The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical 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 in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

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 Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel sealing device designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.

AI/ML Overview

The provided text describes the 510(k) summary for the Medline ReNewal Reprocessed LigaSure Exact Dissector, a remanufactured surgical instrument, not an AI-powered diagnostic device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "test set," "ground truth," "experts," "adjudication," "MRMC study," and "training set" as typically applied to AI/ML diagnostic devices, are not applicable in this context.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of functional characteristics, materials, and technological aspects.

Here's how to reframe the information based on the provided text for a non-AI medical device:

The device under review is the Medline ReNewal Remanufactured LigaSure Exact Dissector, without Nano-coating (LF2019). This is a reprocessed version of a legally marketed predicate device. The "acceptance criteria" in this context refer to demonstrating that the reprocessed device performs equivalently to the original and meets necessary safety and functional standards.

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

Acceptance Criteria Category	Specific Criteria (Implied by testing)	Reported Device Performance (Summary from text)
Functional Performance	Equivalent sealing, cutting, and grasping capabilities to the predicate device.	"The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests: Functional performance: simulated use and artificial soiling; visual inspection; device functionality; in vivo acute and chronic animal studies."
Electrical Safety	Safe electrical operation and insulation.	"Electrical Safety" testing performed.
Cleaning Validation	Effective removal of biological and other contaminants from used devices to ensure reprocessing quality.	"Cleaning Validation" performed.
Biocompatibility	Materials of construction (post-reprocessing) do not elicit adverse biological responses.	"Biocompatibility" testing performed.
Sterilization Validation	Device is terminally sterilized and maintains sterility.	"Sterilization Validation" performed.
Packaging & Shelf Life	Packaging maintains device integrity and sterility for the specified shelf life.	"Packaging and shelf life validation" performed.
Residuals Testing	Acceptable levels of process residuals (e.g., ethylene oxide, ethylene chlorohydrin).	"bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing" performed.
Product Stability	Device maintains its properties and performance over its shelf life.	"Product stability" testing performed.
Indications for Use	Same as the predicate device.	"The predicate and proposed devices in this application have the same indications for use and technological characteristics." (See "Indications for Use" section in the comparison table, which is identical to the predicate).
Technological Characteristics	Maintain essential features and operation as the predicate device, with understanding of nano-coating difference.	"The technological characteristics, materials, and the fundamental scientific technology of the subject device is equivalent to the predicate device. The proposed device is a reprocessed version of the predicate device... The original equipment manufacturer of the LigaSure Exact Dissector, Nano-coated applied a nano-coating to the device jaws to reduce tissue sticking. Medline ReNewal does not replace the coating on the device jaws in its process..."

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

The document summarizes testing categories but does not provide specific sample sizes or provenance information for each test performed (e.g., how many devices were tested for functional performance or biocompatibility). This level of detail is typically found in the full 510(k) submission, not the summary document.

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

This concept is not applicable for a reprocessed surgical instrument. The assessment is based on quantifiable engineering and biological tests, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication method for the test set:

Not applicable. Testing involves objective measurements and predefined pass/fail criteria for mechanical and biological performance.

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:

Not applicable. This is a reprocessed surgical instrument, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical surgical instrument.

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

For this type of device, "ground truth" is established through:

Engineering specifications and performance standards: The device must meet predefined mechanical, electrical, and functional parameters.
Biological safety standards: Biocompatibility testing compares material responses to established safe limits.
Sterilization efficacy standards: Validation ensures a specified sterility assurance level (SAL).
Comparison to predicate device performance: The reprocessed device is expected to perform comparably to the original during functional tests.

8. The sample size for the training set:

Not applicable. There is no "training set" for a reprocessed surgical instrument.

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

Not applicable.

Summary

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

April 29, 2024

Surgical Instrument Service and Savings Inc. Stephanie Boyle Mays Senior Regulatory Affaiirs Specialst, QA/RA (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K232511

Trade/Device Name: Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NUJ, GEI Dated: August 17, 2023 Received: August 18, 2023

Dear Stephanie Boyle Mays:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.29 Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality

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Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

232511

Device Name

Medline ReNewal Remanufactured LigaSure Exact Dissector, without Nano-coating (LF2019)

Indications for Use (Describe)

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.

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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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. On the left is the Medline logo, which is a blue square with a white cross inside. To the right of the Medline logo is the word "Renewal" in large, green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.

510(k) 232511 Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

Submitter/Owner	Surgical Instrument Service and Savings (dba Medline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756
Contact/Prepared by	Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • smays@medline.com
Date Prepared	August 17, 2023
Device NameandClassification	Proprietary/TradeName:	Medline ReNewal Remanufactured LigaSure ExactDissector, without Nano-coating
	Common or UsualName	Bipolar sealing device
	RegulatoryName/Reference	Electrosurgical, cutting & coagulation & accessories21 CFR § 878.4400
	Regulatory Class	2
	Product Code	GEI
	Panel	General & Plastic Surgery
	510(k) Number	K202917
PredicateDevice	Proprietary orTrade Name	LigaSure Exact Dissector, Nano-coated
	Common or UsualName	Bipolar sealing device
	RegulatoryName/Reference	Electrosurgical, cutting & coagulation & accessories21 CFR § 878.4400
	Regulatory Class	2
	Product Code	GEI
	Panel	General & Plastic Surgery
	Manufacturer	Covidien LLC, 5920 Longbow Dr., Boulder, CO 80301
DeviceDescription	The Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vesselsealing device designed for use with compatible Covidien electrosurgicalgenerators that include vessel sealing capabilities to ligate (seal) and divide(cut) vessels, tissue bundles, and lymphatics clamped between the jaws,grasp tissue, and perform blunt dissection during general surgicalprocedures (as indicated) using radio frequency (RF) energy.A hemostat style body allows the user to open or close the instrument jawsduring vessel sealing and cutting, with a single activation buttonincorporated into the body of the device.
TechnologicalCharacteristics	The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the predicate device. Theproposed device is a reprocessed version of the predicate device. K202917LigaSure Exact Dissector, Nano-coated was used as the primary predicateto support intended use, technological characteristics, and functionalperformance specifications.
	The original equipment manufacturer of the LigaSure Exact Dissector,Nano-coated applied a nano-coating to the device jaws to reduce tissuesticking. Medline ReNewal does not replace the coating on the device jawsin its process of decontamination, inspections, packaging and sterilization.
Non-clinicalTestingSummary	The functional characteristics of the subject device have been evaluatedand found to be substantially equivalent to the predicate device based onthe following tests:Functional performance: simulated use and artificial soiling; visual inspection; device functionality; in vivo acute and chronic animal studies Electrical Safety Cleaning Validation: Biocompatibility: Sterilization Validation Packaging and shelf life validation; bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing Product stability

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Image /page/5/Picture/0 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left and consists of a blue square with a white cross inside and the word "MEDLINE" below the cross. To the right of the Medline logo is the word "Renewal" in large, bold, green and blue letters. Below "Renewal" is the phrase "Full Circle Reprocessing" in smaller, black letters.

Product stability

Summary Table: Predicate and Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated comparison chart.

	Predicate	Proposed	Comparison
View	Covidien LigaSure ExactDissector, Nano-coated	Medline ReNewalRemanufactured LigaSureExact Dissector, withoutNano-coating	As Stated
510(k)	K202917	K232511	N/A
Model Number	LF2019	LF2019	As stated
Common Name	Bipolar sealing device	Bipolar sealing device,	Same
Regulation No.	21 CFR § 878.4400	21 CFR § 878.4400	Same
RegulatoryClass	2	2	Same
Product Code	GEI	GEI	Same
Indications forUse	LigaSure Sealer/Divider is abipolar electrosurgicalinstrument intended for use inopen surgical procedureswhere ligation and division ofvessels, tissue bundles, andlymphatics is desired. TheLigaSure Sealer/ Divider canbe used on vessels (arteriesand veins) up to and including7 mm. It is indicated for use ingeneral surgery and in suchsurgical specialties asurologic, thoracic, plastic, andreconstructive. Proceduresmay include, but are notlimited to, bowel resections,gall bladder procedures,Nissen fundoplication, breastprocedures, and adhesiolysis.The instrument is alsoindicated for open ENTprocedures in adults(thyroidectomy, radical neckdissection, parotidectomy, andtonsillectomy) for ligation anddivision of vessels, lymphaticsand tissue bundles 2-3 mmaway from unintendedthermally-sensitive structuressuch as nerves andparathyroid glands.The LigaSure system has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use theLigaSure system for theseprocedures.	The Medline ReNewalRemanufactured LigaSureSealer/Divider is a bipolarelectrosurgical instrumentintended for use in opensurgical procedures whereligation and division ofvessels, tissue bundles, andlymphatics is desired. TheLigaSure Sealer/ Divider canbe used on vessels (arteriesand veins) up to and including7 mm. It is indicated for use ingeneral surgery and in suchsurgical specialties asurologic, thoracic, plastic, andreconstructive. Proceduresmay include, but are notlimited to, bowel resections,gall bladder procedures,Nissen fundoplication, andadhesiolysis.The instrument is alsoindicated for open ENTprocedures in adults(thyroidectomy, radical neckdissection, parotidectomy, andtonsillectomy) for ligation anddivision of vessels, lymphaticsand tissue bundles 2-3 mmaway from unintendedthermally-sensitive structuressuch as nerves andparathyroid glands.The LigaSure system has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use theLigaSure system for theseprocedures.	Same
TechnologicalCharacteristics	To operate, the device isconnected to a compatiblegenerator and is operated byeither a hand or a food switch.	To operate, the device isconnected to a compatiblegenerator and is operated byeither a hand or a food switch.	Same

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Image /page/6/Picture/0 description: The image contains two logos. The first logo is a blue square with a white star-like shape in the center and the word "MEDLINE" written in white below the shape. The second logo is the word "ReNewal" in green and blue, with the words "Full Circle Reprocessing" written in smaller font below it.

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Image /page/7/Picture/0 description: The image shows the logo for "ReNewal Full Circle Reprocessing". The word "ReNewal" is in a large font, with "Re" in green and "Newal" in blue. Below that is the phrase "Full Circle Reprocessing" in a smaller font. To the left of the text is the Medline logo, which consists of the word "MEDLINE" in blue, next to a blue symbol that looks like a stylized star or compass.

a Neither K202917 nor the current submission included the generators as part of theirrespective submissions. Only device LF2019 is included in the project scope.
Conclusion	The predicate and proposed devices in this application have the sameindications for use and technological characteristics. Based on this and thenon-clinical testing data presented in this 510(k) submission, the MedlineReNewal Remanufactured LigaSure Exact Dissector, without Nano-coatingdevice model LF2019 is substantially equivalent to the predicate device.

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.