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™ 5 mm Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744) 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 instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. 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 outer diameter of the instrument shaft is 5 mm with a working length of 23 cm, 37 cm, or 44 cm.

AI/ML Overview

The provided text describes the regulatory clearance for reprocessed LigaSure Maryland Jaw Sealer/Divider devices and includes information about the performance testing conducted. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria, particularly for AI/machine learning devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent for many of your points:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "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." It also states, "The results of the evaluations demonstrate that the Reprocessed LigaSure Maryland Jaw Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter."

However, specific numerical acceptance criteria (e.g., "burst pressure must be greater than X mmHg") and concrete performance data (e.g., "average burst pressure was Y mmHg") are not provided in the text.

Acceptance Criteria Category	Specific Acceptance Criteria (Not provided in text)	Reported Device Performance (Generalized from text)
Burst Pressure	(e.g., > X mmHg)	Effectively sealed vessels up to 7mm.
Maximum Jaw Temperature	(e.g., < Y degrees Celsius)	Maintained acceptable temperature for sealing.
Device Functionality	(e.g., all functions operate as intended)	Appropriate function of components demonstrated.
Device Reliability	(e.g., specific failure rates, lifespan)	Demonstrated reliability.
Generator Compatibility	(e.g., seamless operation with specified generators)	Compatible with specified Covidien generators.
Biocompatibility	(e.g., no adverse biological reactions)	Passed biocompatibility tests.
Sterilization Validation	(e.g., sterility assurance level (SAL))	Sterilization validated.
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 and IEC 60601-2-18	Compliant with specified IEC standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 and IEC 60601-2-18	Compliant with specified IEC standards.
Packaging Validation	(e.g., package integrity, shelf life)	Packaging validated.

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

Sample size for test set: Not specified. The text only mentions "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
Data provenance: "Preclinical laboratory evaluations in an animal model" implies animal data. It is a prospective study design for these evaluations. The "bench and laboratory testing" would be laboratory-based data, also prospective. The country of origin is not specified.

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

Not applicable / Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic image analysis). For a surgical device, ground truth would be based on objective physical measurements and biological outcomes in animal models, not expert consensus on interpretations.

4. Adjudication method for the test set:

Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert opinions, which is not relevant to the type of testing described for this surgical device.

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:

No. An MRMC study is not mentioned because this device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

No. This device is a manual surgical instrument, not an algorithm. Its performance inherently involves a human operator.

7. The type of ground truth used:

For the "preclinical laboratory evaluations in an animal model," the ground truth was based on:
- Direct observation of hemostasis: "ability to achieve hemostasis of vessels."
- Measurements of thermal spread: "evaluate thermal spread."
- Effectiveness of cutting and coagulation: "effectively cut and coagulated vessels."
For the "bench and laboratory testing," the ground truth would be established through:
- Physical measurements: burst pressure, maximum jaw temperature.
- Functional tests: verifying device functionality, reliability, and generator compatibility against engineering specifications.

8. The sample size for the training set:

Not applicable / Not specified. This device is not an AI/machine learning algorithm that requires a training set in that conventional sense. The "training" for a reprocessed device involves validating the reprocessing methods, which is a different type of validation.

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

Not applicable / Not specified. (See point 8 above). For the reprocessing validation, the "ground truth" would be the successful demonstration that the reprocessed devices meet the original device's specifications and are safe for use, established through validation protocols for cleaning, sterilization, and functional testing.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2018

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

Re: K180499

Trade/Device Name: Reprocessed LigaSure Maryland Jaw Sealer/Divider (Model # LF1723, LF1737, LF1744) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: February 23, 2018 Received: February 26, 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

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

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); 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/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, 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

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

Indications for Use

510(k) Number (if known) K180499

Device Name

Reprocessed LigaSure Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744)

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)

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."

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

Reprocessed Single-Use Device Models Included in Clearance

Device Model	Device Name	Original Manufacturer
LF1723	LigaSure Maryland Jaw Sealer/Divider, 23cm Length	Covidien
LF1737	LigaSure Maryland Jaw Sealer/Divider, 37cm Length	Covidien
LF1744	LigaSure Maryland Jaw Sealer/Divider, 44cm Length	Covidien

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

510(k) SUMMARY

Submitter:

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

Contact: Scott Enalish

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 Maryland Jaw Sealer/Divider (LF1723, LF1737, LF1744)
Common Name:	Bipolar Electrosurgical Instrument
Classification Information:	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (21 CFR§878.4400, Product Code NUJ, Class II)

Predicate Devices:

ModelNumber	510(k)Number	510(k) Title	OriginalManufacturer
LF1723		LigaSure™ 5 mm Maryland Jaw
LF1737	K133338	Sealer/Divider One-step Sealing (LF17XX	Covidien
LF1744		series)

Device Description:

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

. A lever for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
. An activation button at the bottom of the handle for generator power to initiate vessel sealing.
A trigger for actuating the cutter. The cutter can only be actuated when the jaws are closed.
. 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 Valley|ab™ 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.

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 Ivmphatics 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 Maryland Jaw 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 substitution of some components with new components. 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 Maryland Jaw 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 Maryland Jaw Sealer/Divider. This included the following tests:

. Biocompatibilitv
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 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 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 Maryland Jaw 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 Maryland Jaw 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.