LigaSure Curved, Small Jaw, Open Sealer/Divider

K152286 · Covidien · GEI · Sep 8, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K152286
• Device Name: LigaSure Curved, Small Jaw, Open Sealer/Divider
• Applicant: Covidien
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 8, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Device Story

Sterile, single-use, hand-held bipolar electrosurgical instrument; used in open surgical procedures. Input: RF electrosurgical energy from compatible Covidien generators. Operation: Surgeon grasps tissue/vessels with jaws; initiates seal via handswitch or footswitch; RF energy creates tissue fusion; surgeon manually actuates blade to divide tissue along seal line. Output: Sealed and divided tissue. Used in OR by surgeons. Benefits: Controlled tissue response; minimal sticking, charring, and thermal spread. Modification: Alternate dot material on ceramic spacers and addition of etched wetting ring feature.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (IEC 60601-1-2), and design verification (jaw gap, force, cut length, hyperextension, resistance, and renal burst pressure).

Technological Characteristics

Bipolar electrosurgical instrument. Materials include ceramic spacers. Features etched wetting ring. Energy source: RF electrosurgical energy from external generator. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1 (safety), IEC 60601-2-2 (electrosurgical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for ligation and division of vessels (up to 7 mm), tissue bundles, and lymphatics in open general, urologic, thoracic, plastic, and reconstructive surgeries. Also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, tonsillectomy) for tissue 2-3 mm from thermally-sensitive structures. Contraindicated for tubal coagulation/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

• LigaSure™ Curved, Small Jaw, Open Sealer/Divider (K141153)
• LigaSure™ Curved, Small Jaw, Open Sealer/Divider (K113572)
• LigaSure™ Curved, Small Jaw, Open Sealer/Divider (K102470)

Submission Summary (Full Text)

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

September 8, 2015

Covidien Ms. Dawn Tindall Senior Regulatory Affairs Product Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K152286

Trade/Device Name: LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 11, 2015 Received: August 13, 2015

Dear Ms. Tindall:

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 of medical device-related

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known)

K152286

Device Name

LigaSureTM Curved, Small Jaw, Open Sealer/Divider (LF1212A)

#### Indications for Use (Describe)

The LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square logo. The logo is divided into four smaller squares, with a white square in the center.

# 510(k) Summary

Date summary prepared: August 11, 2015

#### 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

#### Contact

Dawn D. Tindall Sr. Regulatory Affairs Product Specialist Telephone: [phone] Fax: [phone] Email: [e-mail]

#### Name of Device

| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
|----------------------|------------------------------------------------------------------------------------------------------|
| Catalog Numbers: | LF1212A |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR § 878.4400, Class II, GEI) |

# Predicate Device

| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
|-----------------|-------------------------------------------------------------|
| Common Name: | Bipolar Vessel Sealing Device |
| Catalog Number: | LF1212A |
| 510(k) Number: | K141153 (cleared 8/14/2014), K113572 (cleared 9/5/2012) |
| | K102470 (cleared 2/7/2011) |
| Manufacturer: | Covidien |
| Recalls: | This device has not been subject to a design-related recall |

No reference devices were used in this submission.

#### Device Description

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue.

The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a handswitch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line.

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The purpose of this submission is to propose the use of an alternate dot material for the LigaSure Curved, Small Jaw, Open Sealer/Divider devices (K141153). There have been no prior submissions for the proposed change. The proposed devices do not contain software.

## Indications for Use

The LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

### Comparison of Technological Characteristics with the Predicate Device

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider devices have the same technological and performance characteristics as the predicate. This Special 510(k) proposes changes to the material of the ceramic spacers on the jaws of the device. The addition of an etched wetting ring feature is also included. The function of the device has not changed.

#### Performance Data

The modification to the LigaSure™ Curved, Small Jaw, Open Sealer/Divider (LF1212A) device was found to not affect safety or performance through design verification testing which confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:

- . Biocompatibility evaluation in accordance with ISO 10993-1:2009
- . Basic safety and essential performance in accordance with IEC 60601-1: 2005, A1: 2012 and IEC 60601-2-2: 2009
- Electromagnetic compatibility in accordance with IEC 60601-1-2: 2007, CORR: July 31, 2010
- . Design verification testing including jaw gap and force, cut length, hyperextension, resistance and renal burst pressure

#### Clinical Studies

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

#### Conclusions

The results of testing demonstrate the device is as safe, effective, and performs as well as the LigaSure™ Curved, Small Jaw, Open Sealer/Divider, the legally marketed device identified herein.