Electrodes with snap / Electrodes with pigtail

K171722 · Shenzhen Konmed Technology Co., Ltd. · GXY · Jan 10, 2018 · Neurology

Device Facts

• Record ID: K171722
• Device Name: Electrodes with snap / Electrodes with pigtail
• Applicant: Shenzhen Konmed Technology Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jan 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.

Device Story

Disposable, flexible, non-sterile cutaneous electrodes; interface between patient skin and electrical stimulators (TENS/EMS). Device consists of electrode pad with snap or pigtail connector; adhesive hydrogel backing eliminates need for external securing materials. Available in round, rectangular, palm, elliptical, and calabash shapes. Used by patients in home or clinical settings for electrical stimulation therapy. Output is electrical current delivered to skin; facilitates nerve or muscle stimulation. Benefits include non-invasive pain management or muscle stimulation. No active electronic components; passive conductive interface.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10. Electrical safety/performance verified via impedance testing, adhesive holding strength, tensile strength, and conformability testing. Compliance with 21 CFR 898 and IEC 60601-1 (Sub-Clause 56.3(c)) confirmed.

Technological Characteristics

Non-sterile, flexible laminated structure. Materials: non-woven fabric substrate, PVC-coated wire/terminal, hydrogel, nylon scrim, silver filament conductive fiber, carbon black conductive film. Connectivity: snap or pigtail connector. Single-patient use. Shelf life: 2 years.

Indications for Use

Indicated for use as a disposable, conductive adhesive interface between patient skin and electrical stimulators (TENS/EMS) for OTC use in adults.

Regulatory Classification

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.

Predicate Devices

• TENS Electrodes (K160081)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|------------------------------------------------------------------|
| <div> <span>[Checkbox 1]</span> <span>[Checkbox 2]</span> </div> |

| | 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: [phone] Fax: [phone] 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: [phone] Email: [e-mail]

#### 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<br>Comparison | Subject device | Primary Predicate | Remark |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name | Electrodes with snap /<br>Electrodes with pigtail | TENS Electrodes | -- |
| 510(K) Number | Applying | K160081 | -- |
| Product Code | GXY | GXY | SE |
| Intended Use /<br>Indications for Use | The proposed device is<br>intended for use as the<br>disposable, conductive<br>adhesive interface between<br>the patient's skin and the<br>electrical stimulator to apply<br>electrical stimulation current,<br>and is intended to be used<br>with legally marketed<br>electrical stimulators, i.e. | The proposed device is<br>intended for use as the<br>disposable, conductive<br>adhesive interface between<br>the patient's skin and the<br>electrical stimulator to apply<br>electrical stimulation current,<br>and is intended to be used<br>with marketed electrical<br>stimulators, i.e. TENS | SE |
| | TENS (Transcutaneous<br>Electrical Nerve Stimulation)<br>and EMS (Electrical<br>Muscular Stimulation). It's<br>for Over-the-Counter (OTC)<br>use. | (Transcutaneous Electrical<br>Nerve Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation).It's for OTC use. | |
| Models of electrode<br>pad | Mode A: Round Shape<br>Electrode<br>Model B: Rectangular Shape<br>Electrode<br>Model C:Palm Shape<br>Electrode<br>Model D:Elliptical Shape<br>Electrode<br>Model E: Calabash Shape<br>Electrode | Model A: Round shape<br>electrode<br>Model B: Rectangular shape<br>Electrode<br>Model C: Crescent shape<br>Electrode<br>Model D: Square shape<br>Electrode<br>Model E:Calabash Shape<br>Electrode | SE<br>Note1 |
| Surface area<br>(Conductive<br>surface) | Model A: 5 cm in diameter<br>Model B: 5 x 11; 6 x 11<br>(cm2)<br>Model C: 7.6 x 4.8 (cm2)<br>Model D: 3 x 4.3 (cm2)<br>Model E: 8.4 x 4.8 (cm2) | Model A: 5cm in diameter<br>Model B: 5*10;6*10(cm2)<br>Model C: 2.4*4.2(cm2)<br>Model D: 3.2*3.2(cm2)<br>Model E: 8.0*5.5 (cm2) | SE<br>Note1 |
| OTC or prescription | For OTC Use | For OTC Use | SE |
| Design features | Substrate/Wire/Hydro-Gel<br>Scrim/Conductive Fiber<br>Carbon Conductive Film<br>/liner | Substrate/Wire/Hydro-Gel<br>Scrim/Conductive Fiber<br>Carbon Conductive Film /liner | SE |
| Materials: | Non-woven fabric+ adhesive | Non-woven fabric+ adhesive | |
| Substrate;<br>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<br>Film; | Carbon Black | Poly-isobutylene, Carbon<br>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<br>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<br>performance on To | >= No. 14 steel ball<br>(Diameter: 11.112 mm)<br>following AS07-003 /<br>GB/T4852-200 | >= No. 14 steel ball (Diameter:<br>11.112 mm) following AS07-<br>003 / GB/T4852-2002 | SE |
| Adhesive<br>holding strength<br>performance | A sample pad with 40mm<br>length and 40 mm width;<br>Hang a weight of 500g<br>without detach within 1min | A sample pad with 25mm<br>length and 25 mm width;<br>Hang a weight of 200g without<br>detach within 30s | SE<br>Note 2 |
| Tensile Strength | Electrode is held up with a<br>weight of 500g hung on the<br>wire, and can hold on at<br>least 1 minutes | Electrode is held up with a<br>weight of 500g hung on the<br>wire, and can hold on at least<br>1 minutes | SE |
| Conformability | No more than 10% of the<br>adhesive area of the device<br>shall have separated from<br>the skin surface at 1 h after<br>application | No more than 10% of the<br>adhesive area of the device<br>shall have separated from the<br>skin surface at 1 h after<br>application | SE |
| Impedance<br>Distribution<br>uniformity test | 1) No significant deviation<br>between resistance<br>values measured for<br>each combination mode.<br><br>2) The maximum value<br>and the minimum value<br>should be within ±10%<br>of average value | 1) No significant deviation<br>between resistance values<br>measured for each<br>combination mode.<br><br>2) The maximum value and<br>the minimum value should<br>be within ±10% of average<br>value | SE |
| Sterility | Non-sterile | Non-sterile | SE |
| Stability and shelf<br>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.

#### 8. Date of the summary prepared: January 5, 2018