(86 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the electrodes, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The Adhesive Electrodes are a component (conductive interface) used with electrical stimulators (TENS, EMS, IF, PGF), which are therapeutic devices. The electrodes themselves transmit electrical current from the stimulator to the patient's skin, but they do not provide the therapeutic treatment directly.
No
Explanation: The device is an "Adhesive Electrode" intended to transmit electrical current from electrical stimulators (like TENS) to the patient's skin for therapeutic purposes, not for diagnosis.
No
The device is described as physical adhesive electrodes composed of fabric, carbon film, and hydrogel, intended to be a conductive interface for electrical stimulators. 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 is to provide a conductive interface between the patient's skin and electrical stimulators (TENS, EMS, IF, PGF) 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 it functions to conduct electricity. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Lack of Diagnostic Function: The device's purpose is to facilitate the delivery of electrical stimulation, which is a treatment modality, not a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Adhesive Electrodes are intended for use as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators i.e. TENS (Transutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Adhesive Electrodes are composed of non-woven fabric, carbon film coated with silver and conductive hydrogel; It is identical in technological characteristics compared to the predicate device, Adhesive Electrodes, OACWN serial cleared in K160138 and the subject devices are also to be sold for over-the-counter (OTC) use and prescription use, which is the same as the predicate device.
Adhesive Electrodes manufactured by Voncare Medical Device Co., Ltd are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.
First layer: Insulating backing material-nonwoven coated with 30-50um bio-compatible medical adhesive tape
Second layer: Conductive film
Third layer: Bio-compatible self-adhesive conductive hydrogel, thickness 1.0+/-0.2mm
Protective silicon liner: PET
The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
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)
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:
Safety and EMC:
ANSI/AAMI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The test result shows the device complies with the standard's requirements.
Performance Data:
-Adhesion Test
-Pair AC Impedance and Current Dispersion Test
-Retention Test
-Reusability and stability test
-Storability Test (Shelf Life)
-EC12 Disposable ECG electrodes
-EC53 ECG Cables and Leadwire
The test results demonstrate the device meets the requirements.
Biocompatibility:
According to ISO10993-1 Fourth edition, 2009-10-15 Annex A Table A.1 -Evaluation tests for consideration, the subject device is classified as: Surface Device > Contact Intact Skin >> Limited Contact Duration(:524h).
Tests conducted: Cytotoxicity Tests (ISO10993-5), Skin Irritation Test (ISO10993-10), Skin Sensitization Test (ISO10993-10).
The test result shows it complies with the requirement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
A.C. Impedance:
§ 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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October 6, 2021
Voncare Medical Device Co., Ltd % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K212191
Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 10, 2021 Received: July 12, 2021
Dear Charles Mack:
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.
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) K212191
Device Name Adhesive Electrodes
Indications for Use (Describe)
The Adhesive Electrodes are intended for use as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators i.e. TENS (Transutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is 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
Device 510k number: K212191 Preparation Date: October 6, 2021
Submitter Information:
Voncare Medical Device Co., Ltd Shiwan Science and Technology Industrial Park, Yongshi Avenue East, Boluo County, Huizhou City, Guangdong Province, China 516127 Tel:+86-752-6730765 Contact person: Mr. Jimmy Zhai (General Manager)
Corresponding Official: Charles Mack Telephone number: 931-625-4938
FDA Registration Number:
Owner/Operator Number: 10047792 Establishment Registration Number: 3011307234
Regulatory Information:
Trade name: Adhesive Electrodes Common Name: Reusable Neurostimulation Electrodes Classification Name: Electrodes, cutaneous Regulation Number: 882.1320 Product Code: GXY Classification: Class II
Predicate Device:
K160138 GMDASZ Adhesive Electrodes (GMDASZ Manufacturing Co., Ltd.)
4
Device Description:
Adhesive Electrodes are composed of non-woven fabric, carbon film coated with silver and conductive hydrogel; It is identical in technological characteristics compared to the predicate device, Adhesive Electrodes, OACWN serial cleared in K160138 and the subject devices are also to be sold for over-the-counter (OTC) use and prescription use, which is the same as the predicate device.
Adhesive Electrodes manufactured by Voncare Medical Device Co., Ltd are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.
First layer: Insulating backing material-nonwoven coated with 30-50um bio-
compatible medical adhesive tape
Second layer: Conductive film
Third layer: Bio-compatible self-adhesive conductive hydrogel, thickness 1.0+/-0.2mm
Protective silicon liner: PET
The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
Indications for Use:
The Adhesive Electrodes are intended for use 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. The electrode is for OTC (Over-The-Counter) or Prescription use.
5
Comparison to predicate device:
| Characteristics | Subject Device | Predicate Device | Difference Discussion |
|---|---|---|---|
| 510K Applicant | Voncare Medical Device Co., Ltd | GMDASZ Manufacturing Co., Ltd. | - |
| 510(K) Number | N/A | K160138 | - |
| Device Name | Adhesive Electrodes | Adhesive Electrodes | - |
| Model | TS0020/TS0030/TS0050/TS5050/ | ||
| TS5089/TS50130 | OACWN1005/OACWN1007/OAC | ||
| WN2505/ OACWN2509 | - | ||
| Regulation | |||
| Number | 882.1320 | 882.1320 | Identical |
| Product Code | GXY | GXY | Identical |
| Classification | |||
| Name | Cutaneous electrode | Cutaneous electrode | Identical |
| OTC or | |||
| Prescription | OTC & Prescription | OTC & Prescription | Identical |
| Medical Specialty | Neurology | Neurology | Identical |
| Intended Use | The Adhesive Electrodes are | ||
| intended for use 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. The electrode is | |||
| for OTC (Over-The-Counter) or | |||
| Prescription use. | The Adhesive Electrodes are | ||
| intended for use 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. The | |||
| electrode is for OTC (Over-The- | |||
| Counter) or Prescription use. | Identical | ||
| Characteristics | Subject Device | Predicate Device | Difference Discussion |
| Design Feature | Three layers: | ||
| 1 insulating backing material: non- | |||
| woven fabric | |||
| 2 Conductive film: Carbon film | |||
| coated with silver/Aluminum foil | |||
| film | |||
| 3 Conductive hydrogel (VG100) | Three layers: |
- Insulation backing material:
Fabric/Foam/Tan fabric - Conductive film: Carbon film
coated with silver/Aluminum foil film - Conductive hydrogel (A, T, or U
gel) | 1. Same - Same
- The material of
conductive hydrogel is
different.
The difference does not
raise any new safety and
effectiveness questions
and complies with the
same biocompatible,
performance, and safety
requirements. |
| Electrical
Connection | Leadwire | Leadwire | Identical |
| Protective Liner | PET | PET | Identical |
| Lead Wire
connector | Leadwire connector .080" female
socket connector | Leadwire connector .080" female
socket connector | Identical |
| Reusable | Reusable | Reusable | Identical |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Identical |
| Self-adhesive | Self-adhesive | Self-adhesive | Identical |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Identical |
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7
| Characteristics | Subject Device | Predicate Device | Difference Discussion |
|---|---|---|---|
| A.C. Impedance | Contact Intact Skin >> Limited Contact Duration(:524h) |
We conducted the applicable tests noted below: Cytotoxicity Tests (ISO10993-5) Skin Irritation Test (ISO10993-10) Skin Sensitization Test (ISO10993-10)
The test result shows it complies with the requirement.
Sterility Information
Not applicable, the subject device is not sterile.
Clinical Study:
No clinical study is included in this submission.
Conclusion:
The submitted new Adhesive Electrodes have the same intended use and similar technological characteristics as the predicate devices. Moreover, the information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the submitted adhesive electrodes are substantially equivalent to the predicate devices.
END