(162 days)
No
The device description and intended use focus solely on the electrode's function as a conductive interface for electrical stimulation. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device itself is an electrode, which is an accessory used with therapeutic devices (TENS and EMS devices), but it does not provide therapy on its own.
No
The device is an electrode for electrical stimulation devices (TENS/EMS) and is explicitly stated to be an "interface between the patient's skin and the electrical stimulation devices." It is not described as detecting, analyzing, or interpreting biological signals to provide a diagnosis.
No
The device description clearly states it is a "Self-adhesive Electrode," which is a physical component used as an interface between the patient's skin and electrical stimulation devices. This indicates it is a hardware device, not software-only.
Based on the provided information, the Mailuokang Self-adhesive Electrode is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Mailuokang Electrode Function: The description clearly states that the Mailuokang Self-adhesive Electrode is a "conductive adhesive interface between the patient's skin and the electrical stimulation devices." It is used for delivering electrical stimulation to the body, not for analyzing bodily specimens.
- Intended Use: The intended use is for TENS and EMS, which are forms of electrical therapy applied to the body's surface.
Therefore, the Mailuokang Self-adhesive Electrode falls under the category of a medical device used for external electrical stimulation, not an IVD.
N/A
Intended Use / Indications for Use
Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
Product codes
GXY
Device Description
Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
Six basic components for Lead Wire Style Electrode: non-woven fabrics; double sides adhesive tape; conducting film; hydrogel; plastic film; carbon fiber wire.
Six basic components for Snap Style Electrode: non-woven fabrics; double sides adhesive tape conducting film; hydrogel; plastic film and snap.
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)
The Mailuokang Self-adhesive Electrode passed self-evaluation tests for impedance and adhesiveness. Mailuokang's electrode has passed three biocompatibility tests: skin irritation, sensitization and cytotoxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K970246, K090198, K142055, K020735
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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2016
Shenzhen Mailuokang Technology Co., Ltd. % Ms. Elena Lu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 2032, International Mayors Communication Centre Shenzhen, Guangdong, 518000 China
Re: K152815
Trade/Device Name: Mailuokang Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: January 28, 2016 Received: February 4, 2016
Dear Ms. Lu:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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) K152815
Device Name Mailuokang Self-adhesive Electrode
Indications for Use (Describe)
Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
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) |
| X 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 submitted as required by requirements of SMDA and 21 CFR §807.92.
Administrative Information
| Date of
| prepared | Summary | Sep., 21, 2015 |
|---|---|---|
| Manufacturer | ||
| information | Company title: | |
| Shenzhen Mailuokang Technology Co., Ltd. | ||
| Company address: | ||
| Rm 602, 6/F, Building B, Nanchang Jianyu No.2 | ||
| Industrial Zone, Gushu Village, Xixiang Street, | ||
| Baoan District, Shenzhen, China | ||
| Phone: +86-755-8525 8460 | ||
| Fax: +86-755-8525 8461 | ||
| Contact Person: Mr. Pandeng. Hu | ||
| E-mail: 1962807321@qq.com | ||
| Submission | ||
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. | |
| Address: Room 2032, International Mayors | ||
| Communication Centre, No. 55 Shizhou middle | ||
| road, Nanshan District, Shenzhen | ||
| Image: [logo] | ||
| 卓远天成 | Contact person: Ms. Elena. Lu; Mr. Field. Fu | |
| E-Mail: elena@cefda.com; | ||
| cefda13485@163.com | ||
| Establishment registration | ||
| number |
number
Device Information
| Type of 510(k) | |
|---|---|
| submission: | |
| Trade Name: | |
| Model: | |
| Classification name: | |
| Review Panel: |
Traditional
Mailuokang Self-adhesive Electrode Lead Wire Style Electrode, Snap Style Electrode Electrode, cutaneous Neurology
4
| Product Code: | GXY |
|---|---|
| Device Class: | II |
| Regulation Number: | 882.1320 |
Predicate Device Information
| Sponsor: | Phoenix Medical Devices, LLC |
|---|---|
| Device: | THERATRODE |
| 510(K) Number: | K112312 |
Device Description
Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
Intended Use
Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example of electrical stimulation devices for current applications of the electrodes includes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Selfadhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
Technological characteristics of the subject device compared to the predicate device
The subject device and the predicate device have the same intended use, similar technological characteristics, and similar material composition. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or
5
effectiveness. Thus, the subject device is substantially equivalent to the predicate device.
The detailed substantially equivalent table is shown as follows:
| Items | Predicate
Device(K112312) | Subject Device | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| General Characteristics | | | |
| Indications
for
Use | To conduct electrical
stimulation from
commercially available
nerve stimulation devices
to the patient's skin.
Single patient use - re-
usable. Self adhering and
re-positionable. Over the
counter use. | Mailuokang Self-adhesive
Electrode is intended for
use as reusable, conductive
adhesive interface between
the patient's skin and the
electrical stimulation
devices. Example electrical
stimulation devices for
current applications of the
electrodes includes, but are
not limited to, TENS
(Transcutaneous Electrical
Nerve Stimulation) and
EMS (Electrical Muscle
Stimulation). Mailuokang
Self-adhesive Electrode is
for prescription use and
over-the-counter use, for
single patient use only. | Substantially
Equivalent
(Note 01) |
| OTC
or
Prescription | OTC or OTC Use | Prescription use and Over-
the-Counter use | Substantially
Equivalent
(Note 02) |
| Classification
Name | Cutaneous Electrode | Cutaneous Electrode | Same |
| Product Code | GXY 882.1320 | GXY 882.1320 | Same |
| Device Class | Class II | Class II | Same |
| Reusable | Yes | Yes | Same |
| Single
patient
Use | Yes | Yes | Same |
| Multiple
Applications | Yes | Yes | Same |
| Sterility Status | Non-sterile | Non-sterile | Same |
| Technical Characteristics | | | |
| Design Features | Four basic components:
- A patient contacting
layer of hydrogel material | Six basic components for
Lead Wire Style Electrode: - non-woven fabrics; | Substantially
Equivalent
(Note 03) |
| Items | Predicate Device(K112312) | Subject Device | Comparison |
| | which has been tested and found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin; - A carbon dispersion pad middle layer that evenly distributes the electrical current across the surface of the electrode;
- A non-conductive top layer of various materials such as spun lace (fabric), polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode | double sides adhesive tape; conducting film; hydrogel; plastic film; carbon fiber wire. Six basic components for Snap Style Electrode: non-woven fabrics; double sides adhesive tape conducting film; hydrogel; plastic film and snap. | |
| | * A wire or conductive carbon fiber lead wire which is glued to the assembly of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. | | |
| Hydrogel
Composition | Unknown | Glyrol, Polyacrylic acid, Water and Salt. | Substantially Equivalent (Note 04) |
| Biocompatibility | Theratrode's hydrogel has passed three biocompatibility tests: skin | Mailuokang's hydrogel has passed three biocompatibility tests: skin | Same |
| Items | Predicate
Device(K112312) | Subject Device | Comparison |
| | irritation,
cytotoxicity and delayed
contact sensitization | irritation, sensitization and
cytotoxicity | |
| Performance test | Measuring the electrical
conductivity (inverse of
impedance) | Measuring the electrode
contact impedance and
adhesion | Substantially
Equivalent
(Note 05) |
| Conductive
Surface Shapes | Various shapes(square,
round, rectangular, oval) | Various shapes
(rectangular, oval, circle) | Substantially
Equivalent
(Note 06) |
| Electrode
Impedance | Unknown | The average value of 10-
hertz (Hz) impedance for 12
electrode pairs connected
gel-to-gel, at a level of
impressed current not
exceeding 100
microamperes (µA) peak-
to-peak (p-p), shall not
exceed 2 kilohms (kΩ).
None of the individual pair
impedances shall exceed 3
kΩ. | Substantially
Equivalent
(Note 07) |
6
7
Discussion about the similarities and differences between the subject device and the predicate device:
Note 01:
The only difference between the subject device and the predicate device are the wordings.
Note 02:
The differences are: the subject device is for prescription use and over-the-counter use while the predicate device is only for OTC use. However, many cutaneous electrodes intended for use with transcutaneous electrical nerve stimulators have been cleared by the FDA for prescription use, e.g., the Axelgaard ValuTrode Neurostimulation Electrodes (K970246), Jiajian Self- adhesive Electrode (K090198). Thus the intended use of the subject device and predicate device are substantially equivalent.
Note 03:
The subject device and predicate device are similar in construction. They both contain four basic components: a non-conductive top layer, a patient contacting layer, a carbon dispersion pad middle layer (similar function for conducting film of Mailuokang Lead Wire
8
Style and Snap Style electrode,) and conductive carbon fiber lead wire (or snap for Snap Style Electrode); while the Mailuokang electrode also contains two additional layer: double sides adhesive tape which is used for attaching the non-woven fabrics and conducting film, and plastic film is a protective layer for the hydrogel. Which the differences will not effect the safety and effectiveness of the Mailuokang Self-adhesive Electrode.
Note 04:
Though the hydrogel composition of the predicate device is unknown, the Mailuokang's hydrogel composition is the same with Electrode pads of GYMFORM ABS&CORE Electrode (K142055) which has been cleared by the FDA. What's more, Mailuokang's electrode and the predicate device's electrode both passed three biocompatibility tests: skin irritation, cytotoxicity and delayed contact sensitization.
Note 05:
Although the subject device and the predicate device conducting different electrical performance tests, they are both used to demonstrate the same performance of the electrode: good conductivity. For the predicate device, the electrical conductivity (inverse of impedance) is measured, while for the subject device, the electrode contact impedance is measured. Many cutaneous electrodes intended for use with transcutaneous electrical nerve stimulators have been cleared by the FDA by passing impedance testing, e.g., SOF-PACH™ Reusable Neurostimulation Electrodes (K020735), Jiajian Self- adhesive Electrode (K090198). Because the Mailuokang Self-adhesive Electrode has the same intended use and fundamental technology as these other electrodes, it is substantially equivalent to them. Moreover, the subject device also considered the adhesion performance. The subject device has passed self-evaluation tests for impedance and adhesiveness. Thus, the performance of subject device is substantially equivalent to the predicate device.
Note 06:
The differences in shapes will not effect the safety and effectiveness of the Mailuokang Selfadhesive Electrode.
Note 07:
Although electrode impedance of the predicate device is unknown, the comparison testing between the predicate device and the subject device was performed according to ANSI/AAMI EC 12:2000/(R)2005 standard, and both the devices passed the testing. Which the
9
differences will not effect the safety and effectiveness of the Mailuokang Self-adhesive Electrode.
Brief discussion of the nonclinical tests
The Mailuokang Self-adhesive Electrode passed self-evaluation tests for impedance and adhesiveness. Mailuokang's electrode has passed three biocompatibility tests: skin irritation, sensitization and cytotoxicity.
Brief discussion of clinical tests
Not applicable.
Other information (such as required by FDA guidance)
No other information.
Conclusions
The subject device Mailuokang Self-adhesive Electrode is substantially equivalent to THERATRODE whose 510(k) number is K112312.