(175 days)
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, 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.
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.
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.
The provided text describes the 510(k) summary for the "LigaSure™ Exact Dissector, Nano-coated" device (K202917). This submission is for an expanded indication for use (inclusion of breast procedures) for a device previously cleared under K173281. The central argument is that the device itself is unchanged from the predicate, and therefore, previously conducted studies and comparable literature support the expanded indication.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance values. Instead, it refers to prior testing and literature as evidence of safety and effectiveness for a device that is mechanically and technologically identical to its predicate. The expanded indication for "breast procedures" is supported by showing that similar LigaSure™ devices have been successfully used in these procedures without new safety concerns.
The comparison table provided (page 5) focuses on technological characteristics for substantial equivalence to the predicate device, not on quantitative performance against pre-defined acceptance criteria for the new indication.
2. Sample size used for the test set and the data provenance
- Test Set Description: The document states, "No design or specification changes are associated with the expanded indication of the LigaSure™ Exact Dissector, Nano-coated (LF2019) device." This implies that no new test set was generated specifically for this submission beyond what was previously submitted for K173281, as the device itself is unchanged.
- Data Provenance: The new expanded indication relies on "Clinical Literature Summary" for breast procedures. The literature pertains to "hemostat-style open LigaSure™ devices," which are similar to the subject device. The provenance of this literature would be varied (e.g., various countries of origin, likely retrospective and prospective studies published in medical journals). No specific sample size for a "test set" in the context of a new study for K202917 is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new primary test set or ground truth establishment process is described for this 510(k) submission. The submission relies on previously established performance data from the predicate device (K173281) and findings from existing clinical literature.
4. Adjudication method for the test set
Not applicable, as no new primary test set or adjudication process is described for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrosurgical instrument, not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical instrument, not an algorithm.
7. The type of ground truth used
The notion of "ground truth" as typically applied to diagnostic AI algorithms does not directly apply here. Instead, the submission relies on:
- Established Performance: Previous bench and animal studies (from K173281).
- Clinical Outcomes Data: From existing clinical literature on similar LigaSure™ devices in breast procedures, demonstrating "effective hemostasis, operative time, blood, thermal damage, and intraoperative and postoperative complications."
8. The sample size for the training set
Not applicable. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI algorithm that requires a training set.
Summary of Device Performance and Rationale for Acceptance:
The device (LigaSure™ Exact Dissector, Nano-coated) is being cleared for an expanded indication to include "breast procedures." The submission's core argument for acceptance is based on substantial equivalence to its own predicate device (also LigaSure™ Exact Dissector, Nano-coated, cleared under K173281) and a reference device (LigaSure™ Curved, Small Jaw, Open Sealer/Divider, K152286).
The key points are:
- Identical Device: The subject device is unchanged from its predicate in terms of intended use, design, performance, and technological characteristics. The only difference is the updated "indications for use" to include breast procedures.
- Prior Performance Data: Evidence of safety and effectiveness for the device's fundamental operation was presented in the original 510(k) (K173281), including:
- Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 (electrical safety, EMC)
- Biocompatibility (ISO 10993-1)
- Device functionality
- Bench burst pressure
- In vivo acute and chronic animal studies
- Clinical Literature Summary: To support the expanded indication for breast procedures, a review of clinical literature was conducted. This literature demonstrates that "hemostat-style open LigaSure™ devices" (including the reference device, which was the predicate for the original LigaSure Exact) have been successfully used in breast procedures. The outcomes reported (hemostasis, operative time, blood loss, thermal damage, complications) were consistent with other surgical procedures performed with LigaSure™ devices.
- Conclusion: The manufacturer concludes that, since the device itself is identical to its cleared predicate and literature supports the safe and effective use of similar LigaSure™ technology in breast procedures, no new safety issues are identified, and the device is suitable for the proposed expanded indications.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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: 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(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(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(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 DeviceLigaSure™ Exact Dissector, Nano-coated(LF2019) | Predicate DeviceLigaSure™ Exact Dissector, Nano-coated (LF2019) [K173281] | Results(compared topredicate) |
|---|---|---|---|
| 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 bipolarelectrosurgical instrument intended for use inopen surgical procedures where ligation anddivision of vessels, tissue bundles, andlymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries andveins) up to and including 7 mm. It isindicated for use in general surgery and insuch surgical specialties as urologic, thoracic,plastic, and reconstructive. Procedures mayinclude, but are not limited to, bowelresections, gall bladder procedures, Nissenfundoplication, breast procedures, andadhesiolysis.The instrument is also indicated for open ENTprocedures in adults (thyroidectomy, radicalneck dissection, parotidectomy, andtonsillectomy) for ligation and division ofvessels, lymphatics and tissue bundles 2-3 mmaway from unintended thermally-sensitivestructures such as nerves and parathyroidglands.The LigaSure system has not been shown tobe effective for tubal sterilization or tubalcoagulation for sterilization procedures. Donot use the LigaSure system for theseprocedures. | The LigaSure Sealer/Divider is a bipolarelectrosurgical instrument intended for usein open surgical procedures where ligationand division of vessels, tissue bundles,and lymphatics is desired. The LigaSureSealer/ Divider can be used on vessels(arteries and veins) up to and including 7mm. It is indicated for use in generalsurgery and in such surgical specialties asurologic, thoracic, plastic, andreconstructive. Procedures may include,but are not limited to, bowel resections,gall bladder procedures, Nissenfundoplication and adhesiolysis.The instrument is also indicated for openENT procedures in adults (thyroidectomy,radical neck dissection, parotidectomy,and tonsillectomy) for ligation anddivision of vessels, lymphatics and tissuebundles 2-3 mm away from unintendedthermally-sensitive structures such asnerves and parathyroid glands.The LigaSure system has not been shownto be effective for tubal sterilization ortubal coagulation for sterilizationprocedures. Do not use the LigaSuresystem for these procedures. | Addition ofsurgicalspecialties andprocedures,same intendeduse |
| Contraindications | None | None | Same |
| Maximum VesselDiameter | 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/Nylonpouch | Same |
| Energy Type | Electrical (RF) bipolar energy | Electrical (RF) bipolar energy | Same |
| Compatible EnergyPlatform* | ForceTriad energy platform(K110268)Valleylab™ LS10 (K143654)Valleylab™ FT10 (K191601) | ForceTriad energy platform(K110268)Valleylab™ LS10 (K143654)Valleylab™ FT10 (K191601) | Same |
| Energy Activation | Handswitch or footswitch | Handswitch or footswitch | Same |
| Hand-activated ButtonDesign | 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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.