Jiajian Self-Adhesive Electrode
Device Facts
| Record ID | K192568 |
|---|---|
| Device Name | Jiajian Self-Adhesive Electrode |
| Applicant | Wuxi Jiajian Medical Instrument Co., Ltd. |
| Product Code | GXY · Neurology |
| Decision Date | Feb 3, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
Non-sterile, flexible cutaneous electrodes transmit electrical stimulation current (TENS/EMS) to patient skin. Composed of non-woven fabric tape, polyurethane electrically conductive carbon cloth, and biocompatible conductive hydrogel. Available in various shapes (round, rectangle, elliptical, calabash, butterfly, saddle, rhombus, meniscus, palm) and connection types (lead wire or snap button). Used as an interface between patient skin and nerve/muscle stimulators. Operated by patients or clinicians in indoor/outdoor settings. Output is electrical current delivery; healthcare providers use output to facilitate therapeutic stimulation. Benefits include effective, safe electrical conduction for nerve/muscle stimulation.
Clinical Evidence
No clinical data included. Substantial equivalence supported by bench testing: lead wire compliance (AAMI/ANSI ES 60601-1), impedance/conformability/fluid tolerance (IEC 60601-2-2), peel strength, shelf life (ASTM F1980), reuse testing, and biocompatibility (ISO 10993-5, ISO 10993-10).
Technological Characteristics
Materials: Non-woven fabric, polyurethane conductive carbon cloth, biocompatible hydrogel (ValueTrode Carbon, K970426). Sensing/Actuation: Passive conductive interface. Energy: Conducts electrical stimulation. Dimensions: Various shapes/sizes (e.g., round Ø20-85mm). Connectivity: Lead wire (2mm/2.5mm female socket) or snap button (2.5-5mm male socket). Sterilization: Non-sterile. Standards: AAMI/ANSI ES 60601-1, IEC 60601-2-2, ASTM F1980, ISO 10993.
Indications for Use
Indicated for patients requiring electrical stimulation (TENS/EMS) via cutaneous electrodes. For single patient, multiple application use. Suitable for OTC and prescription use.
Regulatory Classification
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.
Predicate Devices
- JIAJIAN Self-adhesive Electrode (K090198)
Submission Summary (Full Text)
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February 3, 2021
Wuxi Jiajian Medical Instrument Co., Ltd Caihong Sun Manager NO.35 Baigiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu 214116 China
### Re: K192568
Trade/Device Name: Jaijian Self-Adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 4, 2021 Received: January 7, 2021
### Dear Caihong Sun:
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 probibitions 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K192568
Device Name Self-adhesive Electrode
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| <div> <span></span>For In-Situ Use in OFF-Site Indoor Settings </div> | <div> <span></span>For In-Situ Use in OFF-Site Outdoor Settings </div> |
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|X | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Jiajian. The logo is in a teal color and features the text "JIA JIAN" in a sans-serif font. A check mark is used in place of the space between the two words. Below the text is the company name in Chinese characters.
## 510(k) Summary [As required by 21 CFR 807.92]
## 1. Submission Information:
| 510(k) Number: | K192568 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 31, 2020 |
| Type of 510(k) Submission: | Special |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co.,Ltd<br>No.35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China<br>214116<br>E-mail: sch@jjmed.com.cn<br>Tel: 86 510-88745788 |
| Contactor: | Doris Dong (Consultant)<br>Shanghai CV Technology Co., Ltd.<br>Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 China<br>E-mail: doris.d@ceve.org.cn<br>Tel: 86 21-31261348 |
## 2. Device Description:
| Proprietary Name: | Self-adhesive Electrode |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cutaneous electrode |
| Classification Name: | Cutaneous electrode |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | The Self-adhesive electrode is intended to be used to transmit electrical<br>stimulation current to the patient's skin. Example electrical stimulations<br>for current applications of the electrodes are: TENS and EMS. |
| Device Description: | The Self-adhesive electrode, lead wire type and snap button type, are<br>non-sterile flexible structures, composed of materials commonly used in<br>this application:<br>First layer: Non-woven fabric tape<br>Second layer: Polyurethane (PU) electrically conductive carbon cloth<br>(Hebei Kangshengda Electronic Technology Co., Ltd)<br>Third layer: Biocompatible conductive hydrogel coupling media<br>(ValueTrode Carbon, K970426), which has passed the required skin<br>sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity<br>testing criteria as specified in ISO ISO 10993-5.<br>The electrodes are designed for single patient / multiple application use. It<br>can be used for low-frequency or medium-frequency nerve or muscle |
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Image /page/4/Picture/0 description: The image shows the logo for Jiajian. The logo is in blue and consists of the word "JIAJIAN" in a sans-serif font, with a check mark above the "I". Below the word "JIAJIAN" is the company name in Chinese characters. The logo also includes the registered trademark symbol.
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.
### 3. Predicate Device Identification
K090198 - JIAJIAN Self-adhesive Electrode
#### 4. Non-Clinical Test Conclusion
Bench tests were conducted on Self-adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:
· 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 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.
- · Biocompatibility testing according to ISO 10993-5:2009 and ISO 10993-10:2010.
### 5. Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not including in this submission
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Image /page/5/Picture/0 description: The image shows the logo for Jiajian, a medical company. The logo is in blue and features the company name in English and Chinese. The English name is "JIA JIAN" and the Chinese name is "佳健医疗".
| 6. Substantially Equivalent Comparison Conclusion | | | | |
|---------------------------------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | Parameters | New Device | Predicate Device | Remark |
| 1 | 510(k) Number | K192568 | K090198 | -- |
| 2 | 510(k) Holder | Wuxi Jiajian Medical Instrument Co., Ltd | Wuxi Jiajian Medical Instrument Co., Ltd | Same |
| 3 | Trade Name | Self-adhesive Electrode | Jiajian Self- adhesive Electrode | -- |
| 4 | Common Name | Cutaneous electrode | Cutaneous electrode | Same |
| 5 | Classification Name | Electrode, cutaneous | Electrode, cutaneous | Same |
| 6 | Product Code | GXY | GXY | Same |
| 7 | Regulation Number | 882.1320 | 882.1320 | Same |
| 8 | Medical Specialty | Neurology | Neurology | Same |
| 9 | Device Class | II | II | Same |
| 10 | Indications for use | The Self-adhesive electrode is intended to be used to<br>transmit electrical stimulation current to the patient's skin.<br>Example electrical stimulations for current applications of<br>the electrodes are: TENS and EMS. | The self-adhesive electrode is intended to be used to<br>apply electrical stimulation current to the patient's skin.<br>Example electrical stimulations for current applications of<br>the electrodes are: TENS and EMS. | Same |
| 11 | Target population | Single patient use and multiple application | Single patient use and multiple application | Same |
| 12 | Type of use | OTC and Prescription use | OTC and Prescription use | Same |
| 13 | Design (shape & connection) | Round, Rectangle, Elliptical, Calabash, Butterfly, Saddle<br>shape, Rhombus, Meniscus shape, Palm shape according to<br>customized specification.<br>Lead wire with female socket, or snap button with male<br>snap connector. | Round, Rectangle, Oval, Gourd, Butterfly, Saddle<br>according to customized specification.<br>Lead wire with female socket. | Similar<br>Note 1 |
| 14 | Materials | - Non-woven fabric tape<br>- Polyurethane (PU) electrically conductive carbon cloth<br>(Hebei Kangshengda Electronic Technology Co., Ltd)<br>- Biocompatible conductive hydrogel coupling media<br>(Value Trode Carbon. K970426) | - Non-woven fabric tape<br>- Electrically conductive carbon cloth (ValueTrode<br>Carbon, K970426)<br>- Biocompatible conductive hydrogel coupling media<br>(Value Trode Carbon. K970426) | Similar<br>Note 2 |
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Image /page/6/Picture/0 description: The image shows the logo for JIA JIAN, a medical company. The logo is in blue and features the company name in English and Chinese. The English name is "JIA JIAN" and the Chinese name is "佳健医疗".
| 15 | Electrode Pad<br>Size | | Round | Min.Ø20mm; Max.Ø85mm | Round | Min.Ø20mm; Max.Ø80mm | Similar<br>Note 1 |
|----|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------|
| | | | Rectangle | Min.26×26mm; Max.190×110mm | Rectangle | Min.3×10mm; Max.80×130mm | |
| | | | Elliptical | Min.85×45mm; Max.240×100mm | Oval | Min.50×120mm; Max.100×240mm | |
| | | | Calabash | Min.90×47mm; Max.200×88mm | Gourd | Min.85×50mm; Max.170×100mm | |
| | | | Butterfly | Min.73×53mm; Max.195×95mm | Butterfly | Min.55×75mm; Max.95×165mm | |
| | | | Saddle shape | Min.82×35mm; Max.150×220mm | Saddle | Min.75×110mm; Max.150×220mm | |
| | | | Rhombus | Min.136×66mm; Max.200×88mm | | | |
| | | | Meniscus shape | Min.115×40mm; Max.200×88mm | | | |
| | | | Palm shape | 74×47mm | | | |
| 16 | Electrode<br>Impedance of<br>Electrode Pad | | Round | 302~577Ω | Round | 290~1000Ω | Similar<br>Note 3 |
| | | | Rectangle | 303~646Ω | Rectangle | | |
| | | | Elliptical | 407~676Ω | Oval | | |
| | | | Calabash | 401~602Ω | Gourd | | |
| | | | Butterfly | 402~626Ω | Butterfly | | |
| | | | Saddle shape | 401~642Ω | Saddle | | |
| | | | Rhombus | 401~648Ω | | | |
| | | | Meniscus shape | 403~655Ω | | | |
| | | | Palm shape | 402~638Ω | | | |
| 17 | --Patient contact<br>area of electrode | | Round | Min.3.14cm²; Max.56.716cm² | Round | Min.3.14cm²; Max.50.24cm² | Similar<br>Note 3 |
| | | | Rectangle | Min.6.76cm²; Max.209cm² | Rectangle | Min.0.3cm²; Max.104cm² | |
| | | | Elliptical | Min.38.25cm²; Max.240cm² | Oval | Min.60cm²; Max.240cm² | |
| | | | Calabash | Min.42.3cm²; Max.176cm² | Gourd | Min.42.5cm²; Max.170cm² | |
| | | | Butterfly | Min.38.69cm²; Max.185.25cm² | Butterfly | Min.41.25cm²; Max.156.75cm² | |
| | | | Saddle shape | Min.14.35cm²; Max.330cm² | Saddle | Min.82.5cm²; Max.330cm² | |
| | | | Rhombus | Min.89.76cm²; Max.176cm² | | | |
| | | | Meniscus shape | Min.46cm²; Max.176cm² | | | |
| | | | Palm shape | | | | |
| 18 | Max. current<br>Density of<br>Electrode (Use<br>IRMS=10mA for<br>calculation ) | Round | 34.78cm²<br>3.18mA/cm² (Ø20mm: 3.14cm²)<br>1.48mA/cm² (26×26mm: 6.76cm²)<br>0.52mA/cm² (85×45mm/2: 19.13cm²)<br>0.24mA/cm² (90×47mm: 42.3cm²)<br>0.52mA/cm² (73×53mm/2: 19.35cm²)<br>0.70mA/cm² (82×35mm/2: 14.35cm²)<br>0.11mA/cm² (136×66mm: 89.76cm²)<br>0.22mA/cm² (115×40mm: 46cm²)<br>0.29mA/cm² (74×47mm: 34.78cm²) | Round<br>Rectangle<br>Oval<br>Gourd<br>Butterfly<br>Saddle | 3.18mA/cm² (Ø20mm: 3.14cm²)<br>33.3mA/cm² (3×10mm: 0.3cm²)<br>0.17mA/cm² (50×120mm: 60cm²)<br>0.24mA/cm² (85×50mm: 42.5cm²)<br>0.48mA/cm² (55×75mm/2: 20.625cm²)<br>0.24mA/cm² (75×110mm/2: 41.25cm²) | Similar<br>Note 3 | |
| 19 | Hydrogel<br>thickness | 35mils ± 5mils (0.89mm ± 0.13mm) | | 35mils ± 5mils (0.89mm ± 0.13mm) | | Same | |
| 20 | Hydrogel pH | 4.2 ± 1.0 | | 4.2 ± 1.0 | | Same | |
| 21 | Hydrogel volume<br>resistivity | 1500 ohm-cm max | | 1500 ohm-cm max | | Same | |
| 22 | Standards meet | • Lead wires test per 8.5.2.3 of AAMI/ANSI ES 60601-1;<br>• Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6<br>and 201.15.101.7 of ANSI AAMI IEC 60601-2-2:2009;<br>• Impedance Test (Dispersion Test) per FDA's requirement;<br>• Peel strength test according to manufacturer's requirement;<br>• Shelf life test per ASTM F1980:2016<br>• Reuse test per FDA's requirement. | | ISO14971;<br>ISO 13485;<br>EN 980;<br>ANSI/AAMI EC12;<br>IEC 60601-1. | | | Similar<br>Note 4 |
| 23 | Biocompatibility | ISO10993-5; ISO10993-10 | | ISO10993-5; ISO10993-10 | | Same | |
| 24 | Sterility Status | Non-sterile | | Non-sterile | | Same | |
| 25 | Electrical safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | | Lead wire meets IEC 60601-1 | | Same | |
| 26 | Other<br>Performance | Good electrical conductivity, good adhesive property | | Good electrical conductivity, good adhesive property | | Same | |
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Image /page/7/Picture/0 description: The image features the logo for JIA JIAN, a medical company. The logo is in a teal color and includes the company name in English and Chinese. The English name, "JIA JIAN," is written in a bold, sans-serif font, with a checkmark symbol integrated into the design. Below the English name, the Chinese characters for "JIA JIAN" are displayed in a smaller font size.
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Image /page/8/Picture/0 description: The image shows the logo for JIAJIAN. The logo is in blue and consists of the word "JIAJIAN" in a stylized font, with a checkmark incorporated into the letter "J". Below the word "JIAJIAN" are four Chinese characters. To the right of the word "JIAJIAN" is a circled R, indicating that the logo is a registered trademark.
Differences between proposed device and predicate device, reference device:
### Note 1:
The proposed device has two comection methods happ button type, while the predicate device only has one lead wire type. The provosed device ads more electrodes of various shapes and sizes than the predicate device.
- . Regarding the differences in connection method: Both lead wire type electrodes have passed performance tests.
- . Regarding the differences in shape: All shapes of electrodes have passed performance tests.
Regarding the differences in size: We have selected the maximum size electrodes of each shape to carry out the performance tests, and all have passed the tests. . In addition, all test samples were drawn from thatchs, with 3 samples for each specification. Therefore, there differences will not cause any and effectiveness issues.
## Note 2:
The conductive carbon cloth of the proposed device. The final entre electrodes manufactured have passed biocompatibility tests. So, this difference will not cause any safety and effectiveness issues.
## Note 3:
The patient contact area of the is different from the predicate device. Based on analysis of the maximum current density calculation results, this difference will no cause any safety and effectiveness issues.
The maximum current density of the proposed ceve. According to the calculation results, the naxmum current density of all electrodes except for the round shapes does not exceed 2m2 (cle 6060-2-0). The maximum current density of the round electrode of the proposed device is consistent with that of the predicate device. And we added relevant waring item 6 & item 11) and warming symbol (see label) in the user manual. Therefor, these differences will not cause any safety and effectiveness issues.
The impediate of the proposed device is between 302-6762, within the range of 290-10002 of the predice on each electrode is vell-distibution. Therefore, these differences will not cause any safety and effectiveness issues.
Note 4:
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Image /page/9/Picture/0 description: The image shows the logo for JIA JIAN. The logo is in blue and features the text "JIA JIAN" in a bold, sans-serif font. A check mark is incorporated into the logo. Below the English text is the Chinese text "佳健医疗".
The proposed device has performance tests than the predicate device, including peeling, current distribution testing, acceleated aging testing and simulated use testing etc. All tests comply with the rest results show that the proposed device can meet the intended requirements. Therefore, these differences will not cause any safety and effectiveness issues.
#### The Conclusions:
Based on the successful electrode current distribution test results, Self-adherse Electrode is and effective when used as an interfice between a user's skin and an approved neve and musics. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as affective, and performs as well as the legally marketed devices in the subject device is substantally equivalent to the predicate device.
