(164 days)
DL 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 limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
DL Adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.
DL Adhesive Electrode is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate) or LDPE(Low Density Polyethylene).
DL Adhesive Electrode is non-sterile and intended for single adult patient multiple application use. The Adhesive Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.
The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
The provided document is a 510(k) Pre-market Notification for the DL Self-adhesive Electrode (K182111). The document describes the device, its intended use, and importantly, presents non-clinical testing to demonstrate substantial equivalence to predicate devices, thereby ensuring its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DL Adhesive Electrode are primarily based on comparisons with two predicate devices:
- Primary Predicate: K152648 - Ennova Self-adhesive Electrode
- Reference Predicate: K100418 - Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode (specifically for the conductive hydrogel)
The equivalence is demonstrated through various non-clinical (bench) tests and a direct comparison of technological characteristics.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from predicate) | Reported Device Performance (DL Adhesive Electrode) | Met/Not Met | Notes |
|---|---|---|---|---|
| Intended Use | Transmit electrical current to patient skin for transcutaneous electrical stimulation (TENS/EMS) | Same | Met | Indications for use are identical to the primary predicate. |
| Target Population | Single patient use and multiple application | Same | Met | |
| Design (Shape & Connection) | Round, rectangle, oval, butterfly; Lead wire with female socket or snap button with male connector | Round, rectangle, butterfly, oval; Lead wire with female socket or snap button with male connector | Met | The device offers similar shapes and connection types, with some differences in size ranges (detailed below). |
| Materials | Top cover material, electrically conductive carbon cloth, biocompatible conductive hydrogel, electrode carrier liner | Same | Met | The conductive hydrogel is specifically identified as being imported from Covidien, USA, and is the same as used in the K100418 predicate. |
| Hydrogel Thickness | 1.0mm ±0.2mm (from primary predicate) | 1.0mm ±0.2mm | Met | Identical to the primary predicate. The reference predicate K100418 had 0.89mm, but the subject device matched the primary. |
| Hydrogel Volume Resistivity | 1500 ohm-cm maximum (from both predicates) | 1500 ohm-cm maximum | Met | Identical to both predicates. |
| Electrode Impedance | Range varies by shape (e.g., Round 397~612Ω for primary predicate) | Range varies by shape (e.g., Round 415~599Ω) | Met | All reported impedance ranges for the DL Adhesive Electrode (Round, Rectangle, Oval, Butterfly) fall within or are comparable to the ranges of the primary predicate. Differences are minor and deemed acceptable. |
| Maximum Current for Power Density (based on a specific TENS device K112288) | 13.7mA r.m.s | 13.7mA r.m.s | Met | Calculation method and resulting maximum current are identical to the primary predicate. |
| Current Density of Electrode Pad | Ranges vary by shape and predicate. For example, Primary Predicate Round Min.0.36mA/cm² Max.1.70mA/cm² | Ranges vary by shape. For example, DL Electrode Round Min.0.242mA/cm² Max.5.386mA/cm² | Met | While some specific min/max values differ slightly, the overall current densities are within acceptable therapeutic ranges and are deemed substantially equivalent. The key is that they do not exceed harmful levels. |
| Maximum Power Density of Electrode Pad | Max 0.25 W/cm² (FDA guidance) | Round 0.0369W/cm², Rectangle 0.006W/cm², Oval 0.0024W/cm², Butterfly 0.0013W/cm² | Met | All reported power densities are significantly below the FDA guidance of 0.25 W/cm², a critical safety criterion to reduce the risk of thermal burns. |
| Connector Retention Force | Lead wire with female socket: 10.80N; Snap button with male snap connector: 9.60N (from primary predicate) | Lead wire with female socket: 10.85N; Snap button with male snap connector: 9.61N | Met | Slightly higher (better) than the predicate, indicating robust connection. |
| Biocompatibility | Complies with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Sensitization) | Complies with ISO 10993-5, ISO 10993-10 | Met | Verified by tests. |
| Sterility Status | Non-sterile | Non-sterile | Met | Consistent with predicate. |
| Electrical Safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Met | |
| Other Performance | Good electrical conductivity, good adhesive property | Good electrical conductivity, good adhesive property | Met | Confirmed by testing. |
| Shelf Life | 3 years (from reference predicate K100418) | 2 years | Not Met (but acceptable) | Shelf life is shorter than the reference predicate, but a specific shelf life test (ASTM F1980:2016) was performed and validated a 2-year shelf life for the new device. This difference is not considered to raise new questions of safety or effectiveness. |
| Stainless Steel Adhesion (180° peel) | 136 grams minimum (≈1.3N) (from reference predicate K100418) | 136 grams minimum (≈1.3N) | Met | Identical to the reference predicate. |
| Hydrogel Composition & pH | Water (Aqua) with Inorganic Salt; Water, Glycerin, Polymer, Polyol, Amorphous Silica, Inorganic Salt, Potassium Chloride; pH 3.0-3.5 | Same | Met | Identical to the reference predicate, indicating use of the same or highly similar hydrogel. |
Study Details:
The document explicitly states: "Clinical data was not including in this submission."
Therefore, the device's substantial equivalence is demonstrated solely through non-clinical (bench) testing and comparison of technical characteristics to legally marketed predicate devices.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The document only lists the standards applied and that "Bench tests were conducted on DL Adhesive Electrode to verify that the proposed device met all design specifications."
- Data Provenance: The tests were performed internally or by accredited labs on samples of the DL Adhesive Electrode. The data origin is thus the manufacturer's testing or contract testing facilities, likely within China (where the manufacturer is located). The provenance is prospective with respect to the regulatory submission, as these tests were conducted specifically to support this 510(k). No patient data is involved.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical data was used, there was no "ground truth" derived from expert consensus on patient cases. The "ground truth" for the non-clinical tests are the specified performance limits within the referenced national and international standards (e.g., AAMI, ISO, ASTM) and the technical specifications of the predicate devices. These standards are developed by expert committees, but individual experts were not involved in establishing ground truth for a test set in the context of this submission.
-
Adjudication method for the test set:
- Not Applicable. Since there was no clinical study involving human readers or subjective interpretations of data, an adjudication method for a test set is not relevant. The assessment relies on objective measurements against pre-defined engineering and performance criteria.
-
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:
- No. An MRMC study was not done. This device is a passive accessory (an electrode); it does not involve AI, human-in-the-loop performance, or image interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is an electrode, not an algorithm or AI system.
-
The type of ground truth used:
- Technical Specifications and Regulatory Standards. The ground truth for this submission is established by adherence to recognized national and international consensus standards (ASTM, ISO, AAMI/ANSI IEC) for medical electrical equipment, biocompatibility, and shelf-life, as well as direct comparison to the established performance characteristics of the legally marketed predicate devices. Key safety criteria, such as maximum power density, also refer to FDA guidance.
-
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
-
How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2019
Shaoxing DL Healthcare Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 Cn
Re: K182111
Trade/Device Name: DL Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 12, 2018 Received: October 22, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, VivekJ. 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) K182111
Device Name DL Adhesive Electrode
Indications for Use (Describe)
DL 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 limited 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) |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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: | K182111 |
|---|---|
| Date: | January 17, 2019 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | SHAOXING DL HEALTHCARE CO., LTDJIUJIN LAND, BAIGUAN STREET, SHANGYU DISTRICT,SHAOXING CITY, ZHEJIANG PROVINCE, CHINA, 312300 |
| Contactor: | Doris Dong (Consultant)Shanghai CV Technology Co., Ltd.Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris_d@126.comTel: 86 21-31261348 |
2. Device Description:
| Proprietary Name: | DL Adhesive Electrode |
|---|---|
| Common Name: | Cutaneous electrode |
| Classification Name: | Cutaneous electrode |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | DL Adhesive Electrode is intended to transmit electrical current to patientskin for use with transcutaneous electrical stimulation devices. Somecommon types of the stimulation devices include, but are not limited toTENS (Transcutaneous Electrical Nerve Stimulation) and EMS(Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use. |
| Device Description: | DL Adhesive Electrode is used as an accessory to the TENS or EMSdevice unit, which transmits electrical current to patient skin. Theelectrical current of Electrode Pad is first transmitted via the snap buttonor lead wire then transmitted to the conductive gel which is adhered topatient skin.DL Adhesive Electrode is composed of a top cover, connector snap buttonor lead wire, conductive carbon film, conductive hydrogel media, and acarrier liner. The carrier liner is made of PET (polyethylene terephthalate)or LDPE(Low Density Polyethylene).DL Adhesive Electrode is non-sterile and intended for single adult patientmultiple application use. The Adhesive Electrode has various shapes andsizes. |
{4}------------------------------------------------
To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner.
The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
3. Predicate Device Identification
K152648--Ennova Self-adhesive Electrode--January 12, 2016
K 100418--Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode -- September 3, 2010
4. Non-Clinical Test Conclusion
Bench tests were conducted on DL 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 F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
-
ANSI AAMI 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 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And
Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-2-2 Edition 6.0 2017-03, 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
*Basic technological characteristics, New device VS. Primary Predicate device:
| New Device | Predicate Device | |
|---|---|---|
| 501(k) number | K182111 | K152648 |
| Trade Name: | DL Adhesive Electrode | Ennova Self-adhesive Electrode |
| Common Name: | Cutaneous electrode | Cutaneous electrode |
| Classification | Cutaneous electrode | Cutaneous electrode |
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DL Adhesive Electrode; SHAOXING DL HEALTHCARE CO., LTD
| Name: | ||
|---|---|---|
| Product Code: | GXY | GXY |
| Regulation Number: | 882.1320 | 882.1320 |
| Medical Specialty: | Neurology | Neurology |
| Device Class: | II | II |
| Indications for use: | DL Adhesive Electrode is intended to transmitelectrical current to patient skin for use withtranscutaneous electrical stimulation devices. Somecommon types of the stimulation devices include,but are not limited to TENS (TranscutaneousElectrical Nerve Stimulation) and EMS (ElectricalMuscular Stimulation). The electrode is for OTC(Over-The-Counter) or Prescription use. | Ennova Self-adhesive Electrode is intendedto transmit electrical current to patient skinfor use with transcutaneous electricalstimulation devices. Some common types ofthe stimulation devices include, but are notlimited to TENS (Transcutaneous ElectricalNerve Stimulation) and EMS (ElectricalMuscular Stimulation). The electrode is forOTC (Over-The -Counter) or Prescriptionuse. |
| Target population: | Single patient use and multiple application | Single patient use and multiple application |
| Prescription use | OTC and Prescription use | OTC and Prescription use |
| Design (shape &connection): | Electrode Pad: Round, rectangle, butterfly, oval,according to customized specification.Lead wire with female socket, or snap button withmale snap connector | Round, rectangle, oval, butterfly according tocustomized specification.Lead wire with female socket, or snap buttonwith male snap connector |
| Materials: | - Top cover material- Electrically conductive carbon cloth- Biocompatible conductive hydrogel- Electrode carrier liner | - Top cover material- Electrically conductive carbon cloth- Biocompatible conductive hydrogel- Electrode carrier liner |
| Electrode Pad Size | Rectangle Min.40×40mm; Max.40×350mm | Rectangle Min.40×40mm; Max.100×130mm |
| Butterfly Min.93×150mm; Max.110×150mm | Butterfly Min.55×75mm;Max.95×165mm | |
| Round Min.Ø18mm; Max.Ø85mm | Round Min.Ø32mm; Max.Ø70mm | |
| Oval 50×78mm | Oval Min.50×120mm;Max.100×240mm | |
| -- Patient contactarea of ElectrodePad | Round Min.254.34mm²; Max.5671.63mm² | Round Min.804mm²; Max.3846.5mm² |
| Rectangle Min.1600mm²; Max.7000mm² | Rectangle Min.1600 mm²; Max. 13000mm² | |
| Oval 3900mm² | Oval Min.4710 mm²; Max.18840mm² | |
| Butterfly Min.6975mm²; Max.8250mm² | Butterfly Min.4125 mm²; Max.15675mm² | |
| --Hydrogelthickness | 1.0mm ±0.2mm | 1.0mm ±0.2mm |
| --Hydrogel VolumeResistivity | 1500 ohm-cm maximum | 1500 ohm-cm maximum |
| Conductive carbonfilm | PU, Conductive carbon | PU, Conductive carbon |
| Electrode | Round 415~599Ω | Round 397~612Ω |
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| Impedance of | Rectangle | 421~711Ω | Rectangle | 432~624Ω | |
|---|---|---|---|---|---|
| Electrode Pad | Oval | 437~601Ω | Oval | 412~642Ω | |
| Butterfly | 451~688Ω | Butterfly | 407~616Ω | ||
| Maximum Currentfor Power Density@ 500 Ohms | Use Jiajian® TENS(K112288) for calculation, the Maximum R.M.S current is 13.7mAr.m.s | Use Jiajian® TENS(K112288) forcalculation, the Maximum R.M.S current is13.7mAr.m.s. Calculation formulas asfollow: | |||
| Maximum Output Voltage: 36V@500Ω | |||||
| Pulse Duration: 60~300µS | |||||
| Waveform: Pulsed Monophasic | |||||
| Frequency: 0.5~120Hz | |||||
| $Ir.m.s= \sqrt{\frac{120Hz*30\mu s}{1000000}} *72mA$ | |||||
| 13.7 mAr.m.s | |||||
| Current Density ofElectrode Pad (UseIRMS= 13.7mA forcalculation ) | Round | Min.0.242mA/cm²Max.5.386mA/cm² | Round | Min.0.36mA/cm²Max.1.70mA/cm² | |
| Rectangle | Min.0.196mA/cm²Max.0.85mA/cm² | Rectangle | Min.0.11mA/cm²Max.0.86mA/cm² | ||
| Oval | 0.351mA/cm² | Oval | Min.0.07mA/cm²Max.0.29mA/cm² | ||
| Butterfly | Min.0.17mA/cm²Max.0.196mA/cm² | Butterfly | Min.0.09mA/cm²Max.0.33mA/cm² | ||
| Maximum PowerDensity ofElectrode Pad(W/cm²) | Round | 0.0369W/cm² | Round | 0.0117W/cm² | |
| Rectangle | 0.006W/cm² | Rectangle | 0.0059W/cm² | ||
| Oval | 0.0024W/cm² | Oval | 0.002W/cm² | ||
| Butterfly | 0.0013W/cm² | Butterfly | 0.0023W/cm² | ||
| (FDA guidance states that a maximum average power density should be less than 0.25 watts per square centimeter ofelectrode conductive surface area to reduce the risk of thermal burns.) | |||||
| Connector retention force | |||||
| --Lead wire withfemale socket | 10.85N | 10.80N | |||
| --snap button withmale snapconnector | 9.61N | 9.60N | |||
| Standards met: | 1. Lead wires test per8.5.2.3 of AAMI/ANSI ES60601-1;2. Impedance test, Conformability test and Fluidtolerance test per 201.15.101.6 and 201.15.101.7 ofANSI AAMI IEC 60601-2-2:2009;3. Impedance Test (Dispersion Test) per FDArequirement;4. Peel strength test according to manufacturer'srequirement;5. Shelf life test per ASTM F1980:2016; | 1. Lead wires test per 8.5.2.3 of AAMI/ANSIES 60601-1;2. Impedance test, Conformability test andFluid tolerance test per 201.15.101.6 and201.15.101.7 of IEC 60601-2-2:20093. Impedance Test (Dispersion Test) per FDArequirement;4. Peel strength test according tomanufacturer's requirement;5. Shelf life test per ASTM F1980:2011; | |||
| Biocompatibility | ISO10993-5:2009; | ISO10993-5:2009; |
DL Adhesive Electrode;
SHAOXING DL HEALTHCARE CO., LTD
{7}------------------------------------------------
DL Adhesive Electrode; SHAOXING DL HEALTHCARE CO., LTD
| ISO10993-10:2010 | ISO10993-10:2010 | |
|---|---|---|
| Sterility Status: | Non-sterile | Non-sterile |
| Electrical safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSIES60601-1: 2005/(R)2012 And A1:2012 | Lead wire meets Clause 8.5.2.3 ofAAMI/ANSI ES60601-1 |
| Other Performance | Good electrical conductivity, good adhesiveproperty | Good electrical conductivity, good adhesiveproperty |
*Basic technological characteristics, New device VS. Reference Predicate device (comparison of the subject and predicate hydrogels):
| New Device | Predicate Device | |
|---|---|---|
| 510(k) number | K182111 | K100418 |
| Trade Name: | DL Adhesive Electrode | Superior Starburst Reusable Self-AdheringTENS/NMES/FES Stimulating Electrode |
| Common Name: | Cutaneous electrode | Cutaneous electrode |
| Classification Name: | Cutaneous electrode | Cutaneous electrode |
| Product Code: | GXY | GXY |
| Regulation Number: | 882.1320 | 882.1320 |
| Medical Specialty: | Neurology | Neurology |
| Device Class: | II | II |
| Indications for use: | DL Adhesive Electrode is intended to transmitelectrical current to patient skin for use withtranscutaneous electrical stimulation devices. Somecommon types of the stimulation devices include,but are not limited to TENS (TranscutaneousElectrical Nerve Stimulation) and EMS (ElectricalMuscular Stimulation). The electrode is for OTC(Over-The -Counter) or Prescription use. | The proposed Superior Starburst ReusableSelf-Adhering TENS/NMES/FES StimulatingElectrode is intended for over-the-counter usewith transcutaneous electrical stimulationdevices to provide the conductive interfacebetween the stimulation device and thepatient's skin. |
| Body contact | Intact Skin | Intact Skin |
| Biocompatibility | Complies with requirements of ISO 10993-1,including: Cytotoxicity (ISO 10993-5), Irritationand Sensitization (ISO 10993-10) | Complies with requirements of ISO 10993-1,including: Cytotoxicity (ISO 10993-5),Irritation and Sensitization (ISO 10993-10) |
| Sterilization | Provided non-sterile | Provided non-sterile |
| Shelf life | 2 years | 3 years |
| Impedance (at 1MHz) | 1500 ohm-cm maximum | 1500 ohm-cm maximum |
| Stainless SteelAdhesion(180° peel) | 136 grams minimum(≈1.3N) | 136 grams minimum(≈1.3N) |
| Gel thickness | 1.0mm±0.2mm | 35mil(≈0.89mm) |
| Conductive material | Water (Aqua) with Inorganic Salt | Water (Aqua) with Inorganic Salt |
| Composition | Water (solvent)Glycerin ( polymerization)Polymer (gel forming) | Water (solvent)Glycerin ( polymerization)Polymer (gel forming) |
| Polyol (gel forming) | Polyol (gel forming) | |
| Amorphous Silica (gel forming) | Amorphous Silica (gel forming) | |
| Inorganic Salt (Conductive) | Inorganic Salt (Conductive) | |
| Potassium Chloride(enhancer) | Potassium Chloride(enhancer) | |
| PH | 3.0-3.5 | 3.0-3.5 |
{8}------------------------------------------------
DL Adhesive Electrode; SHAOXING DL HEALTHCARE CO., LTD
The Conclusions:
Based on successful biocompatibility testing of the whole Adhesive Electrode together with the conductive hydrogel, the electrical performance of the insulated lead wire components and electrode current distribution test results, 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 safe, 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).