(59 days)
Not Found
No
The description focuses on the physical components and intended use of adhesive electrodes, with no mention of AI or ML capabilities.
No
The device is an accessory (an electrode) for therapeutic devices (TENS and EMS units), but it is not a therapeutic device itself as it does not directly provide therapy.
No
The device is described as a "conductive interface" for electrical stimulators (TENS and EMS), which are therapeutic devices, not diagnostic ones. It helps deliver electrical signals but does not measure or interpret physiological data for diagnosis.
No
The device description explicitly states that the device "mainly consists of substrate and wire," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The described device, Adhesive Electrodes, is a conductive interface used with electrical stimulators (TENS and EMS). Its function is to facilitate the delivery of electrical impulses to the patient's skin for therapeutic purposes (nerve stimulation or muscle stimulation).
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It is a physical interface for delivering electrical current.
- Intended Use: The intended use is to provide a conductive connection for electrical stimulation, not to diagnose or monitor a condition based on biological markers.
Therefore, the Adhesive Electrodes fall under the category of medical devices used for therapy, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Product codes
GXY
Device Description
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
The proposed device, Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator, i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.
The intended environment for the proposed device includes home use and hospital use.
The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.
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
children and adults.
Intended User / Care Setting
Home use and hospital use. OTC 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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
No clinical study is included in this submission.
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/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mav 8, 2017
Reno Medical Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K170744
Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 4, 2017 Received: March 10, 2017
Dear Diana Hong:
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
1
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 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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170744
Device Name Adhesive Electrodes
Indications for Use (Describe)
Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
| 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)
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Tab #7 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: -
-
- Date of Preparation: 2/20/2017
-
- Sponsor Identification
Reno Medical Ltd.
MNC2246 RM1007, 10/F, Ho King Comm CTR , 2-16Fa Yuen Street, Mongkok, KL. Hongkong, CHINA, 999077
Establishment Registration Number: 3008799799
Contact Person: LiMing Ren Position: Management Representative Tel: +86-575-82576147 Fax: +86-575-82563750 Email: liubo.shen@etop-rank.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Adhesive Electrodes Common Name: Electrode
- Identification of Proposed Device
Regulatory Information Classification Name: 882.1320 - Cutaneous electrode.
4
Classification: II Product Code: GXY Regulation Number: 21 CFR 882.1320 Review Panel: Neurology
Intended Use Statement:
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Device Description
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
The proposed device, Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator, i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.
The intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.
The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.
- Identification of Predicate Device 5.
510(k) Number: K132588 Product Name: Adhesive Electrodes Manufacturer: Top-Rank Health Care Co., Ltd.
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
5
Ref.: M3702016
8. Substantially Equivalent (SE) Comparison
The following table compares the DEVICE to the predicate device with respect to intended use, design feature and performance, etc
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GXY | Identical |
| Regulation Number | 21 CFR 880.1320 | Identical |
| Class | II | Identical |
| Intended Use | Adhesive electrodes are intended for use as | |
| the disposable, conductive adhesive interface | ||
| between the patient's skin and the Electrical | ||
| Stimulator. Adhesive Electrodes are intended | ||
| to be used with marketed Electrical | ||
| Stimulators, i.e. TENS (Transcutaneous | ||
| Electrical Nerve Stimulation) and EMS | ||
| (Electrical Muscular Stimulation). It is for | ||
| OTC use. | Identical | |
| Design Feature | Substrate / Wire / Hydro-Gel | |
| Scrim / Conductive Fiber | ||
| Carbon Conductive Film / Liner | Identical | |
| OTC or | ||
| Prescription | For OTC use | Identical |
| Biocompatibility | Conforms to ISO 10993 series standards | Identical |
| Label/Labeling | Complied with 21 CFR part 801 | Identical |
Table 1 Comparison of Technology Characteristics
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.