(23 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 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Self-adhesive Electrode" (K213879), structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list "acceptance criteria" for each parameter in the way a formal study report might. Instead, it demonstrates substantial equivalence to a predicate device (K090198) by comparing various characteristics and reporting that the new device met specific test standards or manufacturer requirements.
The table below presents the comparative data and implies the "acceptance criteria" are generally that the new device's performance is similar to or meets the standards met by the predicate device, or adheres to established industry standards for such devices.
| Parameter | Acceptance Criteria (Implied / Indirect) | Reported Device Performance (New Device) | Remark (from document) |
|---|---|---|---|
| Formulation/Design Characteristics | |||
| Trade Name | (Not applicable for acceptance criteria) | Self-adhesive Electrode | -- |
| Common Name | Same as predicate | Cutaneous electrode | Same |
| Classification Name | Same as predicate | Electrode, cutaneous | Same |
| Product Code | Same as predicate | GXY | Same |
| Device Class | Same as predicate | II | Same |
| Regulation Number | Same as predicate | 882.1320 | Same |
| Medical Specialty | Same as predicate | Neurology | Same |
| Indications for use | Same as predicate | 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. | Same |
| Target population | Same as predicate (Single patient use and multiple application) | Single patient use and multiple application | Same |
| Type of use | Same as predicate (OTC and Prescription use) | OTC and Prescription use | Same |
| Design (shape & connection) | Similar to predicate, customized specification allowed | Round, Rectangle, Elliptical, Calabash, Butterfly, Palm shape according to customized specification. Lead wire with female socket, or snap button with male snap connector. | Similar |
| Materials | Similar to predicate and biocompatible standards met | - Non-woven fabric tape |
- Polyurethane (PU) electrically conductive carbon cloth
- Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426) | Similar |
| Electrode Pad Size | Within ranges comparable to predicate | Round Min.Ø20mm; Max.Ø85mm
Rectangle Min.26×26mm; Max.190×110mm
Elliptical Min.85×45mm;
Calabash Min.90×47mm; Max.200×88mm
Butterfly Min.73×53mm; Max.195×95mm
Palm shape 74×47mm | Similar |
| Performance Characteristics | | | |
| Electrode Impedance of Electrode Pad | Within ranges comparable to predicate | Round: 302577Ω646Ω
Rectangle: 303
Elliptical: 407676Ω602Ω
Calabash: 401
Butterfly: 402626Ω638Ω | Similar |
Palm shape: 402
| Patient contact area of electrode | Within ranges comparable to predicate | Round Min.3.14cm²; Max.56.716cm²
Rectangle Min.6.76cm²; Max.209cm²
Elliptical Min.38.25cm²; Max.240cm²
Calabash Min.42.3cm²; Max.176cm²
Butterfly Min.38.69cm²; Max.185.25cm²
Palm shape 34.78cm² | Similar |
| Max. current Density (IRMS=10mA calculation) | Within ranges comparable to predicate | Round: 3.18mA/cm²
Rectangle: 1.48mA/cm²
Elliptical: 0.52mA/cm²
Calabash: 0.24mA/cm²
Butterfly: 0.52mA/cm²
Palm shape: 0.29mA/cm² | Similar |
| 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 |
| Compliance/Safety Standards | | | |
| Standards meet | Compliance with AAMI/ANSI ES 60601-1, ANSI AAMI IEC 60601-2-2, FDA's Impedance Test, ASTM F1980, and manufacturer's requirements (peeling force, simulation use) | • 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 Edition 6.0 2017-03;
• Impedance Test (Dispersion Test) according to FDA's requirement;
• Peeling force test and Simulation use test according to manufacturer's requirement;
• Shelf life test per ASTM F1980:2016 | Similar |
| Biocompatibility | ISO10993-5; ISO10993-10 | ISO10993-5; ISO10993-10 | Same |
| Sterility Status | Non-sterile (as per predicate) | Non-sterile | Same |
| 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 | Same |
| Other Performance | Good electrical conductivity, good adhesive property (as per predicate) | Good electrical conductivity, good adhesive property | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in terms of patient data. The evaluation relies on non-clinical bench tests performed on the "Self-adhesive Electrode" device itself.
- Sample Size: The document does not explicitly state the number of electrodes tested for each bench test. For example, it lists "Impedance test," "Conformability test," "Fluid tolerance test," "Peeling force test," and "Simulation use test" but doesn't provide the quantity of devices subjected to these tests.
- Data Provenance: The tests were "Bench tests" conducted on the proposed device. The country of origin for the device manufacturer is China (Bozhou Rongjian Medical Appliance Co.,Ltd., Anhui, China). The data is retrospective in the sense that these tests were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve human interpretation or a "ground truth" derived from expert consensus on clinical data. The tests performed were objective bench tests against established standards and comparative measurements.
4. Adjudication Method for the Test Set
This is not applicable as there was no test set involving subjective human assessment or consensus building. The assessments were based on direct measurements and compliance with technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not including in this submission."
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
This is not applicable. The device is a self-adhesive electrode, a physical medical device, not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant. The compliance for the device involves physical and electrical characteristics.
7. The Type of Ground Truth Used
For this device, the "ground truth" or reference for performance and safety is established by:
- Established industry standards: Such as ISO 10993 series for biocompatibility, AAMI/ANSI ES 60601-1, and IEC 60601-2-2 for electrical safety and performance.
- Manufacturer's internal requirements: For tests like peeling force and simulation use.
- Predicate device characteristics: Demonstrating that the new device's properties (materials, dimensions, electrical impedance ranges) are similar to those of a legally marketed predicate device (K090198).
There is no clinical ground truth (e.g., pathology, outcomes data) as no clinical study was performed.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).