The Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider LF4318 is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation of vessels is desired. The Reprocessed LigaSure Impact™ LF4318 is intended to be used with the ForceTriad™ Energy Platform to cut and seal vessels, and to cut, grasp, and dissect tissue during surgery.

The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, oophorectomy, etc. The Reprocessed LigaSure Impact™ LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.

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 Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer / Divider is a hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion (LigaSure™) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion. A blade within the instrument is surgeon actuated to divide tissue.

The instrument has a shaft diameter of 13.5 mm (square), shaft length of 18 cm, and jaw length of 36 mm. The following controls are located on the instrument handle:

A lever for opening and closing the instrument jaws. The mechanism incorporates a latch to hold the jaws in the closed position during vessel sealing and cutting.
An activation button for generator power to initiate vessel sealing.
A trigger for actuating the cutter.
A knob to rotate the instrument jaws.

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attaches to the ForceTriad™ Energy Platform via a ten-foot cord with a LiqaSure™ cable connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform running software version 3.50 or greater.

The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform that is used to power the device or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generator or footswitch.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a study of AI system performance. As such, many of the requested elements for AI device studies are not applicable to this document.

Here's the relevant information based on the provided text, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria in a table format for performance metrics relevant to an AI model (e.g., sensitivity, specificity, AUC). Instead, it lists various types of tests performed to demonstrate that the reprocessed device is "as safe and effective as the predicate" and "operate as originally intended."

Test Type	Reported Performance / Conclusion
Biocompatibility	Performed
Validation of Reprocessing	Performed
Sterilization Validation	Performed
Functional Performance Tests	Performed. Involved electrical safety, electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2), and verification/comparative testing to the predicate device. Bench testing evaluated: burst pressure, thermal spread, max jaw tip temperature, jaw cooling time, device functionality, and device reliability testing.
Electrical Safety Testing	Performed in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2.
Electromagnetic Compatibility Testing	Performed in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2.
Packaging Validation	Performed
Acute and Chronic Pre-clinical Testing	Evaluated thermal spread and the ability to achieve hemostasis of vessels and tissues.
Overall Conclusion	"The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended." "Stryker Sustainability Solutions concludes that the Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is at least as safe and effective to the predicate device as described herein."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI model's performance on a dataset of patient data. The tests performed are on device samples (reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers). The sample sizes for these bench and pre-clinical tests are not detailed in this summary. Data provenance for clinical data is not applicable as this is a device reprocessing submission, not an AI efficacy study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in the context of AI models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device would be its ability to perform its intended function (seal and divide vessels) in a safe and effective manner, which is assessed through a combination of engineering tests and pre-clinical studies, not through expert reading of diagnostic outputs.

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

Not applicable. Adjudication methods are typically used to establish ground truth for diagnostic AI models where there might be disagreement among human experts. This document describes physical device testing.

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 is not an AI-assisted diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical electrosurgical device, not an algorithm.

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

The "ground truth" for this device's performance is established through a combination of:

Engineering specifications and regulatory standards: (e.g., IEC 60601-1 for electrical safety, performance parameters like burst pressure, thermal spread, max jaw tip temperature, jaw cooling time). The predicate device's performance also serves as a benchmark for what constitutes acceptable performance.
Pre-clinical testing: Acute and chronic studies evaluating hemostasis and thermal spread in tissues, often involving animal models or cadaveric tissue.
Functionality and reliability testing: Verification that the device's components operate as intended.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI algorithm.

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

Not applicable. As there is no AI algorithm, there is no training set and no ground truth for a training set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

June 25, 2015

Stryker Sustainability Solutions Mr. Scott English Staff Regulatory Affairs Specialist 1810 West Drake Drive Tempe, Arizona 85283

Re: K150538

Trade/Device Name: Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: May 20, 2015 Received: May 21, 2015

Dear Mr. English:

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.

Sincerely yours,

Jennifer R. Stevenson -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

Reprocessed Single Use Device Models Included in Clearance:

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Device Model	Device Name	OriginalManufacturer
LF4318	LigaSure ImpactTM Curved, Large Jaw, OpenSealer/Divider	Covidien

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Indications for Use

510(k) Number (if known) K150538

Device Name

Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Dividers

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5: 510(k) SUMMARY

Submitter:

Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283

Contact:

Scott English Staff Regulatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) scott.english@stryker.com

Date of Preparation: March 2, 2015

Name of Device:

Trade/Proprietary Name:	Reprocessed LigaSure Impact™ Curved, Large Jaw, OpenSealer/Divider
Common Name:	Bipolar Electrosurgical Open and Laparoscopic Instruments
Classification Name:	Electrosurgical, Cutting & Coagulation Accessories,Laparoscopic & Endoscopic, Reprocessed(21 CFR§878.4400, Product Code NUJ, Class II)

Predicate Devices:

Model Number	510(k) Number	510(k) Title	Original Manufacturer
LF4318	K123444	LigaSure Impact Curved, Large Jaw, Open Sealer/Divider	Covidien

Device Description:

The instrument has a shaft diameter of 13.5 mm (square), shaft length of 18 cm, and jaw length of 36 mm. The following controls are located on the instrument handle:

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A lever for opening and closing the instrument jaws. The mechanism ● incorporates a latch to hold the jaws in the closed position during vessel sealing and cutting.
An activation button for generator power to initiate vessel sealing. .
. A trigger for actuating the cutter.
A knob to rotate the instrument jaws. .

The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform running software version 3.50 or greater.

Intended Use:

The Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider LF4318 is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The Reprocessed LigaSure Impact™ LF4318 is intended to be used with the ForceTriad™ Energy Platform to cut and seal vessels, and to cut, grasp, and dissect tissue during surgery.

The indications for use include open procedures (general, urologic, vascular, thoracic, and avnecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The Reprocessed LigaSure Impact™ LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.

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.

Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed LigaSure Impact™ Curved, Large Jaw. Open Sealer/Divider is equivalent to the predicate device. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations.

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Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider. This included the following tests:

Biocompatibility
. Validation of Reprocessing
. Sterilization Validation
Functional Performance Tests .
. Electrical Safety Testing
Electromagnetic Compatibility Testing ●
Packaging Validation ●

The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2, and verification/comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including: burst pressure, thermal spread, max jaw tip temperature, jaw cooling time, device functionality, and device reliability testing.

Acute and chronic pre-clinical testing was conducted to evaluate thermal spread and the ability to achieve hemostasis of vessels and tissues.

The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.

Conclusion:

Stryker Sustainability Solutions concludes that the Reprocessed LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is at least as safe and effective to the predicate device as described herein.

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.