The Electrode Pad is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Device Description

Electrode Pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.

Electrode Pad is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate).

Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Electrode Pad (K241512), focusing on the requested information.

It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI-powered medical device. Therefore, much of the requested information, particularly concerning AI device performance metrics, human reader studies, and detailed ground truth establishment for a test or training set, is not present in this type of document because the device is a simple "Electrode Pad" and not an AI-enabled diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate comparison, standards, and specifications)	Reported Device Performance (Subject Device K241512)
Electrical Performance:
Electrode Impedance per ANSI AAMI IEC 60601-2-2	426-635 Ω (within predicate range 415-688 Ω)
Lead wires test per AAMI/ANSI ES 60601-1 (Clause 8.5.2.3)	Meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1: 2005/(R)2012 And A1:2012
Electrical safety per AAMI/ANSI ES 60601-1 (for lead wire)	Meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1: 2005/(R)2012 And A1:2012
Material Performance:
Hydrogel thickness	0.75±0.15mm (Similar to predicate's 1.0mm±0.2mm)
Stainless Steel Adhesion (180° peel)	136 grams minimum (≈1.3N) (Same as predicate)
Biocompatibility:
Cytotoxicity (ISO 10993-5)	Complies with ISO 10993-5:2009
Skin Sensitization (ISO 10993-10)	Complies with ISO 10993-10:2010 (predicate) / ISO 10993-10:2021 (subject device)
Irritation (ISO 10993-23)	Complies with ISO 10993-23:2021
Shelf Life/Aging:
Accelerated aging (ASTM F1980-16)	Tested to ensure 2 years shelf life (Same as predicate)
Sterilization:
Non-sterile	Non-sterile (Same as predicate)

2. Sample Size Used for the Test Set and Data Provenance

This document describes performance testing for a non-AI hardware device (an electrode pad). Therefore, the concept of a "test set" in the context of machine learning, with associated data provenance, is not applicable here. The tests conducted are non-clinical, laboratory-based tests on the physical device components and batches of manufactured electrodes. The document does not specify general "sample sizes" for all tests, but implies testing was sufficient to meet standard requirements. The provenance of the data is from the manufacturer's internal testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this is a physical medical device, not an AI diagnostic tool, there is no "ground truth" derived from expert interpretation for a test set. Acceptance is based on meeting technical specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. 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 an electrode pad, not an AI system. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical electrode pad, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by:

International Standards: Adherence to standards like ISO 10993 series for biocompatibility, ASTM F1980-16 for accelerated aging, and AAMI/ANSI ES 60601-1 / IEC 60601-2-2 for electrical safety and impedance.
Predicate Device Specifications: Demonstrating performance within ranges or equivalent to a legally marketed predicate device (K182111 DL Adhesive Electrode) for key parameters such as impedance and adhesion.
Design Specifications: The device met its own design specifications.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device. The concept of a "training set" is irrelevant in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth establishment.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2025

ShenZhen Deliduo Medical Technology Co., Ltd % Wu Jarvis Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China

Re: K241512

Trade/Device Name: Electrode Pad Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 10, 2025 Received: January 10, 2025

Dear Wu Jarvis:

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 (the 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 available 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.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

{2}------------------------------------------------

assistance/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,

Heather L. Dean -S

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

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K241512

Device Name

Electrode Pad

Indications for Use (Describe)

It is is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

ShenZhen Deliduo Medical Technology Co.,Ltd.

B1406, 14th Floor, Block B, Fenglin International Center, Building 3,Hongji Garden, Zhongcheng District 4, Jixiang Community, Longcheng Street, Longgang District, Shenzhen City, Guangdong China 518116

510(k) Summary

K241512

Applicant Information: ShenZhen Deliduo Medical Technology Co.,Ltd. Address: B1406, 14th Floor, Block B, Fenglin International Center, Building 3,Hongji Garden, Zhongcheng District 4, Jixiang Community, Longcheng Street, Longgang District, Shen zhen City, Guangdong China 518116 Contact Person: Andy Liu Tel: +86- 13728752377

Prepared date: January 9th,2025

Device information Trade Name: Electrode Pad Common Name: Cutaneous electrode Classification name: Cutaneous electrode Regulation Number: 882.1320 Product code: GXY
Predicate device K182111 DL Adhesive Electrode SHAOXING DL HEALTHCARE CO., LTD.

4. Indication for use

5. Device description

Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.

{5}------------------------------------------------

ShenZhen Deliduo Medical Technology Co.,Ltd. B1406, 14th Floor, Block B, Fenglin International Center, Building 3,Hongji Garden, Zhongcheng District 4, Jixiang Community, Longcheng Street, Longgang District, Shenzhen City, Guangdong China 518116

	Subject Device(K241512)	Predicate Device (K182111)	Comparison
Trade Name	Electrode Pad	DL Adhesive Electrode	N/A
Common Name	Cutaneous electrode	Cutaneous electrode	Same
Classificationname	Cutaneous electrode	Cutaneous electrode	Same
Product Code	GXY	GXY	Same
RegulationNumber	882.1320	882.1320	Same
MedicalSpecialty	Neurology	Neurology	Same
Device Class	II	II	Same
Indications foruse	The Electrode Pad is intendedto transmit electrical currentto patient skin for use withtranscutaneous electricalstimulation devices. Somecommon types of thestimulation devices include,but are not limited to TENS(Transcutaneous ElectricalNerve Stimulation) and EMS(Electrical MuscularStimulation). The electrode isfor OTC (Over-The -Counter)or Prescription use.	DL Adhesive Electrode isintended to transmit electricalcurrent to patient skin for usewith transcutaneous electricalstimulation devices. Somecommon types of thestimulation devices include, butare not limited to TENS(Transcutaneous ElectricalNerve Stimulation) and EMS(Electrical MuscularStimulation). The electrode isfor OTC (Over-The-Counter) orPrescription use.	Same
Targetpopulation	Single patient use andmultiple application	Single patient use and multipleapplication	Same
Prescription use	OTC and Prescription use	OTC and Prescription use	Same
Design (shape&Connection )	Electrode Pad: rectangle,square, according tocustomized specification.Lead wire with female socket,or snap button with malesnap connector	Electrode Pad: Round,rectangle, butterfly, oval,according to customizedspecification.Lead wire with female socket,or snap button with male snapconnector	Similar
Materials	- Top cover material- Electrically conductivecarbon cloth	- Top cover material- Electrically conductive carboncloth	Same
	hydrogel	hydrogel
	- Protective film (Electrode carrier liner)	- Electrode carrier liner
Electrode Pad Size	Rectangle:50100mmSquare:5050mm	Rectangle:4040mm~40350mmButterfly:3150mm~110150mmRound: Ø18mm~ Ø85mmOval: 50*78mm	Different*1
Patient contact area ofElectrode Pad	Rectangle:$5000mm^2$Square: $2500mm^2$	Round:$254.34mm^2$ ~ $5671.63mm^2$Rectangle: $1600m^2$ ~ $7000mm^2$Oval: $3900mm^2$Butterfly: $6975mm^2$ ~ $8250mm^2$	Different*1
Hydrogelthickness	0.75±0.15mm	1.0mm±0.2mm	Similar
ElectrodeImpedancetesting	426-635 Ω	415-688 Ω	Similar
Conductivecarbon film	PU/PE conductive film,	PU, Conductive carbon	Similar
Shelf life	2 years	2 years	Same
Stainless SteelAdhesion (180°peel)	136 grams minimum(≈1.3N)	136 grams minimum(≈1.3N)	Same
Biocompatibility	ISO10993-5:2009;ISO10993-10:2010	ISO10993-5:2009;ISO10993-10:2010	Same
Sterilization	Non-sterile	Non-sterile	Same
Electrical safety	Lead wire meets Clause8.5.2.3 of AAMI/ANSIES60601-1: 2005/(R)2012 AndA1:2012	Lead wire meets Clause 8.5.2.3of AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012	Same

1. Comparison of the device character

{6}------------------------------------------------

ShenZhen Deliduo Medical Technology Co.,Ltd.

Difference*1 analysis:

The devices' size difference causes the Patient contact area difference, the difference will not raise any new risk of effectiveness or safety issues. The subject devices pass the Electrical safety and Impedance testing.

1. Non-Clinical Test Conclusion

{7}------------------------------------------------

ShenZhen Deliduo Medical Technology Co.,Ltd.

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device or reference device. The test results demonstrated that the proposed device complies with the following standards:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization
A ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
A ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices.
A Peel strength testing(180° stainless steel peel)
Impedance test per ANSI AAMI IEC 60601-2-2
A Lead wires test per AAMI/ANSI ES 60601-1

Clinical Test

None.

1. The Conclusions:
  Based on successful biocompatibility testing of devices, the electrical performance of the insulated lead wire components and Impedance testing, Adhesive Electrode is safe and effective when used as an interface between a user's skin and an approved nerve and muscle stimulation device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices under K182111.

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).