(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.
§ 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).