(217 days)
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 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.
This document, a 510(k) summary for the Monopolar Electrode Surgical Instrument, describes its acceptance criteria and the studies performed to demonstrate equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (K142208) rather than providing specific performance metrics against pre-defined acceptance criteria in the format typically seen with novel device studies. Instead, it relies on demonstrating that the new device shares fundamental technological characteristics and performs comparably to the predicate device through non-clinical testing.
The document states: "Verification and verification results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate devices K142208."
The comparison table in the document provides the basis for this claim:
| Item | Acceptance Criteria (Predicate Device K142208) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Regulation No. | 878.4400 | 878.4400 | Same |
| Regulation Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Models (Types) | Forceps: Grasper, Babcock Forceps, Clinch Forceps, Rat Tooth Forceps, Dissector Forceps; Scissors; Electrodes: Monopolar J Hook Probe, Monopolar L Hook Probe | Forceps: Grasper, Babcock Forceps, Clinch Forceps, Rat Tooth Forceps, Johan Forceps, Duckbill Forceps, Dissector Forceps; Scissors; Electrodes: Monopolar J Hook Coagulation Electrode, Monopolar L Hook Coagulation Electrode | Similar |
| 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 dissection manipulation and cutting. | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection and cutting. | Same |
| Structure | Handle, shaft and jaw tips | Handle, shaft and jaw tips | Same |
| Shaft Length | 330mm | 200mm/280mm/340mm, 250mm/330mm/450mm | Similar |
| 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 IEC 60601-2-2 | Yes | Yes | Same |
The acceptance criteria for "similarity" are not explicitly quantified (e.g., within X% of the predicate) but are generally implied by demonstrating compliance with the same recognized standards and having comparable functional characteristics.
2. Sample size used for the test set and data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists several non-clinical tests performed:
- Biocompatibility: Tests were performed according to ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization and irritation), and ISO 10993-11 (systemic toxicity). The document does not specify the sample size for these tests, nor the country of origin or whether the data was retrospective or prospective. These are typically laboratory tests.
- Electrical Safety: Tests were performed according to IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2. No sample size, country of origin, or data type is specified.
- Sterility: The sterilization process was validated "under consideration of recognized standards" to achieve a sterility assurance level of 10^-6 for EO sterilization. No specific sample size, country of origin, or data type is mentioned for the validation study itself, but this would typically involve testing a batch of representative devices.
- Packing and Shelf Life: Shelf life was determined as 3 years through "an analysis of the shelf-life stability of the materials used... as well as an analysis of the packaging materials and processes." No specific sample size, country of origin, or data type is mentioned.
These are all non-clinical, laboratory-based tests. The document does not indicate any clinical test data was used for the submission, stating: "Substantial equivalence does not depend on clinical test data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for a medical device (surgical instrument), and the "ground truth" for its performance is established through engineering and biocompatibility testing against recognized standards, not through expert review of data like in an AI/diagnostic imaging context. No clinical ground truth or expert interpretation of images for a test set is mentioned or required for this type of device according to the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As explained above, this is a device submission based on non-clinical testing and comparison to a predicate, not an AI or diagnostic imaging submission requiring expert adjudication of results.
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
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a manual surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Ground truth is established by the specified ISO standards' methodology and criteria for cytotoxicity, sensitization, irritation, and systemic toxicity.
- Electrical Safety: Ground truth is established by the electrical safety parameters defined in the IEC 60601 series of standards.
- Sterility: Ground truth is a sterility assurance level (SAL) of 10^-6, verified by standard sterilization validation protocols.
- Device Performance (Overall): Ground truth is the performance characteristics and safety profile of the legally marketed predicate device (K142208), as well as compliance with relevant engineering and material standards.
8. The sample size for the training set
Not applicable. This device does not use an algorithm or AI that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an algorithm or AI that requires a training set.
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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).
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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
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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
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Unimicro MedicalSystems(Shenzhen) Co., Ltd. | Monopolar LaparoscopicAccessories | K142208 |
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 | ||
| Model | Device Description | Specification |
| LS1001S | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ5*250mm |
| LS1001 | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ5*330mm |
| LS1001L | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ5*450mm |
| LS1002S | Monopolar Curved Metzenbaum Scissors | Φ5*250mm |
| LS1002 | Monopolar Curved Metzenbaum Scissors | Φ5*330mm |
| LS1002L | Monopolar Curved Metzenbaum Scissors | Φ5*450mm |
| LS1003S | Monopolar Curved Mini Metzenbaum Scissors, insulation to the tip | Φ5*250mm |
| LS1003 | Monopolar Curved Mini Metzenbaum Scissors, insulation to the tip | Φ5*330mm |
| LS1003L | Monopolar Curved Mini Metzenbaum Scissors, insulation to the tip | Φ5*450mm |
| LS1004S | Monopolar Straight Metzenbaum Scissors | Φ5*250mm |
| LS1004 | Monopolar Straight Metzenbaum Scissors | Φ5*330mm |
| LS1004L | Monopolar Straight Metzenbaum Scissors | Φ5*450mm |
| LS1041S | Articulating Curved Metzenbaum Scissors | Φ5*250mm |
| LS1041 | Articulating Curved Metzenbaum Scissors | Φ5*330mm |
| LS1041L | Articulating Curved Metzenbaum Scissors | Φ5*450mm |
| LS6001S | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ3*200mm |
| LS6001 | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ3*280mm |
| LS6001L | Monopolar Curved Metzenbaum Scissors, insulation to the tip | Φ3*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.
| Model | Device Description | Specification |
|---|---|---|
| LS1011S | Monopolar Maryland Dissector | $Ф5*250mm$ |
| LS1011 | Monopolar Maryland Dissector | $Ф5*330mm$ |
| LS1011L | Monopolar Maryland Dissector | $Ф5*450mm$ |
| LS1012S | Monopolar Modified Maryland Dissector | $Ф5*250mm$ |
| LS1012 | Monopolar Modified Maryland Dissector | $Ф5*330mm$ |
| LS1012L | Monopolar Modified Maryland Dissector | $Ф5*450mm$ |
| LS1042S | Articulating Maryland Dissector | $Ф5*250mm$ |
| LS1042 | Articulating Maryland Dissector | $Ф5*330mm$ |
| LS1042L | Articulating Maryland Dissector | $Ф5*450mm$ |
| LS6011S | Monopolar Maryland Dissector | $Ф3*200mm$ |
| LS6011 | Monopolar Maryland Dissector | $Ф3*280mm$ |
| LS6011L | Monopolar Maryland Dissector | $Ф3*340mm$ |
Table C. Models and Specifications for Monopolar Grasping Forceps
| Device Name: Monopolar Electrode Surgical Instrument | ||
|---|---|---|
| Jaw Tip Family: Grasping Forceps | ||
| Model | Device Description | Specification |
| LS1021S | Monopolar Fenestrated Johann Grasper | Ф5*250mm |
| LS1021 | Monopolar Fenestrated Johann Grasper | Ф5*330mm |
| LS1021L | Monopolar Fenestrated Johann Grasper | Ф5*450mm |
| LS1022S | Monopolar Long Jaw Fenestrated Johann Grasper | Ф5*250mm |
| LS1022 | Monopolar Long Jaw Fenestrated Johann Grasper | Ф5*330mm |
| LS1022L | Monopolar Long Jaw Fenestrated Johann Grasper | Ф5*450mm |
| LS1023S | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Ф5*250mm |
| LS1023 | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Ф5*330mm |
| LS1023L | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Ф5*450mm |
| LS1024S | Monopolar Blunt Tip Atraumatic Grasper | Ф5*250mm |
| LS1024 | Monopolar Blunt Tip Atraumatic Grasper | Ф5*330mm |
| LS1024L | Monopolar Blunt Tip Atraumatic Grasper | Ф5*450mm |
| LS1025S | Monopolar Clinch Grasper | Ф5*250mm |
| LS1025 | Monopolar Clinch Grasper | Ф5*330mm |
| LS1025L | Monopolar Clinch Grasper | Ф5*450mm |
| LS1026S | Monopolar Rat Tooth Claw Grasper | Ф5*250mm |
| LS1026 | Monopolar Rat Tooth Claw Grasper | Ф5*330mm |
| LS1026L | Monopolar Rat Tooth Claw Grasper | Ф5*450mm |
| LS1027S | Monopolar Babcock Grasper | Ф5*250mm |
| LS1027 | Monopolar Babcock Grasper | Ф5*330mm |
| LS1027L | Monopolar Babcock Grasper | Ф5*450mm |
| LS1028S | Monopolar Allis Grasper | Ф5*250mm |
| Device Name: Monopolar Electrode Surgical Instrument | ||
| Jaw Tip Family: Grasping Forceps | ||
| Model | Device Description | Specification |
| LS1028 | Monopolar Allis Grasper | Φ5*330mm |
| LS1028L | Monopolar Allis Grasper | Φ5*450mm |
| LS1029S | Monopolar Duckbill Grasper | Φ5*250mm |
| LS1029 | Monopolar Duckbill Grasper | Φ5*330mm |
| LS1029L | Monopolar Duckbill Grasper | Φ5*450mm |
| LS1030S | Monopolar Wave Teeth Grasper | Φ5*250mm |
| LS1030 | Monopolar Wave Teeth Grasper | Φ5*330mm |
| LS1030L | Monopolar Wave Teeth Grasper | Φ5*450mm |
| LS1043S | Articulating Monopolar Johann Fenestrated Grasper | Φ5*250mm |
| LS1043 | Articulating Monopolar Johann Fenestrated Grasper | Φ5*330mm |
| LS1043L | Articulating Monopolar Johann Fenestrated Grasper | Φ5*450mm |
| LS1044S | Articulating Clinch Grasper | Φ5*250mm |
| LS1044 | Articulating Clinch Grasper | Φ5*330mm |
| LS1044L | Articulating Clinch Grasper | Φ5*450mm |
| LS6021S | Monopolar Johann Fenestrated Grasper | Φ3*200mm |
| LS6021 | Monopolar Johann Fenestrated Grasper | Φ3*280mm |
| LS6021L | Monopolar Johann Fenestrated Grasper | Φ3*340mm |
| LS6022S | Monopolar Long Jaw Fenestrated Johann Grasper | Φ3*200mm |
| LS6022 | Monopolar Long Jaw Fenestrated Johann Grasper | Φ3*280mm |
| LS6022L | Monopolar Long Jaw Fenestrated Johann Grasper | Φ3*340mm |
| LS6023S | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Φ3*200mm |
| LS6023 | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Φ3*280mm |
| LS6023L | Monopolar Extra Long Jaw Fenestrated Johann Grasper | Φ3*340mm |
| LS6024S | Monopolar Blunt Tip Atraumatic Grasper | Φ3*200mm |
| LS6024 | Monopolar Blunt Tip Atraumatic Grasper | Φ3*280mm |
| LS6024L | Monopolar Blunt Tip Atraumatic Grasper | Φ3*340mm |
| LS6025S | Monopolar Clinch Grasper | Φ3*200mm |
| LS6025 | Monopolar Clinch Grasper | Φ5*280mm |
| LS6025L | Monopolar Clinch Grasper | Φ5*340mm |
| LS6026S | Monopolar Rat Tooth Claw Grasper | Φ3*200mm |
| LS6026 | Monopolar Rat Tooth Claw Grasper | Φ3*280mm |
| LS6026L | Monopolar Rat Tooth Claw Grasper | Φ3*340mm |
| LS6027S | Monopolar Babcock Grasper | Φ3*200mm |
| LS6027 | Monopolar Babcock Grasper | Φ3*280mm |
| LS6027L | Monopolar Babcock Grasper | Φ3*340mm |
| LS6028S | Monopolar Allis Grasper | Φ3*200mm |
| Device Name: Monopolar Electrode Surgical Instrument | ||
| Jaw Tip Family: Grasping Forceps | ||
| Model | Device Description | Specification |
| LS6028 | Monopolar Allis Grasper | Φ3*280mm |
| LS6028L | Monopolar Allis Grasper | Φ3*340mm |
| LS6029S | Monopolar Duckbill Grasper | Φ3*200mm |
| LS6029 | Monopolar Duckbill Grasper | Φ3*280mm |
| LS6029L | Monopolar Duckbill Grasper | Φ3*340mm |
| LS6030S | Monopolar Wave Teeth Grasper | Φ3*200mm |
| LS6030 | Monopolar Wave Teeth Grasper | Φ3*280mm |
| LS6030L | Monopolar Wave Teeth Grasper | Φ3*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
| Model | Device Description | Specification |
|---|---|---|
| LS1031S | L Hook Coagulation Electrode | Φ5*250mm |
| LS1031 | L Hook Coagulation Electrode | Φ5*330mm |
| LS1031C | L Hook Coagulation Electrode, with Cable | Φ5*330mm |
| LS1031L | L Hook Coagulation Electrode | Φ5*450mm |
| LS1031LC | L Hook Coagulation Electrode, with Cable | Φ5*450mm |
| LS1032S | J Hook Coagulation Electrode | Φ5*250mm |
| LS1032 | J Hook Coagulation Electrode | Φ5*330mm |
| LS1032L | J Hook Coagulation Electrode | Φ5*450mm |
| LS1033S | Scalpel Coagulation Electrode | Φ5*250mm |
| LS1033 | Scalpel Coagulation Electrode | Φ5*330mm |
| LS1033L | Scalpel Coagulation Electrode | Φ5*450mm |
| LS1034S | Ball Coagulation Electrode | Φ5*250mm |
| LS1034 | Ball Coagulation Electrode | Φ5*330mm |
| LS1034L | Ball Coagulation Electrode | Φ5*450mm |
| LS1035S | Scoop Coagulation Electrode | Φ5*250mm |
| LS1035 | Scoop Coagulation Electrode | Φ5*330mm |
| LS1035L | Scoop Coagulation Electrode | Φ5*450mm |
| LS1036S | Needle Coagulation Electrode | Φ5*250mm |
| LS1036 | Needle Coagulation Electrode | Φ5*330mm |
| LS1036L | Needle Coagulation Electrode | Φ5*450mm |
| LS1038S | L Hook Coagulation Electrode, with Extended Insulation | Φ5*250mm |
| LS1038 | L Hook Coagulation Electrode, with Extended Insulation | Φ5*330mm |
| LS1038L | L Hook Coagulation Electrode, with Extended Insulation | Φ5*450mm |
| LS1045S | Articulating Hook Coagulation Electrode | Φ5*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 | ||
| Model | Device Description | Specification |
| LS1045 | Articulating Hook Coagulation Electrode | Φ5*330mm |
| LS1045L | Articulating Hook Coagulation Electrode | Φ5*450mm |
| LS6031S | L Hook Coagulation Electrode | Φ3*200mm |
| LS6031 | L Hook Coagulation Electrode | Φ3*280mm |
| LS6031L | L Hook Coagulation Electrode | Φ3*340mm |
| LS6032S | J Hook Coagulation Electrode | Φ3*200mm |
| LS6032 | J Hook Coagulation Electrode | Φ3*280mm |
| LS6032L | J Hook Coagulation Electrode | Φ3*340mm |
| LS6033S | Scalpel Coagulation Electrode | Φ3*200mm |
| LS6033 | Scalpel Coagulation Electrode | Φ3*280mm |
| LS6033L | Scalpel Coagulation Electrode | Φ3*340mm |
| LS6034S | Ball Coagulation Electrode | Φ3*200mm |
| LS6034 | Ball Coagulation Electrode | Φ3*280mm |
| LS6034L | Ball Coagulation Electrode | Φ3*340mm |
| LS6035S | Scoop Coagulation Electrode | Φ3*200mm |
| LS6035 | Scoop Coagulation Electrode | Φ3*280mm |
| LS6035 | Scoop Coagulation Electrode | Φ3*340mm |
| LS6036S | Needle Coagulation Electrode | Φ3*200mm |
| LS6036 | Needle Coagulation Electrode | Φ3*280mm |
| LS6036L | Needle Coagulation Electrode | Φ3*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 DeviceMonopolar ElectrodeSurgical Instrument | Predicate DeviceMonopolar LaparoscopicAccessories | Result |
|---|---|---|---|
| Regulation No. | 878.4400 | 878.4400 | Same |
| RegulationClass | II | II | Same |
| Item | Subject DeviceMonopolar ElectrodeSurgical Instrument | Predicate DeviceMonopolar LaparoscopicAccessories | Result |
| Product Code | GEI | GEI | Same |
| Models | Forceps: GrasperBabcock ForcepsClinch ForcepsRat Tooth ForcepsJohan ForcepsDuckbill ForcepsDissector ForcepsScissors | Forceps: GrasperBabcock ForcepsClinch ForcepsRat Tooth ForcepsDissector ForcepsScissors | Similar |
| Electrodes:Monopolar J HookCoagulation ElectrodeMonopolar L HookCoagulation Electrode | Electrodes:Monopolar J Hook ProbeMonopolar L Hook Probe | ||
| IntendedUse/Indicationsfor Use | The device is a family ofinstruments whichincludes scissors, probesand forceps which areintended to be used ingeneral laparoscopicsurgical proceduresrequiring the use ofMonopolar Electrosurgicalcutting and/orcoagulation. | The device is a family ofinstruments whichincludes scissors, probesand forceps which areintended to be used ingeneral laparoscopicsurgical proceduresrequiring the use ofMonopolar Electrosurgicalcutting and/orcoagulation. | 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/340mm250mm/330mm/450mm | 330mm | Similar |
| Item | Subject DeviceMonopolar ElectrodeSurgical Instrument | Predicate DeviceMonopolar LaparoscopicAccessories | Result |
| Sterilization | EO | EO | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-11 | ISO 10993-5ISO 10993-10ISO 10993-11 | Same |
| Meets the IEC60601-2-2 | 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.
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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.
§ 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.