Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized image of three human profiles facing right, with a design that resembles an abstract bird or wing above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 23, 2015 SterilMed % Dr. Sew-Wah Tay Libra Medical 8401 73rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428 Re: K143260 Trade/Device Name: Reprocessed Vessel Sealers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: January 23, 2015 Received: January 26, 2015 Dear Dr. Tay: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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" (21CFR 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. # 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 {2}------------------------------------------------ Page 3 – Dr. Sew-Wah Tay ### Device Models Subject to Clearance: | Model<br>Number | Device Description | Shaft<br>Diameter | Shaft<br>Length | Shaft<br>Rotation | |-----------------|----------------------------------------------------------------------------------|-------------------|-----------------|-------------------| | LF1637 | Reprocessed Covidien Ligasure 5 mm,<br>Blunt Tip, Laparoscopic<br>Sealer/Divider | 5 mm | 37 cm | 180° | {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K143260 Device Name Reprocessed Vessel Sealers #### Indications for Use (Describe) The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. Indications for use include general laparoscopic procedures including urologic, vascular, thoracoscopic, and gynecologic procedures where ligation of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectory, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The reprocessed vessel sealer/dividers can be used to on vessels and lymphatics up to and including 7 mm, and tissue bundles. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {4}------------------------------------------------ ## II. SUMMARY AND CERTIFICATION ## A. 510(k) Summary | Submitter and Manufacturer: | Nicole Boser<br>Sterilmed, Inc.<br>5010 Cheshire Parkway N, Suite 2<br>Plymouth, MN 55446 | |------------------------------------|---------------------------------------------------------------------------------------------------------------| | Manufacturing Facility<br>Address: | 11400 73rd Avenue North<br>Maple Grove, MN 55369 | | Primary Contact: | Sew-Wah Tay PhD<br>Libra Medical, Inc.<br>Tel: 612-801-6782<br>Fax: 763-477-6357<br>Email: swtay@libramed.com | | Secondary Contacts: | Nicole Boser<br>Tel: (763) 488-2050<br>Fax: (763) 488-3441<br>Email: nboser@sterilmed.com | | Date of Submission: | 12 November 2014 | | Trade Name: | Reprocessed Vessel Sealer | | Regulation Name: | Electrosurgical, cutting & coagulation accessories,<br>laparoscopic & endoscopic, reprocessed | | Regulation Number | 21 CFR 878.4400 | | Device Classification: | Class II | | Product Code: | NUJ | | Predicate Devices: | Covidien LigaSure™ 5 mm, Blunt Tip Laparoscopic Sealer/Divider (K130744).<br>Sterilmed Reprocessed Vessel Sealer (K123096) | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description: | The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical<br>instrument designed exclusively for use with the ForceTriad™ energy platform<br>(generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and<br>lymphatics clamped between the jaws, grasping tissue, and blunt dissection<br>during laparoscopic general surgical procedures (as indicated) using radio<br>frequency (RF) energy. A hand actuated lever allows the user to open and close<br>the instrument jaws, and includes a latching mechanism that holds the jaws in the<br>closed position during vessel sealing and cutting. | | Intended Use: | The reprocessed vessel sealer/dividers are intended for use in general and<br>gynecological laparoscopic surgical procedures where ligation and<br>division of vessels and lymph is desired.<br><br>Indications for use include general laparoscopic procedures including<br>urologic, vascular, thoracic and thoracoscopic, and gynecologic<br>procedures where ligation and division of the vessels is performed. These<br>procedures include laparoscopically assisted vaginal hysterectomy, Nissen<br>fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device<br>has not been shown to be effective for tubal sterilization or tubal<br>coagulation for sterilization procedures, and should not be used for these procedures.<br><br>The reprocessed vessel sealer/dividers can be used to on vessels and<br>lymphatics up to and including 7 mm, and tissue bundles. | | Technological<br>Characteristics: | The reprocessed vessel sealer has the same technological and performance<br>characteristics as the predicate, K130744. Similar to the predicate, this<br>reprocessed device seals vessels and lymphatics using radio frequency (RF)<br>energy to achieve its intended use and can mechanically divide the sealed areas<br>or tissue with a mechanical cutting device. The manner of reprocessing and<br>testing is identical to predicate K123096, Sterilmed reprocessed vessel sealer. | | Functional and<br>Safety Testing: | Representative samples of reprocessed devices were tested to demonstrate<br>appropriate functional characteristics. Process validation testing was performed<br>to validate the cleaning and sterilization procedures as well as device packaging.<br>In addition, the manufacturing process includes visual and validated functional<br>testing of all products produced. | | Summary of<br>Non-clinical Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization<br>validation (ISO 11135, USP <71>), ethylene oxide residual testing (ISO 10993-<br>7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-<br>life validation (ASTM 1980-07). In addition, validation of functional<br>performance (bench testing) was performed through simulated use, visual<br>inspection, and fatigue testing. Testing performed:<br>• Electrical Safety (IEC 60601-2-2)<br>• Device Functionality<br>• Vessel Seal Burst (Static and Burst Pressure)<br>• Vessel Seal Thermal Spread<br>• Mold Stress<br>• Drop<br>• Spillage<br>• Push<br>Performance testing shows the reprocessed vessel sealers to perform as<br>originally intended. | | Conclusion: | Sterilmed concludes that the reprocessed vessel sealer is safe, effective, and<br>substantially equivalent to the predicate device, Covidien LigaSure™ 5 mm,<br>Blunt Tip, Laparoscopic Sealer/Divider (K130744), as described in this<br>premarket notification submission. The reprocessing and validation methods<br>used are similar to the Sterilmed reprocessed vessel sealer predicate device<br>(K123096). | {5}------------------------------------------------