Ennova Self-adhesive Electrode

K152648 · Suzhou Ennova Electronics Technology Co.,Ltd · GXY · Feb 18, 2016 · Neurology

Device Facts

• Record ID: K152648
• Device Name: Ennova Self-adhesive Electrode
• Applicant: Suzhou Ennova Electronics Technology Co.,Ltd
• Product Code: GXY · Neurology
• Decision Date: Feb 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Device Story

Accessory for TENS/EMS devices; transmits electrical current from stimulator to patient skin. Composed of cover, connector (lead wire or snap button), conductive carbon film, and conductive hydrogel. Used by adult patients in clinical or home settings. Current flows from stimulator through lead wire/snap button to conductive hydrogel adhered to skin. Healthcare providers or patients apply electrodes to skin; stimulator settings determine current delivery. Benefits include facilitating electrical stimulation for nerve/muscle therapy.

Clinical Evidence

No clinical data included. Bench testing only: biocompatibility (ISO 10993-5, ISO 10993-10), accelerated aging (ASTM F1980), electrical safety (AAMI/ANSI ES60601-1, IEC 60601-2-2), impedance testing, and adhesive testing.

Technological Characteristics

Materials: PU cover, conductive carbon film, conductive hydrogel, PET release liner. Connectivity: Lead wire (female socket) or snap button (male). Energy: Passive conductor for external TENS/EMS stimulators. Standards: ASTM F1980, ISO 10993-5/10, AAMI/ANSI ES60601-1, IEC 60601-2-2. Non-sterile, single-patient multiple-use.

Indications for Use

Indicated for adult patients (age 18+) requiring transcutaneous electrical nerve stimulation (TENS) or electrical muscular stimulation (EMS) via an external stimulation device.

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

• Jiajian Self-adhesive Electrode (K090198)
• Zekang Self-adhesive Electrode (K150971)

Reference Devices

• Jiajian TENS (K112288)
• Axelgaard Hydrogel (K130987)
• Axelgaard Hydrogel (K970426)
• Covidien Hydrogel (K100418)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures facing right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2016

Suzhou Ennova Electronics Technology Co.,Ltd % Doris Dong Manager Shanghai CV Technology Co., Ltd Room 1706, No.128 Songle Rd., Songjiang Area Shanghai, 201600 CHINA

Re: K152648

Trade/Device Name: Ennova Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 12, 2016 Received: January 19, 2016

Dear Doris Dong:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -A

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) K152648

Device Name Ennova Self-adhesive Electrode

#### Indications for Use (Describe)

Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### Section 5 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Submission Information:

| 510(k) Number: | K152648 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 12, 2016 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Suzhou Ennova Electronics Technology Co., Ltd.<br>Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu<br>Province, 215124 China |
| Contactor: | Doris Dong<br>Shanghai CV Technology Co., Ltd.<br>Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, 201600 China<br>E-mail: [e-mail]<br>Tel: [phone] / Fax: [phone] |

#### 2. Device Description:

| Proprietary Name: | Ennova Self-adhesive Electrode |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cutaneous electrode |
| Classification Name: | Cutaneous electrode |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use. |
| Device Description: | Ennova Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. Ennova Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient(age=18) multiple application use. Ennova Self-adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner. |

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The conductive hydrogel is imported from Axelgaard, USA, which was 510(k) cleared with number of K130987. And the whole Ennova Self-adhesive Electrode together with the conductive hydrogel has again passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.

#### 3. Predicate Device Identification

| 510k number | Device name | Manufacturer | Date cleared |
|-------------|---------------------------------|---------------------------------------------|--------------|
| K090198 | Jiajian Self-adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd | 2009 |
| K150971 | Zekang Self-adhesive Electrode | Jiangsu Zekang Medical Technology Co., Ltd. | 2015 |

#### 4. Non-Clinical Test Conclusion

Bench tests were conducted on the proposed Self-adhesive Electrode 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:

- ASTM F1980 (Reapproved 2011), Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)

- ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro

Cytotoxicity. (Biocompatibility)

- ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)

- AAMI / ANSI ES60601-1:2005/(R) 2012, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

- IEC 60601-2-2 Edition 5.0 2009-02, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

#### 5. Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data was not including in this submission.

#### 6. Substantially Equivalent Comparison Conclusion

Detailed comparison data is included in Section 9 of "Substantial Equivalence Discussion" of this 510(k) submission.

| | New Device | Predicate Device 1 | Predicate Device 2 | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 501(k) number | K152648 | K150971 | K090198 | | | |
| Trade Name: | Ennova Self-adhesive Electrode | Zekang Self-adhesive Electrode | Jiajian Self-adhesive Electrode | | | |
| Common Name: | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | | | |
| Classification | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | | | |
| Name: | | | | | | |
| Product Code: | GXY | GXY | GXY | | | |
| Regulation | 882.1320 | 882.1320 | 882.1320 | | | |
| Number: | | | | | | |
| Medical | Neurology | Neurology | Neurology | | | |
| Specialty: | | | | | | |
| Device Class: | II | II | II | | | |
| Indications for<br>use: | | Ennova Self-adhesive Electrode | | Zekang Self-adhesive Electrode is | | The self-adhesive electrode is |
| | | is intended to transmit electrical | | intended to transmit electrical current | | intended to be used to apply |
| | | current to patient skin for use | | to patient skin for use with | | electrical stimulation current to |
| | | with transcutaneous electrical | | transcutaneous electrical stimulation | | the patient's skin. |
| | | stimulation devices. Some | | devices. Some common types of the | | Example electrical stimulations |
| | | common types of the stimulation | | stimulation devices include, but are | | for current applications of the |
| | | devices include, but are not limit | | not limit to TENS (Transcutaneous | | electrodes are: TENS and EMS. |
| | | to TENS (Transcutaneous | | Electrical Nerve Stimulation) and | | |
| | | Electrical Nerve Stimulation) | | EMS (Electrical Muscular | | |
| | | and EMS (Electrical Muscular | | Stimulation). The electrode is for | | |
| | | Stimulation). The electrode is for | | OTC (Over-The -Counter) or | | |
| | | OTC (Over-The -Counter) or | Prescription use. | | | |
| | Prescription use. | | | | | |
| Target<br>population: | | Single patient use and multiple<br>application | | Single patient use and multiple<br>application | | Single patient use and multiple<br>application |
| Design (shape): | | Round, rectangle, oval and<br>butterfly, according to | | Round, rectangle, oval, gourd,<br>butterfly and saddle, according to | | Round, rectangle, oval, gourd,<br>butterfly and saddle, according to |
| | | customized specification. | | customized specification. | | customized specification. |
| Size of electrodes | Round | Min.Ø32mm<br>Max.Ø70mm | Round | Min.Ø20mm<br>Max.Ø70mm | Round | Min.Ø20mm<br>Max.Ø80mm |
| | Rectangle | Min.40×40mm<br>Max.100×130mm | Rectangle | Min.20×20mm<br>Max.150×150mm | Rectangle | Min.30×10mm<br>Max.80×130mm |
| | Oval | Min.50×120mm<br>Max.100×240mm | Oval | Min.50×120mm<br>Max.100×240mm | Oval | Min.50×120mm<br>Max.100×240mm |
| | Butterfly | Min.55×75mm<br>Max.95×165mm | Butterfly | Min.55×75mm<br>Max.95×165mm | Butterfly | Min.55×75mm<br>Max.95×165mm |
| | | | Gourd | Min.85×50mm<br>Max.170×100mm | Gourd | Min.85×50mm<br>Max.170×100mm |
| | | | Saddle | Min.75×110mm<br>Max.150×220mm | Saddle | Min.75×110mm<br>Max.150×220mm |
| Patient contact<br>area | Round | Min.804mm²<br>Max.3846.5mm² | Round | Min.314mm²<br>Max.3846.5mm² | Round | Min.314mm²<br>Max.5024mm² |
| | Rectangle | Min.1600 mm²<br>Max.13000mm² | Rectangle | Min.400 mm²<br>Max.22500mm² | Rectangle | Min.300 mm²<br>Max.10400mm² |
| | Oval | Min.4710 mm²<br>Max.18840mm² | Oval | Min.4710 mm²<br>Max.18840mm² | Oval | Min.4710 mm²<br>Max.18840mm² |
| | Butterfly | Min.4125 mm²<br>Max.15675mm² | Butterfly | Min.4125 mm²<br>Max.15675mm² | Butterfly | Min.4125 mm²<br>Max.15675mm² |
| | | | Gourd | Min.4250 mm²<br>Max.17000mm² | Gourd | Min. 4250 mm²<br>Max.17000mm² |
| | | | Saddle | Min.8250 mm²<br>Max.33000mm² | Saddle | Min.8250 mm²<br>Max.33000mm² |
| Impedance<br>parameters | Round | $397\text{~}612 \Omega$ | Round | $300\text{~}500 \Omega$ | Round | $300\text{~}1000 \Omega$ |
| | Rectangle | $432\text{~}624 \Omega$ | Rectangle | $300\text{~}700 \Omega$ | Rectangle | |
| | Oval | $412\text{~}642 \Omega$ | Oval | $500\text{~}700 \Omega$ | Oval | |
| Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu Province, 215124 China | | | | | | |
| | Butterfly | 407~616 Ω | Butterfly | 400~600 Ω | Butterfly | 400~600 Ω |
| | | | Gourd | 400~600 Ω | Gourd | |
| | | | Saddle | 400~800 Ω | Saddle | |
| Current<br>density(Use<br><span style="font-style:italic">I</span> RMS= 13.7mA for<br>calculation ) | Round | Min.0.36mA/cm2<br>Max.1.70mA/cm2 | Round | Min.0.36mA/cm2<br>Max.4.36mA/cm2 | Round | Min.0.27mA/cm2<br>Max.4.36mA/cm2 |
| | Rectangle | Min.0.11mA/cm2<br>Max.0.86mA/cm2 | Rectangle | Min.0.06mA/cm2<br>Max.3.43mA/cm2 | Rectangle | Min.0.13mA/cm2<br>Max.4.57mA/cm2 |
| | Oval | Min.0.07mA/cm2<br>Max.0.29mA/cm2 | Oval | Min.0.07mA/cm2<br>Max.0.29mA/cm2 | Oval | Min.0.07mA/cm2<br>Max.0.29mA/cm2 |
| | Butterfly | Min.0.09mA/cm2<br>Max.0.33mA/cm2 | Butterfly | Min.0.09mA/cm2<br>Max.0.33mA/cm2 | Butterfly | Min.0.09mA/cm2<br>Max.0.33mA/cm2 |
| | | | Gourd | Min.0.08mA/cm2<br>Max.0.32mA/cm2 | Gourd | Min.0.08mA/cm2<br>Max.0.32mA/cm2 |
| | | | Saddle | Min.0.04mA/cm2<br>Max.0.17mA/cm2 | Saddle | Min.0.04mA/cm2<br>Max.0.17mA/cm2 |
| Maximum Power<br>Density (W/cm2) | Round | 0.0117W/cm2 | Round | 0.0299W/cm2 | Round | 0.0299W/cm2 |
| | Rectangle | 0.0059W/cm2 | Rectangle | 0.0235W/cm2 | Rectangle | 0.0313W/cm2 |
| | Oval | 0.002W/cm2 | Oval | 0.002W/cm2 | Oval | 0.002W/cm2 |
| | Butterfly | 0.0023W/cm2 | Butterfly | 0.0023W/cm2 | Butterfly | 0.0023W/cm2 |
| | | | Gourd | 0.0022W/cm2 | Gourd | 0.0022W/cm2 |
| | | | Saddle | 0.0011W/cm2 | Saddle | 0.0011W/cm2 |
| (FDA guidance states that a maximum average power density should be less than 0.25 watts per square<br>centimeter of electrode conductive surface area to reduce the risk of thermal burns.) | | | | | | |
| Maximum<br>Current for<br>Power Density @<br>500 Ohms |…