The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Device Description

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.

AI/ML Overview

The request is for information on the acceptance criteria and study proving device performance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737, and LF1744), as detailed in the FDA 510(k) summary K182588.

Based on the provided document, the device is a reprocessed version of a legally marketed predicate device. The submission primarily focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers with 510(k) K141153) through performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the functional characteristics of the proposed reprocessed devices have been evaluated and found to be equivalent to the predicate devices. The acceptance criteria are implied to be that the reprocessed device performs comparably to the new predicate device across various tests.

Acceptance Criterion (Implied)	Reported Device Performance
Electrical Safety & Electromagnetic Compatibility (EMC)	In accordance with IEC 60601-2-2 and 60601-1-2. (The reprocessed device meets these standards, implying equivalence to the predicate which would also meet these standards).
Simulated Use	Evaluated and found equivalent to the predicate devices. This implies the reprocessed devices perform as expected during simulated surgical procedures.
Device Integrity	Evaluated and found equivalent to the predicate devices. This suggests the physical and structural integrity of the reprocessed devices is maintained.
Blade Trigger Advance/Return	Evaluated and found equivalent to the predicate devices. The cutting mechanism functions correctly.
Activation Button Device Recognition	Evaluated and found equivalent to the predicate devices. The device properly interacts with the associated electrosurgical generators.
Thermal Analysis Characterization	Evaluated and found equivalent to the predicate devices. The reprocessed device's thermal performance (e.g., heat generation during use) is comparable to the predicate.
Tissue Sticking	Evaluated and found equivalent to the predicate devices. The reprocessed device minimizes tissue sticking during use, similar to the predicate.
Burst Pressure	Evaluated and found equivalent to the predicate devices. This likely refers to the strength of the seal created by the device on vessels, demonstrating its ability to occlude vessels effectively, comparable to the predicate.
Histopathology	Evaluated and found equivalent to the predicate devices. This suggests the tissue effects (e.g., thermal damage, seal quality) produced by the reprocessed device are similar to those of the predicate.
Seal Quality	Evaluated and found equivalent to the predicate devices. This is a direct measure of the effectiveness of the device in sealing vessels, confirming it performs comparably to the predicate.
Cleaning: Protein, and Carbohydrates (Residuals After Reprocessing)	Evaluated and found equivalent to the predicate devices. This confirms the reprocessing methods effectively remove biological contaminants to a safe level, meeting the standards necessary for a reprocessed device. (Though "equivalent to the predicate" is stated, for cleaning, the acceptance is typically passing a defined threshold for residuals, implying the reprocessed devices meet these thresholds).
Biocompatibility: Cytotoxicity, Sensitization, Irritation, Pyrogenicity, and Acute Systemic Toxicity	Evaluated and found equivalent to the predicate devices. This indicates that the materials and reprocessing do not induce adverse biological responses, meeting established biocompatibility standards. (Similar to cleaning, "equivalent to the predicate" here means meeting the same biological safety standards of a new device).
Performance Qualification	Evaluated and found equivalent to the predicate devices. This generally refers to verification that the manufacturing process consistently produces device that meets specifications.
Sterilization Validation	Evaluated and found equivalent to the predicate devices. This confirms the sterilization process effectively renders the reprocessed devices sterile to an acceptable sterility assurance level (SAL).
Product Stability	Evaluated and found equivalent to the predicate devices. This assesses the device's ability to maintain its safety and performance characteristics over its shelf life.

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

The document does not specify the exact sample sizes used for each of the performance tests. It broadly states "The functional characteristics of the proposed devices have been evaluated..." without providing numerical details for the test sets.

The data provenance is not explicitly stated in terms of country of origin. Given it is an FDA submission for a device manufactured by "Surgical Instrument Service and Savings Inc (dba Medline ReNewal)" and the predicate is from "Covidien," it can be inferred that the testing and data would be primarily from the United States, following U.S. regulatory guidelines. The data is retrospective in the sense that it relies on established standards and comparisons to an already legally marketed predicate device, rather than a novel prospective clinical trial for the reprocessed device's primary effectiveness.

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

The document does not mention the use of experts to establish ground truth for this type of device comparison study. The tests listed are primarily engineering and laboratory-based performance evaluations (e.g., electrical, mechanical, material, and in-vitro or ex-vivo tissue property tests). For biocompatibility and histopathology, qualified laboratories and pathologists would perform the evaluations, but their specific number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations by multiple readers/experts. The testing involves objective measurements against established engineering and biological standards.

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 not a study involving AI or human readers for diagnostic interpretation. It is a performance evaluation of a reprocessed surgical instrument.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance evaluation of this reprocessed device is established by:

Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers, K141153). The reprocessed device is deemed substantially equivalent if its performance matches or falls within acceptable ranges compared to the predicate.
Industry Standards: Compliance with international and national standards (e.g., IEC 60601 series for electrical safety, ISO standards for biocompatibility and sterilization, and internal performance specifications), which represent a form of accepted "ground truth" for device safety and performance.
Laboratory-based measurements: Objective measurements of physical, chemical, and biological properties through various tests (e.g., burst pressure, protein residuals, cytotoxicity).
Histopathology: Evaluation of tissue effects, performed by qualified personnel (likely pathologists), forms a 'ground truth' for tissue interaction.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the seal is the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 31, 2018

Surgical Instrument Service and Savings Inc (dba Medline ReNewal) Ms. Stephanie Boyle Mays Senior Regulatory Specialist. Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K182588

Trade/Device Name: Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (Model # LF1723, LF 1737, and LF1744) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: September 18, 2018 Received: September 20, 2018

Dear Ms. Mays:

We have reviewed vour 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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Long H. Chen Lona H. Chen=S -2 Date: 2018.10.31 17:43:50 -04'00' 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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Indications for Use

510(k) Number (if known) K182588

Device Name

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (LF1723, LF1737, LF1744)

Indications for Use (Describe)

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (atteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

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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Device Model	Device Name	OriginalManufacturer
LF1723	Maryland Jaw Sealer Divider(13-mm jaw and 5-mm diameter x 23-cmlong shaft)	Covidien
LF1737	Maryland Jaw Sealer Divider(13-mm jaw and 5-mm diameter x 37-cmlong shaft)	Covidien
LF1744	Maryland Jaw Sealer Divider(13-mm jaw and 5-mm diameter x 44-cmlong shaft)	Covidien

Reprocessed Single-Use Device Model Included in Submission:

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Image /page/4/Picture/1 description: The image shows the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with a white cross and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in green letters, and below that is the phrase "Full Circle Reprocessing" in smaller, blue letters.

K182588 510(k) 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 • E: smays@medline.com
Date Prepared	October 29 2018
Device NameandClassification	Proprietary/Trade Name:	Medline ReNewal Reprocessed LigaSure MarylandJaw Sealer/Dividers models LF1723, LF1737, andLF1744
	Common or Usual Name	Bipolar electrosurgical instrument
	Regulatory Name/Reference	Electrosurgical cutting and coagulation device andaccessories reprocessed, 21 CFR § 878.4400
	Regulatory Class	Class II
	Product Code	NUJ
	Panel	General & Plastic Surgery
	510(k) Number	K141153
PredicateDevice	Proprietary or Trade Name	LigaSure Maryland Jaw One Step Sealer/Dividersmodels LF1723, LF1737, and LF1744
	Common or Usual Name	Bipolar electrosurgical instrument
	Regulatory Name/Reference	Electrosurgical cutting and coagulation device andaccessories reprocessed, 21 CFR § 878.4400
	Regulatory Class	Class II
	Product Code	GEI
	Panel	General & Plastic Surgery
	Manufacturer	Covidien5920 Longbow Dr., Boulder, CO 80301
DeviceDescription	The Medline ReNewal Reprocessed LigaSure Maryland JawSealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with theCovidien electrosurgical generators to ligate (seal) and divide (cut) vessels,tissue bundles and lymphatics during open and minimally invasive generalsurgical procedures using radio frequency (RF) energy. A hand actuatedmechanism allows the user to open and close the instrument jaws. Whenthe instrument jaws are correctly placed over tissue or vessel to be sealed,the user operates a second control to initiate delivery of bipolar energy,which seals the tissue. When the sealing cycle is complete, the useroperates a separate control to activate a knife, which divides the tissuealong the seal line.
Indications foruse	The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divideris a bipolar electrosurgical instrument intended for use in minimally invasiveor open surgical procedures where ligation and division of vessels, tissuebundles, and lymphatics is desired. The LigaSure Sealer/Divider can beused on vessels (arteries and veins) up to and including 7 mm. It isindicated for use in general surgery and such surgical specialties asurologic, vascular, thoracic, and gynecologic. Procedures may include, butare not limited to, Nissen fundoplication, colectomy, cholecystectomy,adhesiolysis, hysterectomy, oophorectomy, etc.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. K141153LigaSure Maryland Jaw Sealer/Divider was used as the primary predicateto support intended use, technological characteristics, and functionalperformance 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; burst pressure; histopathology; seal quality; Cleaning: protein, and carbohydrates; Biocompatibility: cytotoxicity sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability

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Image /page/5/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white cross and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.

The generators are not reprocessed by Medline ReNewal.

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Image /page/6/Picture/0 description: The image contains the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left, followed by the word Renewal in green and blue. Below that is the phrase "Full Circle Reprocessing" in a smaller font.

	Predicate	Proposed	Comparison
DeviceCharacteristics	Covidien LigaSure MarylandJaw One Step Sealer/Divider	Medline ReNewal LigaSureMaryland Jaw Sealer/Divider	As Stated
510(k)	K141153	TBD	N/A
Model Numbers	LF1723, LF1737, and LF1744	LF1723, LF1737, and LF1744	Same
Common Name	Bipolar electrosurgicalinstrument	Bipolar electrosurgicalinstrument	Same
Regulation No.	21 CFR § 878.4400	21 CFR § 878.4400	Same
Regulatory Class	Class II	Class II	Same
Product Code	GEI	NUJ	As stated
Indications forUse	The LigaSure Sealer/Divider isa bipolar electrosurgicalinstrument intended for use inminimally invasive or 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 suchsurgical specialties asurologic, vascular, thoracic,and gynecologic. Proceduresmay include, but are notlimited to, Nissenfundoplication, colectomy,cholecystectomy,adhesiolysis, hysterectomy,oophorectomy, etc.The LigaSure system has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use theLigaSure system for theseprocedures.	The Medline ReNewalReprocessed LigaSureMaryland Jaw Sealer/Divideris a bipolar electrosurgicalinstrument intended for use inminimally invasive or 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 suchsurgical specialties asurologic, vascular, thoracic,and gynecologic. Proceduresmay include, but are notlimited to, Nissenfundoplication, colectomy,cholecystectomy,adhesiolysis, hysterectomy,oophorectomy, etc.The LigaSure system has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use theLigaSure system for theseprocedures.	Same
	Predicate	Proposed	Comparison
DeviceCharacteristics	Covidien LigaSureMaryland Jaw One StepSealer/Divider	Medline ReNewal LigaSureMaryland JawSealer/Divider	As stated
Power Platforma	• LF1723 = ForceTriad SWv3.6 or higher.• LF1737 = VL FT10 GENSW v1.0 or higher• LF1744 = VL LS10 GENSW v1.0 or higher	• LF1723 = ForceTriad SWv3.6 or higher.b• LF1737 = VLFT10GEN SWv1.0 or higher• LF1744 = VLLS10GEN SWv1.0 or higher	Same
TechnologicalCharacteristics	The LigaSure Maryland JawOne Step Sealer/Divider usesbipolar RF energy to seal anddivide vessels up to andincluding 7 mm in diameter.	The LigaSure Maryland JawOne Step Sealer/Divider usesbipolar RF energy to seal anddivide vessels up to andincluding 7 mm in diameter.	Same
aForceTriad generator was cleared under K070162; VL FT10 generator was cleared underK151649; and the VL LS10 generator was cleared under K143654. None of the generatorswill be reprocessed by Medline ReNewal. They are not a part of this submission.
Conclusion	Based on comparisons of the indications for use, intended use, technologicalcharacteristics, and performance data to the predicate devices, MedlineReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider modelsLF1723, LF1737, and LF1744 are substantially equivalent to the predicatedevices.

Summary Table: Predicate and Medline ReNewal Reprocessed LigaSure Maryland Jaw Open Sealer/Divider device comparison chart.

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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white star and the word "MEDLINE" in white letters. The Renewal logo is on the right side of the image and consists of the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it. The Renewal logo also has a trademark symbol.

K182588 Medline ReNewal

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.