AcuSnare Polypectomy Snare - Duckbill

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. July 18, 2019 Wilson-Cook Medical, Inc. Doris Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, North Carolina 27105 K191048 Re: > Trade/Device Name: AcuSnare Polypectomy Snare - Duckbill Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: FDI Dated: April 18, 2019 Received: April 19, 2019 Dear Doris Hawks: 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 {1}------------------------------------------------ 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 medical devices and radiation-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 Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191048 Device Name AcuSnare Polypectomy Snare - Duckbill #### Indications for Use (Describe) The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract. Type of Use (Select one or both, as applicable) | <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-----------------------------------------------------------------------------------------------------| | <div> <span> <b> </b> 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}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background. The logo is simple and clean, and the red and white colors are eye-catching. Wilson-Cook Medical, Inc. 4900 Bethania Station Road, Winston-Salem, NC 27105, USA. Phone:336.744.0157 Fax: 336-201-5994 www.cookmedical.com #### Special 510k - Summary 008. April 18, 2019 ## Applicant Information | Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy | |------------|------------------------------------------------------| | | 4900 Bethania Station Road | | | Winston-Salem, North Carolina 27105 | | Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist | | Phone: | (336) 744-0157 ext. 396293 | | Fax: | (336) 201-5994 | ## Device Information | Trade Name: | AcuSnare Polypectomy Snare - Duckbill | |----------------------|-------------------------------------------------| | Common Name: | Polypectomy Snare | | Classification Name: | Endoscopic electrosurgical unit and accessories | | Regulation Number: | 21 CFR 876.4300 | | Product Code: | FDI | | Classification: | Class II, | | Review Panel: | Gastroenterology-Urology | | Predicate Device | | |------------------|----------------------------| | Name: | AcuSnare Polypectomy Snare | | 510(k) Number: | K173673 | | Date: | Cleared August 24, 2018 | ## Device Description The AcuSnare Polypectomy Snare - Duckbill (ASDB) is a sterile, single use device compatible with the accessory channel of endoscope. This type endoscopic polypectomy device is designed to connect to an electrosurgical unit via an active cord accessory and the drive cable delivers energy through the snare head to cut and/or cauterize tissue as described in the instructions for use. The device consists of a handle, sheath, drive cable and wire loop snare head. The sheath is comprised of {4}------------------------------------------------ polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath. ## Intended Use The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract. # Substantial Equivalence Minor design changes were made to the predicate AcuSnare Polypectomy Snare cleared to market via K173673. These changes include adding a new duckbill shape configuration along with cannula components required to manually form the snare into a duckbill shape. Configuration of the snare does not change the method of operation or the intended use of the device. The subject device is substantially equivalent to the predicate device with respect to the intended use, operating mechanism, materials and technological characteristics # Performance Data The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device. ## Conclusion We believe risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes. We believe that the subject device is substantially equivalent to the predicate device in terms of intended use and performance characteristics (key operating principles, materials and technological characteristics).