Disposable neutral electrodes are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.

Solid Electrosurgical pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical pads are for use with generators that have a CQMS (i.e. REM,ARM,NESSY etc.).

Device Description

Disposable neutral electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in electrosurgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrodes helps to prevent unintended HF burns. The solid electrosurgical pads are designed to be compatible with generators without Contact Quality Monitoring System (CQMS), and the split electrosurgical pads are designed to be compatible with the Contact Quality Monitoring System (CQMS) of compatible generators. The models share the same design elements (functional design, technology design, packaging, etc.) but have different sizes and shapes. The models are designed for adults, children, and neonates, separate catalog numbers are assigned for the intended patients, and pre-attached cord.

Disposable neutral electrodes consist of foam backing, cable connection area, conductive aluminum foil, conductive adhesive gel layer and release liner. The pads are applied on a release liner. The surface of the conductive aluminum foil is fully covered with a soft, conformable conductive adhesive gel.

The electrode backing is made of foam material. The electrodes are supplied with or without cable. For the non-corded pads, a reusable cable is not available as an accessory.

AI/ML Overview

The provided text describes the 510(k) premarket notification for "Disposable Neutral Electrodes" (K242204). This device is classified as an accessory to electrosurgical cutting and coagulation devices. The document focuses on demonstrating substantial equivalence to a predicate device (K203494) through non-clinical performance testing and comparison of characteristics.

This document does not include information about a study that proves a device meets acceptance criteria related to AI/ML software performance. Specifically, it does not contain information on:

Acceptance criteria for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
Sample sizes for test sets used to evaluate AI/ML performance.
Data provenance for AI/ML test sets.
Number and qualifications of experts for ground truth establishment in an AI/ML context.
Adjudication methods for AI/ML test sets.
Multi-reader multi-case (MRMC) comparative effectiveness studies involving AI assistance.
Standalone algorithm performance.
Types of ground truth for AI/ML (e.g., pathology, outcomes data).
Training set details for AI/ML.

The "Performance Testing" section (page 7) and "Comparison with Predicate Device" section (pages 8-9) refer to engineering and biocompatibility testing for a hardware medical device (neutral electrodes), not AI/ML software.

Therefore,Based on the provided text, I cannot answer your request as it pertains to AI/ML software performance. The document describes the premarket notification for a physical medical device (Disposable Neutral Electrodes) and details the non-clinical testing performed to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. It does not mention any AI/ML components or studies to evaluate AI/ML performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

September 25, 2024

Dongguan Quanding Medical Supplies Co., Ltd. % Jett Li Regulation Manager Guangzhou KEADA Biological Tech Co., Ltd. 6F, No.1 TianTai road Science City, LuoGang District GuangZhou, Guangdong 510000 China

Re: K242204

Trade/Device Name: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI

Dated: January 23, 2024 Received: July 26, 2024

Dear Jett Li:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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-devices/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 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

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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,

Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.09.25 09:02:55 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242204

Device Name

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1 510 (k) submitter

1.1 Sponsor

Company Name: Dongguan Quanding Medical Supplies Co., Ltd.

Address: No.3 Yongfa East Road, Dongshan, Qishi Town, Dongguan City, Guangdong, China

Phone: +86- 189 2372 2306

Email: 2851139778@qq.com

Contact Person (including title): Grace Zhao (General Manager)

1.2 Application Correspondent

Guangzhou KEADA Biological Tech Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China Contact Person: Mr. Jett Li Title: Regulation Manager Tel: +86-13512755282 Email: jianda-lee@foxmail.com

2 Date Prepared

2024-01-23

3 Subject Device Information

Trade Name: Disposable Neutral Electrodes
Common Name: Disposable Neutral Electrodes
Classification Name: Electrosurgical cutting and coagulation device and accessories

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Review Panel: General & Plastic Surgery
Product Code: GEI
Regulation Number: 21 CFR 878.4400
Regulation Class: 2

4 Predicate device Information

Legally marketed device K203494 Trade Name: Nissha Medical Technologies Neutral Electrodes Classification Name: Electrosurgical cutting and coagulation device and accessories Review Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Regulation Class: 2

5 Device Description

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The electrode backing is made of foam material. The electrodes are supplied with or without cable. For the non-corded pads, a reusable cable is not available as an accessory.

6 Indications for Use

IEC60601-1	Medical electrical equipment -Part 1: General requirementsfor basic safety and essential performance
IEC 60601-1-2	Medical electrical equipment -Part 1-2: General requirements for basic safety and essentialperformance -Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-2-2: 2017	Medical electrical equipment- Part 2-2: Particularrequirements for the basic safety and essential performanceof high frequency surgical equipment and high frequencysurgical accessories.
ISO 10993-5:2009	biological evaluation of medical devices -- part 5: tests for invitro cytotoxicity.
ISO 10993-10:2010	biological evaluation of medical devices - part 10: tests forskin sensitization.
ISO 10993-23: 2021	biological evaluation of medical devices - part 10: tests forirritation

7 Complied Standards

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8 Performance Testing

As part of demonstrating safety and effectiveness of Nissha Medical Technologies Neutral Electrodes and in showing substantial equivalence to the predicate devices, Nissha Medical Technologies completed several non-clinical performance tests. The Nissha Medical Technologies Neutral Electrodes meet all the requirements for overall design, biocompatibility and electrical safety with results confirming that the design output meets the design inputs and specifications for the devices. The Nissha Medical Technologies Neutral Electrodes passed all the testing in accordance with internal requirements, and international standards shown below to support substantial equivalence of the predicate devices:

. The device passed performance testing conducted according to standard IEC 60601-2-2:2017 "Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" and IEC 60601-1, relevant requirements. The testing conducted Thermal performance, Contact impedance, Adhesion, Shelf-life, Cord attachment, Cord connector and Cord insulation.

. Biocompatibility testing per ISO 10993-1 confirmed that the finished devices are biocompatible, and do not induce new risks. Testing per ISO 10993-5 Cytotoxicity was showing a slight reactivity, and ISO 10993-10 (Skin Irritation and Sensitization) was showing no adverse results.

Shelf Life Testing - According to accelerated aging of the Nissha Medical Technologies Neutral Electrodes and subsequent electrical safety testing, as it is required in subclause 201.15.101.8 of the standard IEC 60601-2-2, it has been demonstrated that the Nissha Medical Technologies Neutral Electrodes can be labeled with a shelf-life of 24 months.

9 Biocompatibility

Biocompatibility testing per ISO 10993-1 confirmed that the finished devices are biocompatible, and do not induce new risks. Testing per ISO 10993-5 Cytotoxicity was showing a slight reactivity, and ISO 10993-10 (Skin Irritation and Sensitization) was showing no adverse results.

10 Clinical Performance

No human clinical testing is required to support the medical device as the intended use is equivalent

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to the predicate devices. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11 Comparison with Predicate Device

Description	Subject Device	Predicate Device	Device Comparison
Manufacturer	Dongguan QuandingMedical Supplies Co., Ltd.	Nissha MedicalTechnologies Ltd.	-
510(k) Number	-	K203494	-
Product Code	GEI	GEI	Same
RegulationNumber	21 CFR 878.4400	21 CFR 878.4400	Same
RegulationName	Electrosurgical cutting andcoagulation device andaccessories	Electrosurgical cutting andcoagulation device andaccessories	Same
Indications forUse	Disposable neutral electrodesare indicated for use toadhere to the patient over theentire pad surface tocomplete an electrical circuitduring electrosurgerybetween the electrosurgicalgenerator, the activeelectrode and the patient.Solid Electrosurgical padsare for use with generatorsthat do not have a ContactQuality Monitoring System(CQMS). SplitElectrosurgical pads are foruse with generators that havea CQMS (i.e.REM,ARM,NESSY etc.).	Nissha MedicalTechnologies NeutralElectrodes -SWAROPLATE:Neutral electrodes are anaccessory for monopolarHF-surgery and representthe large area and lowimpedance contact with thepatient's skin required forreturning the electric currentto the HF-generator. Neutralelectrodes are self-adhesive,ready-to-use disposableproducts.The SWAROPLATE neutralelectrodes of NisshaMedical Technologies arenot intended for use in HighCurrent Mode. These areapplications with highcurrent and / or longactivation periods whereheating factors of more than30 A2s in a 60 s periodoccur.	Words isdifferent, but theIndications forUse is identical
Description	Subject Device	Predicate Device	DeviceComparison
		Nissha MedicalTechnologies NeutralElectrodes – BostonScientific:Neutral electrodes are anaccessory for monopolarHF-surgery and representthe large area and lowimpedance contact with thepatient's skin required forreturning the electric currentto the HF-generator. Neutralelectrodes are self-adhesive,ready-to-use disposableproducts.The Boston ScientificNeutral Electrodes REFDGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25are intended to be used incombination with thedevices "Boston ScientificG4™ and 1A/1BRadiofrequencyGenerators".
Prescription orOTC	Prescription	Prescription	Same
Mechanism ofAction	Disposable neutral electrodesare indicated for use toadhere to the patient over theentire pad surface tocomplete an electrical circuitduring electrosurgerybetween the electrosurgicalgenerator, the activeelectrode and the patient.	Neutral electrodes serve toreturn the current from thepatient to the electrosurgicalunit (ESU) during HFsurgery in monopolarapplication.	Words isdifferent, but theMechanism ofAction is identical
TechnologyOverview	Multi-layer device consistingof:	Multi-layer deviceconsisting of:	Similar
Description	Subject Device	Predicate Device	DeviceComparison
	Conductive aluminum foilBacking materialConductive adhesive gellayerRelease liner	Backing materialConductive layerConductive adhesivehydrogelCover material
Population	Neonates, Children, Adults	Neonates, Children, Adults	Same
AnatomicalLocation	Select a well convex area(muscle) next to the area tobe operated but at least 20cm far from it, possibly onthe forearm, on the thigh oron a whip.	Muscular or wellvascularized convex skinsite, as close as possible tothe operating field	Similar
	Weight rangeaccording toIEC 60601-2-2	>15kg: AdultsBetween 5 and 15kg:Children<5kg: Neonates	>15kg (33lbs) Adults>5kg (11lbs) Children andAdultsBetween 5 and 15kg (11 to33lbs) Children<5kg (11lbs) Neonates	Similar
		Conductivearea	>15kg Adults: 130-173 cm²Between 5 and 15kgChildren: 65-94cm²<5kg Neonates: 65-94 cm²	128-170 cm² Adults 105 -110 cm² Children andAdults71 - 72 cm² Children 32-37cm² Neonates	Similar*Note 1
Power			Adults not limitedChildren and Adults notlimitedChildren limited to 250WNeonates limited to 150W	Adults not limitedChildren and Adults notlimitedChildren limited to 250WNeonates limited to 150W	Similar
	Material		Polymer foam or nonwovensAluminum foilAdhesive gelRelease liner	Conductive laminate:Al-foil / PET and medicalgrade hydrogel Backing:PE-foam Cover: releaseliner	Similar
		Cable lengthfor prewiredelectrodes	3 meters	3 meters	Same
Self-adhesive			Yes	Yes	Same
Sterile			Non-sterile	Non-sterile	Same
Single-Use/disposable	Yes	Yes	Same
	Description	Subject Device	Predicate Device	DeviceComparison
	Shelf Life	24 months	24 months	Same
Complies withISO 10993-1;10993- 5 and10993-10	Yes	Yes	Same
Complies withrelevantclauses of IEC60601-2-2	Yes	Yes	Same
ElectricalSafety TestingPassed	Yes	Yes	Same
Compatibilitywith HFGenerators(ESU)	Yes, several ESUs have beenevaluated for compatibility.	Yes, several ESUs havebeen evaluated forcompatibility and a"Declaration ofCompatibility" is availablefor end-users.	Similar
Packaging	Sealed pouch	Sealed pouch	Same
Accessory	For electrodes providedwithout cable, reusable cableavailable	For electrodes providedwithout cable, reusablecable available	Same

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K242204

Sponsor: Dongguan Quanding Medical Supplies Co., Ltd.

Subject Device: Disposable Neutral Electrodes

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K242204

Sponsor: Dongguan Quanding Medical Supplies Co., Ltd.

Subject Device: Disposable Neutral Electrodes

Note 1 : The subject device has a similar conductive area as compared to the reference device no matter adults, neonates, and children.

The only obvious difference is that the maximum conductive area of the neonates model is larger than that of the predicate device. As is well known to all, when dispersive electrodes with larger areas were used, the maximum temperature decreases. with the areas raised. Also consider that the subject device has passed IEC60601-1, EN60601-1-2, IEC 60601-2-2 tests.

Thus, the subject device has same safety features in thermal performance than the reference device, the difference in conductive areas will not affect the safety and effectiveness of the subject device.

12 Statement of Substantial Equivalence

The Disposable Neutral Electrodes have the same indications for use, technological characteristics, and performance characteristics as the predicate devices. Electrosurgical Pads is as safe, as effective, and performs as well as the predicate devices.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.