The LigaSure™ Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.

The device is also indicated for open ENT procedures in adults (thyroidectorny, radical neck dissection, parotidectorny, and tonsillectorny) 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.

Device Description

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue.

LigaSure instruments attach to the generator with a ten-foot containing a "smart" connector. This connector functions as a unique product identifier for device-specific recognition by the generator. The Curved, Small Jaw, Open Sealer/Divider instrument is designed to be both ergonomic and intuitive for the user. Its hemostat-style body and symmetrically placed controls facilitate handling by both left and righthanded users, and its small, curved jaws maximize visibility and access when the instrument is used in confined surgical spaces.

Ring handles function to allow the user to grasp tissue by opening and closing the jaws of the instrument. The interior surfaces of the jaws contain the electrodes, which serve to ligate by delivering energy to the grasped tissue. RF energy can be activated by the user in two ways: (1) through the use of a single button incorporated into the handle body or (2) through the use of a footswitch attached to the generator. A cutting mechanism functions to mechanically divide tissue following tissue fusion. It consists of a stainless steel blade and is controlled by the user through a trigger located on the handle body.

AI/ML Overview

The device in question is the LigaSure™ Curved, Small Jaw, Open Sealer / Divider (LF1212) by Covidien, a bipolar electrosurgical instrument. The purpose of this submission (K113572) is to expand its indications for use to include ENT procedures and remove a warning regarding specific surgical procedures requiring precision. There are no physical changes to the device itself; the design remains the same as its predicate (K102470).

This 510(k) summary does not use a typical "acceptance criteria" table in the form of specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various performance characteristics. For a device like an electrosurgical instrument, "acceptance criteria" are implicitly met if its performance is comparable to or better than previously cleared, substantially equivalent devices, particularly regarding safety and effectiveness.

Here's an interpretation of the performance data and how it addresses the 'acceptance criteria' in the context of substantial equivalence:

1. Table of "Acceptance Criteria" (interpreted as performance comparison to predicates) and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (LigaSure LF1212)
Burst Pressure	Equivalent or superior mean burst pressure on isolated vessels to predicate devices (LigaSure™ Curved, Small Jaw, Open Sealer/Divider (K102470) and LigaSure™ Precise Instrument Vessel Sealing System (K010010)).	"The subject device was shown to yield higher mean burst pressures on isolated vessels than the predicates."
Thermal Profile	Equivalent or superior (lower) mean temperatures after single and multiple activations compared to predicate devices.	"Thermal profile studies showed the subject device has consistently lower mean temperatures than the predicates after single and multiple activations."
Mean Thermal Spread	Comparable mean thermal spread to predicate devices for all vessel sizes evaluated.	"The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated."
Usability/Usability	Adequate assurance of safety and performance (human factors/usability) in simulated operating environments, including ENT space.	"Usability was evaluated with users in simulated operating environments, including in the ENT space. These studies consisted of several formative and one summative study, which demonstrate the instrument provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator."
Clinical Effectiveness/Safety in ENT Procedures	Demonstrable safety and effectiveness for use in ENT procedures, supported by existing clinical knowledge and experience.	"An assessment of published clinical literature demonstrates that there is a considerable body of knowledge and experience that shows the use of LigaSure instruments in ENT procedures is safe and effective." The submission also argues that "The use of the LigaSure Curved, Small Jaw, Open Sealer / Divider in ENT procedures does not raise any new types of questions of safety and effectiveness compared with the predicate devices currently used for these procedures."

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to predicates) is a preclinical bench and animal testing study combined with usability studies and a clinical literature review.

2. Sample Size and Data Provenance (for test set, relevant for bench/animal testing and usability):

Preclinical Bench Testing (Burst Pressure & Thermal Profile): The document states "Preclinical comparative bench testing... was conducted." It does not specify the exact sample size for isolated vessels or the number of activations for thermal profile tests. The data provenance is implied to be laboratory testing conducted by Covidien.
Animal Testing (Thermal Spread): The document states "Animal Testing: The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated." It does not specify the number of animals or the number of vessel seals performed. The data provenance is likely internal animal studies conducted by Covidien.
Usability / Human Factors: "These studies consisted of several formative and one summative study." It does not specify the number of users (sample size) for these studies. The data provenance is internal usability studies.

All these studies appear to be prospective in nature, as they were conducted specifically for this submission to compare the device against predicates or assess usability. The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's location and the FDA submission.

3. Number of Experts and Qualifications (for establishing ground truth for the test set):

Bench and Animal Testing: The establishment of ground truth for metrics like burst pressure, thermal profile, and thermal spread typically relies on objective physical measurements and established scientific methodologies, not expert consensus in the human interpretation sense. Therefore, the "experts" would be the scientists and engineers conducting and analyzing these objective tests, following standardized protocols. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, as this is not a diagnostic device.
Usability Studies: "Usability was evaluated with users... in the ENT space." These users are the "experts" in terms of operating the device. While their specific qualifications (e.g., "surgeon with X years of experience") are not detailed, it can be inferred that they were medical professionals (surgeons or surgical assistants) experienced in surgical procedures, likely ENT specialists given the mention of "ENT space." No specific number of experts for "ground truth setting" is given in the context of interpretation of results, as the usability studies themselves generate the data.
Clinical Literature Review: An "assessment of published clinical literature" was performed. This implies medical experts (likely regulatory affairs personnel or medical scientists within Covidien) evaluated existing peer-reviewed studies. No specific number or qualifications of these reviewers are provided.

4. Adjudication Method (for the test set):

Since the "acceptance criteria" are based on objective physical measurements (burst pressure, thermal profile, thermal spread) and directly observed usability, rather than subjective interpretations by multiple experts, a formal "adjudication method" like 2+1 or 3+1 for resolving discrepancies in expert opinions is not applicable or described. The results of bench and animal tests are typically analyzed statistically. Usability studies involve observations and feedback, rather than adjudication of 'ground truth'.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and would not be applicable for this type of device (a surgical instrument). MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess changes in diagnostic accuracy or efficiency. This device is a surgical tool, not an image interpretation or diagnostic aid. Therefore, no effect size of human readers improving with AI assistance is reported.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance study (algorithm only without human-in-the-loop) was not done and is not applicable for this device. This device is a manual surgical instrument that requires a human operator for its function; it does not contain a standalone algorithm in the sense of AI performing a task independently. The "algorithm" here refers to the energy delivery system within the ForceTriad™ platform, which is always used with the human-controlled instrument.

7. Type of Ground Truth Used:

Bench Test (Burst Pressure, Thermal Profile): The ground truth is based on objective physical measurements using scientific equipment and standardized test methods (e.g., pressure gauges, temperature probes).
Animal Testing (Thermal Spread): Ground truth is based on objective pathological assessment of tissue sections (histology) or direct macroscopic measurements of the thermal damage zone in animal models.
Usability Studies: Ground truth is based on observed user performance, task completion, and user feedback in simulated environments, assessed against predefined safety and performance metrics.
Clinical Literature: The "ground truth" for clinical safety and effectiveness in ENT procedures is derived from the published outcomes data and expert consensus within the scientific and medical literature.

8. Sample Size for the Training Set:

This device is a hardware surgical instrument, not a machine learning or AI algorithm in the typical sense that would require a "training set" for model development. The "ForceTriad™ energy platform (generator)" delivers energy, and its design would be based on engineering principles and previous device experience, not statistical learning from a "training set" of data. Therefore, the concept of a "training set" and its sample size is not applicable or addressed in this submission.

9. How Ground Truth for Training Set Was Established:

As there is no "training set" in the context of a machine learning model, the question of how its ground truth was established is not applicable. The device's 'training' or development is based on engineering design, preclinical testing, and iterative improvements, not a data-driven model training process.

Summary

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510(k) Summary

Date summary prepared: 8/29/2012

510(k) Submitter/Holder

Covidien IIc 5920 Lonabow Drive Boulder, CO 80301

Contact

John Van Hoven Sr. Associate, Regulatory Affairs Telephone: 303-476-7502 Fax: 303-516-8307 Email: john vanhoven@covidien.com

Name of Device

LigaSure™ Curved, Small Jaw, Open Sealer / Divider Trade Name: Catalog Number: LF1212 Common Name: Bipolar electrosurgical instrument Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II, GEI).

Purpose of Submission

The purpose of this submission is to modify the indications for use statement to include the specific indication to use the device in ENT procedures and to remove the warning statement surrounding specific surgical procedures around which precision is required. There were no physical changes made to the device associated with the proposed expanded indication; the device design is unchanged from that cleared under K102470.

This submission followed the "Guidance for Industry and FDA Staff. Format for Traditional and Abbreviated 510(k)s, 2005," the "Guidance for Industry on General / Specific Intended Use, 1998," and the "Draft Guidance for Industry and FDA Staff: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, 2011."

Predicate Devices

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:

Trade Name:	LigaSure™™ Curved, Small Jaw, Open Sealer/Divider
Device Common Name:	Bipolar electrosurgical instrument
Catalog Number:	LF1212
510(k) Number:	K102470 (cleared 2/7/2011)
Manufacturer:	Covidien, formerly Valleylab, a division of Tyco Healthcare
Trade Name:	LigaSure™™ Precise Instrument Vessel Sealing System
Device Common Name:	Bipolar electrosurgical instrument
Catalog Number:	LS1200
510(k) Number:	K010010 (cleared 4/2/2001)
Manufacturer:	Covidien, formerly Valleylab, a division of Tyco Healthcare

Device Description

510(k): LigaSure ™ Curved, Small Jaw, Open Sealer/Divider - LF1212

SFP 5 2012

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procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue.

Intended Use

The LigaSure™ Curved, Small Jaw, Open Sealer/Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and iymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.

The device is also indicated for open ENT procedures in adults (thyroidectorny, radical neck dissection, parotidectomy, and tonsillectomy) for ligation 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.

Technological and Performance Characteristics

The LigaSure Curved, Small Jaw, Open Sealer / Divider is the same device as the predicate K102470. The function of the device has not changed. The LigaSure Curved, Small Jaw, Open Sealer/Divider is similar in design and utilizes radio frequency (RF) technology to achieve its intended use similarly to the predicate devices.

Performance Data

The design of the LigaSure Curved, Small Jaw, Open Sealer/Divider is unchanged and the information provided in K102470 is applicable to the device subject of this submission.

Preclinical Bench Testing: Preclinical comparative bench testing for burst pressure and thermal profile was conducted with the LigaSure Curved, Small Jaw, Open Sealer/Divider and its predicates to demonstrate equivalent performance. The subject device was shown to yield higher mean burst pressures on isolated vessels than the predicates; in addition, thermal profile studies showed the subject device has consistently lower mean temperatures than the predicates after single and multiple activations.

Animal Testing: The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated.

Usability / Human Factors

Usability was evaluated with users in simulated operating environments, including in the ENT space. These studies consisted of several formative and one summative study, which demonstrate the instrument provides adequate assurance.of safety and performance (in regards to human factors/usability aspects) for the patient and operator.

Clinical Literature

An assessment of published clinical literature demonstrates that there is a considerable body of knowledge and experience that shows the use of LigaSure instruments in ENT procedures is safe and effective.

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K1/3572
pg 3 of 3

Substantial Equivalence

In establishing substantial equivalence of the LigaSure Curved, Small Jaw, Open Sealer / Divider to the predicate devices, Covidien EbD evaluated the intended use, indications for use, technological characteristics, reported adverse events, published clinical literature, and instrument risk profiles. The use of the LigaSure Curved, Small Jaw, Open Sealer / Divider in ENT procedures does not raise any new types of questions of safety and effectiveness compared with the predicate devices currently used for these procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread. The eagle is facing to the right.

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

Covidien % Mr. John Van Hoven Surgical Solutions 5920 Longbow Drive Boulder, CO 80301

SEP 0 5 2012

Re: K113572

Trade/Device Name: LigaSure™ Curved, Small Jaw, Open Sealer / Divider (LF1212) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 29, 2012 Received: August 30, 2012

Dear Mr. Van Hoven:

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 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.

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Page 2 - Mr. John Van Hoven

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Erine Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K113572

Device Name: LigaSure™ Curved, Small Jaw, Open Sealer / Divider (LF1212)

Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D) and/or

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

E.D. Keith

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Surg.
and Restorative Devices

510(k) Number K113572

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.