The Electrosurgical Generator (HV-300A, HV-400) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

Device Description

The proposed device (HV-400 and HV-300A) is an electrosurgical generator with, monopolar and bipolar, high frequency current isolation outputs. The proposed device is independent equipment, which include generator and accessories. The main components are front panel ( power switch, touchable screen, operation key, indicator, connector for accessories), back panel (volume controller, foot switch interface, power cable outlet and fuse) and inner component (display panel, main board, control board, speaker etc.). The accessories include power cable, III-2 cable and foot switch). The two models of proposed device share appearance, function, accessories, the only difference is the output parameter.

AI/ML Overview

The provided text describes an Electrosurgical Generator (HV-300A, HV-400) and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth methodology, expert qualifications, MRMC study, standalone algorithm performance) is not applicable or not provided in this document.

However, based on the non-clinical tests conducted, we can infer the acceptance criteria for basic safety and essential performance, and the study showing the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance)
Basic Safety and Essential Performance: IEC 60601-1:2005 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)	The test results demonstrated that the proposed device complies with IEC 60601-1:2005.
Electromagnetic Compatibility (EMC): IEC 60601-1-2:2007 (Medical electrical equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic compatibility - requirements and tests)	The test results demonstrated that the proposed device complies with IEC 60601-1-2:2007.
Safety of High-Frequency Surgical Equipment (Specific Performance): IEC 60601-2-2:2009 (Medical electrical equipment Part 2-2: Particular requirements for safety of high frequency surgical equipment)	The test results demonstrated that the proposed device complies with IEC 60601-2-2:2009.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/Not provided. The tests described are non-clinical hardware tests against international standards, not performance evaluations on a data set with a specific sample size of patient data.
Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Ground truth in the context of diagnostic or AI performance is not relevant for these hardware safety and performance tests. Compliance with standards is typically assessed by engineers and testing bodies.

4. Adjudication method for the test set

Not applicable/Not provided. This concept is relevant for expert disagreement resolution in diagnostic studies, not for compliance testing of electrosurgical generators to established ISO/IEC 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 device is an electrosurgical generator, which is a hardware device for surgical procedures, not an AI or diagnostic imaging system that would involve human readers.

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

No. This device is a hardware electrosurgical generator. It does not involve a standalone algorithm in the sense of AI or software performance evaluation.

7. The type of ground truth used

The "ground truth" here is the requirements set forth by the specific international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2). The device's performance was compared directly against these documented technical specifications and limits within the standards.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device that involves training sets.

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

Not applicable/Not provided.

Summary

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K130760

Section 3 510 Summary

page 1 of (4)

Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number:

1. Date of Submission: Mar. 15, 2013
  SEP 16 2013

Sponsor Identification

Beijing Jinhengwei Technology Development Co.,Ltd. East side on 2nd floor of south building, No.631 xingong village, Nanyuan area, Fengtai District, Beijing, China 100069

Establishment Registration Number: Not yet registered

Contact Person: Mr. Ligang Mao Position: General Manager Tel: +86-10-67916414 Fax: +86-10-67916414 Email: youyou1975@vip.sina.com

Submission Correspondent 3.
Mr. Ligang Mao Beijing Jinhengwei Technology Development Co.,Ltd. East side on 2nd floor of south building,No.631 xingong village, Nanyuan area, Fengtai District, Beijing, China 100069 T: +86-10-67916414 F: +86-10-67916414 E: youyou1975@vip.sina.com

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Section 3 510 Summary

KIK30760

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1. Proposed Device Identification
  Proposed Device Name: Electrosurgical Generator Proposed Device Model: HV-400, HV-300A Device Common Name: Electrosurgical Unit and Accessories

Regulatory Information: Classification Name:Electrosurgical Unit and Accessories: Classification: II; Product Code: GEI; Regulation Number: 21 CFR 878.4400; Review Panel: General& Plastic Surgery;

Intended Use Statement:

The Electrosurgical Generator (HV-300A, HV-400) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

Predicate Device Identification న.
510(k) Number: K072041 Predicate Device Name: Bovie IDS-400 Manufacturer: Bovie Medical

510(k) Number: K944602 Predicate Device Name: Force FX Manufacturer: Valleylab Inc.

Device Description 6.
The proposed device (HV-400 and HV-300A) is an electrosurgical generator with, monopolar and bipolar, high frequency current isolation outputs.

The proposed device is independent equipment, which include generator and accessories. The main components are front panel ( power switch, touchable screen, operation key, indicator, connector for accessories), back panel (volume controller, foot switch interface, power cable outlet and fuse) and inner component (display panel, main board, control board, speaker etc.). The accessories include power cable, III-2

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Section 3 510 Summary

K130760

Page 3 of (4)

cable and foot switch).

... . . . . .

The two models of proposed device share appearance, function, accessories, the only difference is the output parameter

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

IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic compatibility - requirements and tests

IEC 60601-2-2:2009 Medical electrical equipment Part 2-2: Particular requirements for safety of high frequency surgical equipment.

1. Substantially Equivalent (SE) Conclusion
  The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device(K072041)	Predicate Device(K944602)
Product Code	GEI	Same	Same
RegulationNumber	878.4400	Same	Same
Intended Use	The Electrosurgical Generator(HV-300A, HV-400) is anon-sterile, reusable multi-purposeelectrosurgical generator that isdesigned to perform monopolar andbipolar functions in the operatingarena.	Same	Similar
Type	HF energy	Same	Same
Output waveform	Monopolar and bipolar	Same	Same

Table 3-1 Comparison of Technology Characteristics

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: . Section 3 510 Summary

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Operationsystem	Touchable TFT screen andfoot switch	Same	Same
Working voltage	110-220V AC±10%	Same	Same
Safety	IEC 60601-1	Same	Same
EMC	IEC 60601-1-2	Same	Same
Performance	IEC 60601-2-2	Same	Same
Features	LCD touchable screen,foot switch	Same	Same

The proposed device(s), Electrosurgical Generator (HV-300A, are determined to be Substantially Equivalent (SE) to the predicate device(s), Bovie IDS-400 and Force FX, in respect of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the seal for the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming the body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

Beijing Jinhengwei Technology Development Corporation, Ltd. Mr. Ligang Mao General Manager East side on 2nd Floor of south building, No.631 xingong village Nanyuan area, Fengtai District, Beijing, China 100069

September 16, 2013

Re: K130760

Trade/Device Name: Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 23, 2013 Received: August 1, 2013

Dear Mr. Mao:

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 10 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 fabeling 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default,htm. 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/Safety/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 toil-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,

Neil R Ogden .. 2013.09.26 14:29:58 -04'00' for Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130760

Section II Indications for Use

510(k) Number: Device Name:

Indications for Use:

The proposed device is intended for use is:

The Electrosurgical Generator (HV-300A, HV-400) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.

& PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

O 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)

Long H. Chen-A

Page 1 of 1

(Division Sign-off)for MXM Division of Surgical Devices 510 (k) Number K130760

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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.