(155 days)
No
The device description and intended use are for a simple electrode accessory that transmits electrical current. There is no mention of any computational or analytical functions that would require AI/ML. The performance studies are standard bench tests for electrical and biocompatibility properties.
No
The device is described as an accessory electrode for transcutaneous electrical stimulation devices (like TENS or EMS), which transmit electrical current to the skin. It does not independently perform a therapeutic function but facilitates the operation of therapeutic devices.
No
This device is an electrode that transmits electrical current for stimulation, not for diagnostics. Its purpose is to deliver current from TENS or EMS devices, which are therapeutic, not diagnostic.
No
The device description clearly outlines physical components such as a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. The performance studies also focus on physical properties like biocompatibility and electrical safety, not software validation.
Based on the provided information, the Ennova Self-adhesive Electrode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices." This describes a device that interacts with the patient's body externally to deliver electrical stimulation, not a device used to examine specimens derived from the human body.
- Device Description: The description details the physical components and how it functions as an accessory to TENS or EMS devices, which are used for external electrical stimulation. It does not mention any components or processes related to testing biological samples.
- Performance Studies: The performance studies listed focus on aspects like accelerated aging, biocompatibility (cytotoxicity, irritation, sensitization), and electrical safety standards relevant to devices that interact with the body. There are no studies related to the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
In summary, the Ennova Self-adhesive Electrode is a medical device used for delivering electrical current to the skin for therapeutic purposes, which falls under the category of external stimulation devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
GXY
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. The conductive hydrogel is imported from Axelgaard, USA, which was 510(k) cleared with number of K130987.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient skin
Indicated Patient Age Range
adult patient (age=18)
Intended User / Care Setting
Not Found
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
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
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.
Key Metrics
Not Found
Predicate Device(s):
Reference Device(s):
K130987, K970426, K100418, K112288
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/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
1
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 (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 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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. |
| Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu | |
| Province, 215124 China | |
| Contactor: | Doris Dong |
| Shanghai CV Technology Co., Ltd. | |
| Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, 201600 China | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 / Fax: 86 21-37824346 |
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. |
4
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 | ||||||
| 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 | ||||||
| population: | Single patient use and multiple | |||||
| application | Single patient use and multiple | |||||
| application | Single patient use and multiple | |||||
| application | ||||||
| Design (shape): | Round, rectangle, oval and | |||||
| butterfly, according to | Round, rectangle, oval, gourd, | |||||
| butterfly and saddle, according to | Round, rectangle, oval, gourd, | |||||
| butterfly and saddle, according to | ||||||
| customized specification. | customized specification. | customized specification. | ||||
| Size of electrodes | Round | Min.Ø32mm | ||||
| Max.Ø70mm | Round | Min.Ø20mm | ||||
| Max.Ø70mm | Round | Min.Ø20mm | ||||
| Max.Ø80mm | ||||||
| Rectangle | Min.40×40mm | |||||
| Max.100×130mm | Rectangle | Min.20×20mm | ||||
| Max.150×150mm | Rectangle | Min.30×10mm | ||||
| Max.80×130mm | ||||||
| Oval | Min.50×120mm | |||||
| Max.100×240mm | Oval | Min.50×120mm | ||||
| Max.100×240mm | Oval | Min.50×120mm | ||||
| Max.100×240mm | ||||||
| Butterfly | Min.55×75mm | |||||
| Max.95×165mm | Butterfly | Min.55×75mm | ||||
| Max.95×165mm | Butterfly | Min.55×75mm | ||||
| Max.95×165mm | ||||||
| Gourd | Min.85×50mm | |||||
| Max.170×100mm | Gourd | Min.85×50mm | ||||
| Max.170×100mm | ||||||
| Saddle | Min.75×110mm | |||||
| Max.150×220mm | Saddle | Min.75×110mm | ||||
| Max.150×220mm | ||||||
| Patient contact | ||||||
| area | Round | Min.804mm² | ||||
| Max.3846.5mm² | Round | Min.314mm² | ||||
| Max.3846.5mm² | Round | Min.314mm² | ||||
| Max.5024mm² | ||||||
| Rectangle | Min.1600 mm² | |||||
| Max.13000mm² | Rectangle | Min.400 mm² | ||||
| Max.22500mm² | Rectangle | Min.300 mm² | ||||
| Max.10400mm² | ||||||
| Oval | Min.4710 mm² | |||||
| Max.18840mm² | Oval | Min.4710 mm² | ||||
| Max.18840mm² | Oval | Min.4710 mm² | ||||
| Max.18840mm² | ||||||
| Butterfly | Min.4125 mm² | |||||
| Max.15675mm² | Butterfly | Min.4125 mm² | ||||
| Max.15675mm² | Butterfly | Min.4125 mm² | ||||
| Max.15675mm² | ||||||
| Gourd | Min.4250 mm² | |||||
| Max.17000mm² | Gourd | Min. 4250 mm² | ||||
| Max.17000mm² | ||||||
| Saddle | Min.8250 mm² | |||||
| Max.33000mm² | Saddle | Min.8250 mm² | ||||
| Max.33000mm² | ||||||
| Impedance | ||||||
| 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 | ||||||
| density(Use | ||||||
| I RMS= 13.7mA for | ||||||
| calculation ) | Round | Min.0.36mA/cm2 | ||||
| Max.1.70mA/cm2 | Round | Min.0.36mA/cm2 | ||||
| Max.4.36mA/cm2 | Round | Min.0.27mA/cm2 | ||||
| Max.4.36mA/cm2 | ||||||
| Rectangle | Min.0.11mA/cm2 | |||||
| Max.0.86mA/cm2 | Rectangle | Min.0.06mA/cm2 | ||||
| Max.3.43mA/cm2 | Rectangle | Min.0.13mA/cm2 | ||||
| Max.4.57mA/cm2 | ||||||
| Oval | Min.0.07mA/cm2 | |||||
| Max.0.29mA/cm2 | Oval | Min.0.07mA/cm2 | ||||
| Max.0.29mA/cm2 | Oval | Min.0.07mA/cm2 | ||||
| Max.0.29mA/cm2 | ||||||
| Butterfly | Min.0.09mA/cm2 | |||||
| Max.0.33mA/cm2 | Butterfly | Min.0.09mA/cm2 | ||||
| Max.0.33mA/cm2 | Butterfly | Min.0.09mA/cm2 | ||||
| Max.0.33mA/cm2 | ||||||
| Gourd | Min.0.08mA/cm2 | |||||
| Max.0.32mA/cm2 | Gourd | Min.0.08mA/cm2 | ||||
| Max.0.32mA/cm2 | ||||||
| Saddle | Min.0.04mA/cm2 | |||||
| Max.0.17mA/cm2 | Saddle | Min.0.04mA/cm2 | ||||
| Max.0.17mA/cm2 | ||||||
| Maximum Power | ||||||
| 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 | ||||||
| centimeter of electrode conductive surface area to reduce the risk of thermal burns.) | ||||||
| Maximum | ||||||
| Current for | ||||||
| Power Density @ | ||||||
| 500 Ohms | Use Jiajian® TENS(K112288) | Use Jiajian® TENS(K112288) for | ||||
| calculation, the Maximum R.M.S current is 13.7mAr.m.s. | Use Jiajian® TENS(K112288) for | |||||
| calculation, the Maximum R.M.S current is 13.7mAr.m.s. | ||||||
| Calculation formulas as follow: | ||||||
| Maximum Output Voltage: | ||||||
| 36V@500Ω | ||||||
| Pulse Duration: 60~300µS | ||||||
| Waveform:Pulsed Monophasic | ||||||
| Frequency:0.5~120Hz | ||||||
| $Ir.m.s= *72mA=13.7 mAr.m.s$ | ||||||
| Material | ||||||
| Composition | - Top cover material |
- Conductive carbon film:
PU, Conductive carbon - Biocompatible conductive
hydrogel - Electrode carrier liner | | - Top cover material
- Conductive carbon film:
PU, Conductive carbon - Biocompatible conductive hydrogel
- Electrode carrier liner | | - Top cover material
- Electrically conductive carbon
cloth - Biocompatible conductive
hydrogel - Electrode carrier liner | |
| Lead wire type
and
characteristics | Lead wire with female socket, or
snap button with male snap
connector | | Lead wire with female socket, or snap
button with male snap connector | | Lead wire with female socket | |
5
Suzhou Ennova Electronics Technology Co., Ltd.
Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu Province, 215124 China
6
Suzhou Ennova Electronics Technology Co., Ltd.
Suzhou Ennova Electronics Technology Co., Ltd.
Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu Province, 215124 China
7
Suzhou Ennova Electronics Technology Co., Ltd.
Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu Province, 215124 China
| thickness | |||
|---|---|---|---|
| Biocompatibility | ISO10993-5:2009; | ISO10993-5:2009; | ISO 10993-5: 1999; |
| ISO10993-10:2010 | ISO10993-10:2010 | ISO 10993-10: 2002 | |
| Electrical safety | Lead wire meets Clause 8.5.2.3 | Lead wire meets Clause 8.5.2.3 of | Lead wire meets 56.3C of IEC |
| of AAMI/ANSI ES60601-1 | AAMI/ANSI ES60601-1 | 60601-1 | |
| Other | |||
| Performance | Good electrical conductivity, | ||
| good adhesive property | Good electrical conductivity, good | ||
| adhesive property | Good electrical conductivity, | ||
| good adhesive property |
| Discussion: | |
|---|---|
| Similarities between New device | |
| and Predicate Device: | Similar intended use, composition, safety performance,complied standards |
| Differences between New device | |
| and Predicate Device: | Note 1: |
| The Size and Patient contact area are a little different between proposed device and | |
| predicate device, based on the impedance dispersion test, these differences will not raise | |
| any questions of safety and effectiveness of the subject device. | |
| Note 2: | |
| Ennova devices used AG700 Series Hydrogel from Axelgaard which was 510(k) cleared | |
| with number of K130987. Jiajian devices used ValuTrode@GEL from Axelgaard which was | |
| 510(k) cleared with number of K970426. The conductive hydrogel of Zekang device is | |
| imported from Covidien, USA, which was 510(k) cleared with number of K100418. Since | |
| they are all from cleared devices, these differences will not raise any questions of safety and | |
| effectiveness of the subject device. | |
| Note 3: | |
| There are a little difference of the impedance between the proposed device and predicate | |
| device, but the impedance values of proposed device are within the range specified by the | |
| predicate device, so these small difference will not raise any questions of safety and | |
| effectiveness. | |
| Conclusion: |
Based on successful biocompatibility testing of the skin contacting conductive hydrogel, the electrical performance of the insulated lead wire components and electrode current distribution test results, Ennova Self-adhesive Electrode is safe and effective when used as an interface between a user's skin and an approved nerve and muscle stimulation device. The conclusions drawn from the non-clinical tests demonstrate that the device is as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.