The LF1637 LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Device Description

The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) 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 clamped between the jaws, grasping tissue, and blunt dissection during laparoscopic general surgical procedures (as indicated) using radio frequency (RF) energy. A hand actuated lever allows the user to open and close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device, the LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637). This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo safety and effectiveness through a traditional clinical study with explicitly defined acceptance criteria and statistical analysis as one might find for a novel device.

Therefore, the information requested regarding acceptance criteria, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI-driven device is largely not applicable in the context of this 510(k) submission for a surgical instrument.

However, I can extract the relevant information from the document to address the spirit of your request within the confines of what is provided:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a surgical device like this, "acceptance criteria" are typically demonstrated through successful completion of specified engineering, mechanical, and preclinical tests, showing that the modified device performs comparably to the predicate device and meets safety standards. The document doesn't list specific numerical acceptance criteria for each test, but it states that the device "operated as intended and is as safe and effective as the predicate device."

Test Category	Reported Device Performance	Acceptance Criteria (Implicit from 510(k) comparison)
Bench Testing
IEC 60601-1 compliance	Performed	Compliance with standard
IEC 60601-2-2 compliance	Performed	Compliance with standard
Mechanical testing (blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever latching/unlatching force, power curve performance)	Performed	Performance comparable to predicate device and within design specifications
Renal and pulmonary burst pressure	Performed	Performance comparable to predicate device
Preclinical Testing
Sealing and dividing vessels up to 7mm	Demonstrated	Effective sealing and division of vessels up to 7mm
Ability to achieve hemostasis	Demonstrated	Effective hemostasis
Lymphatic burst pressure	Performed	Performance comparable to predicate device
Chronic animal study	Performed	No unexpected adverse events, long-term safety demonstrated

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as "test set" in the context of a diagnostic study. For mechanical and preclinical testing, the number of samples or animals used for each specific test is not detailed in the summary.
Data Provenance: The testing was conducted by Covidien, the device manufacturer. The document does not specify the country of origin for the data (e.g., where animal studies were conducted if applicable) or if it's retrospective or prospective. Given the nature of a 510(k), it would be prospective testing specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a surgical instrument and a 510(k) submission, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set in the conventional sense. The "ground truth" is established through the physical and physiological performance observed in bench and preclinical (animal) tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is not a diagnostic study requiring human adjudication for interpretation of results. The results of the mechanical and preclinical tests are objective measurements or observations of device performance.

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 study is for a surgical instrument, not an AI-assisted diagnostic tool. No human reader performance improvement with or without AI assistance was evaluated.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The "standalone performance" of the device is implicitly demonstrated through the bench and preclinical testing where the device is operated according to its intended use and evaluated against performance metrics. The device itself is an electrosurgical instrument operated by a surgeon, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: For this type of device, the "ground truth" is based on the objective physical and biological performance characteristics, verified through:
- Compliance with recognized electrical safety standards (IEC 60601-1, IEC 60601-2-2).
- Quantitative mechanical measurements (e.g., jaw force, burst pressure).
- Qualitative and quantitative observations in preclinical (animal) studies of vessel sealing, hemostasis, and tissue division.
- The predicate device's established safety and effectiveness.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that uses a "training set." The device is a physical surgical instrument.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI model, there is no ground truth established for it in this context.

Summary

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APR 0 5 2013

510(k) Summary

Date summary prepared: 3/18/2013

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Diane Reed Sr. Regulatory Affairs Product Specialist Telephone: 303-581-7093 Fax: 303-530-6313 Email: diane.reed@covidien.com

Name of Device

Trade Name:	LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider
Catalog Number:	LF1637
Common Name:	Bipolar Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400,class II GEI)

Predicate Device

The LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637) was compared to and found to be substantially equivalent to the following product of comparable type in commercial distribution:

Trade Name:	LigaSureTM 5 mm Blunt Tip Laparoscopic Sealer/Divide
Device Common Name:	Bipolar Electrosurgical Instrument
Catalog Number:	LF1537
510(k) Number:	K092879 (cleared 10/16/2009)
Manufacturer:	Covidien

Device Description

Indications for Use

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Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Technological Characteristics

The LigaSure 5 mm, Blunt Tip, Laparoscopic Sealer/Divider has the same technological and performance characteristics as the predicate, K092879. This Special 510(k) presents proposed modifications relating to the jaw, handle, and component material changes. The function of the device has not changed. Similar to the predicate, this new device seals vessels and lymphatics using radio frequency (RF) energy to achieve its intended use and can mechanically divide the sealed areas or tissue with a mechanical cutting device.

Performance

Evidence of safety and effectiveness was obtained from both bench and preclinical testing to support the intended use of this device includes:

. Testing in accordance with IEC 60601-1
Testing in accordance with IEC 60601-2-2 .
. Mechanical testing such as blade return, grasping performance, jaw temperature, jaw force, button activation force, knife deployment force, lever latching/unlatching force, and power curve performance
. Renal and pulmonary burst pressure

Preclinical testing includes:

. Sealing and dividing vessels up to and including 7 mm
. Ability to achieve hemostasis of tissue and vessels
t Lymphatic burst pressure
Chronic animal study .

The results of the testing demonstrate that the proposed device, the LF1637, operated as intended and is as safe and effective as the predicate device.

510(k): LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider - LF1637

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Letter dated: April 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Covidien % Ms. Diane Reed Senior Regulatory Affairs Product Specialist 5920 Longbow Drive Boulder, Colorado 80301

Re: K130744

Trade/Device Name: LigaSure™ 5mm Blunt Tip Laparoscopic 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: March 18, 2013 Received: March 19, 2013

Dear Ms. Reed:

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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Page 2 - Ms. Diane Reed

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Mielkerson -S

Mark N. Melkerson Acting Director Division of Surgical 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): K130744

Device Name: LigaSure™ 5 mm Blunt Tip Laparoscopic Sealer/Divider (LF1637)

Indications for Use:

Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny. Nissen fundoplication, colectorny, adhesiolysis, oophorecotmy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure 5 mm Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7 mm, and tissue bundles.

Prescription Use >| — AND/OR (Part 21 CFR 801 Subpart D)

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)

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For

(Division Sign-Off)

Division of Surgical Devices

510(k) Number K130744

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.