The Reprocessed 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 specialties 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 Covidien™ LigaSure™ Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a bipolar electrosurgical instrument intended for use with the Covidien Electrosurgical Generators in general and gynecologic laparoscopic/open 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. The outer diameter of the instrument shaft is 5 mm with a working length of 37 cm. 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. The cutter can only be actuated when the jaws are closed and latched.
A rotation wheel 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 generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform and Valleylab™ FT10 Energy Platform.

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 generators or footswitch.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (LF1637). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this reprocessed device revolve around demonstrating substantial equivalence to the original predicate device (Covidien™ LigaSure™ Blunt Tip Laparoscopic Sealer/Divider LF1637). This typically means the reprocessed device must meet the same performance specifications as the original. The text outlines the types of tests performed to achieve this, and the reported performance confirms equivalence.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Functional Performance	Verification/comparative testing to the predicate device. Evaluation of:	The reprocessed device 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. "The design, materials, and intended use of the reprocessed device 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 size is utilized."
	- Burst pressure
	- Maximum jaw temperature
	- Device functionality
	- Device reliability
	- Generator compatibility
Electrical Safety	IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18	Performance testing demonstrated compliance with these standards.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Performance testing demonstrated compliance with this standard.
Biocompatibility	(Specific tests not detailed, but states "Biocompatibility" was conducted)	Results demonstrate satisfaction of biocompatibility requirements.
Reprocessing Validation	(Specific tests not detailed, but states "Validation of Reprocessing" was conducted)	The validated reprocessing methods ensure the device meets specified safety and cleanliness standards. Each individual device is `tested for appropriate function of its components prior to packaging and labeling operations.`
Sterilization Validation	(Specific tests not detailed, but states "Sterilization Validation" was conducted)	The validated sterilization methods ensure the device meets specified sterility assurance levels.
Packaging Validation	(Specific tests not detailed, but states "Packaging Validation" was conducted)	Ensures package integrity and sterility maintenance.
Clinical Performance (Preclinical)	Acute and Chronic survival studies (animal model) to evaluate thermal spread and hemostasis achievement.	The results of the evaluations demonstrate that the Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter and achieved hemostasis.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample sizes for each test set (e.g., number of devices tested for burst pressure, number of animals in preclinical studies). It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."

Data Provenance: The preclinical studies were conducted in an animal model, making them prospective in nature. The bench testing would also be prospective, evaluating newly reprocessed devices. The country of origin for the data is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts or an expert panel to establish ground truth for the performance testing. The ground truth for functional performance (like burst pressure, jaw temperature, functionality, reliability, and generator compatibility) would be established through direct physical measurements and engineering specifications, compared against the predicate device's known performance. Similarly, the preclinical animal studies would rely on observable physiological outcomes (e.g., successful hemostasis, measured thermal spread) as their ground truth.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurements against engineering specifications and observable biological outcomes in animal models, rather than subjective human interpretation needing consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was performed as this device is a surgical instrument and not an imaging or diagnostic device that would typically involve human readers. The study focuses on the physical and functional performance of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a surgical instrument, not an AI algorithm. Its performance is inherent to its mechanical and electrical design, not dependent on an algorithm.

7. The Type of Ground Truth Used

Bench and Laboratory Testing: Ground truth was established through engineering specifications, physical measurements, and comparison to the predicate device's known performance across various parameters (burst pressure, max jaw temperature, functionality, reliability, generator compatibility).
Preclinical Animal Studies: Ground truth was established through observable physiological outcomes in an animal model, such as successful hemostasis and measured thermal spread, which are direct indicators of the device's intended biological effect.

8. The Sample Size for the Training Set

This question is not applicable. The document describes the testing and validation of a reprocessed medical device, not an AI system. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set mentioned in the context of this device's submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 16, 2017

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

Re: K172856

Trade/Device Name: Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (Model: LF1637) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: September 19, 2017 Received: September 20, 2017

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 (OS) regulation (21 CFR Part 820);

{1}------------------------------------------------

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/MedicalDeviceRegulationandGuidance/) 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@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S3 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172856

Device Name

Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (LF1637)

Indications for Use (Describe)

The Reprocessed 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 speciaties 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Reprocessed Single-Use Device Models Included Clearance

Device Model	Device Name	Original Manufacturer
LF1637	LigaSure Blunt Tip Laparoscopic Sealer/Divider	Covidien

{4}------------------------------------------------

SECTION 5: 510(k) SUMMARY

Submitter:

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

Contact:

Mr. Scott English, BS, RAC Staff Requlatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) scott.english@stryker.com

Date of Preparation: September 19, 2017

Name of Device:

Trade/Proprietary Name:	Reprocessed LigaSure Blunt Tip LaparoscopicSealer/Divider (LF1637)
Common Name:	Bipolar Electrosurgical Laparoscopic Instruments
Classification Information:	Electrosurgical, Cutting & Coagulation AccessoriesLaparoscopic & Endoscopic, Reprocessed(21 CFR§878.4400, Product Code NUJ, Class II)

Predicate Devices:

Model Number Number	510(k)	510(k) Title	OriginalManufacturer
LF1637	K141153	LigaSure Tissue Sealer/Dividers	Covidien

Device Description:

. 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. ●

{5}------------------------------------------------

A trigger for actuating the cutter. The cutter can only be actuated when the jaws . are closed and latched.
. A rotation wheel to rotate the instrument jaws.

The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform and Valleylab™ FT10 Energy Platform.

Intended Use:

The Reprocessed 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 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:

Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers work in conjunction with Covidien electrosurgical generators. They use bipolar radiofrequency energy to seal tissues, blood vessels, and lymphatics. The devices also use mechanical action to divide tissue along the seal line. The design, materials, and intended use of the reprocessed device 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 size is utilized. The differences between the predicate 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 the LigaSure Blunt Tip Laparoscopic Sealer/Dividers 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.

{6}------------------------------------------------

Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed LigaSure Blunt Tip Laparoscopic 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, IEC 60601-2-2, and IEC 60601-2-18, 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, maximum jaw 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. The studies were done to evaluate thermal spread and the ability to achieve hemostasis of the reprocessed device. The results of the evaluations demonstrate that the Reprocessed LigaSure Blunt Tip Laparoscopic 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:

The results of bench testing and preclinical laboratory evaluations demonstrate that the Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers are at least as safe and effective and perform as well as the identified legally marketed 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.