K Number
K230650
Device Name
Monopolar Electrode Surgical Instrument
Date Cleared
2023-10-12

(217 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.
Device Description
The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.
More Information

Not Found

No
The description focuses on the mechanical and electrical aspects of a standard electrosurgical instrument and does not mention any AI/ML components or functionalities.

No
The device is described as a surgical instrument used to cut, dissect, manipulate, and cauterize tissues, which falls under diagnostic or surgical applications rather than therapeutic.

No
The device is described as a surgical instrument used for cutting, dissecting, manipulating, and cauterizing tissues during laparoscopic procedures, not for diagnosing conditions.

No

The device description clearly outlines physical components like a conductive jaw tip, insulated shaft, and conductive post, and mentions sterilization and electrical safety testing, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation." This describes a surgical tool used on the patient's body, not a device used to examine specimens from the body (which is the definition of an IVD).
  • Device Description: The description details a surgical instrument with a jaw tip, shaft, and connection for an electrosurgical generator. This aligns with a surgical tool, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

Therefore, this device is a surgical instrument, not an IVD.

N/A

Intended Use / Indications for Use

The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

Product codes

GEI

Device Description

The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.

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

Not Found

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

Verification and verification results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate devices K142208.

Key Metrics

Not Found

Predicate Device(s)

K142208

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.

October 12, 2023

VHMED (Nantong) Co. Ltd. % Jun Peng Principal Consultant P&L Scientific, Inc. 1430 S. Dixie Hwy Suite 105 Coral Gables, Florida 33146

Re: K230650

Trade/Device Name: Monopolar Electrode Surgical Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2023 Received: September 12, 2023

Dear Jun Peng:

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 (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 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).

1

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 OS 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.

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 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.

Long H. Chen -S Digitally signed by Long H. Chen-S
Date: 2023.10.12 13:24:14 -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

2

Indications for Use

510(k) Number (if known) K230650

Device Name Monopolar Electrode Surgical Instrument

Indications for Use (Describe)

The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

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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Image /page/3/Picture/0 description: The image is a logo for VHIMED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy". The logo is simple and modern, and it conveys a sense of professionalism and expertise.

510(k) Summary

This 510(k) summary is being submitted in accordance with 21 CFR §807.92.

1. Applicant/Submitter

VHMED (Nantong) Co. Ltd.

Address: A1, 173 Ganjiang Road, Tongzhou Bay, Jiangsu, 226332 China

Tel: +86(0) 513 8692 0166

Fax: +86(0) 513 8692 0266

E-mail: info@vhmed.com

2. Submission Contact Person

Mr. Jun Peng

Address: P&L SCIENTIFIC, INC.

1430 S. Dixie Hwy STE 105, Coral Gables, FL 33146

Tel: (305) 345 6018

Fax: (305) 397 0289

E-mail: jpeng@plscientificinc.com

3. Subject Device

Trade Name: Monopolar Electrode Surgical Instrument

Common Name: Laparoscopic Instrument and Accessory

Classification Name: Electrosurgical, Cutting & Coagulation & Accessories

Classification Requlation Number: 878.4400

Device Class: II

Product Code: GEI

4. Predicate Device

Table 1. Predicative Device Information

ManufacturerDevice Name510(k) Number
Unimicro Medical
Systems(Shenzhen) Co., Ltd.Monopolar Laparoscopic
AccessoriesK142208

Page 1 of 9

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Image /page/4/Picture/0 description: The image shows the logo for VHMED, a company that specializes in laparoscopy. The logo is green and features the letters "VHMED" in a stylized font. Below the logo, the words "Excellence in Laparoscopy" are written in a smaller font. The logo is simple and modern, and it conveys the company's focus on quality and innovation.

5. Device Description

The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.

6. Product Specification

Table A. Models and Specifications for Monopolar Scissors

Device Name: Monopolar Electrode Surgical Instrument
Jaw Tip Family: Scissors
ModelDevice DescriptionSpecification
LS1001SMonopolar Curved Metzenbaum Scissors, insulation to the tipΦ5*250mm
LS1001Monopolar Curved Metzenbaum Scissors, insulation to the tipΦ5*330mm
LS1001LMonopolar Curved Metzenbaum Scissors, insulation to the tipΦ5*450mm
LS1002SMonopolar Curved Metzenbaum ScissorsΦ5*250mm
LS1002Monopolar Curved Metzenbaum ScissorsΦ5*330mm
LS1002LMonopolar Curved Metzenbaum ScissorsΦ5*450mm
LS1003SMonopolar Curved Mini Metzenbaum Scissors, insulation to the tipΦ5*250mm
LS1003Monopolar Curved Mini Metzenbaum Scissors, insulation to the tipΦ5*330mm
LS1003LMonopolar Curved Mini Metzenbaum Scissors, insulation to the tipΦ5*450mm
LS1004SMonopolar Straight Metzenbaum ScissorsΦ5*250mm
LS1004Monopolar Straight Metzenbaum ScissorsΦ5*330mm
LS1004LMonopolar Straight Metzenbaum ScissorsΦ5*450mm
LS1041SArticulating Curved Metzenbaum ScissorsΦ5*250mm
LS1041Articulating Curved Metzenbaum ScissorsΦ5*330mm
LS1041LArticulating Curved Metzenbaum ScissorsΦ5*450mm
LS6001SMonopolar Curved Metzenbaum Scissors, insulation to the tipΦ3*200mm
LS6001Monopolar Curved Metzenbaum Scissors, insulation to the tipΦ3*280mm
LS6001LMonopolar Curved Metzenbaum Scissors, insulation to the tipΦ3*340mm

Table B. Models and Specifications for Monopolar Dissecting Forceps

Device Name: Monopolar Electrode Surgical Instrument Jaw Tip Family: Dissecting Forceps

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Image /page/5/Picture/0 description: The image shows the VH-MED logo. The logo is in green and consists of the letters "VH-MED" in a stylized font. Below the logo, the words "Excellence in Laparoscopy" are written in a smaller font, also in green. The logo appears to be for a medical company or organization specializing in laparoscopic procedures.

ModelDevice DescriptionSpecification
LS1011SMonopolar Maryland Dissector$Ф5*250mm$
LS1011Monopolar Maryland Dissector$Ф5*330mm$
LS1011LMonopolar Maryland Dissector$Ф5*450mm$
LS1012SMonopolar Modified Maryland Dissector$Ф5*250mm$
LS1012Monopolar Modified Maryland Dissector$Ф5*330mm$
LS1012LMonopolar Modified Maryland Dissector$Ф5*450mm$
LS1042SArticulating Maryland Dissector$Ф5*250mm$
LS1042Articulating Maryland Dissector$Ф5*330mm$
LS1042LArticulating Maryland Dissector$Ф5*450mm$
LS6011SMonopolar Maryland Dissector$Ф3*200mm$
LS6011Monopolar Maryland Dissector$Ф3*280mm$
LS6011LMonopolar Maryland Dissector$Ф3*340mm$

Table C. Models and Specifications for Monopolar Grasping Forceps

Device Name: Monopolar Electrode Surgical Instrument
Jaw Tip Family: Grasping Forceps
ModelDevice DescriptionSpecification
LS1021SMonopolar Fenestrated Johann GrasperФ5*250mm
LS1021Monopolar Fenestrated Johann GrasperФ5*330mm
LS1021LMonopolar Fenestrated Johann GrasperФ5*450mm
LS1022SMonopolar Long Jaw Fenestrated Johann GrasperФ5*250mm
LS1022Monopolar Long Jaw Fenestrated Johann GrasperФ5*330mm
LS1022LMonopolar Long Jaw Fenestrated Johann GrasperФ5*450mm
LS1023SMonopolar Extra Long Jaw Fenestrated Johann GrasperФ5*250mm
LS1023Monopolar Extra Long Jaw Fenestrated Johann GrasperФ5*330mm
LS1023LMonopolar Extra Long Jaw Fenestrated Johann GrasperФ5*450mm
LS1024SMonopolar Blunt Tip Atraumatic GrasperФ5*250mm
LS1024Monopolar Blunt Tip Atraumatic GrasperФ5*330mm
LS1024LMonopolar Blunt Tip Atraumatic GrasperФ5*450mm
LS1025SMonopolar Clinch GrasperФ5*250mm
LS1025Monopolar Clinch GrasperФ5*330mm
LS1025LMonopolar Clinch GrasperФ5*450mm
LS1026SMonopolar Rat Tooth Claw GrasperФ5*250mm
LS1026Monopolar Rat Tooth Claw GrasperФ5*330mm
LS1026LMonopolar Rat Tooth Claw GrasperФ5*450mm
LS1027SMonopolar Babcock GrasperФ5*250mm
LS1027Monopolar Babcock GrasperФ5*330mm
LS1027LMonopolar Babcock GrasperФ5*450mm
LS1028SMonopolar Allis GrasperФ5*250mm
Device Name: Monopolar Electrode Surgical Instrument
Jaw Tip Family: Grasping Forceps
ModelDevice DescriptionSpecification
LS1028Monopolar Allis GrasperΦ5*330mm
LS1028LMonopolar Allis GrasperΦ5*450mm
LS1029SMonopolar Duckbill GrasperΦ5*250mm
LS1029Monopolar Duckbill GrasperΦ5*330mm
LS1029LMonopolar Duckbill GrasperΦ5*450mm
LS1030SMonopolar Wave Teeth GrasperΦ5*250mm
LS1030Monopolar Wave Teeth GrasperΦ5*330mm
LS1030LMonopolar Wave Teeth GrasperΦ5*450mm
LS1043SArticulating Monopolar Johann Fenestrated GrasperΦ5*250mm
LS1043Articulating Monopolar Johann Fenestrated GrasperΦ5*330mm
LS1043LArticulating Monopolar Johann Fenestrated GrasperΦ5*450mm
LS1044SArticulating Clinch GrasperΦ5*250mm
LS1044Articulating Clinch GrasperΦ5*330mm
LS1044LArticulating Clinch GrasperΦ5*450mm
LS6021SMonopolar Johann Fenestrated GrasperΦ3*200mm
LS6021Monopolar Johann Fenestrated GrasperΦ3*280mm
LS6021LMonopolar Johann Fenestrated GrasperΦ3*340mm
LS6022SMonopolar Long Jaw Fenestrated Johann GrasperΦ3*200mm
LS6022Monopolar Long Jaw Fenestrated Johann GrasperΦ3*280mm
LS6022LMonopolar Long Jaw Fenestrated Johann GrasperΦ3*340mm
LS6023SMonopolar Extra Long Jaw Fenestrated Johann GrasperΦ3*200mm
LS6023Monopolar Extra Long Jaw Fenestrated Johann GrasperΦ3*280mm
LS6023LMonopolar Extra Long Jaw Fenestrated Johann GrasperΦ3*340mm
LS6024SMonopolar Blunt Tip Atraumatic GrasperΦ3*200mm
LS6024Monopolar Blunt Tip Atraumatic GrasperΦ3*280mm
LS6024LMonopolar Blunt Tip Atraumatic GrasperΦ3*340mm
LS6025SMonopolar Clinch GrasperΦ3*200mm
LS6025Monopolar Clinch GrasperΦ5*280mm
LS6025LMonopolar Clinch GrasperΦ5*340mm
LS6026SMonopolar Rat Tooth Claw GrasperΦ3*200mm
LS6026Monopolar Rat Tooth Claw GrasperΦ3*280mm
LS6026LMonopolar Rat Tooth Claw GrasperΦ3*340mm
LS6027SMonopolar Babcock GrasperΦ3*200mm
LS6027Monopolar Babcock GrasperΦ3*280mm
LS6027LMonopolar Babcock GrasperΦ3*340mm
LS6028SMonopolar Allis GrasperΦ3*200mm
Device Name: Monopolar Electrode Surgical Instrument
Jaw Tip Family: Grasping Forceps
ModelDevice DescriptionSpecification
LS6028Monopolar Allis GrasperΦ3*280mm
LS6028LMonopolar Allis GrasperΦ3*340mm
LS6029SMonopolar Duckbill GrasperΦ3*200mm
LS6029Monopolar Duckbill GrasperΦ3*280mm
LS6029LMonopolar Duckbill GrasperΦ3*340mm
LS6030SMonopolar Wave Teeth GrasperΦ3*200mm
LS6030Monopolar Wave Teeth GrasperΦ3*280mm
LS6030LMonopolar Wave Teeth GrasperΦ3*340mm

Page 3 of 9

006_VH-FD001-01 510(k) Summary

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Image /page/6/Picture/0 description: The image shows the logo for VH-MED, a company that specializes in laparoscopy. The logo is a green color and features the company name in a stylized font. Below the logo is the tagline "Excellence in Laparoscopy".

Page 4 of 9 006_VH-FD001-01 510(k) Summary

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Image /page/7/Picture/0 description: The image is a logo for VH-MED, a company that specializes in excellence in laparoscopy. The logo is green and features the letters "VH-MED" in a stylized font. The words "Excellence in Laparoscopy" are written in a smaller font below the logo. The logo is simple and modern, and it conveys the company's focus on quality and innovation.

Table D. Models and Specifications for Monopolar Electrodes

ModelDevice DescriptionSpecification
LS1031SL Hook Coagulation ElectrodeΦ5*250mm
LS1031L Hook Coagulation ElectrodeΦ5*330mm
LS1031CL Hook Coagulation Electrode, with CableΦ5*330mm
LS1031LL Hook Coagulation ElectrodeΦ5*450mm
LS1031LCL Hook Coagulation Electrode, with CableΦ5*450mm
LS1032SJ Hook Coagulation ElectrodeΦ5*250mm
LS1032J Hook Coagulation ElectrodeΦ5*330mm
LS1032LJ Hook Coagulation ElectrodeΦ5*450mm
LS1033SScalpel Coagulation ElectrodeΦ5*250mm
LS1033Scalpel Coagulation ElectrodeΦ5*330mm
LS1033LScalpel Coagulation ElectrodeΦ5*450mm
LS1034SBall Coagulation ElectrodeΦ5*250mm
LS1034Ball Coagulation ElectrodeΦ5*330mm
LS1034LBall Coagulation ElectrodeΦ5*450mm
LS1035SScoop Coagulation ElectrodeΦ5*250mm
LS1035Scoop Coagulation ElectrodeΦ5*330mm
LS1035LScoop Coagulation ElectrodeΦ5*450mm
LS1036SNeedle Coagulation ElectrodeΦ5*250mm
LS1036Needle Coagulation ElectrodeΦ5*330mm
LS1036LNeedle Coagulation ElectrodeΦ5*450mm
LS1038SL Hook Coagulation Electrode, with Extended InsulationΦ5*250mm
LS1038L Hook Coagulation Electrode, with Extended InsulationΦ5*330mm
LS1038LL Hook Coagulation Electrode, with Extended InsulationΦ5*450mm
LS1045SArticulating Hook Coagulation ElectrodeΦ5*250mm

Page 5 of 9

006_VH-FD001-01 510(k) Summary

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Image /page/8/Picture/0 description: The image is a logo for VH-MED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy". The logo is simple and modern, and it conveys the company's focus on quality and innovation.

Device Name: Monopolar Electrode Surgical Instrument
Jaw Tip Family: Electrodes
ModelDevice DescriptionSpecification
LS1045Articulating Hook Coagulation ElectrodeΦ5*330mm
LS1045LArticulating Hook Coagulation ElectrodeΦ5*450mm
LS6031SL Hook Coagulation ElectrodeΦ3*200mm
LS6031L Hook Coagulation ElectrodeΦ3*280mm
LS6031LL Hook Coagulation ElectrodeΦ3*340mm
LS6032SJ Hook Coagulation ElectrodeΦ3*200mm
LS6032J Hook Coagulation ElectrodeΦ3*280mm
LS6032LJ Hook Coagulation ElectrodeΦ3*340mm
LS6033SScalpel Coagulation ElectrodeΦ3*200mm
LS6033Scalpel Coagulation ElectrodeΦ3*280mm
LS6033LScalpel Coagulation ElectrodeΦ3*340mm
LS6034SBall Coagulation ElectrodeΦ3*200mm
LS6034Ball Coagulation ElectrodeΦ3*280mm
LS6034LBall Coagulation ElectrodeΦ3*340mm
LS6035SScoop Coagulation ElectrodeΦ3*200mm
LS6035Scoop Coagulation ElectrodeΦ3*280mm
LS6035Scoop Coagulation ElectrodeΦ3*340mm
LS6036SNeedle Coagulation ElectrodeΦ3*200mm
LS6036Needle Coagulation ElectrodeΦ3*280mm
LS6036LNeedle Coagulation ElectrodeΦ3*340mm

7. Intended Use/Indications for Use

The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.

8. Substantial Equivalence

8.1 Comparison between Monopolar Electrode Surgical Instrument and K142208

| Item | Subject Device
Monopolar Electrode
Surgical Instrument | Predicate Device
Monopolar Laparoscopic
Accessories | Result |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Regulation No. | 878.4400 | 878.4400 | Same |
| Regulation
Class | II | II | Same |
| Item | Subject Device
Monopolar Electrode
Surgical Instrument | Predicate Device
Monopolar Laparoscopic
Accessories | Result |
| Product Code | GEI | GEI | Same |
| Models | Forceps: Grasper
Babcock Forceps
Clinch Forceps
Rat Tooth Forceps
Johan Forceps
Duckbill Forceps
Dissector Forceps
Scissors | Forceps: Grasper
Babcock Forceps
Clinch Forceps
Rat Tooth Forceps
Dissector Forceps
Scissors | Similar |
| | Electrodes:
Monopolar J Hook
Coagulation Electrode
Monopolar L Hook
Coagulation Electrode | Electrodes:
Monopolar J Hook Probe
Monopolar L Hook Probe | |
| Intended
Use/Indications
for Use | The device is a family of
instruments which
includes scissors, probes
and forceps which are
intended to be used in
general laparoscopic
surgical procedures
requiring the use of
Monopolar Electrosurgical
cutting and/or
coagulation. | The device is a family of
instruments which
includes scissors, probes
and forceps which are
intended to be used in
general laparoscopic
surgical procedures
requiring the use of
Monopolar Electrosurgical
cutting and/or
coagulation. | Same |
| Operation Mode | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection and cutting. | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue dissection manipulation and cutting. | Same |
| Structure | Handle, shaft and jaw tips | Handle, shaft and jaw tips | Same |
| Shaft Length | 200mm/280mm/340mm
250mm/330mm/450mm | 330mm | Similar |
| Item | Subject Device
Monopolar Electrode
Surgical Instrument | Predicate Device
Monopolar Laparoscopic
Accessories | Result |
| Sterilization | EO | EO | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-11 | ISO 10993-5
ISO 10993-10
ISO 10993-11 | Same |
| Meets the IEC
60601-2-2 | Yes | Yes | Same |

Table 2. Comparison to K142208

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Image /page/9/Picture/0 description: The image is a logo for VHIMED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy." The logo is simple and modern, and it conveys the company's focus on quality and innovation.

10

Image /page/10/Picture/0 description: The image is a logo for VHIMED, a company that specializes in laparoscopy. The logo is green and features the company name in a stylized font. Below the company name is the tagline "Excellence in Laparoscopy". The logo is simple and professional, and it conveys the company's focus on quality and expertise.

9. Performance Data

Verification and verification results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate devices K142208.

9.1 Biocompatibility

The biocompatibility tests were performed in accordance with the FDA recognized standards:

  • l ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
  • -ISO 10993-10:2010, Biological evaluation of medical devices —Part 10: Tests for skin sensitization and irritation
  • -ISO 10993-11:2017, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity

9.2 Electrical Safety

The devices subject to this submission have been tested according to the requirements of IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18 and IEC 60601-1-2.

9.3 Sterility

The sterilization process has been validated under consideration of recognized standards. Testing shows that the products can be EO sterilized with a sufficient

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Image /page/11/Picture/0 description: The image is a logo for VHMED, a company that specializes in laparoscopy. The logo is green and features the letters "VHMED" in a stylized font. Below the letters, the words "Excellence in Laparoscopy" are written in a smaller font. The logo is simple and modern, and it conveys the company's focus on quality and innovation in the field of laparoscopy.

sterility assurance level of 10-6 by use of standard sterilization parameters.

9.4 Packing and Shelf Life

The shelf life about the Monopolar Electrode Surgical Instrument is 3 years. The shelf life period for the device was determined through an analysis of the shelf-life stability of the materials used in the design of the device, as well as an analysis of the packaging materials and processes.

10. Clinical Testing

Substantial equivalence does not depend on clinical test data.

11. Substantial Equivalence Summary/Conclusion

Based on device comparison information and non-clinical testing, the differences between Monopolar Electrode Surgical Instrument and predicate devices will not raise any new issues of safety and effectiveness. Monopolar Electrode Surgical Instrument is substantially equivalent to legally marketed predicate devices.