LigaSure Exact Dissector, Nano-coated

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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). 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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 {2}------------------------------------------------ #### 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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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: 720-361-5290 Fax: 303-530-6313 Email: nancy.k.sauer@medtronic.com ## 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ | 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 | {6}------------------------------------------------ #### 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.