(163 days)
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or 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 surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
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.
The Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider (LF1623, LF1637) devices are sterile single-use, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics clamped between the jaws, grasping tissue and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. A hand-actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not include software.
The document describes the Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider (a reprocessed medical device) and its substantial equivalence to its predicate device. This is a premarket notification (510(k)) for a reprocessed electrosurgical instrument, not a new AI/ML device. Therefore, many of the requested categories related to AI performance, sample sizes for test/training sets, expert ground truth, and MRMC studies are not applicable.
However, I can extract information relevant to the device's acceptance criteria and the studies performed to demonstrate its equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device through various performance tests. The reported device performance aligns with these criteria by achieving comparable results to the predicate.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 60601-2-2 | Found to be equivalent to the predicate devices. |
| Electromagnetic Compatibility | IEC 60601-1-2 | Found to be equivalent to the predicate devices. |
| Functional Equivalence | Simulated use | Found to be equivalent to the predicate devices. |
| Device integrity | Found to be equivalent to the predicate devices. | |
| Blade trigger advance/return | Found to be equivalent to the predicate devices. | |
| Shaft knob rotation | Found to be equivalent to the predicate devices. | |
| Device recognition | Found to be equivalent to the predicate devices. | |
| Handle locking | Found to be equivalent to the predicate devices. | |
| Thermal Performance | Thermal analysis characterization | Found to be equivalent to the predicate devices. |
| Sealing Performance | Burst pressure | Found to be equivalent to the predicate devices. |
| Histopathology | Found to be equivalent to the predicate devices. | |
| Seal quality | Found to be equivalent to the predicate devices. | |
| Tissue sticking | Found to be equivalent to the predicate devices. | |
| Reprocessing Effectiveness | Cleaning (protein and carbohydrates) | Demonstrated effective cleaning. |
| Biocompatibility | Sensitization, irritation, pyrogenicity, acute systemic toxicity | Demonstrated biocompatibility. |
| Stability/Shelf Life | Sterilization validation | Demonstrated sterility post-reprocessing. |
| Product stability | Demonstrated stability over time, likely covering shelf-life claims. | |
| Overall Equivalence | Comparison of indications for use, intended use, technological characteristics, and performance data. | The reprocessed devices are substantially equivalent to the predicate in terms of indications for use, intended use, technological characteristics, and performance data. The only stated difference in device characteristics is the length of the shaft. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. For medical device reprocessing, usually, a sufficient number of devices are reprocessed and then subjected to the tests listed to demonstrate performance consistent with new devices and specified reprocessing parameters. The provenance of the data is prospective testing conducted by Medline ReNewal to support the substantial equivalence claim for their reprocessed devices. The country of origin of the data is not explicitly stated but is implicitly linked to the applicant (Medline ReNewal, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable in the context of this 510(k) submission for a reprocessed surgical instrument. "Ground truth" usually refers to definitive labels or diagnoses for AI/ML model training and evaluation. Here, the "ground truth" for demonstrating device performance relies on established engineering standards (e.g., IEC standards), material science, and biological testing methodologies (histopathology, biocompatibility tests), which are evaluated by qualified professionals in those fields (e.g., engineers, biologists, pathologists). The document does not specify the number or qualifications of these testing personnel.
4. Adjudication method for the test set
Not applicable. The tests performed are objective measurements (e.g., electrical resistance, burst pressure, chemical residue, histopathology) against established standards or comparisons to the predicate device's performance, rather than subjective assessments requiring adjudication.
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 medical device clearance for a reprocessed surgical instrument, not an AI/ML diagnostic or assistive device. There are no "human readers" or AI assistance involved in the function or evaluation of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument and does not incorporate an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the "ground truth" for this device's performance is based on:
- Established engineering standards: For electrical safety, EMC, and mechanical performance.
- Material science principles: For device integrity, handle locking, etc.
- Biological testing methodologies: For burst pressure, histopathology (tissue effects), tissue sticking, biocompatibility, cleaning efficacy (protein/carbohydrate residue).
- Comparison to the predicate device: The ultimate "ground truth" for a 510(k) is demonstrating performance that is equivalent to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no AI/ML component, therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component or training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
Surgical Instrument Service And Savings Inc. Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K160333
Trade/Device Name: Medline ReNewal Reprocessed LigaSure Blunt Tip 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: June 17, 2016 Received: June 20, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 yours,
Christopher J. Ronk -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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Page 3 - Ms. Brandi Panteleon
Reprocessed Single-Use Device Models Included in Clearance:
| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| LF1623 | LigaSure Blunt Tip Open Sealer/Divider(5 mm x 23 cm) | Covidien |
| LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider(5 mm x 37 cm) | Covidien |
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Indications for Use
510(k) Number (if known) K160333
Device Name
Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider
Indications for Use (Describe)
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vesses, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on veins) up to and including 7 mm. It is indicated for use in general surgery and such specialities 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Reprocessed Single-Use Device Models Included in Clearance:
| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| LF1623 | LigaSure Blunt Tip Open Sealer/Divider(5 mm x 23 cm) | Covidien |
| LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider(5 mm x 37 cm) | Covidien |
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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star to the right of it. To the right of the Medline logo is the word "Renewal", with "Re" in green and "Newal" in blue. Underneath the word "Renewal" is the phrase "Full Circle Reprocessing" in blue.
Summary K160333
| Submitter/Owner | Medline ReNewal2747 SW 6th St.Redmond, OR 97756 |
|---|---|
| Contact Name | Brandi PanteleonDirector, Quality Assurance and Regulatory AffairsP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com |
| Prepared by | Stephanie Boyle MaysRegulatory Affairs Specialist, Regulatory AffairsP: 541-516-4205F: 541-516-4180E: smays@medline.com |
| Date Prepared | February 3, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed LigaSure Blunt TipSealer/DividerCommon Name: Bipolar electrosurgical instrument |
| Classification | Electrosurgical cutting and coagulation device and accessoriesProduct code: NUJClass: Class II, non-exempt |
| PredicateDevice | K142929 LigaSure Blunt Tip Sealer/Divider |
| ReferenceDevice | K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt TipSealer/Divider, Maryland Jaw One Step Sealer/Divider, curved |
| Device Models | LF1623 and LF1637 |
| DeviceDescription | The Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider(LF1623, LF1637) devices are sterile single-use, hand-held bipolar vesselsealing devices designed for use with Covidien electrosurgical generatorsthat include vessel sealing capabilities to ligate (seal) and divide (cut)vessels, tissue bundles and lymphatics clamped between the jaws,grasping tissue and blunt dissection during open and minimally invasivegeneral surgical procedures (as indicated) using radio frequency (RF)energy. A hand-actuated lever allows the user to open or close theinstrument jaws, and includes a latching mechanism that holds the jaws inthe closed position during vessel sealing and cutting. The proposed devicesdo not include software. |
| Intended Use | The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolarelectrosurgical instrument intended for use in minimally invasive or opensurgical 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 usein general surgery and such surgical specialities as urologic, vascular,thoracic and gynecologic. Procedures may include, but are 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 and reference devices.The proposed devices are reprocessed versions of the predicate andreference devices. |
| 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, IEC 60601-2-2, and IEC 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 acute systemictoxicity; 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 predicate andreference devices, Medline ReNewal Reprocessed LigaSure Blunt TipSealer/Dividers (LF1623 and LF1637) are substantially equivalent to thepredicate. |
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Image /page/6/Picture/0 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 in green and blue, and the words "Full Circle Reprocessing" are below the Renewal logo.
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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a large, bold font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it.
| DeviceCharacteristics | Predicate | Proposed | Reference Device | Comparison |
|---|---|---|---|---|
| Covidien LigaSureBlunt Tip Sealer/Divider | Medline ReNewal LigaSureBlunt Tip Sealer/Divider | Covidien LigaSure5-mm Blunt TipLaparoscopicSealer/Dividera | Same devices;differentmanufacturer | |
| Predicate 510(k) | K142929 | K160333 | K141153 | N/Ab |
| Model Numbers | LF1623 | LF1623, LF1637 | LF1637 | N/A |
| DeviceDescription | The Covidien LigaSure Blunt TipSealer/Divider (LF1623, LF1644)devices are sterile single-use,hand-held bipolar vessel sealingdevices designed for use withCovidien electrosurgicalgenerators that include vesselsealing capabilities to ligate (seal)and divide (cut) vessels, tissuebundels and lymphatics clampedbetween the jaws, grasping tissueand blunt dissection during openand minimally invasive generalsurgical procedures (as indicated)using radio frequency (RF) energyA hand-actuated lever allows theuser to open or close theinstrument jaws, and includes alatching mechanism that holds thejaws in the closed | The Medline ReNewalReprocessed LigaSure Blunt TipSealer/Divider (LF1623, LF1637)devices are sterile single-use,hand-held bipolar vessel sealingdevice is designed for use withCovidien electrosurgicalgenerators that include vesselsealing capabilities to ligate (seal)and divide (cut) vessels, tissuebundles and lymphatics clampedbetween the jaws, grasping tissueand blunt dissection during openand minimally invasive generalsurgical procedures (as indicate)using radio frequency (RF) energy.A hand-actuated lever allows theuser to open or close theinstrument jaws, and includes alatching mechanism that holds thejaws in the closed position | Same as predicate | • K142929(predicate) andproposed devicesinclude open andlaparoscopic blunttip sealer/dividers.• K141153(reference) andproposed devicesspecify use of theForceTriad energysystem. TheForceTriad systemis a Covidienelectrosurgicalgenerator that isincluded in theK142929description. |
Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart.
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Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a large, bold font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it.
| DeviceCharacteristics | Predicate | Proposed | Reference Device | Comparison |
|---|---|---|---|---|
| Covidien LigaSureBlunt Tip Sealer/Divider | Medline ReNewal LigaSure BluntTip Sealer/Divider | Covidien LigaSure5-mm Blunt TipLaparoscopic Sealer/Divider | Same devices;differentmanufacturer | |
| DeviceDescription(concluded) | position during vessel sealing andcutting.The proposed devices do notinclude software. | during vessel sealing and cutting.The proposed devices do notinclude software. | (as stated previously) | · All devices areLigaSure blunt-tipsealer/dividers |
| Indications forUse (IFU) | The LigaSure Sealer/Divider is abipolar electrosurgical instrumentintended for use in minimallyinvasive or open surgicalprocedures where ligation anddivision of vessels, tissue bundles,and lymphatics is desired. TheLigaSure Sealer/Divider can beused on vessels (arteries andveins) up to and including 7 mm. Itis indicated for use in generalsurgery and surgery specialties asurologic, vascular, thoracic andgynecologic. Procedures mayinclude, but are not limited to,Nissen fundoplication, colectomy,cholecystectomy, adhesiolysis,hysterectomy, oophorectomy, etc. | The Medline ReNewalReprocessed LigaSureSealer/Divider is a bipolarelectrosurgical instrument intendedfor use in minimally invasive oropen surgical procedures whereligation and division of vessels,tissue bundles, and lymphatics isdesired. The LigaSureSealer/Divider can be used onvessels (arteries and veins) up toand including 7 mm. It is indicatedfor use in general surgery andsuch surgical specialities asurologic, vascular, thoracic andgynecologic. Procedures mayinclude, but are not limited to,Nissen fundoplication, colectomy,cholecystectomy, adhesiolysis,hysterectomy, oophorectomy, etc. | Same as predicate | Indications for use forthe K142929predicate LigaSureSealer/Divider andthe proposed devicesare the same. TheIFU for K142929includes both theLF1623 and LF1637in the instructions thataccompany thedevices. |
Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart (continued).
(continued)
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Image /page/9/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The logo features the Medline logo on the left, which is a blue stylized star. To the right of the Medline logo is the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font.
Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart (concluded). Table 1:
| DeviceCharacteristics | Predicate | Proposed | Reference Device | Comparison |
|---|---|---|---|---|
| Covidien LigaSureBlunt Tip Sealer/Divider | Medline ReNewal LigaSure BluntTip Sealer/Divider | Covidien LigaSure5-mm Blunt TipLaparoscopic Sealer/Divider | Same devices;differentmanufacturer | |
| Indications forUse (concluded) | The LigaSure system has notbeen shown to be effective fortubal sterilization or tubalcoagulation for sterilizationprocedures. Do not use theLigaSure system for theseprocedure. | The LigaSure system has not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures. Do notuse the LigaSure system for theseprocedures. | (as stated previously) | (as stated previously) |
| Power Platform | ForceTriad SW v.3.60 or higherfor LF1623ForceTriad SW v. 3.50 or higherfor LF1637° | ForceTriad SW v.3.60 or higher forLF1623ForceTriad SW v. 3.50 or higherfor LF 1637 | ForceTriad SW v. 3.50 orhigher for LF1637 | Same |
| TechnologicalCharacteristics | The only differences between thepredicate and subject devices arethe length of the shaft.Note: predicate device forK142929 is reference deviceK141153 | The technological characteristicsand the fundamental scientifictechnology of the subject devicesare identical to the predicate andreference devices. The proposeddevices are a reprocessed versionof the predicate and referencedevices. | Same as predicate. | Same |
| a Only the LigaSure 5 mm Blunt Tip Sealer/Divider is included in this submission from reference device K141153. Medline ReNewal is not |
including the LigaSure Curved Small Jaw Sealer/Divider of the Maryland Jaw One Step Sealer/Dividers in this submission. b
N/A = not applicable. C
ForceTriad generator was cleared under K070162: It will not be reprocessed, and it is not part of this submission.
§ 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.