Rotatable Snares

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 30, 2016 Boston Scientific Corporation Michael Secondini Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752 Re: K160637 Trade/Device Name: Rotatable Snares Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI, FGX Dated: March 4, 2016 Received: March 7, 2016 Dear Michael Secondini, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 yours, Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a large, bold, sans-serif font. The text is arranged horizontally, with the name "Herbert P. Lerner" appearing first, followed by a hyphen and the letter "S". The background of the image is a light gray color. The text is black. for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160637 Device Name Rotatable Snares Indications for Use (Describe) The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. | 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}------------------------------------------------ # Section 5: 510(K) Summary # 1. Submitter Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 | Contact: | Michael Secondini | |------------|-----------------------------------| | | Sr. Regulatory Affairs Specialist | | Email: | Michael.Secondini@bsci.com | | Telephone: | (508) 683-6503 | | Fax: | (508) 683-5939 | Date Prepared: March 4, 2016 # 2. Device | Trade Name: | Rotatable Snares | |----------------------|------------------------------------------| | Common Name: | Rotatable Snares | | Classification Name: | Snare, Flexible<br>Snare, Non-Electrical | | Regulation Number: | 876.4300<br>876.4730 | | Product Code: | FDI<br>FGX | | Classification: | Class II | # 3. Predicate Device | Trade Name: | Rotatable Snares | |----------------------|------------------------------------------| | Common Name: | Rotatable Snares | | Manufacturer: | Boston Scientific Corporation | | Clearance Numbers: | K131700 | | Classification Name: | Snare, Flexible<br>Snare, Non-Electrical | | Regulation Number: | 876.4300<br>876.4730 | | Product Code: | FDI<br>FGX | | Classification: | Class II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in a dark blue color. The words "Boston Scientific" are stacked on top of each other. Special 510(k) Premarket Notification Rotatable Snares ## 4. Reference Device Trade Name: Single Use Polypectomy Snares Captivator II, Single Use Polypectomy Snares Common Name: Polypectomy Snares Manufacturer: Boston Scientific Corporation K133987 Clearance Numbers: Classification Name: Snare, Flexible Snare, Non-Electrical 876.4300 Regulation Number: 876.4730 Product Code: FDI FGX Classification: Class II ### 5. Device Description The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. #### 6. Indications for Use The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. #### 7. Technological Characteristics This change is modifying the design of the Rotatable Snare to improve ergonomics of the device handle by moving the rotation actuator of the snare to the handle from its current position along the main sheath. The proposed Rotatable Snares are similar in materials, design, and manufacturing process to the predicate Rotatable Snares (K131700) and will use many of the same components as the reference Captivator II Snares (K133987). There are no new patient contacting materials used on the proposed snares. #### 8. Performance Data In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Working Length, Tortuous Path Functionality, Rotation Capability, Handle to Core {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in a serif font and is a dark blue color. The words "Boston" and "Scientific" are stacked on top of each other. The logo is simple and elegant. Wire Tensile Strength, Electrical Resistance, Electrical Safety, and Snare Actuation. The results of all testing were passing. # 9. Conclusion Boston Scientific Corporation has demonstrated that the proposed Rotatable Snares are substantially equivalent to Boston Scientific Corporation's currently marketed Rotatable Snares (K131700).