LigaSure Exact Dissector, Nano-coated

K202917 · Covidien, LLC · GEI · Mar 23, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202917
• Device Name: LigaSure Exact Dissector, Nano-coated
• Applicant: Covidien, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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, breast procedures, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lympatics 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; hemostat-style body with single activation button. Used in open surgery by physicians to grasp, ligate (seal), and divide vessels/tissue bundles. Operates via RF energy delivered by compatible Covidien electrosurgical generators (ForceTriad, Valleylab LS10/FT10). User controls jaw closure and energy activation; device provides hemostasis and tissue division. Benefits include reduced operative time and effective vessel sealing. No changes to design or principle of operation from predicate; expanded indications include breast procedures.

Clinical Evidence

No new clinical studies conducted. Evidence relies on previously submitted bench testing (IEC 60601-1/2-2, burst pressure, functionality), biocompatibility (ISO 10993-1), and in vivo animal studies. Clinical literature review of LigaSure devices in breast procedures (mastectomy, flap reconstruction, axillary lymph node dissection) supports safety and effectiveness, showing successful hemostasis and complication profiles consistent with other surgical procedures.

Technological Characteristics

Bipolar RF electrosurgical instrument; hemostat-style; nano-coated; single-use; EtO sterilized. Compatible with ForceTriad, Valleylab LS10, and FT10 generators. Features bilateral curved jaws, two-stage hand-activation button, and proprietary connector. Materials biocompatible per ISO 10993-1.

Indications for Use

Indicated for open surgical procedures in adults for ligation and division of vessels (arteries/veins up to 7mm), tissue bundles, and lymphatics. Specialties: general, urologic, thoracic, plastic, reconstructive, and ENT (thyroidectomy, radical neck dissection, parotidectomy, tonsillectomy). Contraindicated for tubal sterilization/coagulation.

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™ Exact Dissector, Nano-coated (K173281)

Reference Devices

• LigaSure™ Curved, Small Jaw, Open Sealer/Divider (K152286)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 23, 2021

Covidien Nancy Sauer Director, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301

Re: K202917

Trade/Device Name: LigaSure Exact Dissector, Nano-coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 22, 2021 Received: February 24, 2021

Dear Nancy Sauer:

We have reviewed your Section 5100k) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. 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

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K202917

#### Device Name LigaSure™ Exact Dissector, Nano-coated

#### Indications for Use (Describe)

The 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, breast procedures, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lympatics 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/2 description: The image shows the logo for Covidien. The logo consists of a blue square with a white horizontal line in the middle and a light blue vertical line. To the right of the square is the word "COVIDIEN" in blue sans-serif font.

# 510(k) Summary

Date summary prepared: February 17, 2021

#### 510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

## Contact

Nancy Sauer Director, Regulatory Affairs Telephone: [phone] Fax: [phone] Email: [e-mail]

## Name of Device

| Trade Name: | LigaSure™ Exact Dissector, Nano-coated |
|----------------------|----------------------------------------------------------------------------------------------------|
| Catalog Numbers: | LF2019 |
| 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™ Exact Dissector, Nano-coated |
|----------------------|----------------------------------------------------------------------------------------------------|
| Catalog Numbers: | LF2019 |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR 878.4400, Class II, GEI) |
| 510(k) Number: | K173281 |
| Manufacturer: | Covidien |

#### Reference Device

| Trade Name: | LigaSure™ Curved, Small Jaw, Open Sealer/Divider |
|----------------------|----------------------------------------------------------------------------------------------------|
| Catalog Number: | LF1212/LF1212A |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR 878.4400, Class II, GEI) |
| 510(k) Number: | K152286 |
| Manufacturer: | Covidien |

## Device Description

The LigaSure™ Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy.

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A hemostat style body allows the user to open or close the instrument jaws during and cutting, with a single activation button incorporated into the body of the device.

## How Provided

The LigaSure™ Exact Dissector, Nano-coated (LF2019) device is provided sterile and is intended for single use.

# Compatible Electrosurgical Generators:

- ForceTriad™ Energy Platform (ForceTriad) ●
- Valleylab™ LS10 Generator (VLLS10GEN) ●
- Valleylab™ FT10 Energy Platform (VLF10GEN) .

## Indications for Use

The 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, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, breast procedures, 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.

## Patient Contacting Materials

Twenty-seven parts were determined to come into direct contact with the patient or user. The materials that comprise these parts, their location within the proposed (LF2019) device, and full biocompatibility information were identified in the original premarket submission for the LF2019 device (K173281).

## Comparison of Technological Characteristics with the Predicate Device

The LigaSure™ Exact Dissector. Nano-coated (LF2019) device is unchanged from the predicate device, as cleared under K173281, in terms of intended use, design, performance and technological characteristics. The only difference is that the indications for use have been updated to include breast procedures.

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| Characteristic | Subject Device<br>LigaSure™ Exact Dissector, Nano-coated<br>(LF2019) | Predicate Device<br>LigaSure™ Exact Dissector, Nano-<br>coated (LF2019) [K173281] | Results<br>(compared to<br>predicate) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Classification Regulation | 878.4400 | 878.4400 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Indications for Use | The LigaSure Sealer/Divider is a bipolar<br>electrosurgical instrument intended for use in<br>open surgical procedures where ligation and<br>division of vessels, tissue bundles, and<br>lymphatics is desired. The LigaSure Sealer/<br>Divider can be used on vessels (arteries and<br>veins) up to and including 7 mm. It is<br>indicated for use in general surgery and in<br>such surgical specialties as urologic, thoracic,<br>plastic, and reconstructive. Procedures may<br>include, but are not limited to, bowel<br>resections, gall bladder procedures, Nissen<br>fundoplication, breast procedures, and<br>adhesiolysis.<br>The instrument is also indicated for open ENT<br>procedures in adults (thyroidectomy, radical<br>neck dissection, parotidectomy, and<br>tonsillectomy) for ligation and division of<br>vessels, lymphatics and tissue bundles 2-3 mm<br>away from unintended thermally-sensitive<br>structures such as nerves and parathyroid<br>glands.<br>The LigaSure system has not been shown to<br>be effective for tubal sterilization or tubal<br>coagulation for sterilization procedures. Do<br>not use the LigaSure system for these<br>procedures. | The LigaSure Sealer/Divider is a bipolar<br>electrosurgical instrument intended for use<br>in open surgical procedures where ligation<br>and division of vessels, tissue bundles,<br>and lymphatics is desired. The LigaSure<br>Sealer/ Divider can be used on vessels<br>(arteries and veins) up to and including 7<br>mm. It is indicated for use in general<br>surgery and in such surgical specialties as<br>urologic, thoracic, plastic, and<br>reconstructive. Procedures may include,<br>but are not limited to, bowel resections,<br>gall bladder procedures, Nissen<br>fundoplication and adhesiolysis.<br>The instrument is also indicated for open<br>ENT procedures in adults (thyroidectomy,<br>radical neck dissection, parotidectomy,<br>and tonsillectomy) for ligation and<br>division of vessels, lymphatics and tissue<br>bundles 2-3 mm away from unintended<br>thermally-sensitive structures such as<br>nerves and parathyroid glands.<br>The LigaSure system has not been shown<br>to be effective for tubal sterilization or<br>tubal coagulation for sterilization<br>procedures. Do not use the LigaSure<br>system for these procedures. | Addition of<br>surgical<br>specialties and<br>procedures,<br>same intended<br>use |
| Contraindications | None | None | Same |
| Maximum Vessel<br>Diameter | 7 mm | 7 mm | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization Method | EtO | EtO | Same |
| Packaging | HDPE die cut card in a Tyvek/Nylon pouch | HDPE die cut card in a Tyvek/Nylon<br>pouch | Same |
| Energy Type | Electrical (RF) bipolar energy | Electrical (RF) bipolar energy | Same |
| Compatible Energy<br>Platform* | ForceTriad energy platform<br>(K110268)<br>Valleylab™ LS10 (K143654)<br>Valleylab™ FT10 (K191601) | ForceTriad energy platform<br>(K110268)<br>Valleylab™ LS10 (K143654)<br>Valleylab™ FT10 (K191601) | Same |
| Energy Activation | Handswitch or footswitch | Handswitch or footswitch | Same |
| Hand-activated Button<br>Design | Two-stage | Two-stage | Same |
| Proprietary Connector | Yes | Yes | Same |
| Corded | Yes | Yes | Same |
| Jaw Type | Bilateral | Bilateral | Same |
| Jaw Shape | Curved | Curved | Same |
| Instrument Design | Hemostat style | Hemostat style | Same |

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#### Performance Data

No design or specification changes are associated with the expanded indication of the LigaSure™ Exact Dissector, Nano-coated (LF2019) device. Evidence of safety and effectiveness was presented in the previously submitted 510(k) and includes the following:

- Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2
- . Biocompatibility (ISO 10993-1)
- Device functionality
- Bench burst pressure
- In vivo acute and chronic animal studies

## Relevance of Reference Predicate Device

The LF1212A LigaSure™ Curved, Small Jaw Open Vessel Sealer/Divider is used as a reference device in this submission. This is a valid reference device because it is used for the same intended use as the subject device and it uses the same principle of operation. It is very similar to the LigaSure™ Exact in terms of design and materials. It served as the predicate device for the initial clearance of the LigaSure Exact in premarket notification K173281.

The purpose of the reference device in this submission is to provide reference data for hemostasis performance and thermal spread in a LigaSure™ device for which there is a substantial body of literature showing successful use in breast procedures. The performance comparison between the LigaSure™ Exact and the LigaSure™ Curved Small Jaw supports the conclusion that the published data can be extrapolated to the LigaSure™ Exact device.

## Clinical Literature Summary

A study of literature for breast procedures performed using LigaSure™ devices show that the hemostatstyle open LigaSure™M devices have been used successfully in breast procedures including mastectomy, flap reconstruction, and axillary lymph node dissection. The safety and effectiveness outcomes reported in the literature were associated with effective hemostasis, operative time, blood, thermal damage, and intraoperative and postoperative complications, the same types of outcomes that are reported for other surgical procedures carried out with LigaSure™ devices. There are no new risk concerns for the LigaSure™ Exact Dissector, Nano-coated (LF2019) device when used to perform these procedure types. LigaSure™ technology performed well in the published studies.

## Conclusions

The proposed LigaSure™ Exact Dissector. Nano-coated (LF2019) device for use in breast surgical procedures is substantially equivalent to the predicate LigaSure™ Exact Dissector, Nano-coated (LF2019) for its indicated use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. The previously conducted bench and animal studies and clinical literature discussed in this submission have demonstrated that the device is suitable for the proposed expanded indications and that no new safety issues are identified with these indications.