(164 days)
DL Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
DL Adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.
DL Adhesive Electrode is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate) or LDPE(Low Density Polyethylene).
DL Adhesive Electrode is non-sterile and intended for single adult patient multiple application use. The Adhesive Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.
The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
The provided document is a 510(k) Pre-market Notification for the DL Self-adhesive Electrode (K182111). The document describes the device, its intended use, and importantly, presents non-clinical testing to demonstrate substantial equivalence to predicate devices, thereby ensuring its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DL Adhesive Electrode are primarily based on comparisons with two predicate devices:
- Primary Predicate: K152648 - Ennova Self-adhesive Electrode
- Reference Predicate: K100418 - Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (specifically for the conductive hydrogel)
The equivalence is demonstrated through various non-clinical (bench) tests and a direct comparison of technological characteristics.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from predicate) | Reported Device Performance (DL Adhesive Electrode) | Met/Not Met | Notes |
|---|---|---|---|---|
| Intended Use | Transmit electrical current to patient skin for transcutaneous electrical stimulation (TENS/EMS) | Same | Met | Indications for use are identical to the primary predicate. |
| Target Population | Single patient use and multiple application | Same | Met | |
| Design (Shape & Connection) | Round, rectangle, oval, butterfly; Lead wire with female socket or snap button with male connector | Round, rectangle, butterfly, oval; Lead wire with female socket or snap button with male connector | Met | The device offers similar shapes and connection types, with some differences in size ranges (detailed below). |
| Materials | Top cover material, electrically conductive carbon cloth, biocompatible conductive hydrogel, electrode carrier liner | Same | Met | The conductive hydrogel is specifically identified as being imported from Covidien, USA, and is the same as used in the K100418 predicate. |
| Hydrogel Thickness | 1.0mm ±0.2mm (from primary predicate) | 1.0mm ±0.2mm | Met | Identical to the primary predicate. The reference predicate K100418 had 0.89mm, but the subject device matched the primary. |
| Hydrogel Volume Resistivity | 1500 ohm-cm maximum (from both predicates) | 1500 ohm-cm maximum | Met | Identical to both predicates. |
| Electrode Impedance | Range varies by shape (e.g., Round 397~612Ω for primary predicate) | Range varies by shape (e.g., Round 415~599Ω) | Met | All reported impedance ranges for the DL Adhesive Electrode (Round, Rectangle, Oval, Butterfly) fall within or are comparable to the ranges of the primary predicate. Differences are minor and deemed acceptable. |
| Maximum Current for Power Density (based on a specific TENS device K112288) | 13.7mA r.m.s | 13.7mA r.m.s | Met | Calculation method and resulting maximum current are identical to the primary predicate. |
| Current Density of Electrode Pad | Ranges vary by shape and predicate. For example, Primary Predicate Round Min.0.36mA/cm² Max.1.70mA/cm² | Ranges vary by shape. For example, DL Electrode Round Min.0.242mA/cm² Max.5.386mA/cm² | Met | While some specific min/max values differ slightly, the overall current densities are within acceptable therapeutic ranges and are deemed substantially equivalent. The key is that they do not exceed harmful levels. |
| Maximum Power Density of Electrode Pad | Max 0.25 W/cm² (FDA guidance) | Round 0.0369W/cm², Rectangle 0.006W/cm², Oval 0.0024W/cm², Butterfly 0.0013W/cm² | Met | All reported power densities are significantly below the FDA guidance of 0.25 W/cm², a critical safety criterion to reduce the risk of thermal burns. |
| Connector Retention Force | Lead wire with female socket: 10.80N; Snap button with male snap connector: 9.60N (from primary predicate) | Lead wire with female socket: 10.85N; Snap button with male snap connector: 9.61N | Met | Slightly higher (better) than the predicate, indicating robust connection. |
| Biocompatibility | Complies with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Sensitization) | Complies with ISO 10993-5, ISO 10993-10 | Met | Verified by tests. |
| Sterility Status | Non-sterile | Non-sterile | Met | Consistent with predicate. |
| Electrical Safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Met | |
| Other Performance | Good electrical conductivity, good adhesive property | Good electrical conductivity, good adhesive property | Met | Confirmed by testing. |
| Shelf Life | 3 years (from reference predicate K100418) | 2 years | Not Met (but acceptable) | Shelf life is shorter than the reference predicate, but a specific shelf life test (ASTM F1980:2016) was performed and validated a 2-year shelf life for the new device. This difference is not considered to raise new questions of safety or effectiveness. |
| Stainless Steel Adhesion (180° peel) | 136 grams minimum (≈1.3N) (from reference predicate K100418) | 136 grams minimum (≈1.3N) | Met | Identical to the reference predicate. |
| Hydrogel Composition & pH | Water (Aqua) with Inorganic Salt; Water, Glycerin, Polymer, Polyol, Amorphous Silica, Inorganic Salt, Potassium Chloride; pH 3.0-3.5 | Same | Met | Identical to the reference predicate, indicating use of the same or highly similar hydrogel. |
Study Details:
The document explicitly states: "Clinical data was not including in this submission."
Therefore, the device's substantial equivalence is demonstrated solely through non-clinical (bench) testing and comparison of technical characteristics to legally marketed predicate devices.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The document only lists the standards applied and that "Bench tests were conducted on DL Adhesive Electrode to verify that the proposed device met all design specifications."
- Data Provenance: The tests were performed internally or by accredited labs on samples of the DL Adhesive Electrode. The data origin is thus the manufacturer's testing or contract testing facilities, likely within China (where the manufacturer is located). The provenance is prospective with respect to the regulatory submission, as these tests were conducted specifically to support this 510(k). No patient data is involved.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical data was used, there was no "ground truth" derived from expert consensus on patient cases. The "ground truth" for the non-clinical tests are the specified performance limits within the referenced national and international standards (e.g., AAMI, ISO, ASTM) and the technical specifications of the predicate devices. These standards are developed by expert committees, but individual experts were not involved in establishing ground truth for a test set in the context of this submission.
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Adjudication method for the test set:
- Not Applicable. Since there was no clinical study involving human readers or subjective interpretations of data, an adjudication method for a test set is not relevant. The assessment relies on objective measurements against pre-defined engineering and performance criteria.
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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:
- No. An MRMC study was not done. This device is a passive accessory (an electrode); it does not involve AI, human-in-the-loop performance, or image interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is an electrode, not an algorithm or AI system.
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The type of ground truth used:
- Technical Specifications and Regulatory Standards. The ground truth for this submission is established by adherence to recognized national and international consensus standards (ASTM, ISO, AAMI/ANSI IEC) for medical electrical equipment, biocompatibility, and shelf-life, as well as direct comparison to the established performance characteristics of the legally marketed predicate devices. Key safety criteria, such as maximum power density, also refer to FDA guidance.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 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).