Self-adhesive Electrode

K222252 · Shenzhen Roundwhale Technology Co. , Ltd. · GXY · Jan 19, 2023 · Neurology

Device Facts

• Record ID: K222252
• Device Name: Self-adhesive Electrode
• Applicant: Shenzhen Roundwhale Technology Co. , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jan 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 (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.

Device Story

Device is a multi-layer, reusable, self-adhesive electrode; functions as a conductive interface between patient skin and electrical stimulators (TENS, EMS, IF, PGF). Input: electrical current from stimulator; Output: current delivery to patient skin. Composed of fabric/foam backing, conductive film (carbon/silver/aluminum), and biocompatible hydrogel. Connects via lead wire, snap button, or magnetic button. Used in clinical or home settings by patients or clinicians. Device ensures electrical contact; benefits patient by facilitating therapeutic stimulation. No active electronics or software.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5, -10, -23), electrical safety (ANSI/AAMI ES60601-1), impedance testing, adhesion pull tests, and accelerated aging (ASTM F1980).

Technological Characteristics

Multi-layer construction: fabric/foam backing, conductive film (carbon/silver/aluminum), and conductive hydrogel. Connectivity: lead wire (2mm/2.5mm socket), snap button, or magnetic button. Non-sterile, reusable. Biocompatibility per ISO 10993. Electrical safety per ANSI/AAMI ES60601-1. Impedance <300 ohms.

Indications for Use

Indicated for adult patients requiring electrical stimulation therapy (TENS, EMS, IF/IFC, or PGF) via a conductive interface. No specific contraindications listed beyond standard electrical stimulation precautions.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• ZMI Self-adhesive (K180865)
• Adhesive Electrodes (K160138)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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)

| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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,<br>Longgang district, Shenzhen, China. |
| Contact person: | Zeng Chunming |
| TEL: | [phone] |
| FAX: | [phone] |
| E-mail: | [e-mail] |
| 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,<br>Longgang district, Shenzhen, China. |
| Contact person: | Amos Zou |
| TEL: | [phone] |
| E-mail: | [e-mail] |
| 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;<br>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 sides<br>adhesive 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 of<br>Comparison | Subject Device | Predicate Device | Comm<br>ent |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 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;<br>● Self-adhesive Electrode with Snap<br>/Magnetic connector; | SAE Type | N/A |
| Shape | ● Round(50±0.5mm),<br>● Rectangular(50*30±0.5mm),<br>● Square(50*50±0.5mm,40*40±0.5mm),<br>● Oval(40*80±0.5mm) | ● Round, Rectangular, Square, Oval, and<br>Butterfly | similar<br>1# |
| Color | White | White, Red, Black, and Tan | similar<br>4# |
| Regulation<br>Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Same |
| Indications for<br>Use | Self-Adhesive Electrode is intended for use<br>as a reusable, conductive adhesive<br>interface between the patient's skin and the<br>marketed electrical stimulators (i.e.TENS<br>(Transcutaneous Electrical Nerve<br>Stimulation), EMS (Electrical Muscular<br>Stimulation), IF or IFC(Interferential<br>current) or PGF (Pulsed Galvanic<br>Stimulation) for transmitting electrical<br>current, for OTC (Over-The-Counter) or<br>Prescription use. | ZMI Self-adhesive Electrodes are<br>intended for as a reusable, conductive<br>adhesive interface between the patient's<br>skin and the marketed electrical<br>stimulators (i.e. TENS (Transcutaneous<br>Electrical Nerve Stimulation), EMS<br>(Electrical Muscular Stimulation), IF<br>(Interferential) or PGF (Pulsed Galvanic<br>Stimulation) for transmitting electrical<br>current, for OTC (Over-The-Counter) or<br>Prescription use. | SE |
| OTC or<br>Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target<br>Population | General [Adult] | General [Adult] | Same |
| Design<br>Feature | Six layers:<br>1. Insulation backing material:<br>Fabric/Foam/Tan fabric<br>2. Conductive film: Aluminum foil film<br>/Carbon film/Carbon film coated with<br>silver/<br>3. Conductive hydrogel<br>4.Connection<br>5.double sides adhesive tape<br>6.Release liner | Three layers:<br>1.Insulation backing material:<br>Fabric/Foam/Tan fabric<br>2.Conductive film: Aluminum foil<br>film/Carbon film/Carbon film coated with<br>silver/<br>3.Conductive hydrogel | similar<br>2# |
| Electrical<br>Connection | Leadwire<br>Snap button<br>Magnetic button | Leadwire<br>Snap button<br>Magnetic button | Same |
| Lead Wire<br>connector | .080"/0.1"(2mm/2.5mm) female socket<br>or Pin connector | .080" (2mm) female socket connector | similar<br>3# |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Adhesive<br>Type | Self-adhesive | Self-adhesive | Same |
| Biocompatibi<br>lity | Complies with ISO10993 | Complies with ISO10993 | Same |
| adhesion<br>testing (peel<br>strength ) | ≥7N | ≥7N | Same |
| A.C.<br>Impedance | <300 ohms | <200 ohms | similar<br>6# |
| Force<br>required to<br>remove<br>wire from<br>electrode | More than 6 pounds of force | More than 6 pounds of force | Same |
| Single<br>Patient Use | Yes | Yes | Same |

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Comparison to predicate device 2#:

| Element of<br>comparison | Subject Device | Predicate Device | Com<br>ment |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 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<br>● Self-adhesive Electrode with Snap | OCWN1005, OCWN1007, OCWN2505, OCWN2509, OACWN1005,OACWN1007, | N/A |
| | /Magnetic connector: | OACWN2505, OACWN2509 | |
| Shape | Round(50±0.5mm),<br>Rectangular(50*30±0.5mm),<br>Square(50*50±0.5mm,40*40±0.5mm),<br>Oval(40*80±0.5mm) | Round and Rectangular | similar<br>1# |
| Color | White | Tan | similar<br>4# |
| Regulation<br>Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Same |
| Indications for<br>Use | Self-Adhesive Electrode is intended for use<br>as a reusable, conductive adhesive<br>interface between the patient's skin and the<br>marketed electrical stimulators (i.e.TENS<br>(Transcutaneous Electrical Nerve<br>Stimulation), EMS (Electrical Muscular<br>Stimulation), IF or IFC(Interferential<br>current) or PGF (Pulsed Galvanic<br>Stimulation) for transmitting electrical<br>current, for OTC (Over-The-Counter) or<br>Prescription use. | The adhesive electrodes are intended for as<br>a reusable, conductive adhesive interface<br>between the patient's skin and the marketed<br>electrical stimulators (i.e. TENS<br>(Transcutaneous Electrical Nerve<br>Stimulation), EMS (Electrical Muscular<br>Stimulation), IF(Interferential) or PGF<br>(Pulsed Galvanic Stimulation) for<br>transmitting electrical current, for OTC<br>(Over-The-Counter) or Prescription use. | Same |
| OTC or<br>Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target<br>Population | General [Adult] | General [Adult] | Same |
| Design<br>Feature | Six layers:<br>1. Insulation backing material:<br>Fabric/Foam/ Tan fabric<br>2. Conductive film: Aluminum foil film<br>/Carbon film/Carbon film coated with<br>silver/<br>3. Conductive hydrogel<br>4.Connection<br>5.double sides adhesive tape<br>6. Release liner | Three layers:<br>1. Insulation backing material:<br>Fabric/Foam/Tan fabric<br>2. Conductive film: Carbon film/Carbon<br>film coated with silver/Aluminum foil film<br>3. Conductive hydrogel | Similar<br>2# |
| Electrical<br>Connection | Leadwire,<br>Snap button,<br>Magnetic button | Leadwire | Similar<br>5# |
| Lead Wire<br>connector | Leadwire connector .080"-0.1" (2mm-<br>2.5mm) female socket or Pin<br>connector with insulating outer jacket. | Leadwire connector .080" (2mm) female<br>socket 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 |
| Biocompatibi<br>lity | Complies with ISO10993 | Complies with ISO10993 | Same |
| adhesion<br>testing (peel<br>strength) | ≥7N | ≥7N | Same |
| A.C.<br>Impedance | <300 ohms | <300 ohms | Same |
| Force<br>required to<br>remove<br>wire from<br>electrode | More than 6 pounds of force | More than 6 pounds of force | Same |
| Single<br>Patient 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:

1. 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

2. 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

3. 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.