(90 days)
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
Self-adhesive electrode is available in Lead wire type and snap type. Both types are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference is the lead wire or snap. It functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin.
The provided document is a 510(k) summary for a "Self-adhesive Electrode" device. It outlines the device's technical characteristics and compares them to a predicate device to establish substantial equivalence. However, it does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically expected for a diagnostic or AI-driven medical device.
This document focuses on establishing substantial equivalence for a Class II medical device, which generally means demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves performance testing against recognized standards rather than extensive clinical studies with acceptance criteria based on diagnostic accuracy.
Given the nature of this submission (a 510(k) for a cutaneous electrode), the "acceptance criteria" are primarily based on meeting established electrical, physical, and biocompatibility standards relevant to such devices, rather than clinical performance metrics like sensitivity or specificity for a diagnostic claim.
Here's a breakdown of the requested information based on the provided text, with acknowledgments of what is not present because it's largely irrelevant for this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Subject Device) |
|---|---|
| Electrical impedance | Less than 3KΩ |
| Current uniformity | Current deviation index less than 5% |
| Adhesive performance / Maximum duration use | 30 minutes maximum duration use |
| Biocompatibility (Cytotoxicity) | Passed per ISO 10993-5 (or series) |
| Biocompatibility (Skin Irritation) | Passed per ISO 10993-10 (or series) |
| Biocompatibility (Skin Sensitization) | Passed per ISO 10993-10 (or series) |
| Shelf life | Verified per ASTM F 1980-07 |
| Size | As per specification in Section 4.2 |
2. Sample size used for the test set and the data provenance
- The document does not specify sample sizes for non-clinical performance tests (electrical impedance, current uniformity, adhesion). These are typically bench tests, and exact sample numbers are not detailed in this summary.
- Biocompatibility tests (cytotoxicity, skin irritation, sensitization) are conducted on samples of the device materials, but specific sample numbers (e.g., number of animals or cell cultures) are not provided in this summary.
- Shelf life verification involves testing samples over time, but the specific sample size is not mentioned.
- Data provenance is not explicitly stated in terms of country of origin for the test data, nor is it classified as retrospective or prospective for these non-clinical tests. These are internal engineering and lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device and submission. The "ground truth" for non-clinical performance tests (like electrical impedance or adhesion) is determined by the measurement standard itself (e.g., a multimeter reading, adherence force). For biocompatibility, the "ground truth" is adherence to established biological response criteria laid out in the ISO standards, evaluated by qualified lab personnel, but not "experts" establishing a diagnostic ground truth in the sense of clinical decision-making.
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes, typically for diagnostic devices where there might be inter-reader variability. For the performance and biocompatibility tests described here, the results are objectively measured against defined criteria within recognized standards.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, to assess the impact of AI assistance on human performance. The "Self-adhesive Electrode" is a passive component for electrical stimulation and does not involve AI or human interpretation in its intended use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance evaluation of an algorithm was not done. As stated, this device is a passive electrode and does not contain any algorithms or AI components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance tests: The "ground truth" is defined by the measurement standards and specifications (e.g., impedance values in ohms, percentage of current deviation, adhesion time, physical dimensions).
- For biocompatibility tests: The "ground truth" is defined by the assessment criteria within the ISO 10993 series standards (e.g., lack of cytotoxicity, skin irritation, or sensitization exceeding defined thresholds).
- There is no clinical "ground truth" (like pathology or outcomes data) established for this device, as it's not a diagnostic device.
8. The sample size for the training set
- This question is not applicable. The device is an electrode, not an AI model or a device requiring a "training set" in the machine learning sense. The manufacturer doesn't mention any AI components in the device description or testing.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no training set for an AI model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 7, 2018
Dong Guan Ou Kang Electronics CO., LTD % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, 511470 Cn
Re: K181234
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 9, 2018 Received: May 9, 2018
Dear Field Fu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
for
Sincerely, Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181234
Device Name Self-adhesive electrode
Indications for Use (Describe)
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | X Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date of summary prepared: 08/06/2018 This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Date of summary prepared | |
|---|---|
| Manufacturer information | Company title: Dong Guan Ou Kang Electronics CO.,LTD |
| Company address: 3rd floor, Xiqunli building, Shipai | |
| road, Yanwo village, Shipai town, Dongguan | |
| Phone: +86-0769-82686009 | |
| Fax: +86-0769-82686009 | |
| Contact person: Nianjun Liu | |
| E-mail: nianjun_liu@sohu.com | |
| Submission Correspondent | |
| Name: Shenzhen Joyantech Consulting Co., Ltd | |
| Address: Room 1122, International Mayors | |
| Communication Centre, NO. 55 Shizhou middle road , | |
| Nanshan District, Shenzhen | |
| Contact person: Field Fu; Summer Wu; Elly Xv | |
| E-mail: summer@cefda.com; elly@cefda.com |
2. Device information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade name: | Self-adhesive electrode |
| Model: | Lead wire type electrode and snap type electrode |
| Classification Name: | Electrode, Cutaneous |
| Review panel: | Neurology |
| Product Code: | GXY |
| Device Class | II |
| Regulation number: | 882.1320 |
3. Predicate Device Information
| Sponsor: | Shenzhen Mailuokang Technology Co., Ltd. |
|---|---|
| Device: | Mailuokang Self-adhesive Electrode |
| 510(k) number: | K152815 |
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4. Device description
1) Intended use/indications for use
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
2) Device specification
The specification of self-adhesive electrode is listed below.
| Model | Shape | Product Size(mm) | ConnectorSize (holediameter)(mm) |
|---|---|---|---|
| Non-wovenlead wiretypeelectrode | Rectangularand circular | Rectangular:40×40;40×60;50×50;50×60;50×70;50×90;50×100;60×80;60×90;70×110;90×130 | 2.0, 2.5 |
| Circular:$Ф$ 30; $Ф$ 40; $Ф$ 50; $Ф$ 80 | |||
| Non-wovensnap typeelectrode | Rectangular, circular,oval andhand shape | Rectangular:40×40; 40×80; 50×50; 50×90; 50×100; 60×90 | 3.3, 3.6 |
| Circular:$Ф$ 30; $Ф$ 40; $Ф$ 50; $Ф$ 80 | |||
| Oval:43×30 | |||
| Hand shape:75×46 |
3) Device design
Non-woven lead wire type electrode and non-woven snap type electrode have different appearance and construction. See Figure 1 and Figure 2 for the structure picture of non-woven lead wire type electrode and non-woven snap type electrode.
Image /page/4/Figure/10 description: The image shows a diagram of a layered structure with labels indicating the different components. The layers, from top to bottom, are: 1 Non-woven fabric, 2 Double sides adhesive tape, 3 Conducting film, 4 Hydrogel, and 5 Plastic film. A wire labeled as 6 Carbon fiber wire is connected to the side of the layered structure.
Image /page/4/Figure/11 description: The image shows the text "Figure 1 The structure of non-woven lead wire type electrode". The text appears to be a figure caption. The caption describes the structure of a non-woven lead wire type electrode and is labeled as Figure 1.
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Proposed product: Self-adhesive electrode
Image /page/5/Figure/3 description: The image shows a diagram of a layered structure, with labels indicating the different components. The layers, from top to bottom, are: 1 Non-woven fabric, 2 Double sides adhesive tape, 3 Conducting film, 4 Hydrogel, and 5 Plastic film. There is also a component labeled 6 Snap on the top layer.
Figure 2 The structure of non-woven snap type electrode
4) Materials used
Both non-woven lead wire type electrode and snap type electrode are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference between non-woven lead wire electrode and non-woven snap electrode is lead wire and snap.
5) Physical and performance characteristics of the device
Electrical impedance: less than 3KΩ.
Current uniformity: the current deviation index of the electrode is less than 5%. Adhesive performance: 30 minutes maximum duration use.
6) Principle of Operation
Self-adhesive electrode functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin. Electrical signal from an electrical stimulator is conducted to the self-adhesive electrode through a lead wire or snap; which is dispersed across the conductive film, then transmitted through the conductive adhesive hydrogel to the surface of the patient's skin.
| Component | Material |
|---|---|
| Non-woven fabric | 100% polypropylene in white |
| Conducting film | Carbon paste |
| Hydrogel | Cross linked acrylic resin, polyhydric alcohol, electrolytic salt, additives and de-ionized water |
| Lead wire | PVC |
| Snap | Nickel-clad copper |
7) Material of construction
5. Technological characteristics of the subject device compared to the predicate device
| Items | Predicate(K152815) | Device | Subject Device | Comparison |
|---|---|---|---|---|
| General Characteristics | ||||
| ltems | PredicateDevice(K152815) | Subject Device | Comparison | |
| ClassificationName | Cutaneous Electrode | Cutaneous Electrode | Same. | |
| Product Code | GXY | GXY | Same. | |
| RegulationNumber | 882.1320 | 882.1320 | Same. | |
| Device Class | Class II | Class II | Same. | |
| IntendedUse/Indications for Use | MailuokangSelf-adhesiveElectrode is intendedfor use as reusable,conductive adhesiveinterface between thepatient's skin and theelectrical stimulationdevices. Exampleelectrical stimulationdevices for currentapplications of theelectrodes includes,but are not limited to,TENS(TranscutaneousElectrical NerveStimulation) and EMS(Electrical MuscleStimulation).MailuokangSelf-adhesiveElectrode is forprescription use andover-the-counter use,for single patient useonly. | Self-adhesiveelectrode is intendedfor use as singleuse, conductiveadhesive interfacebetween thepatient's skin and theelectrical stimulationdevices. Somecommon types of thestimulation devicesinclude, but are notlimit to, TENS(TranscutaneousElectrical NerveStimulation) andEMS (ElectricalMuscularStimulation). Theelectrode is for OTC(Over-The-Counter)or Prescription use,for single patient useonly. | Similar. (Note 1) | |
| IntendedUser/PatientPopulation | No specifiedpopulation. | No specifiedpopulation. | Same. | |
| ElectricalConnection | Lead wire or snap. | Lead wire or snap. | Same. | |
| OTC orprescriptionuse | OTC use andprescription use. | OTC use andprescription use. | Same. | |
| Items | PredicateDevice(K152815) | Subject Device | Comparison | |
| Reusable | Yes | No. | Similar. (Note 1) | |
| Single PatientUse | Yes | Yes | Same. | |
| MultipleApplications | Yes | No. | Similar. (Note 1) | |
| SterilityStatus | Non-sterile | Non-sterile | Same. | |
| Technical Characteristics | ||||
| Electrodedimensions(cm) | For lead wire styleelectrode:Rectangular:3×7;4×4;5×5;5×6;5×7;6×9;8×12;8×13For snap styleelectrode:Rectangular:9×4Circle:Ф4; Ф5; Ф8.5Oval:4.5×3 | Fornon-wovenlead-wiretypeelectrode:Rectangular:4×4;4×6;5×5;5×6;5×7;5×9;5×10;6×8;6×9;7×11;9×13Circular:Ф3; Ф4; Ф5; Ф8For non-woven snaptype electrode:Rectangular:4×4; 4×8; 5×5; 5×9;5×10; 6×9Circular:Ф3; Ф4; Ф5; Ф8Oval:4.3×3Hand shape:7.5×4.6 | Similar. (Note 2) | |
| Conductivesurfacearea(cm2) | 12.56~104 | 7~117 | Similar. (Note 2) | |
| DesignFeatures | Six basic componentsfor Lead Wire StyleElectrode:• non-wovenfabrics;• double sidesadhesive tape;• conducting film;• hydrogel;• plastic film; | Six basiccomponents for LeadWire Style Electrode:• non-wovenfabrics;• double sidesadhesive tape;• conducting film;• hydrogel;• plastic film; | Same. |
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Proposed product: Self-adhesive electrode
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Proposed product: Self-adhesive electrode
| Items | Predicate(K152815) | Device | Subject Device | Comparison | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| • carbon fiber wire.Six basic componentsfor Snap StyleElectrode:• non-wovenfabrics;• double sidesadhesive tape;• conducting film;• hydrogel;• plastic film;• snap. | • carbon fiber wire.Six basiccomponents for SnapStyle Electrode:• non-wovenfabrics;• double sidesadhesive tape;• conducting film;• hydrogel;• plastic film;• snap. | |||||||||||||||||||||
| HydrogelComposition | Glyrol, Polyacrylicacid, Water and Salt | Crosslinked acrylicresin, polyhydricalcohol, electrolyticsalt, additives andde-iconized water. | Similar.(Note 43) | |||||||||||||||||||
| Function andconcentrationof eachingredient infinalformulation | Not publicly available. | Ingredient Concentration(WT%) Function Crosslinkedacrylic resin 15-25 Cross-linkingpolymerization. polyhydricalcohol 40-60 Bufferandhumectant. electrolyticsalt 2-10 Ionicconductingmedia additives <0.5 Stabilization. de-iconizedwater 20-40 Solution. | Note 3 |
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| Items | PredicateDevice(K152815) | Subject Device | Comparison |
|---|---|---|---|
| pHofhydrogel | Not publicly available. | 6.5~7.5 | Note 4 |
| Conductivityofhydrogel(S/m) | Not publicly available. | 50 | Note 5 |
| Resistivity(Ωm) | Not publicly available. | 0.02 | Note 5 |
| Volumeofhydrogel(cm³) | Not publicly available. | Thevolumeofhydrogel varies bythe shape ofelectrodes, rangingfrom 0.7 to 11.7. | Note 6 |
| Maximumdurationofuse | 30min. | 30min. | Same. |
| Biocompatibility | Mailuokang's hydrogelhas passed threebiocompatibility tests:skin irritation,sensitization andcytotoxicity. | Self adhesiveelectrode has passed3 biocompatibilitytests: skin irritation,sensitization andcytotoxicity. | Same. |
| PerformanceTest | Measuringtheelectrode contactimpedance andadhesion. | Size, electricalimpedance andadhesion. | Same. |
| ConductiveSurfaceShapes | Various shapes(rectangular, oval,circle) | Various shapes(rectangular, oval,circular, hand shape) | Similar.(Note 2) |
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Discussion of the similarities and differences:
Note 1:
The difference between the subject device and the predicate device is that, the predicate device is intended for multiple uses, while the subject device is intended for single use. The difference does not adversely affect the safety and effectiveness of the device.
Note 2:
The electrode dimension and conductive surface of the predicate device is similar to the subject device. The difference does not adversely affect the safety and effectiveness of the device.
Note 3:
Both Mailuokang self-adhesive electrode and self-adhesive electrode have passed the biocompatibility test, electrode impedance test and adhesion test.
Therefore, the difference in hydrogel composition will not raise any safety or efficacy issues.
Note 4:
The conductive gel is called hydrogel, it is pre-applied to the electrode. The hydrogel pH of the predicate device is unknown, as the subject device has pass the biocompatibility tests performed per ISO 10993 series standards, the difference does not adversely affect the safety and effectiveness of the device.
Note 5:
The conductivity and impedance of the hydrogel in the predicate device is unknown. As both the electrical impedance of the predicate device and the subject device are less than 3kΩ, the difference does not adversely affect the safety and effectiveness of the device.
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Note 6:
The difference in volume of hydrogel does not adversely affect the safety and effectiveness of the device.
6. Brief discussion of the nonclinical tests
Self-adhesive electrode has passed performance tests for size, electrical impedance, current uniformity test and adhesion test is performed according to IEC 60601-2-2:2009 Clause 201.15.101.7.
Self-adhesive electrode has passed 3 biocompatibility tests: cytotoxicity, skin irritation and.skin sensitization. The biocompatibility tests are performed according to ISO 10993-1, 5 and 10.
The shelf life of self-adhesive electrode is verified according to ASTM F 1980-07.
7. Brief discussion of clinical tests
Not applicable.
8. Other information (such as required by FDA guidance)
No other information.
9. Conclusions
The subject device is substantially equivalent to Mailuokang Self-adhesive Electrode whose 510(k) number is K152815.
§ 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).