PANTHER Endo Linear Cutter Staplers with Single Use Loading Units

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three heads, arranged in a row. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 11, 2015 B.j.z.h.f. Panther Medical Equipment Co. Ltd. % Chu Xiaoan Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, CN 102200 Re: K142577 Trade/Device Name: Panther Endo Linear Cutter Staplers With Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: September 12, 2014 Received: September 12, 2014 Dear Mr. Chu Xiaoan, 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 {1}------------------------------------------------ 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, # David Krause -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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142577 #### Device Name PANTHER Endo Linear Cutter Staplers with Single Use Loading Units Indications for Use (Describe) PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. 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) #### 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." {3}------------------------------------------------ ## 510(k) Summary (per 2.1 CFR 807.92) ## 1. Applicant | B.J.ZH.F. Panther Medical Equipment Co. Ltd. | | | |-------------------------------------------------|--|--| | ROM 805, Ruichuang Mansion, NO.9 Wangjing East, | | | | Beijing, 102200, China | | | | Ms. Liu Yu | | | | 8610-6970402-8039 | | | | 9/9/2014 | | | | | | | ## 2. Device Name Trade or Proprietary Name: PANTHER Endo Linear Cutter Stapler with Single Use Loading Units Common/Usual Name: Surgical Stapler with Implantable Staple Classification Name: Implantable Staple Regulation Number: 878.4750 Product Code: GDW Classification: II Panel: General & Plastic Surgery ### 3. Predicate Device ### 3.1 Device Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units with Staple Line Reinforcement (K 080898) ### 3.2 Manufacture Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) ### 4. Intended Use PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. ### 5. Description of the Devices The proposed device. PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (SULU) is sterile (ETO), single-patient-use surgical instruments, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two triple-staggered rows. The Endo Linear Cutter Stapler will accommodate any of the reloading unit with staple cartridge lengths of 30mm, 45mm, {4}------------------------------------------------ and 60mm and come in long or compact shaft lengths, and they may be reloaded and fired up to 25 times in a single procedure. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm SULU. The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications. ### 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing. ### 7. Substantially Equivalent (SE) Conclusion The following table compares the proposed-device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc. | Features & Description | Subject Device | Predicate Device | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Product Code | GDW | Same | | Regulation Number: | 878.4750 | Same | | Class | II | Same | | Intend for use | PANTHER Endo Linear Cutter Stapler<br>with Single Use Loading Units (SULU)<br>has applications in abdominal,<br>gynecologic, pediatric and thoracic<br>surgery for resection, transaction and<br>creation of anastomosis. They may be<br>used for transection and resection of liver<br>substance, hepatic vasculature and biliary<br>structures. | Same | | Cutting Mechanism | Linear Knife | Same | | Operation Principle | Manual | Same | | Safety Mechanism | Green button for preventing from<br>miss-firing. | Same | | Staple shape | B-Shaped | Same | | Closed staple height(mm) | 0.75,1.0, 1.5, 2.0 | Same | | material | Staple<br>ISO 5832-2: Implants for surgery -<br>Metallic materials - Part 2: Unalloyed<br>titanium | Same | #### .Table 1 Product Comparison Table {5}------------------------------------------------ | Kinife | Stainless steel | Same | |------------------|---------------------------------------------------------------------------------------|----------------| | Stapler | Polymeric materials,<br>surgical grade stainless steels,<br>adhesives, and lubricants | Very Similarly | | Sterilization | EtO sterilized , SAL: 10-6 | Same | | Packaging | PET shrink plastic tray and Tyvek<br>®.dialyzed paper | Same | | Shelf life | 36 months | Same | | Biocompatibility | Cytotoxicity Compliance with ISO 10993-5 | Same | | | Irritation Compliance with ISO 10993-10 | Same | | | Sensitization Compliance with ISO<br>10993-10 | Same | Although there is a little different from the Predicate Device, the staple line reinforcement material (the synthetic absorbable film) on the ENDO GIA TM UNIVERSAL Single Use Loading Units (SULUs), but there are no substantial differences between the PANTHER Endo Linear Cutter Stapler with Single Use Loading Units (SULU) and the predicate devices. They have the same or similar indications for use. In addition, the minor differences in the technological characteristics do not raise issues of safety and effectiveness. ### 8. Conclusion The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units, is determined to be Substantially Equivalent (SE) to the predicate device. Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units with Staple Line Reinforcement (K 080898), in respect of safety and effectiveness.