The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A is a bipolar electrosurgical instrument intended for use in 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 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, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss 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 coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Device Description

The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line. The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A.

The key aspect of this document is demonstrating substantial equivalence to an existing predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The study's purpose is not to prove the device meets pre-defined clinical acceptance criteria for a novel functionality, but rather to show that the reprocessed device performs as safely and effectively as the original, legally marketed device.

Therefore, the "acceptance criteria" here largely refer to demonstrating performance consistent with the predicate device across various functional and safety aspects.

Here's an analysis of the acceptance criteria and the study, based on the provided text, while acknowledging that a 510(k) summary often provides high-level information without deep specifics on study methodologies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a reprocessed device, the "acceptance criteria" are generally that the reprocessed device performs equivalently to the original device. The "reported device performance" is the demonstration through various tests that this equivalence is met.

Acceptance Criteria (Equivalence to Predicate)	Reported Device Performance (as demonstrated by testing)
Electrical Safety and Electromagnetic Compatibility	Found equivalent to predicate devices based on tests in accordance with IEC 60601-2-2 and 60601-1-2.
Simulated Use	Functional characteristics evaluated, found equivalent. (Specific metrics not detailed, but implies comparison to predicate performance during simulated surgical scenarios).
Device Integrity	Functional characteristics evaluated, found equivalent. (Implies structural soundness and resistance to failure under expected conditions).
Blade Trigger Advance/Return	Functional characteristics evaluated, found equivalent. (Implies smooth and reliable operation of the cutting mechanism).
Activation Button Device Recognition	Functional characteristics evaluated, found equivalent. (Ensures proper interaction with the electrosurgical generator).
Thermal Analysis Characterization	Functional characteristics evaluated, found equivalent. (Ensures thermal spread remains within acceptable limits, comparable to the predicate).
Tissue Sticking	Functional characteristics evaluated, found equivalent. (Ensures minimal sticking to tissue, similar to the predicate, for ease of use and reduced collateral damage).
Blade Sharpness	Functional characteristics evaluated, found equivalent. (Ensures effective cutting performance comparative to the predicate).
Transient Cooling Analysis Burst Pressure	Functional characteristics evaluated, found equivalent. (Likely assesses the integrity and strength of the sealed vessels under pressure after the sealing cycle, comparing to the predicate).
Histopathology	Functional characteristics evaluated, found equivalent. (Examines tissue changes at a microscopic level after sealing, comparing the reprocessed device's effect to the predicate's).
Seal Quality	Functional characteristics evaluated, found equivalent. (Directly assesses the effectiveness of the vessel sealing functionality, likely through metrics like burst pressure, tensile strength, or visual inspection, against predicate performance).
Cleaning (Protein, Carbohydrates, Endotoxin)	Demonstrated effective cleaning to acceptable levels. (Ensures removal of biological contaminants from previous use).
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity)	Demonstrated acceptable levels for all listed parameters. (Ensures the device materials, after reprocessing, do not elicit harmful biological responses).
Sterilization Validation	Demonstrated effective sterilization. (Ensures the device is sterile when provided for use).
Product Stability	Demonstrated. (Ensures the device maintains its performance and safety over its shelf life after reprocessing).
Intended Use / Indications for Use	The reprocessed device shares the identical Intended Use and Indications for Use as the predicate device. The only difference is the manufacturer of the specific device, and that one is "reprocessed."
Technological Characteristics	The technological characteristics and fundamental scientific technology of the proposed device are identical to the predicate device. Both use bipolar energy to seal and divide vessels up to and including 7mm. Both are designed for use with the ForceTriad Electrosurgical Generator running software version 3.40 or higher.

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

The document does not specify the exact sample sizes for each of the performance tests (e.g., number of devices tested for electrical safety, number of tissue samples for histopathology). It only lists the types of tests performed.

The data provenance is not explicitly stated in terms of country of origin. However, the FDA 510(k) submission process typically requires data generated in accordance with Good Laboratory Practice (GLP) or similar standards. Given it's a US FDA submission, it's highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The data is retrospective in the sense that the predicate device's performance already exists, and the reprocessed device is being compared against it. New prospective testing is done on the reprocessed devices.

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

For a device like this, "ground truth" isn't typically established by expert consensus in the way it would be for an AI diagnostic algorithm. Instead, it's established by:

Engineering specifications and regulatory standards: These define acceptable performance ranges (e.g., electrical parameters, burst pressure requirements, cleanliness levels).
Predicate device's established performance: The predicate device, already on the market, sets the benchmark for equivalent performance.
Scientific and clinical literature: Informing what constitutes safe and effective tissue sealing and cutting.
Pathology results: For tests like histopathology, a qualified pathologist would interpret the tissue samples, but this is part of the test result generation, not "ground truth" establishment in the AI sense.

The document does not mention the number or qualifications of experts establishing ground truth in the context of an AI study. However, the evaluation of the various tests would be performed by qualified personnel (e.g., engineers, microbiologists, toxicologists, pathologists) relevant to each specific test.

4. Adjudication Method for the Test Set

Not applicable in the context of a 510(k) for a reprocessed surgical instrument. Adjudication methods like "2+1" or "3+1" are characteristic of studies establishing ground truth for diagnostic AI, especially in image interpretation, where multiple human readers resolve discrepancies. Here, objective measurements and comparisons to established standards and predicate performance are used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret images or data, and the AI's impact on their performance (with or without AI assistance) is evaluated. This 510(k) is for a physical surgical instrument, not a diagnostic AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. It's a physical electrosurgical instrument that is used by a human surgeon. The performance tests evaluate the instrument's physical and functional capabilities, which are inherently "standalone" in the sense that the instrument itself is being tested, but always within the context of its intended use by a human.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is multifactorial:

Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The reprocessed device must demonstrate equivalent performance across all tested parameters.
Industry Standards and Regulatory Requirements: Technical standards (e.g., IEC 60601 series for electrical safety) and FDA regulations set minimum acceptable performance and safety thresholds.
Objective Measurements: Laboratory tests yield objective data (e.g., electrical resistance, burst pressure, protein levels, cell viability) that can be directly compared against specified limits or predicate device data.
Pathology: For histopathology, the ground truth would be the pathological assessment of tissue effects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth to establish.

Summary

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

May 1, 2017

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

Re: K162751

Trade/Device Name: Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II

Product Code: NUJ Dated: April 19, 2017 Received: April 21, 2017

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

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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 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, 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

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Reprocessed Single-Use Device Models Subject to Clearance:

ModelNumber	Device Name/Description	Original Manufacturer
LF1212A	LigaSure Curved, Small Jaw, Open Sealer/Divider	Covidien

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Indications for Use

510(k) Number (if known) K162751

Device Name

Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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: January 31, 2017 See PRA Statement below.

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Image /page/4/Picture/2 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star-like symbol to the right. To the right of that is a vertical line, followed by the word "Renewal" in green and blue. Underneath "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.

K162751 Summary

Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Name	Brandi PanteleonDirector, Regulatory AffairsP: 541-516-4180F: 541-923-3375E: bpanteleon@medline.com
Prepared by	Stephanie Boyle MaysRequlatory Affairs Specialist, Requlatory AffairsP: 541-516-4205F: 541-923-3375E: smays@medline.com
Date Prepared	September 29, 2016
Device Names	Proprietary Name: Medline ReNewal Reprocessed LigaSure Curved, SmallJaw Open Sealer/Divider LF1212ACommon Name: Bipolar electrosurgical instrument
Classification	Electrosurgical cutting and coagulation device and accessoriesreprocessedProduct code: NUJClass: Class II, non-exempt
PredicateDevice	K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A
DeviceDescription	The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, OpenSealer/Divider LF1212A is a sterile, single-use, hand-held bipolarelectrosurgical instrument designed for use with compatible Covidiengenerators that include vessel sealing capabilities to ligate (seal) and divide(cut) vessels, tissue bundles and lymphatics during open general surgicalprocedures. Covidien electrosurgical generators that include vessel sealingcapabilities deliver precise energy through the device to tissue for acontrolled tissue response to achieve complete and permanent tissuefusion while producing minimal sticking, charring, and thermal spread toadjacent tissue.The surgeon first grasps the vessel or tissue with the jaws of theinstrument. Once the surgeon is confident that the instrument is placedcorrectly, he or she initiates a seal by pressing a hand switch or footswitch.The instrument creates a seal by application of RF electrosurgical energy tovascular structures (vessels and lymph) or tissue bundles interposedbetween the jaws of the instrument. Once the seal cycle is complete, thesurgeon actuates a blade within the instrument to divide tissue along theseal line.The 10-foot cord, cable connector, and generator are not reprocessed byMedline ReNewal.
Intended Use	The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, OpenSealer/Divide LF1212A is a bipolar electrosurgical instrument intended foruse in open surgical procedures where ligation and division of vessels,tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider canbe used on vessels (arteries and veins) up to and including 7 mm. It isindicated for use in general surgery and in such surgical specialties asurologic, thoracic, plastic and reconstructive. Procedures may include, butare not limited to, bowel resections, gall bladder procedures, Nissenfundoplication, and adhesiolysis.The instrument is also indicated for open ENT procedures in adults(thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy)for ligation and division of vessels, lymphatics and tissue bundles 2 - 3 mmaway from unintended thermally-sensitive structures such as nerves andparathyroid glands.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. K152286LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A was used asthe primary predicate to support intended use, technological characteristics,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 60601-2-2 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; activation button device recognition; thermal analysis characterization; tissue sticking; blade sharpness; transient cooling analysis burst pressure; histopathology; seal quality; Cleaning: protein, carbohydrates, and endotoxin; Biocompatibility: cytotoxicity sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification.

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Image /page/5/Picture/2 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.

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Image /page/6/Picture/2 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it.

sterilization validation; and ● ● product stability. Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate Conclusion devices, Medline ReNewal reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF1212A) is substantially equivalent to the predicate devices.

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K162751

Image /page/7/Picture/2 description: The image features the word "ReNewal" in a vertically stacked format, with the "Re" in green and the "Newal" in blue. To the right of "ReNewal" is the phrase "Full Circle Reprocessing" in a smaller, vertically stacked font. Below "ReNewal" is the word "MEDLINE" in blue, accompanied by a stylized logo. The logo consists of a blue star-like shape with an arrow pointing to the right, suggesting a sense of direction or progress.

Predicate and Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider (LF1212A) device

comparison chart. Table 1:

DeviceCharacteristics	Predicate	Proposed	Comparison
Predicate 510(k)	K152286	K162751	N/A
Model Numbers	LF1212A	LF1212A	N/A
IntendedUse/Indications forUsea	The Covidien LigaSure Curved Small Jaw, OpenSealer/Divide model LF1212A is a bipolarelectrosurgical instrument intended for use inopen surgical procedures where ligation anddivision of vessels, tissue bundles, and lymphaticsis desired. The LigaSure Sealer/Divider can beused on vessels (arteries and veins) up to andincluding 7 mm. It is indicated for use in generalsurgery and in such surgical specialties asurologic, thoracic, plastic and reconstructive.Procedures may include, but are not limited to,bowel resections, gall bladder procedures, Nissenfundoplication, and adhesiolysis.The instrument is also indicated for open ENTprocedures in adults (thyroidectomy, radical neckdissection, parotidectomy, and tonsillectomy) forligation and division of vessels, lymphatics andtissue bundles 2 – 3 mm away from unintendedthermally-sensitive structures such as nerves andparathyroid glands.	The Medline ReNewal Reprocessed LigaSureCurved Small Jaw, Open Sealer/Divide modelLF1212A is a bipolar electrosurgical instrumentintended for use in open surgical procedureswhere ligation and division of vessels, tissuebundles, and lymphatics is desired. The LigaSureSealer/Divider can be used on vessels (arteriesand veins) up to and including 7 mm. It isindicated for use in general surgery and in suchsurgical specialties as urologic, thoracic, plasticand reconstructive. Procedures may include, butare not limited to, bowel resections, gall bladderprocedures, Nissen fundoplication, andadhesiolysis.The instrument is also indicated for open ENTprocedures in adults (thyroidectomy, radical neckdissection, parotidectomy, and tonsillectomy) forligation and division of vessels, lymphatics andtissue bundles 2 - 3 mm away from unintendedthermally-sensitive structures such as nerves andparathyroid glands.	Same device;differentmanufacturer
DeviceCharacteristics	PredicateCovidien LigaSure Impact Curved, Large JawSealer/Divider	ProposedMedline ReNewal Reprocessed LigaSureImpact Curved, Large Jaw Sealer/Divider	Comparison
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.parathyroid glands.	Same device;differentmanufacturer
Power Platform	ForceTriad Electrosurgical Generator runningsoftware version 3.40 or higher.b	ForceTriad Electrosurgical Generator runningsoftware version 3.40 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 K1522864 predicate.b Force Triad generator was cleared under K070162: It will not be reprocessed and it is not part of this submission

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Image /page/8/Picture/2 description: The image shows the Medline Renewal logo. The word "Renewal" is written vertically in a combination of green and blue colors. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font. To the left of the word "Renewal" is the Medline logo.

Predicate and: Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF1212A) device compariso
chart (concluded). Table 1:

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.