(81 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a self-adhesive electrode, with no mention of AI or ML algorithms for data processing or decision-making.
Yes
The device is described as "a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC (Interferential current), or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current," which are all therapeutic modalities.
No
The device, a self-adhesive electrode, is intended for transmitting electrical current from marketed electrical stimulators (i.e., TENS, EMS) to the patient's skin, not for diagnosing conditions.
No
The device description clearly outlines physical components like conductive carbon film, adhesive, fabric, and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "conductive interface between the patient's skin and the marketed electrical stimulators" for transmitting electrical current. This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The description details the physical components and how the electrode functions to conduct electrical current to the skin. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on electrical properties, adhesion, biocompatibility, and safety in the context of electrical stimulation, not on diagnostic accuracy or analysis of biological markers.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This self-adhesive electrode does not perform any such function.
N/A
Intended Use / Indications for Use
Self-Adhesive Electrode is intended for as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Product codes
GXY
Device Description
Self-Adhesive Electrodes are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Comytens are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
No. Description Material Composition
1 Top layer Fabric/Foam/ Tan fabric
2 Middle layer Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
3 Bottom layer Biocompatible self-adhesive conductive hydrogel
4 Connection Leadwire/snap button/magnetic button
5 double sides adhesive tape which is used for attaching the non-woven fabrics and conducting film
6 Release liner plastic film is a protective layer for the hydrogel.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Comytens provides lead wire type and snap button/Magnetic button type:
-
Leadwire assembly:
The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. By design, the insulated outer jacket prevents the connection to earth or hazardous voltages. 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. -
Snap button/Magnetic button assembly:
With 2.5~5mm diameter male socket. The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and femaleconnectors. Either method is similar to the lead wire connection providing the friction to create the physicalcontact.
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
General [Adult]
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)
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below. Based on the non-clinical and clinical performance as documented in the device, devices were found to have a safety and effectiveness profile that is similar to the predicate device.
Non-Clinical Data:
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:
Biocompatibility testing:
The biocompatibility evaluation for the Self-Adhesive Electrode conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is contacting for duration of less than 24 hours. And the testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Safety and EMC:
To verify the basic safety and essential performance of the subject device, weperformed the test noted below:
- IEC60601-1:2005+AMD1:2012+AMD2:2020; Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance
The submitted sample(s) complied with the requirements of IEC 60601-1:2005+AMD1:2012+AMD2:2020, Cl.8.5.2.3
Bench Testing:
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 test results demonstrated that the proposed device complies with the following standards:
- Electrical & Impedance Tests
The Self-Adhesive Electrode was tested to assure the current is equally distributed. The Self-Adhesive Electrode was also tested for Impedance to assure proper electrical connection to the skin. - Adhesion tests
The Self-Adhesive Electrode was tested for initial adhesion force after using multiple times. - Connector & Mechanical tests
The Self-Adhesive Electrode has a Snap or magnetic surface with the purpose to clamp the Self-Adhesive Electrode. This connection was tested to assure multiple use and also to assure the TENS stay fixed to the Self-Adhesive Electrode during use. - Packaging testsReal-Time Shelf Life Test Report
The Self-Adhesive Electrode was tested for storage conditions:
- The Self-Adhesive Electrode should not be stored at temperatures lower than 41°E(+5°C) or higher than 80.6°F (+27°C).
- Accelerated Aging
The Self-Adhesive Electrode was tested for accelerate aging in worst storage condition to assure within the expiration date the electrode function as expected.
- ASTM F1980 (Reapproved 2016), Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
Clinical data: No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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November 4, 2022
Guangdong Comytens Medical Technology Co., Ltd Mr. Amos Zou RA Manager Building A-102, No. 24, Jiangjunmao Industrial Zone Wulian, Longgang District Shenzhen, Guangdong 518116 China
Re: K222453
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 12, 2022 Received: August 15, 2022
Dear Mr. Amos Zou:
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,
Tushar Bansal -S
Tushar Bansal, PhD Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222453
Device Name Self-adhesive Electrode
Indications for Use (Describe)
Self-Adhesive Electrode is intended for as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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510(K)SUMMARY
1. Submitter of 510(K):
| Sponsor | |
|---|---|
| Company Name: | Guangdong Comytens Medical Technology Co.,Ltd |
| Address: | Building A-102, No. 24, Jiangjunmao Industrial Zone, Wulian, Longgang District , |
| Shenzhen, Guangdong, China 518116 | |
| Contact person: | Deng Jiuzhen |
| TEL: | +86-13418878095 |
| FAX: | / |
| E-mail: | info@comytens.com 276148005@qq.com |
| Date of Prepared: | Nov, 3 2022 |
Application Correspondent:
| Company Name: | Guangdong Comytens Medical Technology Co.,Ltd |
|---|---|
| Address: | Building A-102, No. 24, Jiangjunmao Industrial Zone, Wulian, Longgang District , |
| Shenzhen, Guangdong, China 518116 | |
| Contact person: | Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | Amos.zou@139.copm |
| Date of Prepared: | Nov, 3 2022 |
2. Proposed Device and code:
| Device Trade Name: | Self-Adhesive Electrode |
|---|---|
| Model Series | Self-Adhesive Electrodes with lead wire; |
| Self-Adhesive Electrodes with Snap/Magnetic connector; | |
| Self-Adhesive Electrode Pads | |
| Regulation Medical Specialty | Neurology |
4
| Product Code: | GXY |
|---|---|
| Regulation number | 21 CFR 882.1320 |
| Device Class | II |
| 510(K) Number | K222453 |
Predicate Device: 3.
| 510(K) | Trade Name | Submitter | Product Code |
|---|---|---|---|
| K180865 | ZMI Self-adhesive | ZMI Electronics, Ltd. | GXY |
Description of Proposed Device: 4.
Self-Adhesive Electrodes are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Comytens are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
| No. | Description | Material Composition |
|---|---|---|
| 1 | Top layer | Fabric/Foam/ Tan fabric |
| 2 | Middle layer | Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film) |
| 3 | Bottom layer | Biocompatible self-adhesive conductive hydrogel |
| 4 | Connection | Leadwire/snap button/magnetic button |
| 5 | double sides | |
| adhesive tape | which is used for attaching the non-woven fabrics and conducting film | |
| 6 | Release liner | plastic film is a protective layer for the hydrogel. |
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Comytens provides lead wire type and snap button/Magnetic button type:
-
Leadwire assembly:
The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. By design, the insulated outer jacket prevents the connection to earth or hazardous voltages. 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. -
Snap button/Magnetic button assembly:
With 2.5~5mm diameter male socket. The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and femaleconnectors. Either method is similar to the lead wire connection providing the friction to create the physicalcontact.
5. Intended for Use
Self-Adhesive Electrode is intended for as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current), or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
5
6. Technical and Performance
The following table compares the device to the predicate device with basic technological characteristics.
Comparison to predicate device:
| Element of
Comparison | Subject Device | Predicate Device | Comm
ent |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 510(k) | K222453 | K180865 | N/A |
| Company | Guangdong Comytens Medical
Technology Co.,Ltd | ZMI Electronics, Ltd. | N/A |
| Device Name | Self-Adhesive Electrodes | ZMI Self-adhesive electrodes | N/A |
| Model name | ● Self-Adhesive Electrodes with leadwire;
● Self-Adhesive Electrodes with Snap
/Magnetic connector;
● Self-Adhesive Electrode Pads | SAE Type | N/A |
| Shape | Square(40*40mm) | Round, Rectangular, Square, Oval, and
Butterfly | similar
1# |
| Color | White, Red, Black, and Tan | White, Red, Black, and Tan | Same |
| Regulation
Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification
Name | Cutaneous electrode | Cutaneous electrode | Same |
| Intended Use | Self-Adhesive Electrode is intended for as
a reusable, conductive adhesive interface
between the patient's skin and the
marketed electrical stimulators (i.e.TENS
(Transcutaneous Electrical Nerve
Stimulation), EMS (Electrical Muscular
Stimulation), IF or IFC(Interferential
current), RUSS(Russian stimulation),
MIC(Microcurrent) or PGF (Pulsed
Galvanic Stimulation) for transmitting
electrical current, for OTC (Over-The-
Counter) or Prescription use. | ZMI Self-adhesive electrodes are
intended for as a reusable, conductive
adhesive interface between the patient's
skin and the marketed electrical
stimulators (i.e. TENS (Transcutaneous
Electrical Nerve Stimulation), EMS
(Electrical Muscular Stimulation), IF
(Interferential) or PGF (Pulsed Galvanic
Stimulation) for transmitting electrical
current, for OTC (Over-The-Counter) or
Prescription use. | Same |
| OTC or
Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target
Population | General [Adult] | General [Adult] | Same |
| Design
Feature | Six layers:
- Insulation backing material:
Fabric/Foam/Tan fabric - Conductive film: Aluminum foil film | Three layers:
- Insulation backing material:
Fabric/Foam/Tan fabric
2.Conductive film: Aluminum foil | similar
2# |
| | /Carbon film/Carbon film coated with
silver/
3.Conductive hydrogel
4.Connection
5.double sides adhesive tape
6.Release liner | film/Carbon film/Carbon film coated with
silver/
3.Conductive hydrogel | |
| Electrical
Connection | Leadwire
Snap button
Magnetic button | Leadwire
Snap button
Magnetic button | Same |
| Lead Wire
connector | .080"/0.1"(2mm/2.5mm) female socket
or Pin connector | .080" (2mm) female socket connector | similar
3# |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Adhesive
Type | Self-adhesive | Self-adhesive | Same |
| Biocompatibi
lity | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C.
Impedance |