LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS

K043273 · Valleylab · GEI · Jan 5, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043273
• Device Name: LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
• Applicant: Valleylab
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired. The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.

Device Story

System comprises microprocessor-based RF generator and dedicated bipolar instruments; used in OR by surgeons. Instruments clamp vessels/tissue bundles up to 7mm; RF energy applied to reform collagen/elastin, creating permanent seal. Microprocessor monitors tissue properties, automatically terminates energy delivery, and allows cooling before signaling cycle completion. Generator also supports standard bipolar cutting/coagulation. Benefits include effective vessel ligation, including lymph vessels, with high burst pressures.

Clinical Evidence

Pre-clinical studies demonstrated effective sealing of lymphatic vessels with burst pressures exceeding physiologic vessel pressures.

Technological Characteristics

Bipolar electrosurgical generator and instruments; RF energy source; microprocessor-controlled feedback loop for tissue monitoring and energy termination; supports vessels up to 7mm.

Indications for Use

Indicated for patients undergoing general, laparoscopic, and gynecologic surgical procedures (including urologic, thoracic, plastic, and reconstructive) requiring vessel or lymph vessel ligation. Contraindicated for tubal sterilization or tubal coagulation procedures.

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

• LigaSure™ Vessel Sealing System (K981916)

Submission Summary (Full Text)

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JAN - 5 2005

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### SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

# KO43273

## LigaSure™ Vessel Sealing System

#### Submitter Information 1.

Valleylab A Division of Tyco Healthcare Group LP 5920 Lonabow Drive Boulder, CO 80301 Contact: Herbert W. Vinson Senior Requlatory Associate Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Date summary prepared: November 24, 2004

#### 2. Name of Device

Trade or Proprietary Name: LigaSure™ Vessel Sealing System

Common/Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories

#### 3. Predicate Devices

The LigaSure™ Vessel Sealing System is substantially equivalent to the following legally marketed medical devices:

- LigaSure™ Vessel Sealing System (K981916) .
#### 4. Device Description

The LigaSure™ Vessel Sealing System consists of a microprocessor-based radiofrequency (RF) generator and a selection of instruments designed to be used exclusively with the LigaSure™ generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.

No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.

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#### 5. Intended Use

The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaqinal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.

#### 6. Summary of Technological Characteristics

The technological characteristics of the LigaSure™ Vessel Sealing System have not been modified.

#### 7. Performance and Clinical Data

Pre-clinical studies have shown that the LigaSure™ Vessel Sealing System effectively seals lymphatic vessels, producing seals with burst pressures substantially greater than the physiologic pressures in the vessels.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern around the edge. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 2005

Mr. Herbert W. Vinson Senior Regulatory Associate Valleylab A Division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, Colorado 80301

Re: K043273

K045275
Trade/Device Name: LigaSure™ Vessel Sealing System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 24, 2004 Received: November 26, 2004

Dear Mr. Vinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we nave reviewed your bection 9 re(s) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars than to the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire in asse approval of a premarket approval application (PMA). allo Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market are act include requirements for annual registration, listing of general controls provisions of the rest lebeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) als. Existing major regulations affecting your device can may be subject to sublements. Ventreiner , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Outs neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised that FDF 5 results of the complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I catal statutes and regirements, including, but not limited to: registration and listing (21 Comply with an the 70t 5 requirements, and 801); good manufacturing practice requirements as set CFR in tool); idoomig (21 OFF Part 820); and if applicable, the electronic forth in the quality Bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Herbert W. Vinson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your of substantial equivalence of your device to a legally promative noticated on " 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 11 you dome office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

### 510(k) Number (if known): K043273

Device Name: LigaSure™ Vessel Sealing System

Indications For Use:

The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general. Iaparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coaqulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.

The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny. etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.

The LigaSure™ Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K043273 510(k) Number_