. (This was for the predicate, but the subject device justified equivalence based on material and prior testing). | Passed |
| ISO 10993-10 (Sensitization) (Predicate Device) | No skin sensitization. (This was for the predicate, but the subject device justified equivalence based on material and prior testing). | Passed |
| ISO 10993-10 (Irritation) (Predicate Device) | No skin irritation. (This was for the predicate, but the subject device justified equivalence based on material and prior testing). | Passed |
| Mechanical Fit Test (Internal) | Device fits mechanically as intended, likely ensuring proper connection to compatible equipment. (Implied expectation for a "Pass" result) | Pass |
| Voltage Continuity Test (Internal) | Demonstrates proper electrical conductivity through the electrode. (Implied expectation for a "Pass" result) | Pass |
| Signal Detection Test (Internal) | Ability to detect quality EMG signals from cutaneous locations. (Explicitly stated in text) | Pass |
| Mechanical Strength Test (Internal) | Device integrity and durability under expected mechanical stresses. (Implied expectation for a "Pass" result) | Pass |
| Sealing Test (Internal) | Ensures the device's sealing integrity, likely to protect internal components or prevent fluid ingress. (Implied expectation for a "Pass" result) | Pass |
| Validation – Compatible Device – Coapt COMPLETE CONTROL System Gen2 | Interoperability and functional compatibility with the specified Coapt system. (Implied expectation for a "Pass" result) | Pass |
| Validation – Compatible Device – Coapt Evaluation Kit | Interoperability and functional compatibility with the specified Coapt evaluation kit. (Implied expectation for a "Pass" result) | Pass |
| Comparison to Predicate Device | ||
| Indications for Use | Same as predicate (non-invasive use with recording and monitoring equipment of Electromyography (EMG)). | Same |
| Use/Field of Application | Compatible with most EMG equipment used globally. | Same |
| Mechanism of Action | Non-invasive transfer of biopotential signals. | Same |
| Electrode Dimensions (Diameter, Surface Area) | Similar to predicate (ControlSeal: Dia 9.906mm, Area 2.73cm2; Predicate: Dia 9.525mm, Area 2.80cm2). The text states "Similar" and that the difference "do not cause any concerns of safety". | Similar |
| Electrode Contact Material | 316L Stainless Steel. | Same |
| Electrode resistivity as a % of typical skin impedance | $3.57 x 10^{-12}%$ (calculated based on material, assumed to be same as predicate). | Same |
| Electrode Connection Thread | Different standard thread sizes than predicate (ControlSeal: 2-56; Predicate: 4-40), but "achieve the same purpose" and "do not raise any concerns of safety or effectiveness." | Similar |
Note: The acceptance criteria for the internal tests (Mechanical Fit, Voltage Continuity, etc.) are inferred from the "Pass" result and the general purpose of such tests in medical device validation. The document states "The ControlSeal 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," which serves as a general overarching acceptance statement for these tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the non-clinical performance data. It mentions "The ControlSeal Electrodes were also tested internally to ensure that it meets device specifications & requirements and operates as intended." No specific number of electrodes or test subjects is provided for these internal tests (Mechanical Fit, Voltage Continuity, Signal Detection, etc.).
There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because no human clinical or retrospective study data is presented. The studies are non-clinical (bench testing) and "internal."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical (bench) study. There was no "ground truth" derived from expert interpretation of images or patient data. The ground truth for the non-clinical tests would be the established engineering specifications and recognized consensus standards (IEEE 2010-2012 and ISO 10993-1).
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication involved as this was a non-clinical (bench) study. The results of the tests (e.g., "Pass") were determined by comparison to predefined specifications or standard requirements.
5. 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
Not applicable. This device is a cutaneous electrode for EMG, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a passive medical device (electrode), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests conducted would be the established engineering specifications, performance standards as defined by the company's design inputs, and the requirements of recognized consensus standards such as IEEE 2010-2012 and ISO 10993-1. For example, for the "Signal Detection Test," the ground truth would be the ability to reliably detect EMG signals of a certain quality, as defined by the specific test protocol. For mechanical tests, it would be compliance with dimensional tolerances, strength requirements, etc.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no mention of a training set as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows 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.
December 30, 2022
Coapt Kevin Dwyer Regulatory Compliance & Legal Affairs Manager 303 W. Institute Pl. Suite 200 Chicago, Illinois 60610
Re: K223605
Trade/Device Name: ControlSeal Electrode (ELSB) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 1, 2022 Received: December 2, 2022
Dear Kevin Dwyer:
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.
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
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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 L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223605
Device Name ControlSeal Electrode (ELSB)
Indications for Use (Describe)
The ControlSeal Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary - ControlSeal Electrode
1. Submitter Information
| Manufacturer: | Coapt, LLC303 W. Institute Pl. Suite 200Chicago, IL 60610 |
|---|---|
| Contact Person: | Kevin DwyerRegulatory Compliance & Legal AffairsManager |
| Contact Information: | (844)262-7800 x716kevin.dwyer@coaptengineering.com |
| Date Prepared: | 12/01/2022 |
2. Device Identification
| Trade/Proprietary Name: | ControlSeal 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 |
|---|---|
| K190416 | Dome Electrodes |
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Image /page/4/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "COA" are in orange, and the letters "PT" are in gray. Below the letters is the text "COMPLETE CONTROL" in gray.
4. Device Description
The ControlSeal 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 ControlSeal Electrode contains the following components:
- . 316L Stainless Steel ControlSeal Electrode Dome
- Passivated 18-8 Stainless Steel Phillips Flat Head 2-56 Screw .
- Stainless Steel Tooth Lock Washer .
- . Protective Cap
- Conducting Ring-Terminal .
- Buna-N Rubber O-Ring .
5. Indication for Use Statement
The ControlSeal 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 ControlSeal Electrode to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials used, performance, and safety/performance testing. The subject device does not raise any new issues of safety or efficacy based on the similarities to the predicate device.
| Manufacturer: | Coapt, LLC | Coapt, LLC | DeviceComparison |
|---|---|---|---|
| Trade Name: | ControlSeal Electrode | Dome Electrode | |
| 510(k) Number | TBD | K190416 | Not applicable |
| ClassificationProduct 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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Image /page/5/Picture/1 description: The image shows the logo for COAPT. The letters "CO" are in orange, while the letters "APT" are in gray. Below the letters is the phrase "COMPLETE CONTROL" in gray.
| Indications for Use | The ControlSeal Electrodesare intended for non-invasiveuse with recording andmonitoring equipment ofElectromyography (EMG). | The Dome Electrodes areintended for non-invasive usewith recording andmonitoring equipment ofElectromyography (EMG). | Same |
|---|---|---|---|
| Use/Field ofApplication | The Coapt ControlSealElectrodes are compatiblewith most of the EMGequipment that are used inthe world. | The Coapt Dome Electrodesare compatible with most ofthe EMG equipment that areused in the world. | Same |
| Mechanism ofAction | Non-invasive transfer ofbiopotential signals | Non-invasive transfer ofbiopotential signals | Same |
| ElectrodeDimensions | Diameter - 9.906 mmSurface Area – 2.73 cm2 | Diameter - 9.525 mmSurface Area – 2.80 cm2 | Similar |
| Electrode ContactMaterial | 316L Stainless Steel | 316L Stainless Steel | Same |
| Electrode resistivityas a % of typicalskin impedance | $3.57 x 10^{-12}%$ | $3.57 x 10^{-12}%$ | Same |
| ElectrodeConnection Thread | Common thread stud | Common thread stud | Similar.Differentstandardthread sizes,but achieve thesame purpose. |
| BiocompatibilityTesting Passed | See ControlSeal ISO 10993Biocompatibility Discussion | ISO 10993-5: CytotoxicityISO 10993-10: SensitizationISO 10993-10: Irritation | Similar |
Both the ControlSeal Electrode and the predicate, Dome Electrode 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.
The intended use of the predicate Dome Electrode is for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG). The intended use of the ControlSeal Electrode the same - for non-invasive use with recording and monitoring equipment of Electromyography (EMG). This does not raise any concerns of safety or effectiveness. The ControlSeal Electrode and predicate Dome Electrode are both recording the electrical potentials passively. Both the ControlSeal Electrode and Dome 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 ControlSeal Electrode and predicate are the same. Both the ControlSeal Electrode and the predicate record biopotential signals from cutaneous locations.
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Image /page/6/Picture/1 description: The image shows the logo for COAPT. The letters "COA" are in orange, and the letters "PT" are in gray. Below the letters is the phrase "COMPLETE CONTROL" in a smaller font.
The ControlSeal Electrode and predicate device share similar physical dimensions and shape. They both have a diameter between 9 and 10mm. Both the ControlSeal Electrode and Dome Electrode share a semi-spherical shape for the contacting surface of the electrodes. The difference in surface area of the contacting surfaces of the ControlSeal Electrode and predicate do not cause any concerns of safety. The ControlSeal Electrode has also passed performance testing demonstrating the ability to detect quality EMG signals from cutaneous locations on a user.
The ControlSeal Electrode contacting surface is made from 316L Stainless Steel. The material of the contacting surface for the predicate Dome Electrode is also made from 316L Stainless Steel. The goal in designing the ControlSeal Electrodes was to create a surface electrode for recording EMG signals that was reusable, biocompatible, and cost effective. The ControlSeal Electrodes underwent performance testing to assess the conductivity of EMG signals. The ControlSeal Electrodes passed all performance testing for EMG signal detection. Additionally, the predicate device, 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. Following the Biocompatibility Risk Analysis, no additional testing is required to evaluate the biocompatibility of the ControlSeal Electrodes. The history of safe use of 316L Stainless Steel in medical devices and comparison to the previously cleared version of the device have resulted in no additional concerns for safety and effectiveness of the ControlSeal Electrode. The intended use, anatomical location, duration, size, material, passivation standard, of the ControlSeal Electrode is the same as the previously cleared device. Dome Electrode. Additionally, there have not been any adverse events in relation to biocompatibility reported for the previously cleared. Dome Electrodes. The 316L Stainless Steel was chosen as the material for the ControlSeal Electrode because it fits the intended application of a reusable, biocompatible, low-cost EMG surface electrode. Also, as discussed in the comparison to uncleared predicate electrodes, stainless steel is widely used in the prosthetic industry.
Because the subject device, ControlSeal Electrode and predicate device, Dome Electrode are made from the same material, they would have the same Electrode resistivity as a % of typical skin impedance. A calculation using the conductivity of the materials, and the average impedance of the skin was performed by comparing the resistivity of gold and 316L Stainless Steel as a percentage of the typical impedance of the skin. The resistance of the skin is about 1000 ohms, making the resistivity of the electrodes 3.57 x 10-12%.
As with the predicate, the ControlSeal Electrode is designed to operate with a wide range of compatible devices. The ControlSeal Electrode can be connected to compatible devices through a standard sized threaded stud. It is not permanently connected to any electrode leads. The predicate device, Dome Electrodes use a 4-40 standard sized thread, and the subject device. ControlSeal Electrode uses a 2-56 standard sized thread. The differences in electrode connection do not raise any concerns of safety or effectiveness of the ControlSeal Electrode, they are simply alternative means of connection to compatible devices. The method of connection of the ControlSeal Electrode does not have an effect on its ability to detect EMG
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Image /page/7/Picture/1 description: The image shows the logo for COAPT Complete Control. The word "COAPT" is written in large, bold letters, with the first two letters in orange and the last two in gray. Below the word "COAPT" is the phrase "COMPLETE CONTROL" in smaller, gray letters. The logo is simple and modern, and the use of color helps to make it stand out.
signals. The ControlSeal Electrodes have passed performance testing for detection of EMG signals.
7. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the ControlSeal Electrode. substantial equivalence to the predicate device, and in showing conformance to the recognized consensus standard IEEE 2010-2012 Recommended Practice for Neurofeedback Systems that are subject to this Special 510(k) submission, Coapt, LLC completed a number of non-clinical performance tests. The ControlSeal 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 ControlSeal 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 ControlSeal 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 |
| Mechanical Strength Test | Pass |
| Sealing Test | Pass |
| Validation – Compatible Device – CoaptCOMPLETE CONTROL System Gen2 | Pass |
| Validation – Compatible Device – CoaptEvaluation Kit | 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 years with proven safety and efficacy. The non-clinical testing detailed in
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this submission supports the 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 ControlSeal 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 ControlSeal Electrodes have received passing results for performance testing of mechanical fit, voltage continuity, signal detection, sealing, and validation testing with compatible devices.
The ControlSeal Electrode, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.
§ 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).