ELECTRODES PAD

K190700 · Shenzhen Bestpad Technology Development Co., Ltd. · GXY · Jun 14, 2019 · Neurology

Device Facts

• Record ID: K190700
• Device Name: ELECTRODES PAD
• Applicant: Shenzhen Bestpad Technology Development Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jun 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.

Device Story

Passive cutaneous electrode; transmits electrical current from external TENS/EMS stimulation devices to patient skin. Input: electrical signal from stimulator via lead wire or snap button. Transformation: signal dispersed through conductive carbon film and conductive hydrogel layer to skin surface. Output: electrical stimulation delivery. Used in clinical or home settings; operated by patients or healthcare providers. Device consists of multi-layer structure: insulation backing (non-woven/PU/PVC/PET/EVA/silicone), double-sided adhesive, conductive carbon film, conductive hydrogel, and plastic protective film. Single-patient, multiple-application use. Benefits: enables delivery of electrical stimulation for therapeutic purposes.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (cytotoxicity, skin irritation, skin sensitization per ISO 10993-1), electrical impedance (<300 ohms), adhesion performance (AAMI EC 12:2000), and shelf-life verification (ASTM F1980-07).

Technological Characteristics

Passive cutaneous electrode. Materials: insulation backing (non-woven/PU/PVC/PET/EVA/silicone), conductive carbon film, conductive hydrogel, stainless steel snap or carbon fiber lead wire. Dimensions: 20-300mm length/width, 1-20mm thickness. Non-sterile, reusable, single-patient use. Complies with IEC 60601-1:2005/A1:2012 (subclause 8.5.2.3) for lead wires.

Indications for Use

Indicated for adults requiring TENS or EMS therapy; intended for OTC or prescription use to transmit electrical current to the skin.

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

• Adhesive Electrodes (K171381)
• Wandy Self-adhesive Electrode (K132998)

Submission Summary (Full Text)

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June 14, 2019

Shenzhen Bestpad Technology Development Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1 Southward Ruifeng Business Center, Guimiao Road Shenzhen, Guangdong, 518000 Cn

Re: K190700

Trade/Device Name: Electrodes Pad Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 25, 2019 Received: March 18, 2019

# Dear Rain Yip:

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/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 mediation-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,

Vivek Pinto, 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

Enclosure

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# Indications for Use

510(k) Number (if known) K190700

Device Name ELECTRODES PAD

#### Indications for Use (Describe)

ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.

| Type of Use (Select one or both, as applicable) | <table><tr><td></td><td> Depository Use (Part 21 CFR 601 Subpart D) </td></tr><tr><td></td><td> On-Site Control Use (21 CFR 601 Subpart G) </td></tr></table> | | Depository Use (Part 21 CFR 601 Subpart D) | | On-Site Control Use (21 CFR 601 Subpart G) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------|--|--------------------------------------------|
| | Depository Use (Part 21 CFR 601 Subpart D) | | | | |
| | On-Site Control Use (21 CFR 601 Subpart G) | | | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# "510(k) Summary" as required by 21 CFR Part 807.92.

# Date: 2019-02-25

#### I. Submitter

Shenzhen Bestpad Technology Development Co., Ltd A16A17 Dong Jing Run Factory A301, Fourth Industrial Zone, Tantou Community, Songgang Street, Bao'an District, Shenzhen City, China

Tel.: [phone] Tax: [phone]

Junwei Xu (General Manager) Tel: [phone] Email: [e-mail]

# II. Device

Type of 510(k): Traditional Trade Name: ELECTRODES PAD Models: leadwire type electrode and snap type electrode Common Name: Cutaneous Electrode Classification Name of the device: Cutaneous Electrode Review Panel: Neurology Regulatory Class: II Product Code: GXY Regulation Number: 21 CFR 882.1320

# III. Predicate Device

| Applicant | Predicate Device | 510(k) Number | Approval Date |
|-------------------------------------------------|----------------------------------|---------------|---------------|
| ShenZhen Quality Medical<br>Technology Co., Ltd | Adhesive Electrodes | K171381 | Dec.13, 2017 |
| Wandy Rubber Industrial<br>Co., Ltd | Wandy Self-adhesive<br>Electrode | K132998 | Dec.20, 2013 |

#### IV. Device Description

ELECTRODES PAD transmit electrical current to patient skin, the electrical current is first transmitted via the snap button or lead wire then transmitted to the conductive hydrogel which is adhered to patient skin.

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ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only. And the PAD is designed for single-patient and multiple application use.

| 1) Device specifications | | | | |
|--------------------------|------------------------------|---------------------------------------------|-------------------------------------------------------------|-------------------------------------|
| Model | Electrical connection method | Insulation backing material(s) | Product size (mm) | Connector size (Hole diameter) (mm) |
| Leadwire type electrode | Leadwire | Non-woven /PU /PVC /PET /EVA foam /silicone | Length: 20~300<br>Width: 20~300<br>Height (thickness): 1~20 | 1.5, 2.0, 2.5, 3.0 |
| Snap type electrode | Snap button | Non-woven /PU /PVC /PET /EVA foam /silicone | Length: 20~300<br>Width: 20~300<br>Height (thickness): 1~20 | 3.2, 3.6, 3.8, 4.0, 4.2 |

#### 1) Device specifications

2) Device design

The leadwire type electrode and snap type electrode both have six basic components. See Figure 1 and Figure 2 for the structure picture of the both model.

Image /page/4/Figure/5 description: The image shows a diagram of a layered structure with labels indicating the different materials used. Layer 1 is labeled as "Non-woven /PU/PVC/PET/EVA /Silicone", layer 2 is "Double sides adhesive tape", layer 3 is "Conducting film", layer 4 is "Hydrogel", and layer 5 is "Plastic film". There is also a "Carbon fiber wire" labeled as layer 6.

Figure 1 The structure of leadwire type electrode

Image /page/4/Figure/7 description: The image shows an exploded view of a layered product. The layers are labeled with numbers and descriptions. Layer 1 is "Non-woven /PU/PVC/PET/EVA/Silicone", layer 2 is "Double sides adhesive tape", layer 3 is "Conducting film", layer 4 is "Hydrogel", layer 5 is "Plastic film", and layer 6 is "Snap".

Figure 2 The structure of snap type electrode

- 3) Materials used
Both models are composed of an insulation backing layer, a double sides adhesive tape, conducting film, hydrogel and plastic film. The construction different between both is leadwire and snap.

Material of construction:

| Component | Description /Material of Construction |
|--------------------------|---------------------------------------|
| Insulation backing layer | □Non-woven/□PU/□PVC/□PET/□EVA |

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| Component | Description /Material of Construction |
|-----------------------------|--------------------------------------------------------------|
| | foam/ silicone |
| Double sides adhesive tape | This layer is used to connect the upper and<br>lower layers. |
| Conducting film | Conductive carbon film |
| Gel | Conductive hydrogel |
| Protective film layer | Plastic film |
| Electrical connection layer | Leadwire: carbon fiber wire<br>Snap: stainless steel |

4) Physical and performance characteristics of the device Electrical impendence: < < 300 ohms Adhesive performance: 30 minutes maximum duration use, in total 30times

- 5) Principle of operation
- ELECTRODES PAD functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin. Electrical signal from a stimulation device is connected to the electrode pad through a lead wire or snap, which is dispersed across the conductive film, then transmitted through the conductive adhesive hydrogel to the surface of the patient's skin.

# V. Indications for Use / Intended Use

ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.

# VI. Comparison of Technological Characteristics With the Predicate Device

The subject device ELECTRODRS PAD has the same intended use and principle operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicated devices. The differences between the subject device and predicate devices do not alter suitability of the subject device for its intended use.

Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:

| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Discussion |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| K Number | K190700 | K171381 | K132998 | N/A |
| Device name/model | ELECTRODES<br>PAD/ Leadwire type<br>electrode and Snap<br>type electrode | Adhesive Electrodes | Wandy<br>adhesive Electrode | N/A |
| Regulation number | 21CFR 882.1320 | 21CFR 882.1320 | 21CFR 882.1320 | Same |
| Product code | GXY | GXY | GXY | Same |
| Classification name | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | Same |
| Location for use | OTC and | OTC and | OTC and | Same |
| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Discussion |
| | Prescription | Prescription | Prescription | |
| Intended<br>use/Indications for<br>Use | ELECTRODES<br>PAD is intended to<br>transmit electrical<br>current to patient<br>skin for use with<br>legally<br>marketed<br>electrical stimulation<br>devices, i.e. TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and<br>EMS (Electrical<br>Muscular<br>Stimulation). . The<br>PAD is for OTC<br>(Over-The-Counter)<br>or Prescription use.<br>The PAD is for<br>adults only. | The Adhesive<br>Electrodes are<br>intended to transmit<br>electrical current to<br>patient skin for<br>TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and<br>EMS (Electrical<br>Muscular<br>Stimulation)<br>applications. It is for<br>OTC (Over-The -<br>Counter) or<br>Prescription use and<br>is to be used for<br>adults only. | Wandy Self-<br>adhesive Electrode<br>is intended to<br>transmit electrical<br>current to patient<br>skin for TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and<br>EMS (Electrical<br>Muscular<br>Stimulation)<br>applications, for<br>OTC (Over-The -<br>Counter) or<br>Prescription use. | SE<br>NOTE 1 |
| Design feature | Six basic<br>components for the<br>electrode:<br>-Electrical<br>connecting layer:<br>Carbon fiber<br>wire/Snap button<br>-Insulation backing<br>material: non-<br>woven/PU/PVC/PE<br>T/EVA<br>foam/Silicone<br>-Double sides<br>adhesive tape<br>-Conducting film:<br>carbon film<br>-Hydrogel<br>-Protective film<br>layer: Plastic film | Three layers:<br>1. Insulation<br>backing<br>material: EVA<br>foam<br>2. Conductive film:<br>Carbon film<br>3. Conductive<br>hydrogel<br>Protective line: PET | Three layers:<br>1. Insulation<br>backing<br>material: Woven<br>Fabric/Foam<br>2. Conductive film:<br>Aluminum/Carb<br>on<br>3. Conductive<br>hydrogel<br>Protective line: PET | SE<br>NOTE 2 |
| Electrical<br>connection | Leadwire<br>Snap button | Snap button | Snap button or lead<br>wire | SE |
| Electrical | <300 ohms | < 300 ohms | < 300 ohms | Same |
| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Discussion |
| impendence | | | | |
| Sterility status | Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable or<br>Disposable? | Reusable | Reusable | Reusable | Same |
| Shelf life (Storage<br>life) | 2 years | Unknown | Unknown | NOTE 3 |
| Single patient use? | Yes | Yes | Yes | Same |
| Target population | Adult | Adult | Adult | SE |
| Patient contacting<br>material | Hydrogel | Hydrogel | Hydrogel | SE<br>NOTE 5 |
| Self-adhesive | Self-adhesive | Self-adhesive | Self-adhesive | Same |
| Biocompatibility<br>feature | Complied with<br>ISO10993 | Complied with<br>ISO10993 | Complied with<br>ISO10993 | SE<br>NOTE 5 |

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#### Comparison in details:

NOTE 1: Although the descriptive text of the "Intended use/Indication for Use" of the subject device is minor different from the predicate device, they are having the substantially equivalent intended purpose. So the differences of descriptive text will not affect its intended use.

NOTE 2: The subject device is designed as multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application. Although the descriptive text of the "Design feature" of the subject device is different from the predicate device, they are having basically substantially equivalent design feature and the subject device has more detailed description: -- The electrical connecting layer of the subject device is by the mean of snap button or lead wire, in the range of the predicate devices.

-- The subject device has various insulating backing materials, but it does not impact safety and effectiveness of the subject device;

--The component of double sides adhesive tape is used to connect the upper and lower layers, it won't raise any concerns of safety or effectiveness.

-- The subject device contains carbon film as a conductive film, in the range of the predicate devices;

--The conductive layer of the subject device and predicate devices all are conductive hydrogel, and passed the biocompatibility tests;

--The subject device adopts plastic film as a protective film layer, substantially equivalent to the predicate devices.

NOTE 3: The shelf life of the subject device has conducted the shelf life verification according to FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard. And the verification has passed.

NOTE 5: The patient contacting material of the subject device and predicate devices all are hydrogel, although their supplier is not sure, they are all complying with ISO 10993 requirements. So this part will not raise any safety or effectiveness issue.

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# VII.Performance Data

- 1) Brief discussion of clinical tests
Not applicable.

- 2) Brief discussion of the nonclinical tests:
Biocompatibility Testing: The ELECTRODES PAD has tested and passed the biocompatibility tests: cytotoxicity, skin irritation, and skin sensitization. And the tests are performed according to the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA.

# Performance Testing:

- > The lead wire part is compliance with 21 CFR 898 by IEC 60601-1:2005/A1:2012 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Subclause 8.5.2.3.
- > The Delivery Test Report has been conducted to verify the product properties before factory delivery according to the manufacturer's acceptance criteria.
- > The Adhesion Test Report has been conducted to verify the maximum use duration of the subject device according to the requirements of the AAMI EC 12_2000(R) 2010 -Section 5.4.
- > The Dispersion and Shelf Life Test Report has been conducted to verify the current dispersion and shelf-life of the subject device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.

#### Summary

Based on the above performance as documented in this application. ELECTRODES PAD was found to have a safety and effectiveness profile that is similar to the predicate devices.

#### VIII. Conclusions

The subject device ELECTRODES PAD is to be concluded substantial equivalent to its predicate devices.