The Reprocessed LigaSure™ 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 and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectorny, 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 Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.

Device Description

The Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider is a multifunctional electrosurgical instrument for use in performing laparoscopic surgical procedures using the ForceTriad™ Energy Platform.

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 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 generator via a ten-foot cable with a Smart™ connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.

The scope of this submission only includes the reprocessed Covidien 100 sealer/divider device and not the ForceTriad™ Energy Platform. Stryker Sustainability Solutions does not reprocess or market the generator.

AI/ML Overview

The provided document is a 510(k) summary for the Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider. It describes the device and its intended use, but it does not contain the level of detail requested for acceptance criteria and study methodology that would typically be found in a clinical trial report or a more extensive validation study summary.

Specifically, the document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed LigaSure 1 Blunt Tip Laparoscopic Sealer/Dividers. This included the following tests: Biocompatibility, Validation of Reprocessing, Sterilization Validation, Functional Performance Tests, Packaging Validation. Performance testing demonstrates that reprocessed devices perform as originally intended."

However, it does not provide quantitative acceptance criteria or detailed results for these tests, nor does it describe a study with a test set, ground truth experts, adjudication methods, or sample sizes in the manner requested.

Therefore, I cannot fill out all parts of your request based on the provided text. I will, however, extract what is explicitly stated in the document.

Acceptance Criteria and Device Performance

The document states that reprocessed devices perform "as originally intended" and are "at least as safe and effective to the predicate device." While this implies that the performance matches the predicate, specific quantitative acceptance criteria and detailed reported device performance are not provided. The testing categories are listed, but not the specific metrics or thresholds.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility requirements met	Device is biocompatible
Reprocessing validated	Reprocessing is validated
Sterilization validated	Sterilization is validated
Functional performance equivalent to predicate	Device functions as originally intended; "at least as safe and effective to the predicate device"
Packaging validated	Packaging is validated

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The studies are described as "Bench and laboratory testing," implying a controlled laboratory environment rather than patient data.

2. 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. The described testing refers to bench and laboratory tests, not studies relying on expert interpretation for ground truth.

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

Not applicable. The described testing refers to bench and laboratory tests, not studies requiring expert adjudication.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI diagnostic tool that would involve human readers.

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

Not applicable in the context of an algorithm. However, the "Functional Performance Tests" could be considered a form of standalone testing for the device itself, demonstrating its physical and electrical properties. The document states: "Performance testing demonstrates that reprocessed devices perform as originally intended."

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

For the "Functional Performance Tests" and other bench tests, the ground truth would be based on predefined engineering specifications, established scientific standards, and comparison to the performance of new (unreprocessed) predicate devices. This is not explicitly detailed but is inferred from the nature of the device and testing.

7. The sample size for the training set

Not applicable. The document describes the reprocessing and validation of a surgical instrument. There is no mention of a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary

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K133578

SECTION 5: 510(k) SUMMARY

APR 1 0 2014

Submitter:

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

Contact:

Jill M. Clark Senior Regulatory Affairs Specialist (480) 763-5300 (o) (480) 763-5310 (f) jill.clark@stryker.com

Ramona Kulik Staff Specialist Regulatory Affairs 480-763-5300 (o) 480-763-2952 (f) ramona.kulik@stryker.com

Date of Preparation:	November 19, 2013
Name of Device:
Trade/Proprietary Name:	Reprocessed LigaSure™ Blunt Tip LaparoscopicSealer/Divider
Common Name:	Bipolar Electrosurgical Open and Laparoscopic Instrument
Classification Name:	Electrosurgical, Cutting & Coagulation Accessories,Laparoscopic & Endoscopic, Reprocessed(21 CFR§878.4400, Product Code NUJ, Class II)

Predicate Device:

ModelNumber	510(k)Number	510(k) Title	Original Manufacturer
LF1537	K092879	LigaSure 5mm Blunt TipLaparoscopic Sealer-Divider	Valleylab(currently known as Covidien)

Device Description:

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:

Stryker Sustainability Solutions
Reprocessed LlgaSure™ Blunt Tip Laparoscopic Sealer/Divider Traditional 510(k)

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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. The cutter can only be actuated when the jaws are . closed and latched.
. 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 generator via a ten-foot cable with a Smart™ connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.

Intended Use:

The Reprocessed LigaSure™ 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 and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectorny, 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 Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.

Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed LigaSure™ Blunt Tip Laparoscopic 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 size 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 Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Dividers includes removal of adherent visible soil and decontamination. Each individual device is

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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 1 Blunt Tip Laparoscopic Sealer/Dividers. This included the following tests:

. Biocompatibility
Validation of Reprocessing .
. Sterilization Validation
. Functional Performance Tests
Packaging Validation .

Performance testing demonstrates that reprocessed devices perform as originally intended.

Conclusion:

Stryker Sustainability Solutions concludes that the Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider is at least as safe and effective to the predicate device as described herein.

Stryker Sustainability Solutions Traditional 510(k)

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 10, 2014

Stryker Sustainability Solutions Ms. Jill Clark Senior Regulatory Affairs Specialist 1810 West Drake Drive Tempe, Arizona 85283

Re: K133578

Trade/Device Name: Reprocessed LigaSure" 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: NUJ Dated: March 10, 2014 Received: March 11, 2014

Dear Ms. Clark:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Jill Clark

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and : Radiological Health

Enclosure

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K133578

Device Name: Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider

Indications For Use: The Reprocessed LigaSure™ 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 biade 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 and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, 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 Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

Traditional 510(k)

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.