(180 days)
Not Found
No
The summary describes a standard electrosurgical generator with no mention of AI/ML capabilities, data processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as an electrosurgical generator designed to perform monopolar and bipolar functions in an operating arena, indicating its use in surgical procedures to treat or alleviate a condition.
No
The device is an electrosurgical generator designed to perform surgical functions (monopolar and bipolar) using high-frequency current, not to diagnose medical conditions.
No
The device description clearly outlines hardware components such as a generator, front panel, back panel, inner components (display panel, main board, control board, speaker), and accessories (power cable, cables, foot switch). This indicates it is a physical hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to perform monopolar and bipolar functions in the operating arena. This indicates a direct interaction with a patient's tissues during surgery.
- Device Description: The description details an electrosurgical generator that produces high-frequency current for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for analyzing biological samples.
Electrosurgical generators are considered medical devices used for surgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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, cable and foot switch).
The two models of proposed device share appearance, function, accessories, the only difference is the output parameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating arena.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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:
-
- Date of Submission: Mar. 15, 2013
SEP 16 2013
- Date of Submission: Mar. 15, 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
1
Section 3 510 Summary
KIK30760
Page 2 of (4)
-
- Proposed Device Identification
Proposed Device Name: Electrosurgical Generator Proposed Device Model: HV-400, HV-300A Device Common Name: Electrosurgical Unit and Accessories
- Proposed Device Identification
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
2
Section 3 510 Summary
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
-
- 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:
- Non-Clinical Test Conclusion
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.
-
- 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.
- Substantially Equivalent (SE) Conclusion
| Item | Proposed Device(s) | Predicate Device
(K072041) | Predicate Device
(K944602) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------|
| Product Code | GEI | Same | Same |
| Regulation
Number | 878.4400 | Same | Same |
| Intended Use | 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. | Same | Similar |
| Type | HF energy | Same | Same |
| Output waveform | Monopolar and bipolar | Same | Same |
Table 3-1 Comparison of Technology Characteristics
111-3
3
. .
: . Section 3 510 Summary
page 4 of (4)
| Operation
system | Touchable TFT screen and
foot 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.
4
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
5
Page 2 - Mr. Ligang Mao
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
6
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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