(176 days)
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
- Top layer: Fabric/Foam/ Tan fabric
- Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
- Bottom layer: Biocompatible self-adhesive conductive hydrogel
- Connection: Leadwire/snap button/magnetic button
- double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film
- Release film: Release film is a protective layer for the hydrogel.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:
- Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer.
- Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket.
This document is an FDA 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. "Self-adhesive Electrode" device. It outlines the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This document pertains to a cutaneous electrode, which is a relatively simple medical device. Therefore, the "acceptance criteria" and "study" described are focused on physical and electrical performance and biocompatibility, not on complex diagnostic accuracy metrics like those for AI-powered imaging devices (e.g., sensitivity, specificity, AUC). The request's points regarding MRMC studies, expert concensus for ground truth, and training data are typically applicable to AI/ML device submissions, which are not relevant to this electrode device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on established industry standards and comparisons to legally marketed predicate devices. The "reported device performance" demonstrates that the proposed device meets or is comparable to these criteria.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Subject Device) | Study/Section Proving Compliance |
|---|---|---|
| Material/Composition: | ||
| Biocompatibility (ISO 10993) | Complies with ISO10993 | 7.2 Biocompatibility testing |
| Physical Characteristics: | ||
| Adhesion Testing (Peel Strength) ≥ 7N | ≥ 7N | 6. Technical and Performance (Comparison Table), 10. NE adhesion |
| Force to remove wire from electrode > 6 pounds | More than 6 pounds of force | 6. Technical and Performance (Comparison Table) |
| Electrical Characteristics: | ||
| A.C. Impedance < 300 ohms | < 300 ohms | 6. Technical and Performance (Comparison Table), 9. Electrical & Impedance Tests |
| Safety and EMC: | ||
| ANSI AAMI ES60601-1 (General req. for basic safety and essential performance) | Complied with requirements of ANSI AAMI ES60601-1 | 7.3 Safety and EMC |
| IEC 60601-2-2:2017 (Specific req. for NE contact impedance) | Complied with requirements of IEC 60601-2-2:2017 section 201.15.101.6 | 9. Electrical & Impedance Tests |
| IEC 60601-2-2:2017 (Specific req. for NE adhesion) | Complied with requirements of IEC 60601-2-2:2017 section 201.15.101.7 | 10. NE adhesion |
| Product Lifecycle: | ||
| Shelf Life (Storage conditions: 41°F to 80.6°F) | Tested for storage conditions | 12. Packaging tests |
| Accelerated Aging (Expiration date) | Tested for accelerated aging | 13. Accelerated Aging |
Study Details:
-
Sample Size used for the test set and data provenance:
- The document does not specify exact sample sizes (e.g., number of electrodes tested) for each non-clinical test. It generally states that "The submitted sample(s) complied..." However, based on the nature of bench testing for these types of devices, standard engineering practices would involve testing multiple units to demonstrate conformity.
- Data Provenance: The tests are "Non-Clinical Data" and "Bench Testing," implying in-house lab testing or third-party lab testing. The document does not specify country of origin for the testing itself, but the company is based in Shenzhen, China. The data is retrospective in the sense that it was generated prior to submission.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This question is not applicable to this type of device submission. For a cutaneous electrode, "ground truth" is established by direct physical, electrical, and chemical measurements against industry standards (e.g., resistance, adhesion force, material composition, cytotoxicity tests). There are no "experts" in the radiological interpretation sense involved in establishing this type of ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are relevant for subjective interpretations, particularly in medical imaging or clinical trials where expert consensus resolves disagreements. For bench testing of an electrode, results are objective measurements derived from direct testing.
-
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:
- This question is not applicable to this device. MRMC studies are used for AI/ML-enabled diagnostic devices where human readers (e.g., radiologists) interact with an AI system. This submission is for a physical electrode, not a diagnostic AI tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable to this device. "Standalone performance" refers to the performance of an algorithm without human intervention, typically in AI/ML diagnostic tools. This device is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on industry standards and objective physical, electrical, and chemical measurements.
- Physical/Mechanical: E.g., measured peel strength (adhesion) against a specified Newton (N) threshold, measured force to remove wires against a specified pound-force threshold.
- Electrical: E.g., measured AC impedance against a specified ohm threshold.
- Biocompatibility: Results of specific ISO 10993 tests (Cytotoxicity, Skin Sensitization, Skin Irritation) which have defined pass/fail criteria based on biological reactions.
- Safety/EMC: Compliance with well-defined performance requirements in standards like ES60601-1 and IEC 60601-2-2.
- The "ground truth" for this device is based on industry standards and objective physical, electrical, and chemical measurements.
-
The sample size for the training set:
- This question is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
-
How the ground truth for the training set was established:
- This question is not applicable for the same reason as above; there is no training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 19, 2023
Shenzhen Roundwhale Technology Co., Ltd. Amos Zou RA Manager 202,2/F, Building 27, Dafa Industrial Park, Longxi Community Longgang Street, Longgang District Shenzhen, Guangdong 518108 China
Re: K222252
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: December 19, 2022 Received: December 19, 2022
Dear Amos Zou:
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Tushar Bansal -S" in a large, sans-serif font. The text is black and stands out against a background that appears to have a faint watermark or design. The name is likely the focus of the image, possibly indicating a person's name or a title.
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K22252
Device Name Self-adhesive Electrode
Indications for Use (Describe)
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| X Over-The-Counter Use (21 CFR 801 Subpart C) |
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Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY
as required by section 21 CFR 807.92
1. Submitter of 510(K):
Sponsor
| Company Name: | Shenzhen Roundwhale Technology Co., Ltd. |
|---|---|
| Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street,Longgang district, Shenzhen, China. |
| Contact person: | Zeng Chunming |
| TEL: | +86-755-23212776 |
| FAX: | +86-755-23212776 |
| E-mail: | zcm@roovjoy.com |
| Date of Prepared: | 12/8/2022 |
Application Correspondent:
| Company Name: | Shenzhen Roundwhale Technology Co., Ltd. |
|---|---|
| Address: | 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street,Longgang district, Shenzhen, China. |
| Contact person: | Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | Amos.zou@139.copm |
| Date of Prepared: | 12/8/2022 |
Proposed Device and code: 2.
| Device Trade Name: | Self-Adhesive Electrode |
|---|---|
| Model Series | Self-Adhesive Electrode with lead wire;Self-Adhesive Electrode with Snap/Magnetic connector; |
| Regulation Medical Specialty | Neurology |
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| Product Code: | GXY |
|---|---|
| Regulation number | 21 CFR 882.1320 |
| Device Class | II |
| 510(k) | K222252 |
3. Predicate Device:
| 510(K) | Trade Name | Submitter | Product Code |
|---|---|---|---|
| K180865 | ZMI Self-adhesive | ZMI Electronics, Ltd. | GXY |
| K160138 | Adhesive Electrodes | GMDASZ Manufacturing Co., Ltd | GXY |
4. Description of Proposed Device:
Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
| No. | Description | Material Composition |
|---|---|---|
| 1 | Top layer | Fabric/Foam/ Tan fabric |
| 2 | Middle layer | Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film) |
| 3 | Bottom layer | Biocompatible self-adhesive conductive hydrogel |
| 4 | Connection | Leadwire/snap button/magnetic button |
| 5 | double sidesadhesive tape | Which is used for attaching the non-woven fabrics and conducting film |
| 6 | Release film | Release film is a protective layer for the hydrogel. |
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:
-
Leadwire assembly:
The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. By design, the insulated outer jacket prevents the connection to earth or hazardous voltages. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/A AMI ES60601-1, subclause 8.5.2.3. -
Snap button/Magnetic button assembly:
With 2.5~5mm diameter male socket. The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and female connectors. Either method is similar to the lead wire connection providing the friction to create the physical contact.
ર. Indications for Use
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS
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(Electrical Muscular Stimulation), IF or IFC (Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
6. Technical and Performance
The following table compares the device to the predicate device with basic technological characteristics.
Comparison to predicate device 1#:
| Element ofComparison | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| 510(k) | K222252 | K180865 | N/A |
| Company | Shenzhen Roundwhale Technology Co., Ltd. | ZMI Electronics, Ltd. | N/A |
| Device Name | Self-adhesive Electrode | ZMI Self-adhesive Electrodes | N/A |
| Model name | ● Self-adhesive Electrode with leadwire;● Self-adhesive Electrode with Snap/Magnetic connector; | SAE Type | N/A |
| Shape | ● Round(50±0.5mm),● Rectangular(5030±0.5mm),● Square(5050±0.5mm,4040±0.5mm),● Oval(4080±0.5mm) | ● Round, Rectangular, Square, Oval, andButterfly | similar1# |
| Color | White | White, Red, Black, and Tan | similar4# |
| RegulationNumber | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| ClassificationName | Cutaneous electrode | Cutaneous electrode | Same |
| Indications forUse | Self-Adhesive Electrode is intended for useas a reusable, conductive adhesiveinterface between the patient's skin and themarketed electrical stimulators (i.e.TENS(Transcutaneous Electrical NerveStimulation), EMS (Electrical MuscularStimulation), IF or IFC(Interferentialcurrent) or PGF (Pulsed GalvanicStimulation) for transmitting electricalcurrent, for OTC (Over-The-Counter) orPrescription use. | ZMI Self-adhesive Electrodes areintended for as a reusable, conductiveadhesive interface between the patient'sskin and the marketed electricalstimulators (i.e. TENS (TranscutaneousElectrical Nerve Stimulation), EMS(Electrical Muscular Stimulation), IF(Interferential) or PGF (Pulsed GalvanicStimulation) for transmitting electricalcurrent, for OTC (Over-The-Counter) orPrescription use. | SE |
| OTC orPrescription | OTC and Prescription | OTC and Prescription | Same |
| TargetPopulation | General [Adult] | General [Adult] | Same |
| DesignFeature | Six layers:1. Insulation backing material:Fabric/Foam/Tan fabric2. Conductive film: Aluminum foil film/Carbon film/Carbon film coated withsilver/3. Conductive hydrogel4.Connection5.double sides adhesive tape6.Release liner | Three layers:1.Insulation backing material:Fabric/Foam/Tan fabric2.Conductive film: Aluminum foilfilm/Carbon film/Carbon film coated withsilver/3.Conductive hydrogel | similar2# |
| ElectricalConnection | LeadwireSnap buttonMagnetic button | LeadwireSnap buttonMagnetic button | Same |
| Lead Wireconnector | .080"/0.1"(2mm/2.5mm) female socketor Pin connector | .080" (2mm) female socket connector | similar3# |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| AdhesiveType | Self-adhesive | Self-adhesive | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| adhesiontesting (peelstrength ) | ≥7N | ≥7N | Same |
| A.C.Impedance | <300 ohms | <200 ohms | similar6# |
| Forcerequired toremovewire fromelectrode | More than 6 pounds of force | More than 6 pounds of force | Same |
| SinglePatient Use | Yes | Yes | Same |
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Comparison to predicate device 2#:
| Element ofcomparison | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| 510(K) No. | K222252 | K160138 | N/A |
| Company | Shenzhen Roundwhale Technology Co., Ltd. | GMDASZ Manufacturing Co., Ltd. | N/A |
| Device Name | Self-adhesive Electrode | Adhesive Electrodes | N/A |
| Model Name | ● Self-adhesive Electrode with leadwire● Self-adhesive Electrode with Snap | OCWN1005, OCWN1007, OCWN2505, OCWN2509, OACWN1005,OACWN1007, | N/A |
| /Magnetic connector: | OACWN2505, OACWN2509 | ||
| Shape | Round(50±0.5mm),Rectangular(5030±0.5mm),Square(5050±0.5mm,4040±0.5mm),Oval(4080±0.5mm) | Round and Rectangular | similar1# |
| Color | White | Tan | similar4# |
| RegulationNumber | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| ClassificationName | Cutaneous electrode | Cutaneous electrode | Same |
| Indications forUse | Self-Adhesive Electrode is intended for useas a reusable, conductive adhesiveinterface between the patient's skin and themarketed electrical stimulators (i.e.TENS(Transcutaneous Electrical NerveStimulation), EMS (Electrical MuscularStimulation), IF or IFC(Interferentialcurrent) or PGF (Pulsed GalvanicStimulation) for transmitting electricalcurrent, for OTC (Over-The-Counter) orPrescription use. | The adhesive electrodes are intended for asa reusable, conductive adhesive interfacebetween the patient's skin and the marketedelectrical stimulators (i.e. TENS(Transcutaneous Electrical NerveStimulation), EMS (Electrical MuscularStimulation), IF(Interferential) or PGF(Pulsed Galvanic Stimulation) fortransmitting electrical current, for OTC(Over-The-Counter) or Prescription use. | Same |
| OTC orPrescription | OTC and Prescription | OTC and Prescription | Same |
| TargetPopulation | General [Adult] | General [Adult] | Same |
| DesignFeature | Six layers:1. Insulation backing material:Fabric/Foam/ Tan fabric2. Conductive film: Aluminum foil film/Carbon film/Carbon film coated withsilver/3. Conductive hydrogel4.Connection5.double sides adhesive tape6. Release liner | Three layers:1. Insulation backing material:Fabric/Foam/Tan fabric2. Conductive film: Carbon film/Carbonfilm coated with silver/Aluminum foil film3. Conductive hydrogel | Similar2# |
| ElectricalConnection | Leadwire,Snap button,Magnetic button | Leadwire | Similar5# |
| Lead Wireconnector | Leadwire connector .080"-0.1" (2mm-2.5mm) female socket or Pinconnector with insulating outer jacket. | Leadwire connector .080" (2mm) femalesocket connector | similar |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Self-adhesive | Self-adhesive | Self-adhesive | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| adhesiontesting (peelstrength) | ≥7N | ≥7N | Same |
| A.C.Impedance | <300 ohms | <300 ohms | Same |
| Forcerequired toremovewire fromelectrode | More than 6 pounds of force | More than 6 pounds of force | Same |
| SinglePatient Use | Yes | Yes | Same |
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Comparison in Detail(s):
1# The shape and size are related to the treatment area may cause higher current density, which leads to discomfort and burns. The current densities for any shaped electrodes exceeding 2mA r.m.s/cm2 may require the special attention of the user.
4#: Top fabric color that makes no direct contact with the human body is mainly for identification and marketing purpose, the subject device will be provided in white only, and that no color additives are to be used. and does not raise any new concerns of safety or effectiveness.
2# The subject device and predicate device are similar in construction. They both contain three basic components: a nonconductive top layer, a patient contacting layer, a carbondispersion pad middle layer, and; while the Self-Adhesive Electrode also contains three additional layer:conductive carbon fiber lead wire (or snap for Magnetic Style Electrode),double sides adhesive tape which is used for attaching the non-woven fabrics and conducting film,and plastic film is a protective layer for the hydrogel. Which the differences will not effectiveness of the Self-Adhesive Electrode.
3# and 5#: The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and female connectors. Either method is similar to the lead wire connection providing the friction to create the physical contact.
6#:A.C. impedance is different from K180865, but identical to K160138,The difference does not raise any new safety and effectiveness questions and complies with the same performance and safety requirements.
7. Performance Testing:
Test Summary:
To establish substantial equivalence to the identified predicate devices, we performed the following tests on the subject device, Adhesive Electrodes TS serial,and the testing results provide evidence that the device complies with the applicable standards requirement and it is substantially equivalent to the predicate devices.
Performance data includes "Non-Clinical Data", brief description of which are shown as below.
7.1 Non-Clinical Data:
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Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:
7.2 Biocompatibility testing
The biocompatibility evaluation for the Self-Adhesive Electrode conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Self-Adhesive Electrodes will have direct contact with human body only at intact skin,the maximum number of times the product can be used is 10-15 times, calculated on the basis of 30 minutes each time, Expected to is expected once a day, The device is intended to be used for a total duration of 30 days maximum, irrespective of the number of uses or replacement of an individual device with a new one. cumulative sum of single, multiple or repeated contact time is likely to exceed 24 h but not exceed 30 d. And the testing included the following tests:
According to the product manual,
- Cytotoxicity -ISO 10993-5:2009
- Skin Sensitization -ISO 10993-23:2021
- Skin Irritation -ISO 10993-10:2021
7.3 Safety and EMC
To verify the basic safety and essential performance of the subject device, weperformed the test noted below:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance
The submitted sample(s) complied with the requirements of ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], Cl.8.5.2.3
7.4 Bench Testing
Bench tests were conducted on 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:
- Electrical & Impedance Tests: Neutral Electrode (NE) contact impedance
The Self-Adhesive Electrode was tested to assure the current is equally distributed. The Self-Adhesive Electrode was also tested for Impedance to assure proper electrical connection to the skin.
The submitted sample(s) complied with the requirements of IEC 60601-2-2:2017 section 201.15.101.6
- NE adhesion: (a) Pull test b) Conformability test
The Self-Adhesive Electrode was tested for initial adhesion force after using multiple times.
The submitted sample(s) complied with the requirements of IEC 60601-2-2:2017 section 201.15.101.7
- Connector & Mechanical tests
The Self-Adhesive Electrode has a Snap or magnetic surface with the purpose to clamp the Self-Adhesive Electrode. This connection was tested to assure multiple use and also to assure the TENS stay fixed to the Self-Adhesive Electrode during use.
4.Packaging tests
Real-Time Shelf Life Test Report
The Self-Adhesive Electrode was tested for storage conditions:
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• The Self-Adhesive Electrode should not be stored at temperatures lower than 41°P(+5°C) or higher than 80.6°F (+27°C).
5. Accelerated Aging
The Self-Adhesive Electrode was tested for accelerate aging in worst storage condition to assure within the expiration date the electrode function as expected.
- ASTM F1980 (Reapproved 2016), Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
8. Conclusions:
The proposed device has the same Indications for Use and similar characteristics as the predicate device, Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any different questions of safety or effectiveness. Roundwhale Ltd. maintains that the Self-Adhesive Electrode is substantially equivalent to the predicate devices in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.
§ 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).