Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, layered on top of each other. The profiles are connected by a flowing, ribbon-like shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 9, 2017 TGS Medical Co., Ltd. % Ms. Diana Hong Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, 200120 China Re: K162710 Trade/Device Name: Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler And Reload, Single Patient Use Linear Cutter And Reload, Single Patient Use Endo Cutter And Reload, Single Patient Use Transverse Cutter And Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 6, 2017 Received: January 10, 2017 Dear Ms. Hong: 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 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. 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}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K162710 K16271U ### Device Name Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload ### Indications for Use (Describe) The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses. The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediativ surgical procedures. It can be used with tissue buttressing materials. The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or minimally invasive surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures. The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas. The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease. The Single Patient Use Transverse Cutter and Reload is intended for transection and or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures. Type of Use (*Select one or both, as applicable*) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ # 510(k) Summary - 1. Sponsor Identification ## TGS Medical Co., Ltd. Building 17, No.8 Jinfeng Road, High-tech Zone, Suzhou, Jiangsu Province, China Establishment Registration Number: Not yet registered Contact Person: Hua Cao Position: General Manager Tel: +86-512-86867776 Fax: +86- 512-86867070 Email: caohua@tgsmedical.com - 2. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) ### Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net {4}------------------------------------------------ #### Identification of Proposed Device 3. Trade Name: Single Use Circular Stapler Single Use Hemorrhoidal Circular Stapler Single Patient Use Linear Stapler and Reload Single Patient Use Linear Cutter and Reload Single Patient Use Endo Cutter and Reload Single Patient Use Transverse Cutter and Reload Common Name: Stapler and Reload Regulatory Information Classification Name: Staple, Implantable Classification: II Product Code: GDW Regulation Number: 21CFR 878.4750 Review Panel: General& Plastic Surgery Classification Name: Stapler, Surgical; Classification: I Exempt Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery Intended Use Statement: The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses. The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of The instrument has application in multiple open or minimally invasive general, anastomoses. gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials. The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures. The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of {5}------------------------------------------------ anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas. The Single Use Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The Single Patient Use Transverse Cutter and Reload is intended for transection, resection and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures. Device Description The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure. Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm. Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in six staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure. Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm, 75mm and 90mm staple for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure. Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 4.2mm and 4.5mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure. {6}------------------------------------------------ Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded. - 4. Identification of Predicate Devices Predicate Device 1 510(k) Number: K030411 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories Predicate Device 2 510(k) Number: K983536 Product Name: PROXIMATE® Curved and Straight Intraluminal Staplers Predicate Device 3 510(k) Number: K020779 Product Name: ENDOPATH and PROXIMATE Linear Cutters and Staplers Predicate Device 4 510(k) Number: K111825 Product Name: DST Series™ Staplers Predicate Device 5 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers Predicate Device 6 510(k) Number: K062869 Product Name: CONTOUR™ Curved Cutter Stapler and Reloads - న. Identification of Reference Devices Reference Device 1 510(k) Number: K080839 Product Name: Echelon™ Gray Cartridge-45mm Reference Device 2 510(k) Number: K112056 Product Name: Echelon Endoscopic Linear Cutter Reload, Black {7}------------------------------------------------ ### 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. The test results demonstrated that the proposed device complies with the following standards: - > ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process. - > ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. - > ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity - > USP 38-NF 33 <85> Bacterial Endotoxins Tests - > ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials; - > ISO 11137-2: 2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose - 7. Clinical Test Conclusion No clinical study is included in this submission. {8}------------------------------------------------ ### 8. Substantially Equivalent (SE) Comparison | Item | Proposed Device | Predicate Device 6 | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Product Code | GDW | K062869 | | Regulation Number | 21 CFR 878.4750 | Same | | Intended Use | The Single Patient Use Transverse Cutter and Reload is intended for transection, resection and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures. | Same | | Cutting Mechanism | Curved Knife | Same | | Operation Principle | Manual | Same | | Safety Mechanism | Reset Knob is used for preventing from mis-firing | Same | | Closed staple height | 1.5mm, 2.0mm | Same | | Closed staple form | Image: staple form | Image: staple form | | Patient-contact material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Unknown | | Sterilization | Irradiation Sterilization | EO Sterilization | | Endotoxin Limit | 20 EU | Same | | Labeling | Conforms with 21 CFR 801 | Same | # Table 1 Comparison of Technology Characteristics for Single Patient Use Transverse Cutter and Reload {9}------------------------------------------------ | Item | Proposed Device | Predicate Device 2 | Item | Proposed Device | Predicate | Reference | Reference | Item | Proposed Device | Predicate Device 4 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------|---------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | | | K983536 | | | Device 5<br>K061156 | Device 1<br>K080839 | Device 2<br>K112056 | Product Code | GDW | K111825 | | Product Code | GDW | Same | Product Code | GDW | Same | Same | Same | Regulation Number | 21 CFR 878.4750 | Same | | Regulation Number | 21 CFR 878.4750 | Same | Regulation<br>Number | 21 CFR 878.4750 | Same | Same | Same | Intended Use | The Single Patient Use Linear Stapler<br>and Reload has applications in<br>abdominal, gynecological, pediatric<br>and thoracic surgical procedures for<br>resection or transection of tissue and<br>creation of anastomosis, including<br>occlusion of the left atrial appendage<br>in open procedures. They may be<br>used for transection and resection of<br>pancreas. | Same | | Intended Use | The Single Use Circular Stapler has<br>application throughout the alimentary<br>tract for end to end, end to side and<br>side to side anastomoses. | Same | Intended Use | The Single Patient Use Endo Cutter<br>and Reload is intended for<br>transection, resection, and/or<br>creation of anastomoses. The<br>instrument has application in<br>multiple open or minimally invasive<br>general, gynecologic, urologic,<br>thoracic, and pediatric surgical<br>procedures. | Same | Same | Same | Cutting Mechanism | N.A. | Same | | Cutting Mechanism | Circular Knife | Same | Cutting<br>Mechanism | Linear Knife | Same | Same | Same | Operation Principle | Manual | Same | | Operation Principle | Manual | Same | Operation<br>Principle | Manual | Same | Same | Same | Safety Mechanism | Safety release for preventing from<br>mis-firing | Same | | Safety Mechanism | Insurance is used for preventing from<br>mis-firing | Same | Safety<br>Mechanism | Green button for preventing from<br>mis-firing | Same | Same | Same | Closed staple height | 1.0mm, 1.5mm, 2.0mm | Same | | Closed staple height | 1.0~2.5mm | Same | Closed staple<br>height | 0.75, 1.0, 1.5, 1.8, 2.0, 2.3mm | 1.0, 1.5,<br>1.8, 2.0mm | 0.75mm | 2.3mm | Closed staple form | Image: staple form | Image: staple form | | Closed staple form | Image: staple form | Image: staple form | Closed staple<br>form | Image: staple form | Image: staple form | Image: staple form | Image: staple form | Patient-contact<br>material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Unknown | | Patient-contact<br>material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Unknown | Patient-contact<br>material | Unalloyed Titanium<br>Acrylonitrile-Butadiene-Styrene<br>Stainless Steel | Unknown | Unknown | Unknown | Sterilization | Irradiation Sterilization | EO Sterilization | | Sterilization | Irradiation Sterilization | EO Sterilization | Sterilization | Irradiation Sterilization | EO<br>Sterilization | EO<br>Sterilization | EO<br>Sterilization | Endotoxin Limit | 20 EU | Same | | Endotoxin Limit | 20 EU | Same | Endotoxin<br>Limit | 20 EU | Same | Same | Same | Labeling | Conforms with 21 CFR 801 | Same | | Labeling | Conforms with 21 CFR 801 | Same | Labeling | Conforms with 21 CFR 801 | Same | Same | Same | | | | Table 2 Comparison of Technology Characteristics for Single Use Circular Stapler {10}------------------------------------------------ Table 3 Comparison of Technology Characteristics for Single Patient Use Endo Cutter and Reload {11}------------------------------------------------ # Table 4 Comparison of Technology Characteristics for Single Patient Use Linear Stapler and Reload {12}------------------------------------------------ | Item | Proposed Device | Predicate Device 3 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Product Code | GDW | K020779 | | Regulation Number | 21 CFR 878.4750 | Same | | Intended Use | The Single Patient Use Linear Cutter<br>and Reload are intended for use in<br>multiple open or surgical procedures<br>for the transection and resection of<br>tissues. Linear cutters are also<br>intended for creation of anastomoses<br>in these procedures. | Same | | Cutting Mechanism | Linear Knife | Same | | Operation Principle | Manual | Same | | Safety Mechanism | Safety release for preventing from<br>mis-firing | Same | | Closed staple height | 1.0mm, 1.5mm, 1.8mm, 2.0mm | Same | | Closed staple form | Image: staple form | Image: staple form | | Patient-contact<br>material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Unknown | | Sterilization | Irradiation Sterilization | EO Sterilization | | Endotoxin Limit | 20 EU | Same | | Labeling | Conforms with 21 CFR 801 | Same | # Table 5 Comparison of Technology Characteristics for Single Patient Use Linear Cutter and Reload {13}------------------------------------------------ | Item | Proposed Device | Predicate Device 1 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | Product Code | GDW | K030411 | | Regulation Number | 21 CFR 878.4750 | Same | | Intended Use | The Single Use Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. | Same | | Cutting Mechanism | Circular Knife | Same | | Operation Principle | Manual | Same | | Safety Mechanism | Safety release for preventing from mis-firing | Same | | Closed staple height | 0.8~2.0mm | Same | | Closed staple form | Image: staple form | Image: staple form | | Patient-contact material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Unknown | | Sterilization | Irradiation Sterilization | EO Sterilization | | Endotoxin Limit | 20 EU | Same | | Labeling | Conforms with 21 CFR 801 | Same | Table 6 Comparison of Technology Characteristics for Single Use Hemorrhoidal Circular Stapler #### Substantially Equivalent (SE) Conclusion 9. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.