(107 days)
The Columbia Scientific, Inc. cutaneous electrotherapy and recording electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals.
Example electrical stimulation current applications of these electrodes are:
- a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief.
- b) Electrical muscle stimulation (EMS) for neck muscle stimulation
- c) Functional electrical stimulation (FES).
- d) Galvanic stimulation.
- e) Microcurrent electrical nerve stimulation (MENS).
- f) Interferential stimulation.
- g) Neuromuscular electrical stimulation (NMES).
Single patient use cutaneous electrodes for the application of electrical stimulation are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals.
The Leadwire is attached to the electrode and is designed to be connected to a transcutaneous external muscle stimulator.
The cutaneous electrodes are single patient /multiple application use and are composed of materials commonly used in this application:
First Layer- Tricot/polyester fabric, coated with biocompatible adhesive.
Second layer- Electrically conductive Activated Carbon Mesh material.
Third layer- Biocompatible conductive Hydrogel coupling media that has been tested for biocompatibility. Test report T1262-809 NAMSA CA. Division
The electrode has one type of connection point that can be used to connect to the stimulation device (For e.g. VitalStim NMES model 5900 or 5905). The lead wire assembly is 60" with .080 inch diameter recessed female socket that is in compliance with IEC 601-1(plus amendments) and section 56.3 of 21 CFR 898.12 Performance Standard and connects to the electrode and the electrical stimulation devices.
The Columbia 600 Electrode and Columbia 06 Leadwire, as described in K080386, is a device designed for applying electrical stimulation current to a patient's skin or recording physiological signals. The submission details a comparison to a predicate device (Pepin Manufacturing Inc. Cutaneous Electrodes, K070807) to establish substantial equivalence, primarily focusing on performance through impedance testing.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Columbia 600 Electrode) |
|---|---|
| Impedance Level: Not explicitly stated as a numerical criterion, but the device must demonstrate impedance levels that are "less than" or at least comparable to the predicate device to prove effectiveness. | Impedance values were "less than the other predicate devices impedance values." |
| All other key characteristics: To be "as safe and effective as the predicate devices and do not pose new questions of safety and effectiveness," implying equivalence in: | The device is "SAME" as the predicate for: |
| - Indications for use | - Indications for use (e.g., TENS, EMS, FES, galvanic, microcurrent, inferential, NMES) |
| - Where used | - Where used (Hospitals and Clinics) |
| - Basic features (Size, adhesive, packaging) | - Basic features (25 mm diameter, non sterile, single patient use, self-adhesive, 4 electrodes in sealed pouch) |
| - Standard met | - Standard met (Conformance to 21CFR 898.12 standard) |
Note: The submission for K080386 does not provide specific numerical acceptance criteria for impedance but rather a comparative statement. The primary "study" is this comparison.
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: Not explicitly stated. The document mentions "impedance testing" was performed, but the number of electrodes or tests conducted is not detailed.
- Data Provenance: Not explicitly stated. Given that the manufacturer is based in Portland, Oregon (Columbia Scientific Development, LLC), it's reasonable to infer the testing was conducted in the US, but this is not confirmed. The study appears to be retrospective in the sense that the test was conducted on the final device for comparison.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for the performance test (impedance) was based on objective measurement rather than expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The test was an objective measurement of impedance, not an assessment requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a passive electrode and leadwire, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers improving with or without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes, in a broad sense. The impedance testing was performed on the device itself (algorithm only, if one considers the inherent electrical properties of the device as its "algorithm") without human intervention affecting the measurement outcome. However, given the nature of the device (a passive electrode), this isn't an "algorithm" in the typical software sense.
7. Type of Ground Truth Used
- Type of Ground Truth: Objective physical measurement. The ground truth for performance was the measured electrical impedance of the electrode, compared against the measured impedance of the legally marketed predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set." The device's design and material properties are determined by engineering and manufacturing processes, not by training on a dataset.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of 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).