(90 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a conductive gel, with no mention of AI or ML technologies.
No
This device is a conductive gel, which is an accessory used with therapeutic devices (TENS and EMS devices) to improve their conductivity, not a therapeutic device itself.
No
The device is a conductive gel used with electric stimulation therapy devices to reduce impedance and improve current distribution, not to diagnose medical conditions.
No
The device description clearly states it is a gel composed of chemical ingredients, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce impedance between electrodes and the skin for electric stimulation therapy (TENS and EMS). This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and components of the gel and its application to intact skin. It does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is characteristic of IVDs.
- Lack of Diagnostic Elements: There is no mention of the device being used to diagnose a disease or condition, monitor a patient's health status through analysis of biological samples, or screen for a specific condition.
- Performance Studies: The performance studies listed (Cytotoxicity, Sensitization, Irritation, Usability, Shelf Life) are focused on the safety and physical performance of the gel in contact with skin, not on its ability to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This conductive gel is used in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.
Product codes
GYB
Device Description
Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intact Skin
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)
Summary of Non-Clinical Testing
Conductive Gel (Model: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250) has been evaluated the safety and performance by lab bench testing as following:
-
In vitro Cytotoxicity Test:
- Purpose: Under the research conditions, determine whether the target device extract is cytotoxic.
- Reference Standard: ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- Acceptance criteria: Under the conditions of this study, the Test Sample were non-cytotoxicity to L929 cells.
- Test results: Pass
-
Skin Sensitization Test:
- Purpose: Under the research conditions, to evaluate the possibility of skin sensitization after topical applications of the test sample on the skin of guinea pig.
- Reference Standard: ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- Acceptance criteria: Under the conditions of this study, the frequency of positive challenge results in sample extract and Negative control animals are 0%, the Positive control is 100%.
- Test results: Pass
-
Skin Irritation Test:
- Purpose: Under the research conditions, to evaluate the possibility of skin irritation after single topical applications of the test sample on the skin of rabbits.
- Reference Standard: ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- Acceptance criteria: Under the conditions of this study, the test sample induce negligible irritation in a rabbit skin single exposure test.
- Test results: Pass
-
Usability Study:
- Purpose: To study how usability will be performed in subject device in order to comply with IEC 62366-1
- Reference Standard: IEC 62366-1 Edition 1.0 2015-02, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- Acceptance criteria: The subject device can meet the usability goal of IEC 62366-1 standards.
- Test results: Pass
-
Shelf Life Test:
- Purpose: To study whether the performance of subject device can meet the 2-year shelf life requirements
- Reference Standard: ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; Guidance document for the "Shelf Life of Medical Devices" issued in April 1991
- Acceptance criteria: All items (Exterior, Package, pH, Impedance and conductivity) tested on both before and after aging samples meet the performance required.
- Test results: Pass
No clinical study is included in this submission.
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
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
December 13, 2022
Top-Rank Health Care Co.,Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technoloy Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China
Re: K222770
Trade/Device Name: Conductive Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB Dated: September 14, 2022 Received: September 14, 2022
Dear Cassie Lee:
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.
1
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 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.
Tushar Bansal -S
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) K222770
Device Name Conductive Gel
Indications for Use (Describe)
Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: December 8, 2022
2. Submitter's Information
Sponsor Name: Top-Rank Health Care Co. Ltd.
Address: Mashan Village, Dongguan Street, Shangyu District, Shaoxing City, Zhejiang
Province, China. 312300
Establishment Registration Number: Applying
Contact name: Gangfeng Lou
Title: Chairman of the board
Tel: +86-0575-82912999
Fax: +86-0575-82912999
E-mail: info@etop-rank.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
3. Subject Device Information
Type of 510(k): Traditional Company Name: Top-Rank Health Care Co. Ltd. Trade/Device Name: Conductive Gel
4
Model Name: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250 510k Review Panel: Neurology Classification Name: Media, Electroconductive Product Code: GYB Regulation Number: 21 CFR 882.1275 Regulatory Class: II
Intended Use / Indications for Use:
Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrode to reduce the impedance of the contact between the electrode and the skin.
4. Predicate Device Information
Predicate Device:
Sponsor: Guangzhou Xinbo Electronic Co., Ltd. Common Name: Media, Electroconductive Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel Classification Name: Media, Electroconductive 510(K) Number: K200402 510k Review Panel: Neurology Product Code: GYB Regulation Number: 21 CFR 882.1275 Regulatory Class: II
Intended Use / Indications for Use:
DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external to reduce the impedance of the contact between the electrode surface and the skin.
5
5. Device Description
Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Device Name | |||
| and Model | Conductive Gel | ||
| Model: TG01-50, TG01-65, TG01-90, TG01-100, | |||
| TG01-125, TG01-160, | |||
| TG01-200, TG01-250 | DR-HO'S Electro Therapy | ||
| Conductive Gel | |||
| Model: DHGEL | -- | ||
| 510(k) Number | K222770 | K200402 | -- |
| Product Code | GYB | GYB | SE |
| Intended Use / | |||
| Indications for | |||
| Use | Intended for use with | ||
| electric stimulation therapy | |||
| devices, such as TENS | |||
| and EMS. Conductive Gel | |||
| is used with external | |||
| electrode to reduce the | |||
| impedance of the contact | DR-HO'S Electro Therapy | ||
| Conductive Gel is intended | |||
| for use with TENS | |||
| (transcutaneous electrical | |||
| nerve stimulation) and EMS | |||
| (electric muscle stimulation) | |||
| therapy. The Conductive Gel | Similar | ||
| Note 1 | |||
| between the electrode and | |||
| the skin. | is used with external to | ||
| reduce the impedance of the | |||
| contact between the | |||
| electrode surface and the | |||
| skin. | |||
| Regulation | |||
| Number | 882.1275 | 882.1275 | SE |
| Body contact | Intact Skin | Intact Skin | SE |
| Sterilization | Non-Sterile | Non-Sterile | SE |
| Shelf life | 2 years | 2 years | SE |
| Impedance (at 1 | |||
| MHz) | $\leq500\Omega$ | 500Ω | Similar |
| Note 2 | |||
| Material | Purified water (solvent); | ||
| Carbopol (gel forming); | |||
| Glycerin (Moisturizing); | |||
| Sodium hydroxide | |||
| (Buffering); Triclosan | |||
| (preservative) | Purified water (solvent); | ||
| Carbopol (gel forming); | |||
| Glycerin (Moisturizing); | |||
| Sodium hydroxide | |||
| (Buffering); Triclosan | |||
| (preservative) | SE | ||
| Percent | |||
| concentration of | |||
| each ingredient | - Purified water: | ||
| 98.25%; |
- Carbopol: 0.5%;
- Glycerin: 1%;
- Sodium hydroxide:
0.2%; - Triclosan: 0.05% | - Purified water: 98.25%
- Carbopol: 0.5%
- Glycerin: 1%
- Sodium hydroxide: 0.2%
- Triclosan: 0.05% | SE |
| pH | 6.5 ~ 7.5 | 7.0-7.5 | Similar
Note 3 |
| Preservative | Triclosan | Triclosan | SE |
| Biocompatibility | Complied with ISO 10993-
5, ISO 10993-10 | Complied with ISO 10993-5,
ISO 10993-10 | SE |
| Cytotoxicity | Yes | Yes | SE |
| Irritation | Yes | Yes | SE |
| Sensitization | Yes | Yes | SE |
| Operating
Environment | Temperature: 540°C106kPa | Temperature: 5
Humidity: ≤80%RH
Atmospheric Pressure:
8640°C106kPa | SE |
Humidity: ≤80%RH
Atmospheric Pressure:
86
| Storage
Environment | Temperature: 540°C106 kPa | Temperature: 5
Humidity: ≤95% RH
Atmospheric Pressure:
5040°C106 kPa | SE |
Humidity: ≤95% RH
Atmospheric Pressure:
50
6. Comparison to predicate device and conclusion
6
7
Comparison in Detail(s):
Note 1:
Although the "Intended Use / Indications for Use" of subject device is slightly different from predicate device, it's just a difference in how they are described. So, the slight difference will not raise any safety or effectiveness issue.
Note 2:
Although the "Impedance" of the subject device is lower than the predicate device, it does not affect the effectiveness of the product in use. So, the slight difference in Impedance will not raise any safety or effectiveness issues.
Note 3:
8
Although the "pH" of the subject device is a little different from the predicate device, both of them are close to the pH value of the human skin surface, the pH is closed to 7 (neutral). So, the slight difference in pH will not raise any safety or effectiveness issues.
7. Test Summary
7.1 Summary of Non-Clinical Testing
Conductive Gel (Model: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250) has been evaluated the safety and performance by lab bench testing as following:
| Test Item | Purpose of the test | Reference Standard | Acceptance criteria | Test results |
|---|---|---|---|---|
| In vitro | ||||
| Cytotoxicity | ||||
| Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009 | ||
| Biological evaluation of medical devices- | ||||
| Part 5: Tests for in vitro cytotoxicity | Under the conditions of this study, the Test Sample were non-cytotoxicity to L929 cells. | Pass | ||
| Skin | ||||
| Sensitization | ||||
| Test | Under the research conditions, to evaluate the possibility of skin sensitization after topical applications of the test sample on the skin of guinea pig. | ISO 10993-10:2010 | ||
| Biological evaluation of medical devices- | ||||
| Part 10: Tests for irritation and skin sensitization | Under the conditions of this study, the frequency of positive challenge results in sample extract and Negative control animals are 0%, the Positive control is 100%. | Pass | ||
| Skin Irritation | ||||
| Test | Under the | |||
| research | ||||
| conditions, to | ||||
| evaluate the | ||||
| possibility of skin | ||||
| irritation after | ||||
| single topical | ||||
| applications of the | ||||
| test sample on the | ||||
| skin of rabbits. | ISO 10993-10:2010 | |||
| Biological evaluation | ||||
| of medical devices- | ||||
| Part 10: Tests for | ||||
| irritation and skin | ||||
| sensitization | Under the | |||
| conditions of this | ||||
| study, the test | ||||
| sample induce | ||||
| negligible irritation | ||||
| in a rabbit skin | ||||
| single exposure | ||||
| test. | Pass | |||
| Usability | ||||
| Study | To study how | |||
| usability will be | ||||
| performed in | ||||
| subject device in | ||||
| order to comply | ||||
| with IEC 62366-1 | IEC 62366-1 Edition | |||
| 1.0 2015-02, Medical | ||||
| devices - Part 1: | ||||
| Application of usability | ||||
| engineering to medical | ||||
| devices [Including | ||||
| CORRIGENDUM 1 | ||||
| (2016)] | The subject device | |||
| can meet the | ||||
| usability goal of | ||||
| IEC 62366-1 | ||||
| standards. | Pass | |||
| Shelf Life | ||||
| Test | To study whether | |||
| the performance | ||||
| of subject device | ||||
| can meet the 2- | ||||
| year shelf life | ||||
| requirements | ASTM F1980-16: | |||
| Standard Guide for | ||||
| Accelerated Aging of | ||||
| Sterile Barrier | ||||
| Systems for Medical | ||||
| Devices; | ||||
| Guidance document | ||||
| for the "Shelf Life of | ||||
| Medical Devices" | ||||
| issued in April 1991 | All items (Exterior, | |||
| Package, pH, | ||||
| Impedance and | ||||
| conductivity) | ||||
| tested on both | ||||
| before and after | ||||
| aging samples | ||||
| meet the | ||||
| performance | ||||
| required. | Pass |
9
10
7.2 Summary of Non-Clinical Testing
No clinical study is included in this submission.
8. Final Conclusion
The subject device "Conductive Gel, (Model: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250)" is as safe and effective and substantially equivalent to the legally marketed predicated K200402.