The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided. Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag. The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.

AI/ML Overview

The provided text describes a submission for a Disposable Neutral Electrode (Model: GP202) and its substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria with performance metrics.

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment cannot be extracted from the provided text. This document is a 510(k) summary focused on demonstrating equivalence and compliance with general safety and performance standards.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided in the requested format. The document states that "Laboratory testing was conducted to validate and verify that the Disposable Electrosurgical Pencil met all design specifications, including electrical safety, EMC, biocompatibility, specification." (Section 5) and that "Electrical safety test, Mechanical performance test, and Biocompatibility test have been done to demonstrate the safety and performance of subject devices." (Section 7.0). However, it does not list specific numerical acceptance criteria (e.g., maximum impedance, minimum adhesion strength) or the quantitative performance results achieved by the device against those criteria. It only states that the tests demonstrated compliance and did not result in safety hazards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be determined from the text. The document does not specify sample sizes for any of the tests (electrical safety, mechanical performance, biocompatibility). It also does not mention data provenance (country of origin, retrospective/prospective). These tests appear to be laboratory-based rather than clinical data tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be determined. This device is a disposable neutral electrode, and the testing described (electrical safety, mechanical, biocompatibility) does not involve human interpretation or "ground truth" established by clinical experts in the way an imaging AI device would. The "ground truth" for these tests would be objective measurements against predefined standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be determined. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement. The laboratory tests for this device would have objective pass/fail criteria based on 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

No. This is not an AI device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Objective standards and measurements. For the tests mentioned (electrical safety, mechanical performance, biocompatibility, EMC), the "ground truth" would be the established international and national standards (e.g., IEC60601-1, IEC 60601-2-2, ISO 10993-5, ISO 10993-10) and objective measurements verifying compliance with these standards.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no training set.

Summary of what the document DOES provide:

Device Name: Disposable Neutral Electrode, Model GP202
Intended Use: For adult patients with conductive adhesive gel, used as a neutral reference during electrosurgical procedures.
Testing Conducted: Electrical safety test, Mechanical performance test, Biocompatibility test.
Compliance Standards:
- "510(k) Guidance Document for General Surgical Electrosurgical Devices"
- ANSI/AAMI American National Standard for Electrosurgical Devices
- IEC60601-1 (International Standard for electrical medical device)
- IEC 60601-2-2 (International Standard for Electrosurgical Devices)
- ISO 10993-5 and ISO 10993-10 (Biocompatibility)
Conclusion: The tests demonstrated compliance with requirements and did not reveal any safety hazards, leading to a conclusion of substantial equivalence to predicate devices and that the device is safe and effective.

Summary

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

1/3510(k) Summary
Sponsor:	Company: CATHAY MANUFACTURING CORP.Address: No.328, Xishe Road, Maogang Town, Songjiang Area, Shanghai City, ChinaContact Name: Ren RenTitle: AssistantTelephone: (86) 021- 57878328E-mail: rubyfantasy@qq.com
Consultant:	Taizhou EBO information Technology Co., LtdContact person: Zhang HuiTelephone: (86) 010-59795724Fax: (86) 010-52214567-5514Email: itczhanghui@gmail.comAUG 2 2 2013
1. Device information:
Proprietary Name:	Disposable Neutral Electrode
Model:	GP202
Regulation Description	Electrosurgical cutting and coagulation device and accessories
Product Code	GEI
Submission Type	510(k)
Regulation Number	21 CFR 878.4400
Device Class	2
2. Predicate Devices

K130027

K102372

ﻬﺎ

Trade/Device Name: OBS Disposable Electrosurgical Pads Models: GBS-Db, GBS-Dm Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories, Regulatory Class: Class II Product Code: GEI

Manufactured by:

Jiangmen City Xinhui BaiSheng Medical Equipment Co., Ltd.

3. Description of the device

The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL

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

EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided.

Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag.

The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.

4. Indications for Use

This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.

5. Testing

Laboratory testing was conducted to validate and verify that the Disposable Electrosurgical Pencil met all design specifications, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards

6. Compared to the predicate device

Disposable Neutral Electrode has been carefully compared to legally marketed devices with respect to intended use, appearance, essential components, materials and performance specifications.

They are similar in intended use, appearance, essential components, materials and performance specifications. Although they may differ from the predicate devices in color and size, it won't affect safety and effectiveness of subject devices.

In addition, performance and safety testing have been done to validate the performance and safety of the device.

7.0 Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as below:

Electrical safety test, Mechanical performance test, and Biocompatibility test have been done to demonstrate the safety and performance of subject devices. Tests was conducted in accordance with the "510(k) Guidance Document for General Surgical Electrosurgical Devices", which outlines safety and performance requirements.

The proposed device is equivalent to the identified predicate device with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices:

The International Standard for electrical medical device: IEC60601-1; the International

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

Standard for Electrosurgical Devices: IEC 60601-2-2; Biocompatibility: ISO 10993-5 and ISO 10993-10.

None of the test demonstrated and design characteristics that violated the requirements of the above mentioned standards or resulted in any safety hazards.

8.0 Conclusions:

The comparison and validation results presented in this 510k notification, show that the GP202 Disposable Neutral Electrode is substantially equivalent to predicated devices and are safe and effective in their intended use.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 22, 2013

Cathay Manufacturing Corporation % Taizon EBO Information Technology Co., Ltd. Zhang Hui No. 328, Xishe Road, Maogang Town, Songhang Area Shanghai, China 201607

Re: K130027

Trade/Device Name: Disposable Neutral Electrode GP202 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 15, 2013 Received: July 25, 2013

Dear Zhang Hui:

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. 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 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

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

Page 2 - Zhang Hui

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter DJRuimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K130027 Disposable Neutral Electrode Device Name:

Indications for Use:

This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua @ Mipper -S

(Division Sign-off) Division of Surgical Devices 510(k) Number K130027

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.