The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The 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, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 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.

Device Description

The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) 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.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (Model LF4318). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Covidien LigaSure Impact LF4318).

Here's an analysis of the acceptance criteria and the study information, extracting what's available from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for each test, nor does it provide a direct numerical "reported device performance" against such criteria. Instead, it states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices based on the following tests."

However, we can infer the type of performance evaluation conducted:

Test Type	Implied Acceptance Criteria (Inferred from "found to be equivalent")	Reported Device Performance (Inferred from "found to be equivalent")
Electrical Safety and EMC (IEC 60601-1, 60601-1-2)	Compliance with international standards for electrical safety and electromagnetic compatibility.	Compliant (equivalent to predicate).
Simulated Use	Performance under simulated surgical conditions comparable to the predicate device.	Equivalent to predicate.
Device Integrity	Structural and functional soundness comparable to the predicate device.	Equivalent to predicate.
Blade Trigger Advance/Return	Proper functioning of the cutting blade mechanism.	Equivalent to predicate.
Shaft Knob Rotation	Proper functioning of the shaft rotation.	Equivalent to predicate.
Device Recognition	Correct recognition by the associated energy platform (ForceTriad).	Equivalent to predicate.
Thermal Analysis Characterization	Thermal profile during use comparable to the predicate device.	Equivalent to predicate.
Handle Locking	Proper functioning of the handle locking mechanism.	Equivalent to predicate.
Burst Pressure	Vessel sealing strength (burst pressure) comparable to the predicate device.	Equivalent to predicate.
Histopathology	Tissue effect (e.g., seal quality, thermal spread) comparable to the predicate device.	Equivalent to predicate.
Seal Quality	Quality of vessel seals comparable to the predicate device.	Equivalent to predicate.
Tissue Sticking	Degree of tissue sticking to the device comparable to the predicate device.	Equivalent to predicate.
Cleaning: Protein, Carbohydrates	Effectiveness of cleaning process to remove biological contaminants to accepted levels.	Met (implied by "equivalent").
Biocompatibility: Sensitization, Irritation	No adverse biological reactions (sensitization, irritation) when in contact with tissues, comparable to predicate.	Met (implied by "equivalent").
Biocompatibility: Pyrogenicity	Absence of fever-inducing substances (pyrogens) to accepted levels.	Met (implied by "equivalent").
Biocompatibility: Acute Systemic Toxicity	Absence of acute toxic effects, comparable to predicate.	Met (implied by "equivalent").
Performance Qualification	Overall functional performance meeting specified requirements.	Met (implied by "equivalent").
Sterilization Validation	Sterility assurance level (SAL) achieved and maintained.	Met (implied by "equivalent").
Product Stability	Device maintaining its characteristics over shelf life.	Met (implied by "equivalent").

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 the sample size for any of the tests conducted.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). The nature of the tests (e.g., simulated use, burst pressure, histopathology, cleaning, biocompatibility) suggests they are prospective bench and lab-based studies, rather than clinical 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)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as this type of preclinical testing typically relies on predefined material properties and functional parameters rather than expert interpretation of complex clinical data. For histopathology, it would typically be a pathologist, but no specifics are given.

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

The document does not describe any adjudication method. This is generally not relevant for the types of bench and lab tests listed.

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 MRMC study was performed or described. The device is a reprocessed electrosurgical 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

Not applicable. This section is for AI/software devices. The device is a physical electrosurgical instrument.

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

The "ground truth" for the performance tests would be established through:

Physical and electrical measurements: For electrical safety, device integrity, blade function, shaft rotation, handle locking, device recognition.
Material and mechanical properties standards: For burst pressure, product stability.
Microscopic evaluation/laboratory analysis: For histopathology (tissue effect), seal quality, tissue sticking, cleaning (protein, carbohydrates).
Standardized biological assays: For biocompatibility (sensitization, irritation, pyrogenicity, acute systemic toxicity).
Sterility testing: For sterilization validation.

These are objective measurements and standardized tests designed to demonstrate equivalence to the predicate device's established performance specifications.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The term "training set" would not apply here.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three heads facing right, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

May 2, 2016

Surgical Instrument Service and Savings, Inc. Ms. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K153745

Trade/Device Name: Medline Renewal Reprocessed Ligasure Impact Open 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: April 7, 2016 Received: April 8, 2016

Dear Ms. Panteleon:

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 devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. 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.

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 vours.

Jennifer R. Stevenson -A

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

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Indications for Use

510(k) Number (if known) K153745

Device Name

Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF4318)

Indications for Use (Describe)

The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Javy, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation of vessels is desired. The 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 gyneoological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 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.

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)

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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a star-like symbol to the left. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in gray below it.

510(k) Summary

Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Name	Brandi PanteleonDirector, Quality Assurance and Regulatory AffairsP: 541-516-4180F: 541-923-3375E: bpanteleon@medline.com
Prepared by	Stephanie Boyle MaysTechnical Writer, Product DevelopmentP: 541-516-4205F: 541-923-3375E: smays@medline.com
Date Prepared	December 23, 2015
Device Names	Proprietary Name: Medline ReNewal Reprocessed LigaSure ImpactCurved, Large Jaw Sealer/Divider (LF4318)Common Name: Bipolar electrosurgical instrument
Classification	Electrosurgical cutting and coagulation device and accessoriesProduct code: NUJClass: Class II, non-exemptClassification Number: 21 CFR § 878.4400
Predicate Device	K123444 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider LF4318
Device Description	The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw,Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolarelectrosurgical instrument designed exclusively for use with the ForceTriadEnergy Platform (cleared under K051644, K070162) to seal and dividevessels (including pulmonary) up to and including 7 mm in diameter, tissuebundles, and lymphatics during open general surgical procedures. TheForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver preciseenergy to tissue for a controlled time period to achieve complete andpermanent tissue fusion.The device combines the benefits of a long, curved jaw and a shaft-basedjaw mechanism for improved access and visibility to critical structures. Thepistol-grip-style handle was designed for improved comfort and usability,with an integrated hand switch and cutter for the subsequent sealing anddividing of tissue. Hand controls have been symmetrically placed tofacilitate handling by both left- and right-handed users. The LF4318 deviceconnects to the ForceTriad energy platform with a 10-foot cord containing aLigaSure cable connector. This connector functions as a unique productidentifier for device -specific recognition by the generator. The 10-foot cord,cable connector, and ForceTriad are not reprocessed by Medline ReNewal.

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Image /page/5/Picture/0 description: The image shows the Medline ReNewal logo. The word "MEDLINE" is in blue, with a blue star to the left of it. To the right of the word "MEDLINE" is a vertical line, followed by the word "ReNewal" in green and blue. Underneath the word "ReNewal" is the phrase "Full Circle Reprocessing".

Intended Use	The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved LargeJaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrumentintended for use in open surgical procedures where ligation and division ofvessels is desired. The LF4318 is intended to be used with the ForceTriadenergy platform to cut and seal vessels, and to cut, grasp and dissecttissue during surgery.The indications for use include open procedures (general, urologic,vascular, thoracic, and gynecological) where ligation and division of vesselsis performed. These procedures include vaginal hysterectomies, Nissenfundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSureImpact 4318 can be used on vessels (arteries, veins, pulmonaryvasculature, and lymph) up to and including 7 mm and tissue bundles.The LigaSure system has not been shown to be effective for tubalsterilization or tubal coagulation for sterilization procedures. Do not use theLigaSure system for these procedures.
TechnologicalCharacteristics	The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate device. The proposeddevices are a reprocessed version of the predicate devices. K123444LigaSure Impact Curved, Large Jaw, Open Sealer/Divider LF4318 wasused as the primary predicate to support intended use, technologicalcharacteristics, and functional performance specifications.
PerformanceTesting	The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices based on the followingtests:electrical safety and electromagnetic compatibility in accordancewith IEC 60601-1 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; shaft knob rotation; device recognition; thermal analysis characterization; handle locking; burst pressure; histopathology; seal quality; tissue sticking; Cleaning: protein, and carbohydrates; Biocompatibility: sensitization, irritation; pyrogenicity, and acutesystemic toxicity; performance qualification; sterilization validation; and product stability.
Conclusion	Based on comparisons of the indications for use, intended use,technological characteristics, and performance data to the predicatedevices, Medline ReNewal reprocessed Medline ReNewal LigaSure Impact,Curved, Large Jaw, Open Sealer/Divider (LF4318) is substantiallyequivalent to the predicate devices.

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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is a blue star-like shape with the word "MEDLINE" in blue letters next to it. To the right of the Medline logo is the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in gray letters below it.

Predicate and Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF4318) device Table 1: comparison chart.

	Predicate	Proposed	Comparison
DeviceCharacteristics	Covidien LigaSure Impact Curved, Large JawSealer/Divider	Medline ReNewal LigaSure Impact Curved,Large Jaw Sealer/Divider	Same device;differentmanufacturer
Predicate 510(k)	K123444	TBD	N/A
Model Numbers	LF4318	LF4318	N/A
IntendedUse/Indications forUsea	The Covidien LigaSure Impact Curved Large Jaw,Open Sealer/Divider is a dedicated bipolarelectrosurgical instrument intended for use inopen surgical procedures where ligation anddivision of vessels is desired. The LF4318 isintended to be used with the ForceTriad energyplatform to cut and seal vessels, and to cut, graspand dissect tissue during surgery.The indications for use include open procedures(general, urologic, vascular, thoracic, andgynecological) where ligation and division ofvessels is performed. These procedures includevaginal hysterectomies, Nissen fundoplication,colectomy, adhesiolysis, oophorectomy, etc. TheLigaSure Impact 4318 can be used on vessels(arteries veins, pulmonary vasculature, andlymph) up to and including 7 mm and tissuebundles.	The reprocessed Medline ReNewal LigaSureImpact Curved Large Jaw, Open Sealer/Divider isa dedicated bipolar electrosurgical instrumentintended for use in open surgical procedureswhere ligation and division of vessels is desired.The LF4318 is intended to be used with theForceTriad energy platform to cut and sealvessels, and to cut, grasp and dissect tissueduring surgery.The indications for use include open procedures(general, urologic, vascular, thoracic, andgynecological) where ligation and division ofvessels is performed. These procedures includevaginal hysterectomies, Nissen fundoplication,colectomy, adhesiolysis, oophorectomy, etc. TheLigaSure Impact 4318 can be used on vessels(arteries veins, pulmonary vasculature, andlymph) up to and including 7 mm and tissuebundles.	Same

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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in large font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" in blue letters next to it.

Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF4318) device comparison chart (concluded).

DeviceCharacteristics	Predicate	Proposed	Comparison
	Covidien LigaSure Impact Curved, Large JawSealer/Divider	Medline ReNewal LigaSure Impact Curved,Large Jaw Sealer/Divider	Same device;differentmanufacturer
IntendedUse/Indications forUse (concluded)a	The LigaSure system has not been shown to beeffective for tubal sterilization or tubalcoagulation for sterilization procedures. Do notuse the LigaSure system for these procedures.	The LigaSure system has not been shown to beeffective for tubal sterilization or tubalcoagulation for sterilization procedures. Do notuse the LigaSure system for these procedures.	Same
Power Platform	ForceTriad Electrosurgical Generator runningsoftware version 3.50 or higher.b	ForceTriad Electrosurgical Generator runningsoftware version 3.50 or higher.b	Same
TechnologicalCharacteristics	The LigaSure Impact Curved Large Jaw, OpenSealer/Divider uses bipolar energy to seal anddivide vessels up to and including 7 mm indiameter.	The LigaSure Impact Curved Large Jaw, OpenSealer/Divider uses bipolar energy to seal anddivide vessels up to and including 7 mm indiameter.	Same
a Intended Use and Indications for Use were the same category in the K123444 predicate.b ForceTriad generator was cleared under K070162: It will not be reprocessed, and it is not part of this submission.

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.