The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The Reprocessed LigaSure Sealer/ Divider can be used on yessels (arteries, veins, pulmonary 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, adhesiolysis, hysterectomy, oophorectomy, 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 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LF4418 is designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm.

The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.

The following controls are located on the instrument handle:

A lever for opening and closing the instrument iaws. 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 triager 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 compatible electrosurgical generator via a cord with a cable connector that identifies the instrument type to the generator.

For the LF4418, the Original Manufacturer applies a non-stick coating to the jaws of the device to reduce tissue sticking. When reprocessing the LF4418, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.

The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform or Valleylab™ FT10 Energy Platform that are 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

This submission describes the reprocessing of a LigaSure Impact surgical device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like training sets, ground truth establishment for training data, expert adjudication, multi-reader multi-case studies, and standalone algorithm performance are not applicable to this document. The provided text primarily focuses on bench and laboratory testing, as well as preclinical animal studies.

Here's an analysis of the provided text based on the applicable criteria:

Acceptance Criteria and Device Performance

The general acceptance criteria are implied to be that the reprocessed device is "as safe and effective as the predicate and operate as originally intended." The specific quantitative acceptance criteria are not explicitly detailed in numerical thresholds. However, the performance data section lists the types of tests conducted to demonstrate this equivalence.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Tests conducted to demonstrate biocompatibility (specific results not detailed, but implied to meet standards).
Validation of Reprocessing	Reprocessing validated (specific results not detailed, but implied to meet standards). Each individual device is tested for appropriate function prior to packaging and labeling. This includes removal of adherent visible soil and decontamination.
Sterilization Validation	Sterilization validated (specific results not detailed, but implied to meet standards).
Functional Performance (Electrical Safety)	Tested in accordance with IEC 60601-1.
Functional Performance (Electromagnetic Compatibility)	Tested in accordance with IEC 60601-1-2.
Functional Performance (General Electrosurgical)	Tested in accordance with IEC 60601-2-2.
Functional Performance (Sealing & Division)	Bench testing evaluated the device's ability to seal and divide vessels up to 7 mm, including: burst pressure, maximum jaw temperature, device functionality, device reliability, and generator compatibility.
Packaging Validation	Packaging validated (specific results not detailed, but implied to meet standards).
Preclinical (Thermal Spread & Hemostasis)	Preclinical laboratory evaluations in an animal model (acute and chronic survival studies) were performed to evaluate thermal spread and the ability to achieve hemostasis of vessels. The results demonstrate that the Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices or animal subjects used in the various tests.
- Data Provenance: The testing was "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model." No country of origin for the data is specified, but it can be inferred to be conducted by Styker Sustainability Solutions or its contracted labs. The data is prospective as it was generated specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this type of device and testing. The "ground truth" for the functional tests is objective measurements (e.g., burst pressure, temperature) and observation of physical outcomes (e.g., successful sealing, coagulation, cutting). For animal studies, the "ground truth" would be observed physiological outcomes and histological analysis conducted by veterinary pathologists or similar experts, though their number and qualifications are not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers. The tests described are primarily objective physical and functional tests.
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, this is a reprocessed surgical instrument, not an AI/ML-powered device. Therefore, an MRMC study and AI-related effect sizes are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is a reprocessed surgical instrument. Standalone algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for the functional and preclinical tests is based on objective physical measurements (e.g., burst pressure, maximum jaw temperature), adherence to engineering standards (e.g., IEC 60601 series), and observed physiological outcomes (e.g., achievement of hemostasis, thermal spread evaluation) in animal models, likely supported by pathology or histological analysis in the animal studies.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set.

Summary

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April 20, 2018

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

Re: K180451

Trade/Device Name: Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (Model # LF4418) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: February 17, 2018 Received: February 20, 2018

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 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);

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Page 2 - Mr. Scott English

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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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K180451

510(k) SUMMARY

Submitter:

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

Contact:

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

Date of Preparation: April 17, 2018

Name of Device:

Trade/Proprietary Name:	Reprocessed LigaSure Impact without Nano-coating Large Jaw,Open Sealer/Divider (LF4418)
Common Name:	Bipolar Electrosurgical Instrument
Classification Name:	Electrosurgical, Cutting & Coagulation Accessories,Laparoscopic & Endoscopic, Reprocessed(21 CFR§878.4400, Product Code NUJ, Class II)

Predicate and Reference Devices:

	ModelNumber	510(k)Number	510(k) Title	OriginalManufacturer
PredicateDevice	LF4318	K141153	LigaSure Tissue Sealer/Dividers(Indications for Use)	Covidien
		K123444	LigaSure Impact Curved, Large Jaw, OpenSealer/Divider	Covidien
ReferenceDevice	LF4318	K150538	Reprocessed LigaSure Impact Curved, Large Jaw,Open Sealer/Divider	StrykerSustainabilitySolutions
ReferenceDevice	LF4418	K162047	LigaSure Impact Curved, Large Jaw, OpenSealer/Divider, Nano-coated	Covidien

Device Description:

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K180451

designed for use with Covidien electrosurgical generators that include vessel sealing capability. The LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7mm.

The following controls are located on the instrument handle:

A lever for opening and closing the instrument iaws. 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 triager 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 compatible electrosurgical generator via a cord with a cable connector that identifies the instrument type to the generator.

Intended Use:

The Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The Reprocessed LigaSure Sealer/Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary 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.

Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider are 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. The differences between the predicate

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K180451

device and the reprocessed device include the replacement of some components with new components. The replacement components are manufactured to the same specifications and from equivalent materials as the components they are replacing. 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 without Nano-coating 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.

Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed LigaSure Impact without Nano-coating 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 7 mm, including: burst pressure, maximum iaw temperature, device functionality, device reliability, and generator compatibility.

Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the reprocessed device. The results of the evaluations demonstrate that the Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter.

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 without Nanocoating Large Jaw, Open Sealer/Divider is at least as safe and effective as the predicate device as described herein.

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Indications for Use

510(k) Number (if known) K180451

Device Name

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (LF4418)

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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Reprocessed Single-Use Device Model Included in Clearance

Device Model	Device Name	Original Manufacturer
LF4418	LigaSure Impact without Nano-coating Large Jaw, OpenSealer/Divider	Covidien

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.