Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use

{0}------------------------------------------------ S001 ## Exhibit 2 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K182217 - 1. Date of Preparation: 2/25/2019 - 2. Sponsor Identification ### Ezisurg (Suzhou) Medical Co., Ltd. Building 16, No.8 Jinfeng Rd., Suzhou National Hi-Tech District, Suzhou 215163 Jiangsu, China. Establishment Registration Number: Not yet registered. Contact Person: Jingtian Ren Position: Regulatory Affairs Engineer Tel: +86-21-50456176-8026 Fax: +86-21-50676156 Email: renjingtian@ezisurg.com - 3. 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: 3609253199 Email: info@mid-link.net {1}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Linear Cutter Staplers and Loading Units for Single Use Circular Staplers for Single Use Common Name: Stapler and Reload Regulatory Information Classification Name: Staple, Implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery Classification Name: Stapler, Surgical; Classification: I Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery Intended Use Statement: The Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses. The Circular Staplers for Single Use has applications throughout the alimentary for end-to-end, end-to-side and side-to-side anastomoses. Device Description The Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm and 100mm length with reload in 2.5mm and 4.5mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure. The Circular Staplers for Single Use 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 is available in 33mm, 29mm, 25mm and 21mm five {2}------------------------------------------------ specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. #### ર . Identification of Predicate Devices Predicate Device 1 510(k) Number: K020779 Product Name: ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers Predicate Device 2 510(k) Number: K983536 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers Predicate Device 3 510(k) Number: K100723 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers #### Non-Clinical Test Conclusion 6. 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 provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility tests. The shelf life test and performance tests were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items. - . Firing Force Test - . Staple Formation Test - . Staple Line Pressure Test - . Staple Line Tensile Test - . Closed Staple Height Test Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity. The test results demonstrated that the proposed device complies with the following standards: - A 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 {3}------------------------------------------------ | K182217 | S001 | E2 510(k) Summary | |---------|------|-------------------| |---------|------|-------------------| - > 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 - > USP 39-NF 34 <151> Pyrogen - 7. Clinical Test Conclusion No clinical study is included in this submission. {4}------------------------------------------------ | K182217 | |---------| |---------| #### Substantially Equivalent (SE) Comparison 8. | Item | Proposed Device | Predicate Device 1 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | K020779 | | Product Code | GDW | GDW | | Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 | | Intended Use | The Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses. | The PROXIMATE Linear and Vascular Linear Cutters with Safety Lockout have application in gastrointestinal, gynecologic, thoracic and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium | | Cutting Mechanism | Linear | Linear | | Operation Principle | Manual | Manual | | Safety Mechanism | Safety release for prevent from mis-firing | Safety release for prevent from mis-firing | | Suture Length | 60mm, 80mm, 100mm | 55, 75mm | | Closed Staple Height | 1.0mm, 1.5mm, 2.0mm | 1.0mm, 1.5mm, 1.8mm, 2.0mm | | Closed staple form | Image: staple form | Image: staple form | | Endotoxin Limit | 20 EU | Same | | Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | ## Table 1 Comparison for Linear Cutter Staplers and Loading Units for Single Use {5}------------------------------------------------ | Item | Proposed Device | Predicate Device 2 | Predicate Device 3 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | | | K983536 | K100723 | | Product Code | GDW | GDW | GDW | | Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 | 21 CFR 878.4750 | | Intended Use | The Circular Staplers for Single Use has<br>applications throughout the alimentary<br>for end-to-end, end-to-side and<br>side-to-side anastomoses. | The PROXIMATER Curved and<br>Straight Intraluminal Staplers have<br>application throughout the alimentary<br>for end to end, end to side and side to<br>side anastomoses. | The Disposable Circular Stapler has<br>application throughout the alimentary<br>tract for end-to-end, end-to-side and<br>side-to-side anastomoses. | | Cutting Mechanism | Circular Knife | Circular Knife | Circular Knife | | Operation Principle | Manual | Manual | Manual | | Safety Mechanism | Safety Release is used for preventing<br>from mis-firing. | Safety Release is used for preventing<br>from mis-firing. | Safety Release is used for preventing<br>from mis-firing. | | Diameter | 21mm, 25mm, 29mm, 31mm, 33mm | 21mm, 25mm, 29mm, 33mm | 25.5mm, 29.5mm | | Closed Staple Height | 1.0~2.5mm | 1.0~2.5mm | 1.5~2.0mm | | Closed staple form | Image: staple form | Image: staple form | Image: staple form | | Endotoxin Limit | 20 EU | 20EU | 20EU | | Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 | Table 2 Comparison for Circular Staplers for Single Use S001 {6}------------------------------------------------ | K182217 | | |---------|--| | | | - 9. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices. {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 16. 2019 Ezisurg (Suzhou) Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. box 120-119 Shanghai, 200120 Cn Re: K182217 Trade/Device Name: Linear Cutter Staplers and Loading Units for Single Use. Circular Staplers for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: August 6, 2018 Received: August 15, 2018 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {9}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. - 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