(504 days)
The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Non-woven fabric tape Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO ISO 10993-5. The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. There are nine shapes of round, rectangle, elliptical, calabash, butterfly, saddle shape, rhombus, meniscus shape and palm shape. For the electrical connection, Jiajian provides lead wire type and snap button type: Lead wire assembly - at least 40mm long wire with 2mm/2.5mm diameter female socket. Snap button assembly - with 2.5~5mm diameter male socket. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.
The provided document is a 510(k) summary for the Jiajian Self-Adhesive Electrode, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through clinical studies in the same way a PMA (Premarket Approval) would require.
Therefore, many of the requested points, particularly those related to clinical studies, MRMC studies, training set details, or complex ground truth establishment, are not applicable to this type of regulatory submission (a 510(k)). The manufacturer's conclusion explicitly states: "Clinical data was not including in this submission."
Instead, the submission relies on bench testing and a comparison to an existing predicate device to demonstrate substantial equivalence, focusing on technical specifications, materials, and non-clinical performance.
Here's an analysis based on the available information:
1. Acceptance Criteria and Reported Device Performance (as demonstrated by testing and comparison):
The document doesn't present a formal table of "acceptance criteria" paired with "reported performance" in the way one might expect from a clinical study. Instead, it outlines the tests performed to show the device's adherence to relevant standards and its substantial equivalence to a predicate device. The implicit acceptance criterion is that the device performs as well as or similarly to the predicate device across key parameters and meets relevant safety standards.
Here's a table summarizing the relevant data points and how they compare to the predicate, as presented in the "Substantially Equivalent Comparison Conclusion" table:
| Parameter | Acceptance Criteria (Implied / Predicate Value) | Reported New Device Performance (Wuxi Jiajian Self-Adhesive Electrode) | Remark |
|---|---|---|---|
| Indications for Use | Intended to be used to apply electrical stimulation current to the patient's skin (TENS and EMS). | Intended to be used to transmit electrical stimulation current to the patient's skin (TENS and EMS). | Same |
| Target population | Single patient use and multiple application | Single patient use and multiple application | Same |
| Type of use | OTC and Prescription use | OTC and Prescription use | Same |
| Design (shapes) | Round, Rectangle, Oval, Gourd, Butterfly, Saddle (according to customized specification). | Round, Rectangle, Elliptical, Calabash, Butterfly, Saddle shape, Rhombus, Meniscus shape, Palm shape (according to customized specification). | Similar (More shapes) |
| Design (connection) | Lead wire with female socket. | Lead wire with female socket, or snap button with male snap connector. | Similar (Additional) |
| Materials | Non-woven fabric tape; Electrically conductive carbon cloth (ValueTrode Carbon, K970426); Biocompatible conductive hydrogel coupling media (Value Trode Carbon. K970426). | Non-woven fabric tape; Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd); Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426). | Similar |
| Electrode Pad Size | Predicate range specified per shape (e.g., Round: Min.Ø20mm; Max.Ø80mm). | New Device range specified per shape (e.g., Round: Min.Ø20mm; Max.Ø85mm). | Similar (Slightly larger range for some shapes) |
| Electrode Impedance | Predicate Round: 290~1000Ω | New Device Round: 302 | Similar (Within predicate range) |
| Patient contact area | Predicate range specified per shape (e.g., Round: Min.3.14cm²; Max.50.24cm²). | New Device range specified per shape (e.g., Round: Min.3.14cm²; Max.56.716cm²). | Similar (Slightly larger range for some shapes) |
| Max. Current Density | Predicate Round: 3.18mA/cm² (Ø20mm: 3.14cm²) | New Device Round: 3.18mA/cm² (Ø20mm: 3.14cm²). Other shapes also calculated, e.g., 0.24mA/cm² for 90x47mm). Max current density of all electrodes except round shapes does not exceed 2mA/cm² (IEC 60601-2-2). | Similar (Round matches, others are below the general limit) |
| Hydrogel Thickness | 35mils ± 5mils (0.89mm ± 0.13mm) | 35mils ± 5mils (0.89mm ± 0.13mm) | Same |
| Hydrogel pH | 4.2 ± 1.0 | 4.2 ± 1.0 | Same |
| Hydrogel Volume Resistivity | 1500 ohm-cm max | 1500 ohm-cm max | Same |
| Standards Met | ISO14971; ISO 13485; EN 980; ANSI/AAMI EC12; IEC 60601-1. | Lead wires test per 8.5.2.3 of AAMI/ANSI ES 60601-1; Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of ANSI AAMI IEC 60601-2-2:2009; Impedance Test (Dispersion Test) per FDA's requirement; Peel strength test according to manufacturer's requirement; Shelf life test per ASTM F1980:2016; Reuse test per FDA's requirement. | Similar (New device tested to more specific relevant standards) |
| Biocompatibility | ISO10993-5; ISO10993-10 | ISO10993-5; ISO10993-10 | Same |
| Sterility Status | Non-sterile | Non-sterile | Same |
| Electrical Safety | Lead wire meets IEC 60601-1 | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Same |
| Other Performance | Good electrical conductivity, good adhesive property | Good electrical conductivity, good adhesive property | Same |
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: For the bench tests (e.g., impedance, conformability, fluid tolerance, peel strength, shelf life, reuse), the document states: "All test samples were drawn from batches, with 3 samples for each specification."
- Data Provenance: The tests were conducted internally by Wuxi Jiajian Medical Instrument Co., Ltd. in China, as indicated by the submitter/manufacturer address. The data is retrospective, as it's part of a premarket submission.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- This is Not Applicable (N/A). For a 510(k) submission based on bench testing and substantial equivalence, "ground truth" established by human experts (like radiologists for image analysis) is not relevant. Performance is measured against engineering specifications and industry standards.
4. Adjudication method for the test set:
- N/A. As there are no human experts establishing a "ground truth" for a medical imaging/AI dataset, no adjudication method is performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- N/A. The document states "Clinical data was not including in this submission." MRMC studies apply to performance of diagnostic devices often involving human interpretation of results, which is not the case for this external electrode.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a passive electrode, not an algorithm or AI. Standalone performance refers to the accuracy of an AI algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" or reference was based on engineering specifications, established industry standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-2-2), and the performance characteristics of the legally marketed predicate device (K090198). Essentially, the device's performance was compared against these defined benchmarks.
8. The sample size for the training set:
- N/A. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- N/A. This is not an AI/ML device requiring a training set or its associated ground truth establishment.
§ 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).