Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. December 14, 2020 Fengh Medical Co., Ltd. % Julie Chen Technical Manager Shanghai Medical Business Consulting Co., Ltd. No. 170 Huajiang Road. Jiading District Shanghai, 201801 Cn Re: K202467 Trade/Device Name: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 23, 2020 Received: December 2, 2020 ### Dear Julie Chen: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K202467 #### Device Name Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Indications for Use (Describe) The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) 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." {3}------------------------------------------------ # 510(k) Summary (As Required by 21 CFR 807.92) #### 1. Date Prepared [21 CFR 807.92(a)(1)] July 20th, 2020 #### 2. Submitter's Information [21_CFR 807.92(a)(1)] | Company Name: | Fengh Medical Co., Ltd. | |------------------|------------------------------------------------------------------------------------------| | Company Address: | D3 No.6 Dongsheng West Road, Jiangyin National High-<br>tech Zone, 214437 Jiangsu, China | | Contact Person: | Jiao Liu | | Phone: | 0086-13815132106 | | Email: | Jiao.liu@fenghmedical.com | Submission Correspondent: Julie Chen Email: julie.chen@mind-link.net Tel: +86 139 1804 5781 #### Trade Name. Common Name. Classification [21 CFR 807.92(a)(2)] 3. Trade Name: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Stapler models include FSAS30, FSAS45, FSAS60, FSAM30, FSAM45, FSAM60, FSAL30, FSAL45, FSAL60, FNMS30, FNMS30, FNMS45, FNMS60, FNMM30, FNMM45, FNMM60, FNML30, FNML45, FNML60, FNAS30, FNAS45, FNAS60, FNAM30, FNAM45, FNAM60, FNAL30, FNAL45, FNAL60, DSMS30, DSMS45, DSMS60, DSMM30, DSMM45, DSMM60, DSML30, DSML45, DSML60, DSAS30, DSAS45, DSAS60, DSAM30, DSAM45, DSAM60, DSAL30, DSAL45, DSAL60, DNMS30, DNMS45, DNMS60, DNMM30, DNMM45, DNMM45, DNMM60, DNML30, DNML45, DNML60, DNAS30, DNAS45, DNAS60, DNAM30, DNAM45, DNAM60, DNAL30, DNAL45, DNAL60, Reloads models include FACC30, FACC45, FACC60, FACW30, FACW45, FACW60, FACB30, FACB45, FACB60, FACG30, FACG45, FACG60, FACY30, FACY45, FACY60, FACX30, {4}------------------------------------------------ FACX45, FACX60, DMCC30, DMCC45, DMCC60, DMCW30, DMCW45, DMCW60, DMCB30, DMCB45, DMCB60, DMCG30, DMCG45, DMCG60, DMCY30, DMCY45, DMCY60, DMCX30, DMCX45, DMCX60, DACC30, DACC45, DACC60, DACW30, DACW45, DACW60, DACB30, DACB45, DACB60, DACG30, DACG45, DACG60, DACY30, DACY45, DACY60, DACX30, DACX45, DACX60 Common Name: Implantable staple Product Code: GDW Regulation Number: 21 CFR 878.4750 Device Class: II ### 4. Identification of Predicate Devices(s) [21 CFR 807,92(a)(3)[ The identification of predicates within this submission is as follow: | Manufacturer: | Fengh Medical Co., Ltd. | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | Disposable Powered Articulating Endoscopic Linear Cutter<br>Stapler & Reloads, Stapler models include FSMS30,<br>FSMM30, FSML30, FSMS45, FSMM45,FSML45,<br>FSMS60, FSMM60, FSML60 Reloads models include<br>FMCC30, FMCW30, FMCB30, FMCG30, FMCY30,<br>FMCX30, FMCC45, FMCW45, FMCB45, FMCG45,<br>FMCY45, FMCX45, FMCC60, FMCW60, FMCB60,<br>FMCG60, FMCY60, FMCX60 | | FDA 510 (k) #: | K182476 | | Common Name: | Cutter/Stapler | | Product Code: | GDW | | Classification Name: | Staple, Implantable; Stapler, Surgical | | Regulation Number: | 21 CFR 878.4750 | | Classification: | Class II | {5}------------------------------------------------ ## 5. Description of the Device [21 CFR 807.92(a)(4)] The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile. single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. Model 30mm series include FSAS30. FSAM30. FSAL30. FNMS30. FNMM30. FNML30. FNAS30, FNAM30, FNAL30, DSMS30, DSMM30, DSML30, DSAS30, DSAM30, DSAL30, DNMS30, DNMM30, DNML30, DNAS30, DNAM30, DNAL30; Model 45mm series include FSAS45, FSAM45, FSAL45, FNMS45, FNMM45, FNML45, FNAS45, FNAM45, FNAL45, DSMS45, DSMM45, DSML45, DSAS45, DSAM45, DSAL45, DNMS45, DNMM45, DNML45, DNAS45, DNAM45, DNAL45; Model 60mm series include FSAS60, FSAM60, FSAL60, FNMS60, FNMM60, FNML60, FNAS60, FNAM60, FNAL60, DSMS60, DSMM60, DSML60, DSAS60, DSAM60, DSAL60, DNMS60, DNMM60, DNML60, DNAS60, DNAM60, DNAL60. The difference between the three series lies in the different anatomized lengths. FSA/DSM/DSA series exclude reloads remover, and FNA/DNM/DNA/ FNM series include reloads remover. There are total 54 models of reloads within the proposed device, three stapler line length: 35.2±2.0mm, 49.3±2.0mm and 61.3±2.0mm; six staple heights: Gray (0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), Black (2.3mm); three colors of cap. FAC series is purple, DAC series is yellow, and DMC series is orange. Power type: internal power supply; DC voltage 12V, rated power 40W Applied parts: Type CF Mode of operation: Non-Continuous Operation Degree of safety when used in the presence of flammable anesthetic gas mixed with flammable anesthetic gas or nitrous oxide mixed with air: Flammable anesthetic gas that cannot be mixed with flammable anesthetic gas or nitrous oxide mixed with air. The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0. {6}------------------------------------------------ Image /page/6/Figure/1 description: The image shows a line drawing of a surgical stapler. The stapler has a long, thin shaft with a stapling head at the end. The handle of the stapler is pistol-grip style. The image also contains the text "IPX4" above the shaft and "IPXO" above the handle. ## 6. Indications for Use [21 CFR 807.92(a)(5)] The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures. | Device<br>Characteristic | Proposed Device | Predicate Device (K182476) | SE<br>Discussion | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Product Name | Disposable Powered<br>Articulating Endoscopic<br>Linear Cutter Stapler & Reloads | Disposable Powered<br>Articulating Endoscopic<br>Linear Cutter Stapler & Reloads | N/A | | Classification | II | II | Same | | Regulation<br>Number | 21 CFR 878.4750 | 21 CFR 878.4750 | Same | | Product Code | GDW | GDW | Same | | Intended Use | The Disposable Powered<br>Articulating Endoscopic Linear<br>Cutter Stapler & Reloads are<br>intended for transection,<br>resection, and/or creation of<br>anastomoses. The instruments<br>have application in multiple<br>open or minimally invasive<br>general abdominal, gynecologic,<br>thoracic, and pediatric surgical<br>procedures. | The Disposable Powered<br>Articulating Endoscopic Linear<br>Cutter Stapler & Reloads are<br>intended for transection,<br>resection, and/or creation of<br>anastomoses. The instruments<br>have application in multiple<br>open or minimally invasive<br>general abdominal, gynecologic,<br>thoracic, and pediatric surgical<br>procedures. | Same | | Manual/Powered | Powered | Powered | Same | | Cutting<br>Mechanism | Stapler places two, triple<br>staggered rows of staples and<br>simultaneously cuts and<br>divides the<br>tissue between the two rows. | Stapler places two, triple<br>staggered rows of staples and<br>simultaneously cuts and<br>divides the<br>tissue between the two rows. | Same | | Safety Feature | Stapler have empty-reload<br>safety protection mechanism. | Stapler have empty-reload<br>safety protection mechanism. | Same | | Main<br>Components | Closing Trigger, Red Firing<br>Trigger Lock, Firing Trigger,<br>Anvil Release Button, Battery<br>Pack, Battery Pack Release Tab,<br>Manual Override | Closing Trigger, Red Firing<br>Trigger Lock, Firing Trigger,<br>Anvil Release Button, Battery<br>Pack, Battery Pack Release Tab,<br>Manual Override | Same | | Materials | Staples: titanium alloy<br>Shaft: stainless steel<br>Cover: polyurethane | Staples: titanium alloy<br>Shaft: stainless steel<br>Cover: polyurethane | Same | | Staple Shape | Standard "B" shaped staple | Standard "B" shaped staple | Same | | Staple Height<br>(closed) | 0.75mm,1.0mm,1.5mm,1.8mm<br>2.0mm, 2.3mm | 0.75mm,1.0mm,1.5mm,1.8mm<br>2.0mm, 2.3mm | Same | | Staple Line<br>Length | 30mm,45mm,60mm | 30mm,45mm,60mm | Same | | Sterilization | Sterilized by Irradiation | Sterilized by Irradiation | Same | | Biocompatibility | Reloads are biocompatible | Reloads are biocompatible | Same | | Electrical Safety<br>Test | Electrical Safety Test (AAMI /<br>ANSI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>c1:2009/(r)2012 and<br>a2:2010/(r)2012) | Electrical Safety Test (AAMI /<br>ANSI ES60601-<br>1:2005/(R)2012 and A1:2012,<br>c1:2009/(r)2012 and<br>a2:2010/(r)2012) | Same | | EMC Test | EMC Test<br>(IEC60601-1-2:2014) | EMC Test<br>(IEC60601-1-2:2014) | Same | #### 7. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)] {7}------------------------------------------------ #### Technological Characteristics [21 CFR 807.92(a)(6)] 8. The Disposable Powered Articulating Endoscopic Linear Cutter Stapler has not changed in the basic design, mechanism of action, intended use when compared to the predicate device. There is no change to reloads in material and structure. The only difference in the current submitted device is the physical appearance of rotating knob, shells and addition of reloads removers. {8}------------------------------------------------ ## 9. Performance Data ### Non-Clinical Performance Test Conclusion There is no FDA recognized performance standard for implanted reloads and staplers. Non-clinical tests were conducted to verify that the proposed device met the requirements of design change and was Substantially Equivalent (SE) to the predicate device. The testing was as follows: - Visual Appearance ● - Sterility ● - Package Seal ● - . Hardness - Anastomosis and Cutting Performance ● - Safety Device - Pressure Resistant Properties ● - Sharpness - Surface Roughness - Flexibility ● - o Matching Performance - Firing Electric Current - Battery Voltage - Motor Rotation Speed ● - Dimensions ● During verification testing, all data meets pre-defined criteria. #### Clinical Test Conclusion No clinical study is included in this submission. #### 10. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device, Disposable Powered Articulating Endoscopic Linear Cutter & Reloads is substantially equivalent to the predicate device.