LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

K130744 · Covidien · GEI · Apr 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130744
• Device Name: LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
• Applicant: Covidien
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Device Story

Sterile, single-use, hand-held bipolar electrosurgical instrument; used with ForceTriad energy platform. Input: tissue bundles, vessels, lymphatics (up to 7 mm) clamped between jaws. Operation: RF energy applied to seal vascular structures; surgeon-actuated blade divides tissue. Used in laparoscopic general/gynecologic/urologic/thoracic surgeries by surgeons. Output: sealed and divided tissue. Benefits: hemostasis and tissue division in minimally invasive procedures.

Clinical Evidence

Bench and preclinical testing performed. Bench testing included IEC 60601-1 and IEC 60601-2-2 compliance, mechanical testing (blade return, grasping, jaw force, power curve), and burst pressure (renal/pulmonary). Preclinical testing included vessel/lymphatic sealing up to 7 mm, hemostasis verification, and chronic animal study.

Technological Characteristics

Bipolar electrosurgical instrument; RF energy source (via ForceTriad platform). Features hand-actuated lever for jaw closure/latching and mechanical blade for tissue division. 5 mm diameter. Sterile, single-use. Complies with IEC 60601-1 and IEC 60601-2-2 standards.

Indications for Use

Indicated for general, gynecologic, urologic, vascular, thoracic, and thoracoscopic laparoscopic procedures requiring ligation and division of vessels (up to 7 mm), lymphatics, and tissue bundles. Contraindicated for tubal sterilization or tubal coagulation for sterilization.

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

• LigaSureTM 5 mm Blunt Tip Laparoscopic Sealer/Divide (K092879)

Submission Summary (Full Text)

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# APR 0 5 2013

# 510(k) Summary

Date summary prepared: 3/18/2013

## 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

#### Contact

Diane Reed Sr. Regulatory Affairs Product Specialist Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Name of Device

| Trade Name: | LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Catalog Number: | LF1637 |
| Common Name: | Bipolar Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400,<br>class II GEI) |

### Predicate Device

The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) was compared to and found to be substantially equivalent to the following product of comparable type in commercial distribution:

| Trade Name: | LigaSureTM 5 mm Blunt Tip Laparoscopic Sealer/Divide |
|---------------------|------------------------------------------------------|
| Device Common Name: | Bipolar Electrosurgical Instrument |
| Catalog Number: | LF1537 |
| 510(k) Number: | K092879 (cleared 10/16/2009) |
| Manufacturer: | Covidien |

### Device Description

The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.

#### Indications for Use

The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

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Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

# Technological Characteristics

The LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider has the same technological and performance characteristics as the predicate, K092879. This Special 510(k) presents proposed modifications relating to the jaw, handle, and component material changes. The function of the device has not changed. Similar to the predicate, this new device seals vessels and lymphatics using radio frequency (RF) energy to achieve its intended use and can mechanically divide the sealed areas or tissue with a mechanical cutting device.

## Performance

Evidence of safety and effectiveness was obtained from both bench and preclinical testing to support the intended use of this device includes:

- . Testing in accordance with IEC 60601-1
- Testing in accordance with IEC 60601-2-2 .
- . Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever latching/unlatching force, and power curve performance
- . Renal and pulmonary burst pressure

Preclinical testing includes:

- . Sealing and dividing vessels up to and including 7 mm
- . Ability to achieve hemostasis of tissue and vessels
- t Lymphatic burst pressure
- Chronic animal study .

The results of the testing demonstrate that the proposed device, the LF1637, operated as intended and is as safe and effective as the predicate device.

510(k): LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider - LF1637

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged in a single line and centered.

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Letter dated: April 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Covidien % Ms. Diane Reed Senior Regulatory Affairs Product Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K130744

Trade/Device Name: LigaSure™ 5mm Blunt Tip Laparoscopic Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 18, 2013 Received: March 19, 2013

Dear Ms. Reed:

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 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.

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

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Page 2 - Ms. Diane Reed

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.

# Mark N. Mielkerson -S

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

Enclosure

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### Indications for Use Statement

510(k) Number (if known): K130744

## Device Name: LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637)

Indications for Use:

The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny. Nissen fundoplication, colectorny, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Prescription Use >| — AND/OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Surgical Devices

510(k) Number K130744