(212 days)
Not Found
No
The summary describes a passive electrode device and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training and test set descriptions.
No.
This device is an accessory (disposable conductive interface) for therapeutic devices (TENS and EMS), not a therapeutic device itself.
No
This device is an electrode, which serves as a conductive interface for applying electrical stimulation. It is not intended for the purpose of diagnosing a medical condition.
No
The device description clearly states it is a physical, disposable electrode pad with a snap or pigtail, composed of laminated, flexible structures and hydro gel. This is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is an electrode intended to apply electrical stimulation to the patient's skin. It is a conductive interface for external electrical stimulators (TENS and EMS).
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient. Its function is purely to deliver electrical current externally.
- Intended Use: The intended use is to apply electrical stimulation, not to diagnose or provide information based on analyzing bodily fluids or tissues.
Therefore, based on the provided information, this device falls under the category of an external electrical stimulation accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.
Product codes
GXY
Device Description
The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient's skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode.
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
Adult only
Intended User / Care Setting
Over-the-Counter (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)
The proposed Electrodes with snap / Electrodes has been evaluated the safety and performance by lab bench testing as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- The electrode wire is compliance with 21 CFR 898 by construction review according to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2018
Shenzhen Konmed Technology Co., Ltd % Cecilia Ceng Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510006 China
Re: K171722
Trade/Device Name: Electrodes with snap / Electrodes with pigtail Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 21, 2017 Received: October 30, 2017
Dear Cecilia Ceng:
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
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
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) K171722
Device Name
Electrodes with snap / Electrodes with pigtail
Indications for Use (Describe)
The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.
| Type of Use (Select one or both, as applicable) |
|---|
| [Checkbox 1] [Checkbox 2] |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Chapter 5. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Shenzhen Konmed Technology Co., Ltd Establishment Registration Number: Applying Address: 703B, Haide building A, Nanxin Road, Nanshan, Shenzhen, China Tel: +86-755-86704558 Fax: +86-755-86704558 Contact Person: Tony (Manager) Email: 2519021651 @qq.com
Application Correspondent:
Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
Trade Name: Electrodes with snap / Electrodes with pigtail Model: Model A: Round Shape Electrode; Model B: Rectangular Shape Electrode; Model C: Palm shape Electrode; Model D: Elliptical Shape Electrode; Model E: Calabash Shape Electrode Common Name: Cutaneous Electrode Classification name: Cutaneous Electrode Review Panel: Neurology Models: Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, Calabash Shape Electrode Product Code: GXY Regulation Class: 2 Regulation Number: 882.1320
3. Predicate Device Information
510(K) Number: K160081 Company Name: CATHAY MANUFACTURING CORP. Trade/Device Name: TENS Electrodes Requlation Number: 882.1320 Regulatory Class: 2 Product Code: GXY
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| Sponsor: | Shenzhen Konmed Technology Co., Ltd |
|---|---|
| Subject Device: | Electrodes with snap / Electrodes with pigtail |
| File No.: | 510(k) Summary |
4. Device Description
The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient's skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode.
5. Intended Use / Indications for Use
The proposed product is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.
6. Test Summary
The proposed Electrodes with snap / Electrodes has been evaluated the safety and performance by lab bench testing as following:
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards �
- � The electrode wire is compliance with 21 CFR 898 by construction review according to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition)
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of the proposed Electrodes with snap / Electrodes is substantially equivalent to the predicate devices quoted below. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject device | Primary Predicate | Remark |
|---|---|---|---|
| Device Name | Electrodes with snap / | ||
| Electrodes with pigtail | TENS Electrodes | -- | |
| 510(K) Number | Applying | K160081 | -- |
| Product Code | GXY | GXY | SE |
| Intended Use / | |||
| Indications for Use | The proposed device is | ||
| intended for use as the | |||
| disposable, conductive | |||
| adhesive interface between | |||
| the patient's skin and the | |||
| electrical stimulator to apply | |||
| electrical stimulation current, | |||
| and is intended to be used | |||
| with legally marketed | |||
| electrical stimulators, i.e. | The proposed device is | ||
| intended for use as the | |||
| disposable, conductive | |||
| adhesive interface between | |||
| the patient's skin and the | |||
| electrical stimulator to apply | |||
| electrical stimulation current, | |||
| and is intended to be used | |||
| with marketed electrical | |||
| stimulators, i.e. TENS | SE | ||
| TENS (Transcutaneous | |||
| Electrical Nerve Stimulation) | |||
| and EMS (Electrical | |||
| Muscular Stimulation). It's | |||
| for Over-the-Counter (OTC) | |||
| use. | (Transcutaneous Electrical | ||
| Nerve Stimulation) and EMS | |||
| (Electrical Muscular | |||
| Stimulation).It's for OTC use. | |||
| Models of electrode | |||
| pad | Mode A: Round Shape | ||
| Electrode | |||
| Model B: Rectangular Shape | |||
| Electrode | |||
| Model C:Palm Shape | |||
| Electrode | |||
| Model D:Elliptical Shape | |||
| Electrode | |||
| Model E: Calabash Shape | |||
| Electrode | Model A: Round shape | ||
| electrode | |||
| Model B: Rectangular shape | |||
| Electrode | |||
| Model C: Crescent shape | |||
| Electrode | |||
| Model D: Square shape | |||
| Electrode | |||
| Model E:Calabash Shape | |||
| Electrode | SE | ||
| Note1 | |||
| Surface area | |||
| (Conductive | |||
| surface) | Model A: 5 cm in diameter | ||
| Model B: 5 x 11; 6 x 11 | |||
| (cm2) | |||
| Model C: 7.6 x 4.8 (cm2) | |||
| Model D: 3 x 4.3 (cm2) | |||
| Model E: 8.4 x 4.8 (cm2) | Model A: 5cm in diameter | ||
| Model B: 510;610(cm2) | |||
| Model C: 2.4*4.2(cm2) | |||
| Model D: 3.2*3.2(cm2) | |||
| Model E: 8.0*5.5 (cm2) | SE | ||
| Note1 | |||
| OTC or prescription | For OTC Use | For OTC Use | SE |
| Design features | Substrate/Wire/Hydro-Gel | ||
| Scrim/Conductive Fiber | |||
| Carbon Conductive Film | |||
| /liner | Substrate/Wire/Hydro-Gel | ||
| Scrim/Conductive Fiber | |||
| Carbon Conductive Film /liner | SE | ||
| Materials: | Non-woven fabric+ adhesive | Non-woven fabric+ adhesive | |
| Substrate; | |||
| Wire; | Wire & Terminal coated PVC | Wire & Terminal coated PVC | SE |
| Hydro-gel; | Hydro-gel | Hydro-gel | Note1 |
| Scrim; | nylon | PET fabric | |
| Conductive fiber; | Silver filaments | Carbon fiber + reinforcing fiber | |
| Carbon conductive | |||
| Film; | Carbon Black | Poly-isobutylene, Carbon | |
| Black | |||
| Biocompatibility | Complied with ISO 10993 | Conforms to ISO10993 | SE |
| Labeling | Confirm to 21 CFR Part 801 | Confirm to 21 CFR Part 801 | SE |
| Electrical | Individual pad impedance | Individual pad impedance | SE |
| Note2 |
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| Sponsor: | Shenzhen Konmed Technology Co., Ltd |
|---|---|
| Subject Device: | Electrodes with snap / Electrodes with pigtail |
| File No.: | 510(k) Summary |
| impedance | below 3000 ohms @ 10 Hz | below 200 ohms @ 60 kHz | |
|---|---|---|---|
| Adhesive | |||
| performance on To | >= No. 14 steel ball | ||
| (Diameter: 11.112 mm) | |||
| following AS07-003 / | |||
| GB/T4852-200 | >= No. 14 steel ball (Diameter: | ||
| 11.112 mm) following AS07- | |||
| 003 / GB/T4852-2002 | SE | ||
| Adhesive | |||
| holding strength | |||
| performance | A sample pad with 40mm | ||
| length and 40 mm width; | |||
| Hang a weight of 500g | |||
| without detach within 1min | A sample pad with 25mm | ||
| length and 25 mm width; | |||
| Hang a weight of 200g without | |||
| detach within 30s | SE | ||
| Note 2 | |||
| Tensile Strength | Electrode is held up with a | ||
| weight of 500g hung on the | |||
| wire, and can hold on at | |||
| least 1 minutes | Electrode is held up with a | ||
| weight of 500g hung on the | |||
| wire, and can hold on at least | |||
| 1 minutes | SE | ||
| Conformability | No more than 10% of the | ||
| adhesive area of the device | |||
| shall have separated from | |||
| the skin surface at 1 h after | |||
| application | No more than 10% of the | ||
| adhesive area of the device | |||
| shall have separated from the | |||
| skin surface at 1 h after | |||
| application | SE | ||
| Impedance | |||
| Distribution | |||
| uniformity test | 1) No significant deviation | ||
| between resistance | |||
| values measured for | |||
| each combination mode. |
-
The maximum value
and the minimum value
should be within ±10%
of average value | 1) No significant deviation
between resistance values
measured for each
combination mode. -
The maximum value and
the minimum value should
be within ±10% of average
value | SE |
| Sterility | Non-sterile | Non-sterile | SE |
| Stability and shelf
life | 2 years | 2 years | SE |
| Re-usable | For single patient | For single patient | SE |
| Intended population | Adult only | No specified population | SE Note 1 |
Comparison in Detail(s):
Note 1:
Although the "Model", " Surface area (Conductive surface)", "Materials" and " Intended population" of the subject device are different from the predicate devices, they are all complying with ISO 10993 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 2:
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| Sponsor: | Shenzhen Konmed Technology Co., Ltd |
|---|---|
| Subject Device: | Electrodes with snap / Electrodes with pigtail |
| File No.: | 510(k) Summary |
Although the "Electrical Impedance" and "Adhesive holding strength performance" are not totally same, they all of the subject devices are different from the predicate devices, they are all complying with performance testing. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 3:
" SE" means substantially equivalent.
Conclusion
The subject device Electrodes with snap / Electrodes with pigtail has all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.