The VECTEC Disposable Monopolar Connection Cable is a sterile single-use device used to connect high frequency monopolar electrosurgical generators to various models of electrosurgical surgical instruments during laparoscopic and endoscopic surgery.

Device Description

The VECTEC Disposable Monopolar Cable is a 2.5 m cable used during routine laparoscopy and endoscopy procedures as the means of conveying high frequency electrical energy from a standard electrosurgical generator to standard electrosurgical instruments during surgery. Examples of such instruments include the range of VECTEC monopolar Scissors, Forceps, Dissectors, and Hook. VECTEC Disposable Monopolar Cables are single-use, sterile devices that are packaged individually and have a 2 or 5-year shelf life providing that the packaging is not damaged. The VECTEC monopolar cable is convenient for use in the operating room while having the high degree of performance expected from a surgical monopolar cable.

AI/ML Overview

The provided text describes the regulatory clearance for the "VECTEC Disposable Monopolar Connection Cable," which is a cable used in electrosurgery. The information requested in the prompt, such as detailed acceptance criteria with numerical performance targets, a specific study proving those targets are met, sample sizes for test and training sets, data provenance, number and qualifications of experts, and adjudication methods, are typically associated with performance evaluations of AI/ML-based medical devices or diagnostics.

The VECTEC Disposable Monopolar Connection Cable, however, is a physical accessory for electrosurgical equipment, not an AI/ML device or diagnostic tool that analyzes data or images. Its performance is assessed through compliance with established safety and electrical standards relevant to medical electrical equipment.

Therefore, much of the requested information does not directly apply to this type of device. I will extract the relevant information from the provided text as it pertains to the device's assessment and then address the non-applicable items.

Acceptance Criteria and Device Performance for VECTEC Disposable Monopolar Connection Cable

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Standard/Requirement	Reported Device Performance
Electrical Safety and Performance	IEC 60601-2-2:2006 (Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment)	"The monopolar cable has been tested against all applicable requirements of IEC 60601-2-2:2006." (Implies successful compliance). This standard covers aspects like high-frequency current leakage, breakdown voltage, insulation, and general safety of electrosurgical equipment to ensure the cable safely and effectively conveys electrical energy.
Sterilization Assurance	ISO 11135-1:2007 (Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)	"Sterilization is performed using ethylene oxide in accordance with ISO 11135-1:2007, with a SAL of 10-6." (Demonstrates compliance with validated sterilization process to achieve a sterility assurance level of 10^-6, meaning a one-in-a-million chance of a non-sterile unit).
Substantial Equivalence	Comparison to predicate device: Karl Storz Endoscopic High Frequency Monopolar Cord (K934985)	"Based on the technical testing and dimensional information and intended use information provided, the VECTEC Disposable Monopolar Cable has been shown to be substantially equivalent to the predicate device listed above." This implies that its safety and effectiveness are comparable to a legally marketed device.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the summary. For devices compliant with international standards like IEC and ISO, testing is typically performed on a representative sample to validate design and manufacturing processes. The document doesn't specify the exact number of units tested.

Data provenance (country of origin, retrospective/prospective) is not relevant in the context of device hardware testing against engineering standards. The testing would have been done in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable as the "ground truth" concept, in the sense of expert consensus on clinical data (e.g., radiology images), is not relevant for the testing of a monopolar connection cable. Compliance with engineering standards (like IEC 60601-2-2 and ISO 11135-1) is verified through objective measurements and validated processes, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective interpretation of data, typically by human readers, which is not the case here.

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

This is not applicable. The device is a physical cable, not an AI or imaging diagnostic tool. An MRMC study is completely irrelevant for this product.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. The device is a physical cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objective compliance with the specified international standards (IEC 60601-2-2 and ISO 11135-1) and demonstrating substantial equivalence to a predicate device. This is established through:

Objective measurements and tests against the requirements outlined in IEC 60601-2-2 for electrical safety and performance.
Validation records for the sterilization process according to ISO 11135-1.
Engineering analysis and comparison (technical specifications, intended use, materials) to show equivalence to the predicate device.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

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K103707 SUMMARY OF SAFETY AND EFFECTIVENESS

1. GENERAL INFORMATION

1.1 Submitter and Owner of the 510(k)

Yves Arboy, President VECTEC Bioparc 03270 Hauterive FRANCE Establishment Registration: 3005459904

1.2 Date of Preparation

December 17, 2010

2. NAME OF THE DEVICES

2.1 Trade/Proprietary Names

VECTEC Disposable Monopolar Connection Cable

2.2 Classification Information

Classification Name:	Electrosurgical cutting and coagulation device and accessories
Classification Regulation:	21 CFR § 878.4400
Class:	II
Product Code:	GEI, electrosurgical, cutting and coagulation and accessories
Panel:	General and Plastic Surgery

3. PREDICATE DEVICE

This 510(k) submission claims substantial equivalence to the following predicate device: Karl Storz Endoscopic High Frequency Monopolar Cord (Karl Storz Endoscopy-America, Inc.), GEI/ 878.4400, K934985.

4. DESCRIPTION OF THE DEVICES

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is not damaged. The VECTEC monopolar cable is convenient for use in the operating room while having the high degree of performance expected from a surgical monopolar cable.

ડ. INDICATIONS FOR USE AND INTENDED USE

SUBSTANTIAL EQUIVALENCE 6.

A comparison of the intended use statements and the an overview of the technology reveals the similarities between the predicate devices and the VECTEC devices:

7. PERFORMANCE TESTING

The monopolar cable has been tested against all applicable requirements of IEC 60601-2-2:2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.

Sterilization is performed using ethylene oxide in accordance with ISO 11135-1:2007, with a SAL of 10-6.

CONCLUSIONS 8.

Based on the technical testing and dimensional information and intended use information provided, the VECTEC Disposable Monopolar Cable has been shown to be substantially equivalent to the predicate device listed above.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

VECTEC % Mandell Horwitz Consulting, LLC Dr. Diane Mandell Horwitz 2995 Steven Martin Drive Fairfax, Virginia 22031

FEB - 4 200

Re: K103707

Trade/Device Name: VECTEC Disposable Monopolar Connection Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 17, 2010 Received: December 20, 2010

Dear Dr. Mandell Horwitz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controlis) 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.

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Page 2 - Dr. Diane Mandell Horwitz

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

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

http://www.fda.gov/MedicalDevices/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Az. B. Rit

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

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K103707

VECTEC Disposable Monopolar Connection Cable Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign Off

(Divisi (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103707

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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.