Signia Four-Bay Smart Charger (to be used with Signia Stapler)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 2, 2017 Covidien Ms. Katherine Choi Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473 Re: K170348 Trade/Device Name: Signia Four-Bay Smart Charger (to Be Used With Signia Stapler) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 2, 2017 Received: February 3, 2017 Dear Ms. Choi: 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 {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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, # 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) K170348 #### Device Name Signia™ Four-Bay Smart Charger #### Indications for Use (Describe) The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas. The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue. The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e., low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of the pancreas. The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri Staple™ 2.0 single use reinforced reloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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." {3}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness ## DATE PREPARED: February 2, 2017 #### SUBMITTER: Covidien 60 Middletown Avenue North Haven, CT 06473 USA #### CONTACT PERSON: Katherine Y. Choi, RAC Principal Regulatory Affairs Specialist Telephone: (203) 492-8412 Fax: (203) 492-5029 #### IDENTIFICATION OF DEVICE: Signia™ Four-Bay Smart Charger (to be used with Signia™ Stapler) Proprietary/Trade Name: Staples, Implantable Classification Name: 21 CFR 878.4750 Requiation Number: Product Code: GDW Class II Device Class: General and Plastic Surgery Review Panel: Surgical Stapler Common Name: #### PREDICATE DEVICE: Proprietary/Trade Name: Signia™ Stapler K160176 (April 26, 2016) 510(k) Number: Classification Name: Staples, Implantable 21 CFR 878.4750 Requlation Number: Product Code: GDW Device Class: Class II General and Plastic Surgery Review Panel: Surgical Stapler Common Name: # DEVICE DESCRIPTION: The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is compatible with Endo GJA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ Otape - roomnology, The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. All of which stay unchanged when compared to the predicate device. The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ The Signia - System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray, and this submission introduces a new accessory, Signia™ Four-Bay Smart Charger. The Smart Charger's primary purpose introduces a new as the Signia Single-Bay Charger in K160176, but the difference is that Smart {4}------------------------------------------------ Charger offers enhanced features such as four charging stations, a touch-screen LCD display, and data management interface in order to improve user convenience. ## INTENDED USE/INDICATIONS FOR USE: The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads Trie Signia - Olapic, When assumments 2.0 single-use reloads and Signia™ loading units with Tri-Willi Theolape - " Connology, " The Suplications in abdominal, gynecological, pediatric, and thoracic Otapic - 2.0 Single doo carthagoo, had creation of anastomosis. It may be used for transection and Surgery for research, transculative, and biliary structures and for transection and resection of the pancreas. The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 The Sightia - Stapler, when asou with Endo One - Carrou appearate target tissue from other certain tissue. The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ The Olgina - Oldpler, whon acount minimally invasive general abdominal, gynecologic, pediatric recimology, nua upplication of tissue and creation of tissue and creation of anastomosis, as well as and thorable surgery for roosenen and atterior resection. It may be used for transection and resection applivation deep in the porner, for and biliary structures and for transection and resection of the pancreas. The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ The olgha - Oldplar, with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads preloaded with polyglycolic acid staple line reinforcement, has applications in romoroco "proloado" proloaded" in d therecic surgery for resection, transection of tissue and creation abounting, gynoongly pound for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas. # SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The Signia™ Four-Bay Smart Charger is designed for use as an accessory with the Signia™ stapler, The Signia - Tour Day offical Jana Jana touch-screen LCD display screen. Its purpose who houded four power handle. The touchscreen LCD is used to indicate the power handle's is to onalye the organia - power hanigdia™ Single Bay Charger in K160176, the Signia™ Four-Bay Smart Charger employs the smart charging mechanism that provides necessary voltage and current regulation for the given battery chemistry. #### SUBSTANTIAL EQUIVALENCE: The Signia™ Stapler used with the Signia™ Four-Bay Smart Charger is substantially equivalent to the TTIe Signia - Olapics asou with the Signia - the Signia " Single-Bay Charger (K160176) since adding a new charger does not affect the stapling technologies employed. Also, when compared to the Signia™ new onarger, the key difference is the Smart Charger offers enhanced features such as four charging stations, touch-screen LCD display and data ports. Other product specifications are very similar. #### SUMMARY OF STUDIES: Non-clinical performance data – Tests performed to demonstrate continued conformance with the FDA recognized standards includes: - 1. Software Verification & Validation per IEC 62304 - 2. Electrical Safety Testing per ANSI/AAMI ES 60601-1 & IEC 60601-1 - 3. EMC Testing per IEC 60601-1-2 - 4. Usability Evaluation per IEC 60601-1-6 & IEC 62366-1 {5}------------------------------------------------ Clinical performance data -- No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies. #### CONCLUSION: Based upon the supporting data summarized above, we concluded that Signia" with the new Based upon the Supporting add Summanized as safe and effective as the legally marketed device accessory, Sigma - Tour-Day Omart Online of safety and effectiveness than the predicate device.