(95 days)
Not Found
No
The device description focuses solely on the physical components and intended use as a conductive interface, with no mention of AI/ML terms or functionalities.
No.
The device itself is an adhesive electrode, which acts as an interface for electrical stimulators. It is not an electrical stimulator (TENS/EMS) that delivers the therapeutic current.
No
Explanation: The device, an adhesive electrode, is described as a "conductive adhesive interface" for electrical stimulators (TENS and EMS), which are therapeutic devices, not diagnostic ones. It facilitates the delivery of stimulation, rather than measuring or assessing a medical condition.
No
The device description explicitly states that the device "mainly consists of substrate and wire," indicating it is a physical hardware component and not software only.
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.
- Device Function: The described device is an adhesive electrode used as a conductive interface between the patient's skin and an electrical stimulator (TENS/EMS). It facilitates the delivery of electrical impulses to the body.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely physical and electrical.
Therefore, the intended use and function of this device clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank 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 interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver 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 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
Not Found
Intended User / Care Setting
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. The test results demonstrated that the proposed device complies with the following standards:
ANSI/AAMI HF18:2001 Electrosurgical devices
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
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21. CFR Section 807.92.
The assigned 510(k) Number: K132588
-
Date of Submission: Jul 20, 2013
-
Sponsor Identification
Top-Rank Health Care Co., Ltd Chencun Village, Dongguan Street, Shangyu, Zhejiang, 312352, China
Establishment Registration Number: 3006626283
Contact Person: Liubo Shen Position: Management Representative Tel:+86-575-82576147 Fax: +86-575-82563750 Email: liubo.shen@ctop-rank.com
- Submission Correspondent
Ms. Diana Hong& Mr. Lee Fu 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
3-1
1
Proposed Device Identification 4.
Proposed Device Name: Adhesive Electrodes Proposed Device Common Name: Electrode
Regulatory Information: Classification Name: Cutaneous Electrode; Classification: 11; 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. Top-Rank 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.
Predicate Device Identification న.
510(k) Number: K070612 Product Name: Top-Rank Adhesive Flectrodes Manufacturer: Top-Rank Health Care Co., Ltd.
Device Description 6.
Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver 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 proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.
2
7. Non-Clinical Test Conclusion
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 demonstrated that the proposed device complies with the following standards:
ANSI/AAMI HF18:2001 Electrosurgical devices
- Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, design feature and performance, etc.
| Table 3-1 Comparison of Technology Characteristics | ||
|---|---|---|
| ITEM | PROPOSED DEVICE | PREDICATE DEVICE |
| Device Name | Adhesive Electrodes | Top-Rank Adhesive Electrodes, K070612 |
| Device Name | Adhesive Electrodes | Top-Rank Adhesive Electrodes |
| Regulation Number | 882.1320 | 882.1320 |
| Product Code | GXY | GXY |
| Classification Name | Cutaneous Electrode | Cutaneous Electrode |
| Device Class | CLASS II | CLASS II |
| Intended Use | Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. | Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). |
| Design Feature | Substrate / Wire / Hydro-Gel | |
| Scrim / Conductive Fiber | ||
| Carbon Conductive Film / Liner | Same | |
| Labeling | Conforms to 21 CFR 801 | Same |
| OTC or Prescription | For OTC use | For prescription use |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 |
| Performance | Complies with ANSI/AAMI HF18:2001 | Complies with ANSI/AAMI HF18:2001 E |
Table 3-1 Comparison of Technology Characteristics
3-3
3
The proposed device. Adhesive Electrodes. is determined to be Substantially Equivalent (SF) to the predicate device. Top-Rank Adhesive Electrodes (K070612), in respect of safety and effectiveness.
.
.
.
.
.
the state of the state of the states
.
.
.
3-4
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2013
Top Rank Health Care Equipment Co., Ltd C/O Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 China
Re: K132588
Trade Name: Adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 8, 2013 Received: November 12, 2013
Dear Ms. 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. Iisting 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
5
Page 2 - Ms. Diana Hong
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.
Joyce M. Whang -S
Victor Krauthamer, Ph.D. for Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
6
Indications for Use
510(k) Number (if known): K132588
Device Name: Adhesive Electrodes
Indications For Use:
Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
વ -ડ
Page 1 of