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 specialities 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 (LF1623, LF1644) devices are sterile (EtO), single-use, 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 open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. 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

This document describes the testing and performance of the LigaSure™ Blunt Tip Sealer/Divider. However, it does not contain explicit "acceptance criteria" presented as quantitative thresholds that the device must meet, nor does it present the "reported device performance" in a structured table directly compared to such criteria for many of the tests.

Instead, the document primarily focuses on verifying that the new shaft lengths of the LigaSure™ Blunt Tip Sealer/Divider devices perform as expected and are substantially equivalent to the predicate device (LigaSure™ Blunt Tip Laparoscopic Sealer/Divider). The studies described are for demonstrating this equivalence and safety, rather than proving performance against specific pre-defined quantitative acceptance criteria in a format typical for AI/software device evaluation.

Here's an attempt to extract and present the information you requested, highlighting where specific details are missing for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for most of the tests in a table, nor does it provide specific numerical performance results for the device against such criteria. Instead, it generally states that tests were conducted and the device "performs as expected" or "met the predefined acceptance criteria" (for the animal study), or that it has a "safety and effectiveness profile that is similar to the predicate device."

Test Category	Acceptance Criteria (as implied/stated)	Reported Device Performance (as stated or implied)
Biocompatibility	Compliance with ISO 10993-1 and specific tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis).	Evaluation conducted; implied to have passed as it supports substantial equivalence.
Electrical Safety & EMC	Compliance with relevant portions of IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18 for electrical safety and IEC 60601-1-2 for EMC.	The system complies with the mentioned standards.
Mechanical/Functional Testing	Device with new shaft lengths perform as expected (for Jaw force, Jaw gap, Device resistance, capacitance, and inductance, Knife deployment force, Lever latching/unlatching/opening force). Implied to be comparable to the predicate.	Testing carried out to verify that the devices with the new shaft lengths perform as expected. No specific numerical values are given.
Ex-vivo Vessel Burst Pressure	To demonstrate bipolar electrosurgical vessel sealing performance comparable to the predicate device.	Testing conducted on both subject and predicate devices. Implied to show comparable performance supporting substantial equivalence.
Thermal Profile	To evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate. Implied: demonstrate comparable thermal characteristics.	Bench thermal profile testing conducted. Implied to show comparable thermal profiles demonstrating substantial equivalence.
Acute Animal Study	Predefined acceptance criteria for hemostasis rates; thermal safety evaluated by macroscopic and histological evaluation to demonstrate that subject devices are as safe and effective as the predicate.	Hemostasis rates met the predefined acceptance criteria. Macroscopic and histological evaluation demonstrated that the subject devices are as safe and effective as the predicate device.
Human Factors and Usability	Compliance with IEC 62366:2007; analysis of user needs and potential use errors; testing to demonstrate representative users can use instruments safely and correctly. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	The usability engineering process applied was in compliance and followed by testing to demonstrate safe and correct use by representative users.

Study Details:

Sample sizes used for the test set and the data provenance:
- Biocompatibility: Not specified beyond "patient-contacting materials" being tested.
- Electrical Safety & EMC: Not specified.
- Mechanical/Functional Testing: Not specified.
- Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal, pulmonary arteries, and lymphatics." The number of samples/vessels is not specified.
- Acute Animal Study: "one female pig" was used.
- Chronic Animal Study: Not applicable to a new study; results from K130744 were carried over due to device similarity.
- Human Factors and Usability: "representative users" were used, but the number is not specified.
- Data Provenance:
  - Ex-vivo: Porcine tissue.
  - Acute Animal Study: Porcine.
  - Other tests (Mechanical, Electrical, Biocompatibility): Likely conducted in a laboratory setting (in-house or contracted).
  - All studies are prospective for the K142929 submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is more pertinent to diagnostic AI devices. For this electrosurgical device, "ground truth" would be established through direct physical measurements, observation of physiological responses (e.g., hemostasis), or pathological evaluation, rather than human expert interpretation of images/data.
- Acute Animal Study: "Macroscopic and histological evaluation of the tissue that was sealed and divided" was performed. These evaluations would typically be done by veterinary pathologists or trained researchers, but their number and specific qualifications are not detailed in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device's testing. Ground truth for performance (e.g., burst pressure, hemostasis, thermal damage) is determined by direct physical measurement, observation, or histological analysis, not by human reader consensus/adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the AI as an aid. The LigaSure™ Blunt Tip Sealer/Divider is a surgical tool, not a diagnostic AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a hand-held surgical instrument requiring human operation. It does not contain an "algorithm" in the sense of an AI or diagnostic software that could perform "standalone." Its performance is always in the context of human use. The document explicitly states, "The proposed devices do not contain software."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Laboratory testing results based on established international standards.
- Electrical Safety & EMC: Measurements against specified standard limits.
- Mechanical/Functional Testing: Direct physical measurements (e.g., force, gap, resistance).
- Ex-vivo Vessel Burst Pressure: Measured burst pressure values of sealed vessels.
- Acute Animal Study: Direct observation of hemostasis and pathological evaluation (macroscopic and histological) of tissue for thermal damage.
- Human Factors and Usability: Observational studies of user interaction and performance of tasks.
The sample size for the training set:
- The LigaSure™ Blunt Tip Sealer/Divider is a hardware electrosurgical device, not an AI or software algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on engineering principles and prior validated predicate devices.
How the ground truth for the training set was established:
- As there is no training set for an AI/software algorithm, this question is not applicable. The functional performance of the device's design is established through engineering design, material science, and testing as described.

Summary

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

January 27, 2015

Covidien Celso Duran Product Associate, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301

Re: K142929

Trade/Device Name: LigaSure™ Blunt Tip Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 25, 2014 Received: November 26, 2014

Dear 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

for

Sincerely yours,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name LigaSure™ Blunt Tip Sealer/Divider

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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510(k) Summary Date summary prepared: 1/27/2015

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Celso Duran Product Associate, Regulatory Affairs Telephone: 303-530-6445 Fax: 303-530-6313 Email: Celso.Duran@Covidien.com

Name of Device

Trade Name:	LigaSure™ Blunt Tip Sealer/Divider
Catalog Numbers:	LF1623, LF1644
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 Laparoscopic Sealer/Divider
Common Name:	Bipolar Vessel Sealing Device
Catalog Number:	LF1637
510(k) Number:	K130744 (cleared 4/17/2013), 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

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 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 specialities as

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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 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 differences between the subject and predicate devices are the length of the shaft.

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 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 tests:

. Cytotoxicity
. Sensitization
Irritation .
Systemic Toxicity ●
Hemolysis

The patient-contacting materials are: stainless steel, ceramic; and polymers including ETFE, polycarbonate, polyamide, polyester, polypthalamide, ABS, and thermoplastic elastomer.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety testing and EMC testing were conducted on the LigaSure™ Blunt Tip Sealer/Divider devices. The system complies with relevant portions of the IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 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 devices with the new shaft lengths perform as expected.

Jaw force
Jaw gap
. Device resistance, capacitance, and inductance
. Knife deployment force

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. 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.

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, one female pig underwent various procedures to assess acute sealing performance and lateral thermal damage by the subject and predicate devices. Hemostasis rates met the predefined acceptance criteria.

The thermal safety of the new LigaSure™ Blunt Tip Sealer/Divider devices 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

Because of similarity to the previously cleared design, the chronic animal study results reported in K130744 are valid for these devices.

Human Factors and Usability

The usability engineering process applied to these products was in compliance with the requirements of IEC 62366:2007 "Medical devices – Application of usability engineering to medical devices", as recognized by FDA. The process included analysis of user needs and potential use errors. This was followed by testing to demonstrate that representative users can use the instruments safely and correctly.

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™ Blunt Tip Sealer/Divider devices were found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusions

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

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.