Starly pad

K221589 · Shenzhen Xingyuanli Technology Co., Ltd. · GXY · Mar 24, 2023 · Neurology

Device Facts

• Record ID: K221589
• Device Name: Starly pad
• Applicant: Shenzhen Xingyuanli Technology Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Mar 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Starly 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 Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.

Device Story

Starly pad is a cutaneous electrode used to transmit electrical current from TENS or EMS devices to patient skin. Device consists of an insulation backing layer, adhesive layer, carbon film, conductive gel layer, protective film, and a snap fastener. Used in healthcare facilities or home settings by adults. Operates by conducting electrical signals from an external stimulator through the conductive gel to the skin surface. Output is the delivery of therapeutic electrical stimulation. Benefits include facilitating TENS/EMS therapy for pain management or muscle stimulation. Device is non-sterile, reusable, and intended for single-patient use for up to 30 days.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), impedance (100-300Ω), skin adhesion (30 uses), and current dispersion (<10%).

Technological Characteristics

Materials: Polypropylene/Poly(ethylene) nonwovens, medical conductive gel. Principle: Passive electrical conduction. Form factor: Square flake, 2.0mm thickness. Connection: Snap fastener. Sterilization: None. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for adults requiring transcutaneous electrical nerve stimulation (TENS) or electrical muscular stimulation (EMS) via legally marketed stimulation devices. Contraindicated for individuals with allergies to device ingredients or for use on skin wounds.

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

• ELECTRODES PAD (K190700)

Submission Summary (Full Text)

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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.

March 24, 2023

Shenzhen Xingyuanli Technology Co., Ltd. Tse Adrian Quality manager 4/F, No.1, TianShiDa Industrial Park, No.79 Longwo Road, Kengzi Street, Pingshan New District Zhezhen, Guandong 518110 China

Re: K221589

Trade/Device Name: Starly pad Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: June 1, 2022 Received: June 1, 2022

Dear Tse Adrian:

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,

# Tushar Bansal -S

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) K221589

Device Name Starly pad

Indications for Use (Describe)

Starly 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 Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) Summary

## 1.1 Submitter Information

- Company: Shenzhen Xingyuanli Technology Co., Ltd. ●
- Address: 4/F, No.1, TianShiDa Industrial Park, No.79 Longwo Road, Kengzi street, Pingshan New District, Shenzhen.
- Phone: [phone] ●
- Contact: Tse Adrian, Quality Manager
- Mail box: [e-mail]
- Date Prepared: Feb. 20, 2023 ●

## 1.2 Device Information

- Trade/Device Name: Starly pad
- Common Name: Cutaneous electrode
- Classification requlation: Requlation number: 21 CFR 882.1320 Requlation Description: Cutaneous electrode. Regulation Medical Specialty: Neurology
- Review Panel: Neurology ●
- Product Code: GXY
- Regulation Number: 21 CFR 882.1320
- Device Class: Class II
- Submission number: K221589
- Biocompatibility information: Contact duration categorization of the Starly Pad is Classification B of Intact skin (prolonged - 24h to 30 d); The device is intended for prolonged use over a maximum period of 30 days.

## 1.3 Predicate Device Information

Predicate Device: ELECTRODES PAD

Manufacturer: Shenzhen Bestpad Technology Development Co., Ltd

510(k) number: K190700

Indication of use:

ELECTRODES PAD is intended to transmit electrical current to patient skin

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for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

The ELECTRODES PAD is for OTC (Over-The-Counter) or Prescription use. The ELECTRODES PAD is for adults only.

No reference devices were used in this submission.

## 1.4 Subject Device Description

- Device Identification
key device components: The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.

Image /page/4/Picture/7 description: The image shows two rectangular, gray, medical electrode pads. Each pad has a small, round, metal connector in the center. The pads are on a clear plastic sheet, and the background is blue.

Fig 1. Entity diagram

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Image /page/5/Figure/1 description: The image shows a diagram of several layers stacked on top of each other. There are six layers in total, labeled with numbers 1 through 6. Layer 6 is on top and has a grid pattern of dots, while the other layers appear to be solid and vary in shade from light gray to black.

Fig 2. Structure diagram

| No. | Name | Description |
|-----|---------------------------------|-------------------------------------------------------------------|
| 1 | Insulation backing layer | Insulate current to prevent current leakage |
| 2 | Adhesive layer | Connect the insulation backing layer and carbon film layer |
| 3 | Carbon film | Conduct and distribute treatment current to next layer |
| 4 | Conductive adhesive piece layer | Conduct treatment current to patient |
| 5 | Protective film | Prevent medical adhesive from sticking to dust |
| 6 | Snap fastener | Connect with therapeutic device that releases an electric current |

## ● Device Characteristics

Patient-contacting material: Conductive adhesive piece layer (Medical conductive gel)

Sterile: The Starly Pad is not supplied sterile and do not require sterilization prior to use.

- Environment of Use:
Healthcare facility/hospital or,

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Home.

- Intended user:
Adult only.

- Brief Written Description of the Device:
Principle of operation: Through the electrical conductivity of the material, the current connected to the device is transmitted steadily to the skin surface of the human body.

Mechanism of action: It's allowed electrical stimulation signal output from electrotherapy device is transmitted to the human body through conductive materials of the Starly Pad.

- . Materials of Use
General type of material used: Nonwovens-Polypropylene and Poly(ethylene)

Duration and type of contact: Classification B of Intact skin (prolonged -24h to 30 d);

- Key Performance Specifications/Characteristics of the Device: ●

| Impedance | 100-300Ω |
|---------------------------|----------|
| Skin adhesion performance | 30 times |

## 1.5 Indications for Use

Starly 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 Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.

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| Comparison<br>Items | Subject Device:<br>Starly pad | Predicate Device:<br>Electrodes pad<br>(K190700) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification & Intended Use | | |
| Classification | GXY<br>Class II<br>21 CFR 882.1320 | GXY<br>Class II<br>21 CFR 882.1320 |
| Classification<br>name | Cutaneous electrode | Cutaneous electrode |
| Intended use | Starly pad is intended to<br>transmit electrical current<br>to patient skin for use with<br>legally marketed electrical<br>stimulation devices, i.e.<br>TENS (Transcutaneous<br>Electrical Nerve<br>Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation). The Starly pad<br>is for OTC (Over-The-<br>Counter) or Prescription<br>use. The Starly pad is for<br>adults only. | ELECTRODES PAD is<br>intended to transmit<br>electrical current to<br>patient skin for use with<br>legally marketed electrical<br>stimulation devices, i.e.<br>TENS (Transcutaneous<br>Electrical Nerve<br>Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation). The PAD is<br>for OTC (Over-The-<br>Counter) or Prescription<br>use. The PAD is for adults<br>only. |
| Environment of<br>Use | For OTC (Over-The-<br>Counter) or Prescription<br>use. | For OTC (Over-The-<br>Counter) or Prescription<br>use. |
| Contraindications | People allergic to this<br>ingredient are not<br>allowed.<br>Contraindicated on skin | People allergic to this<br>ingredient are not<br>allowed.<br>Contraindicated on skin |
| | wounds. | wounds. |
| Comparison<br>Statement | The subject device enjoys the same classification and<br>intended use with the predicate device. | |
| Technological Characteristics | | |
| Principle / Method<br>of Operation | Through the electrical<br>conductivity of the<br>material, the current<br>connected to the device is<br>transmitted steadily to the<br>skin surface of the human<br>body. | Through the electrical<br>conductivity of the<br>material, the current<br>connected to the device is<br>transmitted steadily to the<br>skin surface of the human<br>body. |
| Structural<br>composition | Starly pad consists of<br>nonwovens, conductive<br>adhesive piece, PET film<br>and fastener. | It composed of an<br>insulation backing layer, a<br>double sides adhesive<br>tape, conducting film,<br>hydrogel and plastic film. |
| Shapes | Square flake | Square flake |
| Dimension | Thickness: 2.0mm±0.5mm<br>Width: 20 mm~300 mm<br>(integers specification only,<br>±0.5mm)<br>Length: 20 mm~300 mm<br>(integers specification only,<br>±0.5mm) | (mm)<br>Length: 20~300<br>Width: 20~300<br>Height (thickness): 1~20 |
| Impedance | 100-300Ω | <300Ω |
| Skin<br>adhesion<br>performance | 30 times | 30 times |
| Sterility status | Non-sterile | Non-sterile |
| Reusable<br>or<br>Disposable? | Reusable | Reusable |
| Shelf<br>life<br>(Storage | 2 years | 2 years |
| life) | | |
| Single patient use? | Yes | Yes |
| Self-adhesive | Self-adhesive | Self-adhesive |
| Connection type | Snap fastener | Snap fastener or plug wire |
| Comparison<br>statement | Dimension, Impedance and Connection type is different | |
| Safety & Effectiveness | | |
| Patient contacting<br>material | Conductive adhesive piece<br>layer which made of<br>Medical conductive gel | Hydrogel |
| | ISO 10993-5 | Complied with<br>ISO 10993 |
| Biocompatibility | ISO 10993-10 | Complied with<br>ISO 10993 |
| Comparison<br>statement | The safety and essential effectiveness of the subject<br>device have been evaluated according to the FDA<br>recognized standards. | |

# 1.6 Comparison of Technological Characteristics with the Predicate Device

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# 1.6.1 Comparison summary

# 1. Is the predicate device legally marketed?

The predicate device is the Electrodes pad, manufactured by Shenzhen Bestpad Technology Development Co., LTD, and the 510(k) number is K190700.

The predicate device is legally marketed.

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#### 2. Do the devices have the same intended use?

From the comparison in this section, the subject device (Starly pad) has same intended use with the predicate device. The labeling of the predicate device is consistent with its IFU statements.

The subject device and the predicate device have the same intended use.

#### 3. Do the devices have the same technological characteristics?

Dimension, Impedance and Connection type are different.

#### 4. Do the different technological characteristics of the devices raise different questions of safety and effectiveness?

Determine what questions of safety and effectiveness the different technological characteristics raise:

- Dimension
The dimension specification of the subject device is included in the dimension specification of the predicate device; the length and width of the subject device are the same as the predicate device, but more specific integer value requirements are defined; the thickness of the predicate device is usually customized by the customer, and the thickness of the subject device Fixed to 2.0mm; And key properties such as Impedance and Skin adhesion performance are not directly related to the thickness; this difference does not affect the safety and effectiveness.

- . Impedance
If the impedance is too low, the excessive current might will be conducted through the pad. If the impedance is too high, the current will not able to conducted through the pad. The Impedance specification of the subject device is included in the Impedance specification of the predicate device; the subject device limits the minimum impedance value, which reduces the possibility of excessive current and improves safety; So there is No questions of safety and effectiveness the different impedance raise.

- Connection type
The difference in Connection type only affects the models of electrical stimulation devices that can be connected, and does not affect the key performance and safety of use.

8

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No questions of safety and effectiveness the different technological characteristics raise.

#### 5. Are the methods acceptable?

Test methods in the 031_Performance test report is scientific and clear.

#### 6. Do the data demonstrate substantial equivalence?

The 031_Performance test report provide scientific methods for evaluating different characteristics' effects on safety and effectiveness. Provided data evidence for substantial equivalence by confirming that the performance parameters of the subject device are consistent with the stated data.

#### Conclusion:

Substantial equivalence. In respects of Safety & effectiveness, there is no data provided on the biocompatibility. But the subject device had verified the biocompatibility and the test report is attached in Attachment F.

#### 1.7 Performance data

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility testing

The biocompatibility evaluation for the Starly pad was 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. The testing included the following tests:

- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity

The Starly pad is considered tissue contacting for a duration of more than 24 hours and less than 30 days.

The test report and its reference is below:

| Standard Designation Number | Title of Standard | Report |
|-----------------------------|-------------------|--------|
|-----------------------------|-------------------|--------|

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| | | | <b>number</b> |
|------------------|-----------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Biocompatibility | ISO 10993-5: 2009 | Biological evaluation of<br>medical devices - Part 5: Tests<br>for in vitro cytotoxicity | SSMT-R-2021-<br>01116-01A |
| | ISO 10993-10:<br>2010 | Biological evaluation of<br>medical devices - Part 10:<br>Tests for irritation and skin<br>sensitization | SSMT-R-2021-<br>01116-03A<br>SSMT-R-2021-<br>01116-02A |

## Electrical safety and electromagnetic compatibility (EMC)

Not applicable. The Starly pad not composed with any energy storage components and electronic components.

### Software Verification and Validation Testing

Not applicable. The Starly pad not composed with any software.

## Performance testing

The Starly pad had tested below performance refer to the Performance test report.

| Test item | Test report | Test result |
|---------------------------------|------------------------------------|-------------------------------------------------------------|
| Dimensions | | Thickness: 2.0mm ± 0.5 mm |
| | | Width: 20 mm~300 mm (integers<br>specification only, ±0.5) |
| | | Length: 20 mm~300 mm (integers<br>specification only, ±0.5) |
| Impedance | Starly Pad Performance Test Report | 100-300Ω |
| Skin<br>adhesion<br>performance | | 30 times |
| Shelf life (Storage<br>life) | | 2 years |
| Current Dispersion | | <10% |

#### Animal Study

Animal Study was not performed for the Starly pad as part of the submission.

## Clinical Test

Clinical testing was not performed for the Starly pad as part of the submission.

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# 1.8 Conclusion

From the above analysis, it is proper to conclude that the subject device (Starly pad) will be as safe and effective for usage as the listed predicate devices that have already been on the U.S. market.