(203 days)
No
The device description and intended use focus on the physical properties and function of adhesive electrodes for electrical stimulation, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an accessory (adhesive electrode) used to transmit electrical current from marketed electrical stimulators (which are therapeutic devices) to the patient's skin. It does not perform a therapeutic function independently.
No
Explanation: The device description states its purpose is to transmit electrical current from stimulators to the patient's skin for therapies like TENS or EMS. It does not mention any function related to diagnosing medical conditions.
No
The device is described as a multi-layer, reusable, flexible structure composed of laminated materials, including insulating backing, conductive film, and biocompatible self-adhesive conductive hydrogel. This description clearly indicates a physical hardware component, not a software-only 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 electrodes are for transmitting electrical current between the patient's skin and external electrical stimulators (TENS, EMS, IF, PGF). This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The description details the physical components and function of the electrodes as a conductive interface. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on biological sample analysis.
The device is a medical device used for electrical stimulation, which falls under a different regulatory category than IVDs.
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 (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.
Product codes
GXY
Device Description
Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver are identical in technological characteristics compared to our own previous 510K cleared electrodes in K092546, so this premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use and prescription use.
Adhesive Electrodes composed of Aluminum foil film, are technologically equivalent to the predicate devices - K132998 Wandy self-adhesive electrodes for over-the-counter (OTC) use and prescription use.
Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
First layer: Insulating backing material: Fabric/foam/tan fabric
Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film
Third layer: Biocompatible self-adhesive conductive hydrogel
Protective liner: PET
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. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance 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
patient's skin
Indicated Patient Age Range
The electrodes are used for adults only.
Intended User / Care Setting
OTC (Over-The-Counter) or Prescription use.
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)
The Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver. They are identical to GMDASZ's previous 510K cleared electrodes in K092546 This submission supports a change only to allow the product to be sold for Over-The-Counter (OTC) use. The electrodes are compared to the Wandy Rubber Industrial Co., Ltd. Self-adhesive electrodes. K132998. The mechanical and electrical properties of the submitted GMDASZ electrodes are the same as the Wandy Self-adhesive electrodes.
For Adhesive Electrodes composed of Aluminum foil film, all the materials are same as the previously cleared electrodes in K092546 except the conductive media, so no new biocompatibility tests were conducted. To verify the safety and performance of it, GMDASZ conducted new tests. These tests are the same as our previous cleared prescription electrode in K092546, including safety test, adhesion test, current dispersion test, reusability and stability test as well as some performance test by refer to EC12/EC53. The test result shows the new electrodes with aluminum foil film is identical to the both the GMDASZ and Wandy predicate devices in safety and performance characteristics.
No clinical tests were needed.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
GMDASZ Manufacturing Co., Ltd % Charles Mack Principal Engineer IRC 2250 Duportail Street, M275 Richland, Washington 99352
Re: K160138
Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: June 28, 2016 Received: July 13, 2016
Dear Mr. 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. 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 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J.Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160138
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 (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.
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) |
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
510k Summary
Device 510k number: K160138
Submitter Information:
GMDASZ Manufacturing Co., Ltd. Room E1308, Xihaimingzhu Building, Taoyuan Road , Nanshan District, ShenZhen City, Guangdong Province, P.R. China. Postcode: 518052 Tel: 86-755-86213939 Fax: 86-755-26669658 Contact person: Mr. Xiangjie Zhang (General Manager)
FDA Registration Number:
Owner/Operator Number: 10031210 Establishment Registration Number: 3008197884
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 Devices:
| K092546 | GMDASZ TENS Electrodes (GMDASZ Manufacturing Co., Ltd.) |
|---|---|
| K132998 | Wandy self-adhesive electrodes (WANDY Rubber Industrial Co., Ltd.) |
Device Description:
Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver are identical in technological characteristics compared to our own previous 510K cleared electrodes in K092546, so this premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use and prescription use.
Adhesive Electrodes composed of Aluminum foil film, are technologically equivalent to the predicate devices - K132998 Wandy self-adhesive electrodes for over-the-counter (OTC) use and prescription use.
Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
First layer: Insulating backing material: Fabric/foam/tan fabric Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET
4
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. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance 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.
| Element of
comparison | Subject Device
(K160138) | Predicate Device
(K092546) | Justification |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | GMDASZ Manufacturing
Co., Ltd. | GMDASZ Manufacturing
Co., Ltd. | Same |
| Device Name | Adhesive Electrodes | GMDASZ TENS
Electrodes | N/A |
| Model Name | OCWN1005, OCWN1007,
OCWN2505, OCWN2509,
OACWN1005,
OACWN1007,
OACWN2505,
OACWN2509 | CWN1005, CWN1007,
CWN2505, CWN2509,
ACWN1005,
ACWN1007,
ACWN2505,
ACWN2509 | N/A |
| Regulation Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification
Name | Cutaneous electrode | Cutaneous electrode | Same |
| OTC or
Prescription | OTC and Prescription | Prescription | Predicate device
K132998 (below)
is both OTC and
Rx only.
Additionally, the
labeling has
defined restricted
areas of
application,
exactly like the
predicate device
K132998. |
| Intended Use | The adhesive electrodes | The GMDASZ TENS | Similar |
| | are intended for as a | Electrodes are intended | |
| | reusable, conductive | for use as a reusable, | |
| | adhesive interface between | conductive adhesive | |
| | the patient's skin and the | interface between the | |
| | marketed electrical | patient's skin and the | |
| | stimulators (i.e. TENS | Electrical Stimulator. | |
| | (Transcutaneous Electrical | GMDASZ's reusable | |
| | Nerve Stimulation), EMS | electrodes are designed | |
| | (Electrical Muscular | and intended to be used | |
| | Stimulation), IF | with marketed, Electrical | |
| | (Interferential) or PGF | Stimulators i.e. TENS | |
| | (Pulsed Galvanic | (Transcutaneous | |
| | Stimulation) for | Electrical Nerve | |
| | transmitting electrical | Stimulation), EMS | |
| | current. The electrode is | (Electrical Muscular | |
| | for OTC (Over-The- | Stimulation), IF | |
| | Counter) or Prescription | (Interferential) or PGF | |
| | use. | (Pulsed Galvanic | |
| | | Stimulation). | |
| | | | |
| | | The electrotherapy | |
| | | electrodes are intended to | |
| | | be used to apply electrical | |
| | | stimulation current to the | |
| | | patient's skin. | |
| Design Feature | Three layers: | Three layers: | 1) Same
2) Same except
subject device
has the option of
an Aluminum
foil film. The
Aluminum foil
film is used as a
conductive film
in predicate
K132998
(below).
- Same |
| | 1. Insulation backing | 1. Insulating backing | |
| | material: | material: | |
| | Fabric/Foam/Tan fabric | Fabric/Foam/Tan fabric | |
| | | | |
| | 2. Conductive film: | 2. Conductive plastic | |
| | Carbon film/Carbon film | film: Carbon film/ Carbon | |
| | coated with | film coated with silver | |
| | silver/Aluminum foil film | | |
| | | 3. Conductive hydrogel | |
| | 3. Conductive hydrogel | (A, T or U gel) | |
| | (A, T or U gel) | | |
| | | | |
| Electrical
Connection | Leadwire | Leadwire | Same |
| | | | |
| Protective Liner | PET | PET | Same |
| Lead Wire
connector | Leadwire connector .080"
female socket connector | Leadwire connector .080"
female socket connector | Same |
| | | | |
| | | | |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Self-adhesive | Self-adhesive | Self-adhesive | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C. Impedance |