(155 days)
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.
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 provided text describes a 510(k) premarket notification for the Ennova Self-adhesive Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested details about a study proving device acceptance criteria cannot be extracted from this document, as a clinical study was explicitly not included in this submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document doesn't define "acceptance criteria" in the traditional sense of a clinical trial's primary or secondary endpoints. Instead, it outlines design specifications and performance standards for the device and compares them to predicate devices to establish substantial equivalence.
| Criterion Type | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Ennova Self-adhesive Electrode) |
|---|---|---|
| Intended Use | Transmit electrical current to patient skin for transcutaneous electrical stimulation devices (TENS, EMS). For OTC or Prescription use. | Transmit electrical current to patient skin for transcutaneous electrical stimulation devices (TENS, EMS). For OTC or Prescription use. |
| Target Population | Single patient use, multiple application, adult patients (age ≥ 18). | Single adult patient (age ≥ 18), multiple application use. |
| Biocompatibility | ISO 10993-5:2009/(R) 2014 (Cytotoxicity), ISO 10993-10:2010 (Irritation and Skin Sensitization) | Passed Biocompatibility test per ISO10993-5:2009; ISO10993-10:2010 |
| Shelf Life | Not explicitly detailed as "acceptance criteria," but "Shelf life test" was performed. | Passed Shelf life test. |
| Impedance | Range as seen in predicate devices (e.g., Round: 300~1000 Ω) | Reported ranges for specific shapes. E.g., Round: 397 |
| Adhesion | Not explicitly detailed as "acceptance criteria," but "Adhesive test" was performed. | Passed Adhesive test. |
| Electrical Safety | AAMI / ANSI ES60601-1:2005/(R) 2012, IEC 60601-2-2 Edition 5.0 2009-02 (specifically lead wire characteristics). | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1. |
| Current Density | Ranges derived from predicate devices, ensuring below 0.25 W/cm² to reduce thermal burns. | Values provided for various shapes (e.g., Round: Min.0.36mA/cm² Max.1.70mA/cm²). All reported to be within safety limits as compared to predicate devices. |
| Maximum Power Density | Less than 0.25 W/cm² (FDA guidance) | Values provided for various shapes (e.g., Round: 0.0117W/cm²). All reported to be within safety limits. |
| Other Performance | Good electrical conductivity, good adhesive property. | Good electrical conductivity, good adhesive property. |
| Sterility | ASTM F1980 (Reapproved 2011) - for sterile barrier systems (though the device itself is non-sterile). | Complies with ASTM F1980 (for sterile barrier systems). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable for a clinical study in this submission. The tests performed are bench tests on the physical device components. The document does not specify the number of individual electrodes or batches tested for these non-clinical evaluations.
- Data Provenance: The tests were conducted by Suzhou Ennova Electronics Technology Co., Ltd. in China ("Bench tests were conducted on the proposed Self-adhesive Electrode to verify that the proposed device met all design specifications"). The data is non-clinical, originating from laboratory testing. It is neither retrospective nor prospective in the clinical study sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on non-clinical bench testing against recognized industry standards (e.g., ASTM, ISO, AAMI/ANSI, IEC) and comparison to legally marketed predicate devices. Ground truth in the context of expert consensus (e.g., for image interpretation) is not relevant here. The "ground truth" for these tests comes from objective measurements and adherence to specified performance metrics in the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. The tests performed here are objective bench tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a self-adhesive electrode, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware component (electrode), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established industry standards (e.g., ISO, ASTM, AAMI/ANSI, IEC) and the performance characteristics of legally marketed predicate devices. For example, biocompatibility is assessed against ISO standards, and electrical performance against AAMI/ANSI and IEC standards. The efficacy is inferred from the substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for their intended use.
8. The sample size for the training set:
- Not applicable. This device's approval is based on substantial equivalence demonstrated through bench testing and comparison to predicates, not through machine learning model training.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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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
{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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, JiangsuProvince, 215124 China |
| Contactor: | Doris DongShanghai CV Technology Co., Ltd.Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, 201600 ChinaE-mail: doris_d@126.comTel: 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. |
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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 foruse: | 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. | ||||||
| Targetpopulation: | Single patient use and multipleapplication | Single patient use and multipleapplication | Single patient use and multipleapplication | |||
| Design (shape): | Round, rectangle, oval andbutterfly, 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.Ø32mmMax.Ø70mm | Round | Min.Ø20mmMax.Ø70mm | Round | Min.Ø20mmMax.Ø80mm |
| Rectangle | Min.40×40mmMax.100×130mm | Rectangle | Min.20×20mmMax.150×150mm | Rectangle | Min.30×10mmMax.80×130mm | |
| Oval | Min.50×120mmMax.100×240mm | Oval | Min.50×120mmMax.100×240mm | Oval | Min.50×120mmMax.100×240mm | |
| Butterfly | Min.55×75mmMax.95×165mm | Butterfly | Min.55×75mmMax.95×165mm | Butterfly | Min.55×75mmMax.95×165mm | |
| Gourd | Min.85×50mmMax.170×100mm | Gourd | Min.85×50mmMax.170×100mm | |||
| Saddle | Min.75×110mmMax.150×220mm | Saddle | Min.75×110mmMax.150×220mm | |||
| Patient contactarea | Round | Min.804mm²Max.3846.5mm² | Round | Min.314mm²Max.3846.5mm² | Round | Min.314mm²Max.5024mm² |
| Rectangle | Min.1600 mm²Max.13000mm² | Rectangle | Min.400 mm²Max.22500mm² | Rectangle | Min.300 mm²Max.10400mm² | |
| Oval | Min.4710 mm²Max.18840mm² | Oval | Min.4710 mm²Max.18840mm² | Oval | Min.4710 mm²Max.18840mm² | |
| Butterfly | Min.4125 mm²Max.15675mm² | Butterfly | Min.4125 mm²Max.15675mm² | Butterfly | Min.4125 mm²Max.15675mm² | |
| Gourd | Min.4250 mm²Max.17000mm² | Gourd | Min. 4250 mm²Max.17000mm² | |||
| Saddle | Min.8250 mm²Max.33000mm² | Saddle | Min.8250 mm²Max.33000mm² | |||
| Impedanceparameters | 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 | ||||
| Currentdensity(UseI RMS= 13.7mA forcalculation ) | Round | Min.0.36mA/cm2Max.1.70mA/cm2 | Round | Min.0.36mA/cm2Max.4.36mA/cm2 | Round | Min.0.27mA/cm2Max.4.36mA/cm2 |
| Rectangle | Min.0.11mA/cm2Max.0.86mA/cm2 | Rectangle | Min.0.06mA/cm2Max.3.43mA/cm2 | Rectangle | Min.0.13mA/cm2Max.4.57mA/cm2 | |
| Oval | Min.0.07mA/cm2Max.0.29mA/cm2 | Oval | Min.0.07mA/cm2Max.0.29mA/cm2 | Oval | Min.0.07mA/cm2Max.0.29mA/cm2 | |
| Butterfly | Min.0.09mA/cm2Max.0.33mA/cm2 | Butterfly | Min.0.09mA/cm2Max.0.33mA/cm2 | Butterfly | Min.0.09mA/cm2Max.0.33mA/cm2 | |
| Gourd | Min.0.08mA/cm2Max.0.32mA/cm2 | Gourd | Min.0.08mA/cm2Max.0.32mA/cm2 | |||
| Saddle | Min.0.04mA/cm2Max.0.17mA/cm2 | Saddle | Min.0.04mA/cm2Max.0.17mA/cm2 | |||
| Maximum PowerDensity (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 squarecentimeter of electrode conductive surface area to reduce the risk of thermal burns.) | ||||||
| MaximumCurrent forPower Density @500 Ohms | Use Jiajian® TENS(K112288) | Use Jiajian® TENS(K112288) forcalculation, the Maximum R.M.S current is 13.7mAr.m.s. | Use Jiajian® TENS(K112288) forcalculation, the Maximum R.M.S current is 13.7mAr.m.s.Calculation formulas as follow:Maximum Output Voltage:36V@500ΩPulse Duration: 60 | |||
| MaterialComposition | - Top cover material- Conductive carbon film:PU, Conductive carbon- Biocompatible conductivehydrogel- Electrode carrier liner | - Top cover material- Conductive carbon film:PU, Conductive carbon- Biocompatible conductive hydrogel- Electrode carrier liner | - Top cover material- Electrically conductive carboncloth- Biocompatible conductivehydrogel- Electrode carrier liner | |||
| Lead wire typeandcharacteristics | Lead wire with female socket, orsnap button with male snapconnector | Lead wire with female socket, or snapbutton with male snap connector | Lead wire with female socket |
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Suzhou Ennova Electronics Technology Co., Ltd.
Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu Province, 215124 China
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Suzhou Ennova Electronics Technology Co., Ltd.
Suzhou Ennova Electronics Technology Co., Ltd.
Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou City, Jiangsu Province, 215124 China
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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 | |
| OtherPerformance | Good electrical conductivity,good adhesive property | Good electrical conductivity, goodadhesive property | Good electrical conductivity,good adhesive property |
| Discussion: | |
|---|---|
| Similarities between New deviceand Predicate Device: | Similar intended use, composition, safety performance,complied standards |
| Differences between New deviceand Predicate Device: | Note 1:The Size and Patient contact area are a little different between proposed device andpredicate device, based on the impedance dispersion test, these differences will not raiseany questions of safety and effectiveness of the subject device.Note 2:Ennova devices used AG700 Series Hydrogel from Axelgaard which was 510(k) clearedwith number of K130987. Jiajian devices used ValuTrode@GEL from Axelgaard which was510(k) cleared with number of K970426. The conductive hydrogel of Zekang device isimported from Covidien, USA, which was 510(k) cleared with number of K100418. Sincethey are all from cleared devices, these differences will not raise any questions of safety andeffectiveness of the subject device.Note 3:There are a little difference of the impedance between the proposed device and predicatedevice, but the impedance values of proposed device are within the range specified by thepredicate device, so these small difference will not raise any questions of safety andeffectiveness. |
| 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.
§ 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).