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 Description

The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.

AI/ML Overview

This document details the FDA 510(k) clearance for the Starly pad, a cutaneous electrode. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than a detailed "study that proves the device meets the acceptance criteria" in the context of an AI/ML-based medical device.

Therefore, many of the requested elements for an AI/ML study (like sample size for test set, number of experts, MRMC studies, ground truth establishment for AI training) are not applicable or not present in this document, which pertains to a Class II physical medical device.

However, I can extract the relevant acceptance criteria and performance data for this physical device as described in the provided text.

Device Name: Starly pad
Device Type: Cutaneous Electrode
Regulation Number: 21 CFR 882.1320 (Cutaneous Electrode)
Product Code: GXY

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Starly pad)	Predicate Device Performance (Electrodes pad - K190700)
Dimension	Thickness: 2.0mm ± 0.5mmWidth: 20 mm ~ 300 mm (integers specification only, ±0.5mm)Length: 20 mm ~ 300 mm (integers specification only, ±0.5mm)	Length: 20~~300 mmWidth: 20~~300 mmHeight (thickness): 1~20 mm
Impedance	100-300Ω	<300Ω
Skin Adhesion Performance	30 times	30 times
Shelf Life (Storage Life)	2 years	2 years
Current Dispersion	<10%	Not explicitly stated, but implied by impedance and electrical current transmission function.
Biocompatibility (ISO 10993-5, ISO 10993-10)	Complied with ISO 10993-5: 2009 (Cytotoxicity) and ISO 10993-10: 2010 (Irritation and Skin Sensitization)	Complied with ISO 10993
Sterility Status	Non-sterile	Non-sterile
Reusable/Disposable	Reusable	Reusable
Single Patient Use	Yes	Yes
Self-adhesive	Self-adhesive	Self-adhesive
Connection Type	Snap fastener	Snap fastener or plug wire

Study Details (Applicable to a physical medical device, not AI/ML model validation):

Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each performance test (e.g., how many pads were tested for impedance or adhesion). The data provenance is implied to be from internal testing by Shenzhen Xingyuanli Technology Co., Ltd. (031_Performance test report mentioned and Starly Pad Performance Test Report). The testing is retrospective, conducted prior to the 510(k) submission. No specific country of origin for the data is mentioned beyond the company's location in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical device, and the "ground truth" for its performance (e.g., impedance value, number of adhesion cycles) is established through standardized engineering and biological evaluation tests, not through expert consensus on interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical studies, particularly for diagnostic imaging, where human readers consensus is required. This document refers to laboratory-based performance 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:
Not applicable. This device is a cutaneous electrode, not an AI/ML-driven diagnostic tool. No human reader studies are mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For physical and biocompatibility performance, the "ground truth" is based on:
- Direct measurements: For dimensions, impedance, current dispersion.
- Defined test protocols: For skin adhesion performance (e.g., number of cycles before failure).
- Standardized biological tests: For biocompatibility (Cytotoxicity, Sensitization, Irritation) in accordance with ISO 10993 standards, where the "truth" is the pass/fail outcome based on predefined acceptance criteria for cellular reactions.
The sample size for the training set:
Not applicable. This device does not use an AI/ML model, and therefore has no "training set."
How the ground truth for the training set was established:
Not applicable. See point 7.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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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: +086-15915873605 ●
Contact: Tse Adrian, Quality Manager
Mail box: xkxadrian@gmail.com
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

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ComparisonItems	Subject Device:Starly pad	Predicate Device:Electrodes pad(K190700)
Classification & Intended Use
Classification	GXYClass II21 CFR 882.1320	GXYClass II21 CFR 882.1320
Classificationname	Cutaneous electrode	Cutaneous electrode
Intended use	Starly pad is intended totransmit electrical currentto patient skin for use withlegally marketed electricalstimulation devices, i.e.TENS (TranscutaneousElectrical NerveStimulation) and EMS(Electrical MuscularStimulation). The Starly padis for OTC (Over-The-Counter) or Prescriptionuse. The Starly pad is foradults only.	ELECTRODES PAD isintended to transmitelectrical current topatient skin for use withlegally marketed electricalstimulation devices, i.e.TENS (TranscutaneousElectrical NerveStimulation) and EMS(Electrical MuscularStimulation). The PAD isfor OTC (Over-The-Counter) or Prescriptionuse. The PAD is for adultsonly.
Environment ofUse	For OTC (Over-The-Counter) or Prescriptionuse.	For OTC (Over-The-Counter) or Prescriptionuse.
Contraindications	People allergic to thisingredient are notallowed.Contraindicated on skin	People allergic to thisingredient are notallowed.Contraindicated on skin
	wounds.	wounds.
ComparisonStatement	The subject device enjoys the same classification andintended use with the predicate device.
Technological Characteristics
Principle / Methodof Operation	Through the electricalconductivity of thematerial, the currentconnected to the device istransmitted steadily to theskin surface of the humanbody.	Through the electricalconductivity of thematerial, the currentconnected to the device istransmitted steadily to theskin surface of the humanbody.
Structuralcomposition	Starly pad consists ofnonwovens, conductiveadhesive piece, PET filmand fastener.	It composed of aninsulation backing layer, adouble sides adhesivetape, conducting film,hydrogel and plastic film.
Shapes	Square flake	Square flake
Dimension	Thickness: 2.0mm±0.5mmWidth: 20 mm~~300 mm(integers specification only,±0.5mm)Length: 20 mm~~300 mm(integers specification only,±0.5mm)	(mm)Length: 20~~300Width: 20~~300Height (thickness): 1~20
Impedance	100-300Ω	<300Ω
Skinadhesionperformance	30 times	30 times
Sterility status	Non-sterile	Non-sterile
ReusableorDisposable?	Reusable	Reusable
Shelflife(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
Comparisonstatement	Dimension, Impedance and Connection type is different
Safety & Effectiveness
Patient contactingmaterial	Conductive adhesive piecelayer which made ofMedical conductive gel	Hydrogel
	ISO 10993-5	Complied withISO 10993
Biocompatibility	ISO 10993-10	Complied withISO 10993
Comparisonstatement	The safety and essential effectiveness of the subjectdevice have been evaluated according to the FDArecognized 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.

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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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			number
Biocompatibility	ISO 10993-5: 2009	Biological evaluation ofmedical devices - Part 5: Testsfor in vitro cytotoxicity	SSMT-R-2021-01116-01A
	ISO 10993-10:2010	Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization	SSMT-R-2021-01116-03ASSMT-R-2021-01116-02A

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 (integersspecification only, ±0.5)
		Length: 20 mm~300 mm (integersspecification only, ±0.5)
Impedance	Starly Pad Performance Test Report	100-300Ω
Skinadhesionperformance		30 times
Shelf life (Storagelife)		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.

Regulation Number and Section

§ 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).