The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation 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 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.

Device Description

The LigaSure™ Blunt Tip Sealer/Divider, Nano-coated (LF18XX) devices are sterile, single-use, coated, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. The proposed devices come in three shaft lengths 23 cm (LF1823), 37 cm (LF1837), and 44 cm (LF1844). 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

Here's a breakdown of the acceptance criteria and study information for the Ligasure Blunt Tip, Sealer/Divider, Nano-coated (K162941) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that various tests were conducted to demonstrate "equivalent performance" or that the devices "performed as expected" or "similarly" to the predicate devices. The acceptance criteria for each test inherently relate to achieving this equivalence or expected performance.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1	Devices met required standards for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Materials Mediated Pyrogenicity, Hemolysis.
Electrical Safety and EMC	Compliance with ANSI AAMI ES 60601-1, IEC 60601-2-2, IEC 60601-1-2	Devices complied with relevant clauses of these standards.
Mechanical/Functional Testing	Performed as expected (functional and design specifications met)	Verified performance for Jaw force, Jaw gap, Device resistance, capacitance, and inductance, Jaw Hyper-Extension, Bench Grasping Performance, Device Cycle Test.
Ex-vivo Vessel Burst Pressure	Equivalent performance to predicate devices	Showed equivalent performance between subject and predicate devices.
Acute Animal Study	Equivalent sealing performance and lateral thermal damage to predicate devices. Thermal safety evaluated.	Subject devices performed equivalently to the predicate devices.
Chronic Animal Study	Maintenance of chronic hemostasis for 21 days.	All animals survived 21 days post-op and all seals maintained chronic hemostasis.

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

Biocompatibility: Not specified.
Electrical Safety and EMC: Not specified.
Mechanical/Functional Testing: Not specified.
Ex-vivo Vessel Burst Pressure: Not specified, but involved "excised fresh porcine renal arteries and lymphatics." This suggests in vitro testing using animal tissue. Data provenance is therefore in vitro (animal tissue).
Acute Animal Study: Not specified, but involved "porcine" subjects. This is a prospective animal study. Data provenance is in vivo (animal).
Chronic Animal Study: Not specified, but involved "animals" that survived 21 days post-op (implying a controlled in vivo study). Data provenance is in vivo (animal).

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

There is no mention of human experts being used to establish ground truth for any of the performance tests. The evaluation appears to be based on objective measurements and experimental outcomes (e.g., burst pressure, thermal damage assessment, hemostasis over time).

4. Adjudication Method for the Test Set

Not applicable, as no human readers or subjective assessments requiring adjudication are described for establishing ground truth in the performance tests.

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 assistive tool. Therefore, no MRMC studies or human reader improvement with AI are relevant. The 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

Not applicable. This device is not an algorithm, but a physical electrosurgical instrument. Its performance is inherent to its hardware and function, not software.

7. The Type of Ground Truth Used

Biocompatibility: Established through standardized in vitro tests according to ISO 10993-1.
Electrical Safety and EMC: Established through compliance with specific electrical and EMC standards.
Mechanical/Functional Testing: Established through objective measurements against design specifications.
Ex-vivo Vessel Burst Pressure: Established through direct measurement of burst pressure in ex-vivo animal tissue samples.
Acute Animal Study: Established through direct observation and measurement of sealing performance and lateral thermal damage in in vivo animal models.
Chronic Animal Study: Established through direct observation of animal survival and maintenance of hemostasis over 21 days in in vivo animal models.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

Summary

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

November 14, 2016

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

Re: K162941

Trade/Device Name: Ligasure Blunt Tip, Sealer/Divider, Nano-coated (LF1823, LF1837, LF1844) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 20, 2016 Received: October 21, 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 803); good manufacturing practice requirements as set forth in

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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 (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 yours,

Jennifer R. Stevenson -A

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

510(k) Number (if known) K162941

Device Name

Ligasure™ Blunt Tip Sealer/Divider, Nano-coated (LF1823, LF1837, LF1844)

Indications for Use (Describe)

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)
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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: 11/3/2016

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

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

Name of Device

Trade Name:	LigaSure™ Blunt Tip Sealer/Divider, Nano-coated (LF1823, LF1837, LF1844)
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™ Blunt Tip Sealer/Divider (LF1623, LF1637, LF1644)
Common Name:	Bipolar Vessel Sealing Device
510(k) Number:	K130744 (cleared 04/05/2013), K141153 (cleared 8/14/2014), K142929(cleared 01/27/2015)
Manufacturer:	Covidien
Reference Devices
Trade Name:	LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider, Nano-coated (LF4418)
Common Name:	Bipolar Vessel Sealing Device
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR878.4400, Class II, GEI)
510(k) Number:	K162047
Manufacturer:	Covidien

Device Description

Indications for Use

The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and

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K162941

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 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.

Comparison of Technological Characteristics with the Predicate Device

The application of radio frequency (RF) energy to target tissue is fundamental technology 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 differences between the subject and predicate devices are the addition of a non-stick coating to the jaws of the proposed devices and the replacement of the ceramic dots on the predicate jaw sealplates with DuPont LF500 ceramic dots.

Performance Data

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

Biocompatibility

The biocompatibility evaluation for the LigaSure™ Blunt Tip Sealer/Divider, Nano-coated devices 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:

Cytotoxicity
Sensitization ●
Irritation ●
Systemic Toxicity
Materials Mediated Pyrogenicity .
. Hemolysis

Electrical Safety and Electromagnetic Compatibility (EMC)

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 devices performed as expected.

. Jaw force
. Jaw gap
Device resistance, capacitance, and inductance .
. Jaw Hyper-Extension
Bench Grasping Performance ●
Device Cycle Test

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Ex-vivo Vessel Burst Pressure

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

Acute Animal Study

In the animal study conducted, 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. These studies demonstrated that the subject devices performed equivalently to the predicate devices.

Chronic Animal Study

A chronic study was conducted to assess seal quality over the course of 21 days. 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.

Summarv

Based on the preclinical performance as documented in the performance testing, the LigaSure™ Blunt Tip Sealer/Divider, Nano-coated devices were found to have a safety and effectiveness profile that is similar to the predicate devices.

Conclusions

The subject devices have the same indications for use as the legally marketed predicate devices. Furthermore, design changes made to introduce the subject devices do not raise different kinds of safety and effectiveness questions. Verification and validation data support substantial equivalence of the modified LigaSure™ Blunt Tip Sealer/Divider, Nano-coated devices to the legally marketed predicate devices.

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.