(167 days)
To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin.
Single patient use - re-usable.
Self adhering and re-positionable.
Over the counter use.
Theratrode electrodes are constructed as a layered assembly comprised of four components:
- A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin.
- A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode,
- A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode.
- A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c).
Theratrode electrodes are non-sterile and are intended for multiple use by a single patient to apply electrical stimulation. Theratrode's construction is equivalent to the predicate device's construction.
The provided document, K112312, is a 510(k) summary for Phoenix Medical Devices' Theratrode Family of Cutaneous Electrodes. This document does not describe an AI/ML medical device, and therefore the requested information regarding AI model performance, multi-reader multi-case studies, expert adjudication, training/test sets, and ground truth establishment for AI applications is not applicable to this submission.
Instead, this document details the substantial equivalence of the Theratrode electrodes to a legally marketed predicate device (Lifecare Electrodes, K083302) based on traditional medical device assessment methods.
Here's a breakdown of the relevant information provided:
Acceptance Criteria and Device Performance (for a non-AI/ML device)
The basis for substantial equivalence for this type of device (cutaneous electrodes) primarily relies on:
- Construction: The Theratrode electrodes are constructed in the same manner as the predicate device (layered assembly of hydrogel, carbon dispersion pad, non-conductive top layer, lead wire).
- Materials: Constructed of the same or similar bio-compatible materials to the predicate device.
- Indications for Use: Identical indications for use as the predicate device: "To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use."
- Performance Characteristics: Very similar performance characteristics, specifically electrical conductivity (inverse of impedance).
Acceptance Criteria and Reported Device Performance Table (based on the provided document)
Since there are no established performance standards for cutaneous electrodes, the acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device. The key performance metric assessed was electrical conductivity.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Theratrode) |
|---|---|---|
| Construction | Constructed in the same manner as the predicate device. | Confirmed: Layered assembly (hydrogel, carbon dispersion pad, non-conductive top layer, lead wire). |
| Materials | Constructed of same or similar materials as the predicate device; bio-compatible. | Confirmed: Hydrogel passed three biocompatibility tests (skin irritation, cytotoxicity, delayed contact sensitization). Materials are described as same or similar to predicate. |
| Indications for Use | Identical indications for use as the predicate device. | Confirmed: "To conduct electrical stimulation from common varieties of electrical stimulators to the patient's skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use." - Identical to predicate device's use. |
| Performance Characteristics (Electrical Conductivity) | Equivalent or superior electrical conductivity (inverse of impedance) compared to the predicate device. | "The comparison tests conclusively prove that Theratrode is at a minimum as efficient at conducting electricity as the Predicate device." |
Non-Applicable Information for this Traditional Device Submission
As this is a 510(k) for cutaneous electrodes, and not an AI/ML medical device, the following points from your request are not relevant or discussed in the document:
- Sample size used for the test set and the data provenance: Not an AI test set; bench testing was performed. The document doesn't specify a "sample size" in the context of a dataset for an algorithm. It implies multiple electrodes were tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not generated for this type of device.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating observer performance, typically with imaging or diagnostic devices where human interpretation is central.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the AI sense. The "ground truth" for this device lies in its physical and electrical properties being demonstrably equivalent to a safe and effective predicate.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, the K112312 submission demonstrates substantial equivalence for a traditional medical device (cutaneous electrodes) through a comparison of design, materials, intended use, and bench test performance to a predicate device, rather than through AI/ML model validation methods.
§ 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).