VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE

K103707 · Vectec · GEI · Feb 4, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103707
• Device Name: VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
• Applicant: Vectec
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

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 Story

VECTEC Disposable Monopolar Connection Cable is a 2.5m single-use sterile cable; conveys high-frequency electrical energy from standard electrosurgical generators to monopolar surgical instruments (scissors, forceps, dissectors, hooks). Used in operating rooms during laparoscopic and endoscopic procedures; operated by surgeons. Device facilitates energy delivery for cutting and coagulation; enables standard electrosurgical workflows.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-2-2:2006 (safety of high-frequency surgical equipment) and sterilization validation per ISO 11135-1:2007 (SAL 10-6).

Technological Characteristics

2.5m monopolar connection cable; single-use; sterile (ethylene oxide per ISO 11135-1:2007). Complies with IEC 60601-2-2:2006. Passive electrical conductor.

Indications for Use

Indicated for use in patients undergoing laparoscopic and endoscopic surgery requiring high frequency monopolar electrosurgical instrumentation.

Regulatory Classification

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.

Predicate Devices

• Karl Storz Endoscopic High Frequency Monopolar Cord (K934985)

Submission Summary (Full Text)

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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

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

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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

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.

#### SUBSTANTIAL EQUIVALENCE 6.

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.

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 [phone] or [phone] 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:

.

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.

(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)