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 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. 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. The leadwire type electrode and snap type electrode both have six basic components. 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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the "ELECTRODES PAD" device. It describes the device, its intended use, and its comparison to predicate devices, along with performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Passed cytotoxicity, skin irritation, and skin sensitization tests according to ISO 10993-1.
Electrical Impendence	< 300 ohms (device specification and reported as "Same" to predicate devices).
Adhesive Performance (Maximum Use Duration)	30 minutes maximum duration use, in total 30 times. Demonstrated through an Adhesion Test Report according to AAMI EC 12_2000(R) 2010 - Section 5.4.
Current Dispersion	Verified through a Dispersion and Shelf Life Test Report according to FDA Guidance - Shelf Life of Medical Device and ASTM F1980-07 Standard. The report indicates compliance, though specific quantitative results for dispersion are not detailed but grouped with shelf life verification.
Shelf Life	2 years. Verified through a Dispersion and Shelf Life Test Report according to FDA Guidance - Shelf Life of Medical Device and ASTM F1980-07 Standard. The verification has passed.
Lead Wire Electrical Safety	Compliance with IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Subclause 8.5.2.3.
Product Properties (Factory Delivery)	Compliant with manufacturer's acceptance criteria, as evidenced by a Delivery Test Report.

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

The document does not explicitly state the specific sample sizes used for the non-clinical tests (biocompatibility, adhesion, dispersion, shelf life, electrical safety). The nature of these tests (e.g., in-vitro for cytotoxicity, potentially animal or human for irritation/sensitization, accelerated aging for shelf life) implies a controlled testing environment, but details are not provided. The data provenance is derived from the performance testing conducted by the manufacturer, Shenzhen Bestpad Technology Development Co., Ltd. The document does not specify country of origin for the data beyond the manufacturer's location in Shenzhen, China. These studies are retrospective in the sense that they are conducted on manufactured samples for regulatory submission rather than as a prospective clinical trial.

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

This information is not applicable/not provided in the context of this 510(k) submission. The performance testing described (biocompatibility, electrical impedance, adhesion, shelf life, etc.) are objective, laboratory-based tests. They rely on established industry standards and test methods (e.g., ISO 10993, AAMI EC 12, IEC 60601-1, ASTM F1980) rather than expert consensus or ground truth derived from expert review of subjective data. There is no mention of human experts evaluating results for these specific performance criteria.

4. Adjudication Method for the Test Set

This is not applicable/not provided. As the acceptance criteria are based on objective, quantifiable measures from laboratory testing (e.g., numerical thresholds for impedance, time duration for adhesion, pass/fail for biocompatibility), there is no need for an adjudication method by human experts. The results are typically compared directly against the predefined standards.

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

This is not applicable. The device is an "ELECTRODES PAD," a passive medical device intended to transmit electrical current. It does not involve any artificial intelligence (AI) or machine learning components, nor does it require human readers to interpret output from the device. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to this submission.

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

This is not applicable. As stated above, the device is a passive electrical electrode pad and does not contain any algorithms or AI components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance criteria in this submission is the objective outcome of standardized laboratory tests and compliance with recognized industry standards. For instance:

For biocompatibility, the ground truth is the absence of toxic effects, irritation, or sensitization as defined by ISO 10993.
For electrical impedance, the ground truth is a reading below a specified ohmic value (< 300 ohms).
For adhesion, the ground truth is maintaining adhesion for a defined duration and number of uses according to AAMI EC 12.
For shelf life, the ground truth is maintaining material properties and performance after accelerated aging or real-time studies, as per relevant FDA guidance and ASTM F1980.

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for these technical performance aspects.

8. The Sample Size for the Training Set

This is not applicable. The device is not an algorithm-based or AI-driven device, so there is no "training set" in the context of machine learning. The device's performance is based on its physical and electrical properties, tested through non-clinical methods.

9. How the Ground Truth for the Training Set was established

This is not applicable for the same reason as point 8. There is no training set for this type of device.

Summary

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

Type of Use (Select one or both, as applicable)	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)
	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.: +86 755 8259 3905 Tax: +86 755 8259 1544

Junwei Xu (General Manager) Tel: +86 135 1049 0026 Email: 843216888@qq.com

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 MedicalTechnology Co., Ltd	Adhesive Electrodes	K171381	Dec.13, 2017
Wandy Rubber IndustrialCo., Ltd	Wandy Self-adhesiveElectrode	K132998	Dec.20, 2013

IV. Device Description

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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~~300Width: 20~~300Height (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~~300Width: 20~~300Height (thickness): 1~20	3.2, 3.6, 3.8, 4.0, 4.2

1) Device specifications

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

1. 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 andlower layers.
Conducting film	Conductive carbon film
Gel	Conductive hydrogel
Protective film layer	Plastic film
Electrical connection layer	Leadwire: carbon fiber wireSnap: stainless steel

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

1. 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

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:

ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2	Discussion
K Number	K190700	K171381	K132998	N/A
Device name/model	ELECTRODESPAD/ Leadwire typeelectrode and Snaptype electrode	Adhesive Electrodes	Wandyadhesive 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
ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2	Discussion
	Prescription	Prescription	Prescription
Intendeduse/Indications forUse	ELECTRODESPAD is intended totransmit electricalcurrent to patientskin for use withlegallymarketedelectrical stimulationdevices, i.e. TENS(TranscutaneousElectrical NerveStimulation) andEMS (ElectricalMuscularStimulation). . ThePAD is for OTC(Over-The-Counter)or Prescription use.The PAD is foradults only.	The AdhesiveElectrodes areintended to transmitelectrical current topatient skin forTENS(TranscutaneousElectrical NerveStimulation) andEMS (ElectricalMuscularStimulation)applications. It is forOTC (Over-The -Counter) orPrescription use andis to be used foradults only.	Wandy Self-adhesive Electrodeis intended totransmit electricalcurrent to patientskin for TENS(TranscutaneousElectrical NerveStimulation) andEMS (ElectricalMuscularStimulation)applications, forOTC (Over-The -Counter) orPrescription use.	SENOTE 1
Design feature	Six basiccomponents for theelectrode:-Electricalconnecting layer:Carbon fiberwire/Snap button-Insulation backingmaterial: non-woven/PU/PVC/PET/EVAfoam/Silicone-Double sidesadhesive tape-Conducting film:carbon film-Hydrogel-Protective filmlayer: Plastic film	Three layers:1. Insulationbackingmaterial: EVAfoam2. Conductive film:Carbon film3. ConductivehydrogelProtective line: PET	Three layers:1. Insulationbackingmaterial: WovenFabric/Foam2. Conductive film:Aluminum/Carbon3. ConductivehydrogelProtective line: PET	SENOTE 2
Electricalconnection	LeadwireSnap button	Snap button	Snap button or leadwire	SE
Electrical	<300 ohms	< 300 ohms	< 300 ohms	Same
ComparisonElements	Subject Device	Predicate Device 1	Predicate Device 2	Discussion
impendence
Sterility status	Non-sterile	Non-sterile	Non-sterile	Same
Reusable orDisposable?	Reusable	Reusable	Reusable	Same
Shelf life (Storagelife)	2 years	Unknown	Unknown	NOTE 3
Single patient use?	Yes	Yes	Yes	Same
Target population	Adult	Adult	Adult	SE
Patient contactingmaterial	Hydrogel	Hydrogel	Hydrogel	SENOTE 5
Self-adhesive	Self-adhesive	Self-adhesive	Self-adhesive	Same
Biocompatibilityfeature	Complied withISO10993	Complied withISO10993	Complied withISO10993	SENOTE 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.
1. 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.

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).