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, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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.

Device Description

The LigaSure Impact™ Curved, Large Jaw. Open Sealer/Divider, Nano-coated (LF4418) is a sterile, single-use, coated, hand-held bipolar vessel sealing device designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, pulmonary arteries/veins, and lymphatics during open general surgical procedures (as indicated). A hand actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not contain software.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than to independently prove safety and effectiveness against specific acceptance criteria. Therefore, the document does not contain a typical "acceptance criteria" table with reported device performance metrics in the way one might expect for a de novo device.

Instead, the submission focuses on demonstrating that the new device, which has a non-stick coating added to its jaws, performs comparably to its predicate device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider without the nano-coating) across various performance aspects. The "acceptance criteria" here are implicitly that the new device should not introduce new safety or effectiveness concerns and should perform at least as well as the predicate.

Here's an attempt to structure the information based on the provided text, while acknowledging the limitations of a 510(k) submission not explicitly stating quantifiable acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, explicit quantitative acceptance criteria for each test are not provided in the document. The acceptance criterion is implicitly that the subject device (with nano-coating) should perform comparably to the predicate device (without nano-coating) and not raise new safety or effectiveness questions.

Category	Acceptance Criteria (Implicit from 510(k) Context)	Reported Device Performance (Subject Device vs. Predicate)
Biocompatibility	Pass all relevant ISO 10993-1 tests, showing no adverse biological reactions.	The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Hemolysis tests. Implied: All tests passed, demonstrating acceptable biocompatibility.
Electrical Safety	Comply with ANSI AAMI ES 60601-1 and IEC 60601-2-2 standards.	Electrical safety testing was conducted. Implied: The system complies with relevant clauses of ANSI AAMI ES 60601-1 and IEC 60601-2-2.
EMC	Comply with IEC 60601-1-2 standard.	EMC testing was conducted. Implied: The system complies with IEC 60601-1-2.
Mechanical/Functional	Perform as expected for key mechanical and electrical characteristics (e.g., jaw force, jaw gap, rotation, resistance).	Mechanical, electrical, and functional testing was carried out, including: Jaw force, Jaw gap, Shaft/Jaw Rotation, Device resistance, capacitance, and inductance, Lever latching/unlatching/opening force. Implied: The device performed as expected and comparably to the predicate.
Ex-vivo Vessel Burst Pressure	Demonstrate bipolar electrosurgical vessel sealing performance comparable to the predicate device on various vessels.	Ex-vivo burst pressure testing of excised fresh porcine renal, pulmonary arteries, and lymphatics was conducted on both the subject and predicate devices. Implied: Performance was comparable between the subject and predicate devices, demonstrating equivalent vessel sealing performance.
Thermal Profile	Exhibit a thermal profile (jaw and shaft) comparable to the predicate device, indicating no new thermal safety concerns.	Bench thermal profile testing using porcine tissue was conducted to evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate. Implied: The thermal profile was comparable, indicating similar thermal safety.
Acute Animal Study	Assess acute sealing performance and lateral thermal damage, and demonstrate safety and effectiveness comparable to the predicate.	Two female porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. Evaluation included macroscopic and histological assessment. Reported: These studies demonstrated that the subject devices are as safe and effective as the predicate device.
Chronic Animal Study	Assess seal quality over 21 days, demonstrating maintenance of chronic hemostasis.	A chronic study on five animals was conducted to assess seal quality over 21 days. Reported: All animals survived 21 days post-op and all seals maintained chronic hemostasis. (The comparison to the predicate is implicit; the predicate is established as effective, and this study confirms the subject device's long-term effectiveness in an animal model.)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly delineate what constitutes a "test set" in the context of device approval, as various tests are performed. However, for the animal studies:

Acute Animal Study: Two female porcine were used.
Chronic Animal Study: Five animals (porcine, based on prior mention of porcine tissue) were used.
Ex-vivo Vessel Burst Pressure and Thermal Profile: "Excised fresh porcine renal, pulmonary arteries, and lymphatics" and "porcine tissue" were used, respectively. The sample size for these ex-vivo/bench tests is not specified.
Data Provenance: The origin of the animal and tissue data is preclinical testing (animal and ex-vivo studies). The document does not specify the country of origin, but it is typically conducted by or for the manufacturer, Covidien, based in Boulder, Colorado, USA. The data is prospective with respect to the tests conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish "ground truth" for the preclinical test results.
For the animal studies, "macroscopic and histological evaluation" was performed. This implies assessment by veterinary pathologists or similar experts, but their number and specific qualifications are not mentioned. In a 510(k) submission for a device of this nature, the ground truth for performance characteristics (like burst pressure, thermal damage, hemostasis) is typically established through objective measurements and accepted scientific and histopathological evaluation methodologies rather than subjective expert consensus, as might be the case for image-based diagnostic AI.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set. This type of adjudication is typically relevant for studies involving human interpretation (e.g., medical image reading), which is not the primary focus of the performance tests for this electrosurgical device. The evaluation of test results (e.g., burst pressure measurements, histological findings) is based on objective criteria and standard scientific/pathological assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an electrosurgical instrument, not a diagnostic imaging device that involves human interpretation of medical cases. Comparative effectiveness was demonstrated through preclinical performance testing between the subject device and the predicate device. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated is a physical electrosurgical instrument operated by a human surgeon; it does not contain an algorithm or AI that operates in a "standalone" or "human-in-the-loop" fashion. The device description explicitly states: "The proposed devices do not contain software."

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests was established through:

Objective Measurements: For electrical safety, EMC, mechanical/functional tests (e.g., jaw force, resistance), and ex-vivo burst pressure.
Biological/Pathological Evaluation: For biocompatibility tests (e.g., cytotoxicity, sensitization), thermal profile assessment (using porcine tissue), and animal study outcomes (macroscopic and histological evaluation of tissue for sealing performance, lateral thermal damage, and chronic hemostasis).

There is no pathology used in the sense of diagnosing a disease from a biopsy, but rather in the sense of macroscopic and microscopic evaluation of tissue changes as a result of the device's action. Outcomes data in the animal studies included survival and maintenance of chronic hemostasis.

8. The Sample Size for the Training Set

This question is not applicable to this device. As noted previously, the device does not contain software or AI components that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable to this device, as there is no training set.

Summary

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

September 15, 2016

Covidien Mr. Celso Duran Specialist, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301

Re: K162047

Trade/Device Name: LigaSure Impact Curved, Large Jaw, Open Sealer/divider, Nanocoated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 31, 2016 Received: September 1, 2016

Dear Mr. Duran:

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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely.

Christopher J. Ronk-S

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

Enclosure

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Indications for Use

Page 1 of 1

510(k) Number (if known) K162047

Device Name

LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, 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, veins, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc.

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)

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510(k) Summary Date summary prepared: 8/17/2016

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Celso Duran Specialist, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: celso.duran@medtronic.com

Name of Device

Trade Name:	LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated
Catalog Numbers:	LF4418
Common Name:	Bipolar Vessel Sealing Device
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR878.4400, Class II, GEI)

Predicate Device

Trade Name:	LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider
Catalog Number:	LF4318
Common Name:	Bipolar Vessel Sealing Device
510(k) Number:	K123444 (cleared 1/30/2013), K141153 (cleared 8/14/2014)
Manufacturer:	Covidien
Recalls:	This device has not been subject to a design-related recall

No reference devices were used in this submission.

Device Description

Indications for Use

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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 application of radio frequency (RF) energy is the principle for both the subject and predicate devices. A seal is created by application of RF energy to structures (vascular and lymphatics) interposed between the jaws of the instrument. A blade within the instrument is user actuated to divide tissue after the seal is created. At a high level, the subject and predicate devices are based on the following same technological elements:

Bilateral jaws – used to reach target structures (vascular and lymphatics)
Lever -- incorporates a latch mechanism to hold the jaws in the closed position
Activation button allows RF energy to be activated by the user ●
Cutting trigger allows user to divide (cut) sealed structures .

The only difference between the subject and predicate devices is the addition of a non-stick coating to the jaws of the proposed device.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated device was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
Sensitization
Irritation .
. Systemic Toxicity
o Hemolysis

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety testing and EMC testing was conducted on the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated device. The system complies with relevant clauses of the ANSI AAMI ES 60601-1 and IEC 60601-2-2 standards for electrical safety and IEC 60601-1-2 standard for EMC.

Mechanical / Functional Testing

Mechanical, electrical, and functional testing was carried out to verify that the proposed device performed as expected.

Jaw force
Jaw gap
Shaft/Jaw Rotation ●
Device resistance, capacitance, and inductance ●
Lever latching/unlatching/opening force .

Ex-vivo Vessel Burst Pressure

Ex-vivo burst pressure testing of excised fresh porcine renal, pulmonary arteries, and lymphatics was conducted on both the subject and predicate devices to demonstrate bipolar electrosurgical vessel sealing performance.

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Thermal Profile

Bench thermal profile testing using porcine tissue was conducted to evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate.

Acute Animal Study

In the animal study conducted, two female porcine underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. The thermal safety of the new device was evaluated by macroscopic and histological evaluation of the tissue that was sealed and divided. These studies demonstrated that the subject devices are as safe and effective as the predicate device.

Chronic Animal Study

A chronic study on five animals to assess seal quality over the course of 21 days was conducted. All animals survived 21 days post-op and all seals maintained chronic hemostasis.

Clinical Studies

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

Summary

Based on the preclinical performance as documented in the performance testing, the LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated device was found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusions

The subject device has the same indications for use as the legally marketed predicate device. Furthermore, design change made to introduce the coated device does not raise different kinds of safety and effectiveness questions. Verification and validation data support substantial equivalence of the modified LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nanocoated devices to the legally marketed predicate device.

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Regulation Number and Section

§ 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.