(23 days)
Not Found
No
The description focuses on the physical composition and intended use of a simple electrode for electrical stimulation, with no mention of AI or ML capabilities.
Yes
The device is intended to transmit electrical stimulation current for applications like TENS and EMS, which are therapeutic modalities used for pain relief and muscle stimulation.
No
Explanation: The device is an electrode intended to transmit electrical stimulation current to the patient's skin for applications like TENS and EMS. It is a therapy delivery device, not a diagnostic one.
No
The device description clearly outlines a physical, multi-layered structure composed of materials like non-woven fabric, polyurethane, and hydrogel, which are hardware components. The performance studies also focus on physical and electrical properties of these materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit electrical stimulation current to the patient's skin" for applications like TENS and EMS. This is a therapeutic or physiological function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details the physical components and materials used to conduct electrical current to the skin. It doesn't mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) which is characteristic of IVDs.
- Performance Studies: The performance studies focus on aspects like biocompatibility, electrical properties (impedance), and physical characteristics (peeling force, conformability). These are relevant to a device that interacts with the body for electrical stimulation, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the device's function, description, and testing all point to it being a medical device used for electrical stimulation on the body, not an in vitro diagnostic device used to analyze samples from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
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.
There are six shapes of round, rectangle, elliptical, calabash, butterfly and palm shape. For the electrical connection, Rongjian 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
· ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
· ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization.
• AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD).
· Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
January 5, 2022
Bozhou Rongjian Medical Appliance Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K213879
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: November 24, 2021 Received: December 13, 2021
Dear Doris Dong:
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
1
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 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/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 Advice (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,
for 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
2
Indications for Use
510(k) Number (if known) K213879
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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K213879 |
|---|---|
| Date: | November 24, 2021 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Manufacturer/Applicant: | Bozhou Rongjian Medical Appliance Co.,Ltd. |
| Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou | |
| City, 233500 Anhui, China | |
| Tel: +86-558-7963368 | |
| E-mail: rongjianzl@rjmed.com.cn | |
| Contactor: | Doris Dong (Consultant) |
| Shanghai CV Technology Co., Ltd. | |
| Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 |
2. Device Description
| 2. Device Description | |
|---|---|
| Proprietary Name: | Self-adhesive Electrode |
| Common Name: | Cutaneous electrode |
| Classification Name: | Electrode, cutaneous |
| 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 stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS. |
| Device Description: | 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. |
4
There are six shapes of round, rectangle, elliptical, calabash, butterfly and palm shape. For the electrical connection, Rongjian 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:
· ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
· ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization.
• AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And
Essential Performance (IEC 60601-1:2005, MOD).
· Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of 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.
5. Substantial Equivalent Based on Assessment of Clinical PerformanceData
Clinical data was not including in this submission
5
| Parameters | New Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 1 | 510(k) Number | To be assigned | K090198 | -- |
| 2 | 510(k) Holder | Bozhou Rongjian Medical | ||
| Appliance Co.,Ltd. | Wuxi Jiajian Medical | |||
| Instrument Co., Ltd | -- | |||
| 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 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 is | |||
| intended to be used to apply | ||||
| electrical stimulation current to | ||||
| the patient's skin. Example | ||||
| electrical stimulations for | ||||
| current applications of 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, Palm shape | ||||
| according to customized | ||||
| specification. | ||||
| Lead wire with female socket, or | ||||
| snap button with male snap | ||||
| connector. | Round, Rectangle, Oval, Gourd, | |||
| Butterfly, Saddle according to | ||||
| customized specification. | ||||
| Lead wire with female socket. | Similar | |||
| 14 | Materials | - Non-woven fabric tape |
- Polyurethane (PU) electrically
conductive carbon cloth (Hebei
Kangshengda Electronic
Technology Co., Ltd) - Biocompatible conductive
hydrogel coupling media
(ValueTrode Carbon, K970426) | - Non-woven fabric tape - Electrically conductive carbon
cloth (ValueTrode Carbon,
K970426) - Biocompatible conductive
hydrogel coupling media
(ValueTrode Carbon, K970426) | Similar |
| 15 | Electrode Pad
Size | Round Min.Ø20mm;
Max.Ø85mm | Round Min.Ø20mm;
Max.Ø80mm | Similar |
| | | Rectangle Min.26×26mm;
Max.190×110mm | Rectangle Min.3×10mm;
Max.80×130mm | |
| | | Elliptical Min.85×45mm; | Oval Min.50×120mm; | |
6. Substantially Equivalent Comparison Conclusion
6
| Max.240×100mm | 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 | ||||||
| Palm shape | ||||||
| 74×47mm | Saddle | Min.75×110mm; | ||||
| Max.150×220mm | ||||||
| 16 | Electrode | |||||
| Impedance of | ||||||
| Electrode Pad | Round | 302~577Ω | Round | 290~1000Ω | Similar | |
| Rectangle | 303~646Ω | Rectangle | ||||
| Elliptical | 407~676Ω | Oval | ||||
| Calabash | 401~602Ω | Gourd | ||||
| Butterfly | 402~626Ω | Butterfly | ||||
| Palm shape | 402~638Ω | Saddle | ||||
| 17 | --Patient contact | |||||
| area of electrode | Round | Min.3.14cm²; | ||||
| Max.56.716cm² | Round | Min.3.14cm²; | ||||
| Max.50.24cm² | Similar | |||||
| 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 | ||||||
| Palm shape | 34.78cm² | Saddle | Min.82.5cm²; | |||
| Max.330cm² | ||||||
| 18 | Max. current | |||||
| Density of | ||||||
| Electrode (Use | ||||||
| IRMS=10mA for | ||||||
| calculation ) | Round | 3.18mA/cm² | ||||
| (Ø20mm: 3.14cm²) | Round | 3.18mA/cm² | ||||
| (Ø20mm: | ||||||
| 3.14cm²) | Similar | |||||
| Rectangle | 1.48mA/cm² | |||||
| (26×26mm: 6.76cm²) | Rectangle | 33.3mA/cm² | ||||
| (3×10mm: | ||||||
| 0.3cm²) | ||||||
| Elliptical | 0.52mA/cm² | |||||
| (85×45mm/2: | ||||||
| 19.13cm²) | Oval | 0.17mA/cm² | ||||
| (50×120mm: | ||||||
| 60cm²) | ||||||
| Calabash | 0.24mA/cm² | |||||
| (90×47mm: 42.3cm²) | Gourd | 0.24mA/cm² | ||||
| (85×50mm: | ||||||
| 42.5cm²) | ||||||
| Butterfly | 0.52mA/cm² | |||||
| (73×53mm/2: | ||||||
| 19.35cm²) | Butterfly | 0.48mA/cm² | ||||
| (55×75mm/2: | ||||||
| 20.625cm²) | ||||||
| Palm shape | 0.29mA/cm² | |||||
| (74×47mm: | ||||||
| 34.78cm²) | Saddle | 0.24mA/cm² | ||||
| (75×110mm/2: | ||||||
| 41.25cm²) | ||||||
| 19 | Hydrogel | 35mils ± 5mils (0.89mm ± | 35mils ± 5mils (0.89mm ± | Same |
7
| thickness | 0.13mm) | 0.13mm) | ||
|---|---|---|---|---|
| 20 | Hydrogel pH | 4.2 ± 1.0 | 4.2 ± 1.0 | Same |
| 21 | Hydrogel | |||
| volume | ||||
| 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; | ||||
| • 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 | ISO14971; | |||
| ISO 13485; | ||||
| EN 980; | ||||
| ANSI/AAMI EC12; | ||||
| IEC 60601-1. | Similar | |||
| 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 | |||
| Performance | Good electrical conductivity, good | |||
| adhesive property | Good electrical conductivity, | |||
| good adhesive property | Same |
7. Conclusions
Based on the conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate device K090198.