The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.

Device Description

The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the VECTEC Disposable Trocars and Laparoscopic Accessories, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VECTEC device were based on demonstrating substantial equivalence to predicate devices, particularly regarding safety and performance. The primary performance criteria centered on the dielectric withstand testing requirements for electrosurgical devices.

Acceptance Criteria	Reported Device Performance
Dielectric withstand testing requirements	VECTEC laparoscopic accessories met the dielectric withstand testing
of ANSI/AAMI HF-18:2001	requirements of ANSI/AAMI HF-18:2001.
Substantial equivalence in Intended Use	Demonstrated by similarity in Intended Use to predicate devices.
Substantial equivalence in characteristics	Devices are similar in characteristics to predicate devices.
Biocompatible materials	Composed of biocompatible materials; same as predicate devices.
Energy source compatibility	Monopolar electrosurgical energy is the same as used for predicate devices.
Sterilization	Sterilized using traditional, validated ethylene oxide procedure per EN
	550:1994 to a SAL of 10-6 with acceptable residual EO levels per ISO
	0993-7:1995.

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

The document does not specify a "test set" in the context of clinical data or patient samples. The performance testing described is bench electrosurgical device performance testing. Therefore, there is no information on sample sizes related to human or animal subjects, nor on data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be laboratory-based on the device itself.

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

This information is not applicable to this submission. The "ground truth" for the performance testing was adherence to the ANSI/AAMI HF-18:2001 standard for dielectric withstand testing and comparison to the characteristics of predicate devices. This is a technical standard rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Since there's no clinical test set requiring human interpretation or consensus, there's no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices and bench testing.

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

This question is not applicable. The device is not an algorithm or AI system. It is a physical medical device (trocars and laparoscopic accessories) designed for direct surgical use.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's acceptable performance was primarily:

Engineering Standards: Meeting the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.
Predicate Device Equivalence: Direct comparison of technological characteristics, intended use, materials, and energy source compatibility with already legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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K 07/976

SUMMARY OF SAFETY AND EFFECTIVENESS

GENERAL INFORMATION 1.

1.1 Submitter and Owner of the 510(k)

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

Page 1 of 3

SEP - 6 2007

1.2 Official Correspondent

Diane Mandell Horwitz, Ph.D., RAC THE WEINBERG GROUP INC. 1220 19th Street N.W., Suite 300 Washington, D.C. 20036 Telephone: 703.242.0027 Facsimile: 703.242.0027 Electronic mail: dianehorwitz@gmail.com

1.3 Date of Preparation

July 11, 2007

2. NAME OF THE DEVICES

2.1 Trade/Proprietary Names

VECTEC Disposable Trocars and Laparoscopic Accessories

2.2 Classification Information

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

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Page 2 of 3

SUMMARY OF SAFETY AND EFFECTIVENESS (Continued

PREDICATE DEVICES 3.

Trocars	MTP Disposable Trocars	MTP Medical TechnicalPromotion GMBH(manufactured by VECTEC)	K994066
Scissors	Applied Laparoscopic DisposableMonopolar Scissor	Applied Medical ResourcesCorporation	K062169
Forceps andDissectors	Disposable Re-New Forceps	Microline Pentax, Inc.	K981389
Hook	"Re-New" Laparoscopic Instruments(includes hook configuration)	Microline Pentax, Inc.	K962119

4. DESCRIPTION OF THE DEVICES

INDICATIONS FOR USE AND INTENDED USE ട.

SUBSTANTIAL EQUIVALENCE 6.

The VECTEC Trocars (the subject of this application) and the predicate trocars (K994066) are both manufactured by VECTEC and are identical; thus, they are substantially equivalent.

Substantial equivalence of the scissors, forceps, dissectors, and hook is demonstrated by the similarity in Intended Use of instruments to their predicate. The devices are similar in characteristics to the predicate devices, and both are composed of biocompatible materials. The energy source that is used with the VECTEC accessories, monopolar electrosurgical energy, is the same as used for the predicate devices. Comparison of

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K 0.71976

Page 3 of 3

SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

technological characteristics and bench electrosurgical device performance testing has confirmed that the VECTEC Disposable Trocars and Laparoscopic Accessories are substantially equivalent to the predicate devices.

7. PERFORMANCE TESTING

VECTEC laparoscopic accessories met the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.

CONCLUSIONS 8.

Based on the technical testing and dimensional information and intended use information provided, the VECTEC Disposable Trocars and Laparoscopic Accessories have been shown to be substantially equivalent to the predicate devices listed above.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VECTEC

% The Weinberg Group, Inc. Diane Mandell Horwitz, Ph.D., RAC Regulatory Consultant 1220 Nineteenth Street, Northwest Suite 300 Washington, District of Columbia 20036-2400

SEP -6 2007

Re: K071976

Trade/Device Name: VECTEC Disposable Trocar and Laparoscopic Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 17, 2007 Received: July 17, 2007

Dear Dr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Diane Mandell Horwitz, Ph.D., RAC

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Souall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1. STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K071976

Device Name: VECTEC Disposable Trocar and Laparoscopic Accessories

Indications for Use:

Prescription Use X X (Part 21 CFR 801 Subpart D)

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

(Divis on Sign-Off Division of General. Restorative. and Neurological Devices

510(k) Number /4671974

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.