TRUETOME

{0}------------------------------------------------ K 122203 page 1 of 2 SECTION 5 510(k) SUMMARY ### 510(k) SUMMARY AUG 1 7 2012 ### 1. Submitter: Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4793 Fax: 508-683-5939 Contact: Laurie Pannella Regulatory Affairs Specialist Date Prepared: July 20, 2012 ## 2. Proposed Device: Trade Name: TRUEtome™ Sphincterotome, Classification Name: Endoscopic Electrosurgical Unit and Accessories Regulation Number: 876.4300 Product Code: KNS Classification: Class II #### 3. Predicate Devices: Trade Name: Autotome TM RX Sphincterotome Manufacturer and Clearance Number: Boston Scientific Corporation, K013153 Classification Name: Endoscopic Electrosurgical Unit and Accessories Regulation Number: 876.4300 Product Code: KNS Classification: Class II Trade Name: UltratomeTM XL Sphincterotome Manufacturer and Clearance Number: Boston Scientific Corporation, K930022 Classification Name: Endoscopic Electrosurgical Unit and Accessories Regulation Number: 876.4300 Product Code: FDI Classification: Class II # 4. Proposed Device Description: TRUEtome™ Sphincterotome when connected to a monopolar current may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The TRUEtome™ Sphincterotome is a 200 cm, triple lumen sphincterotome that tapers from 7 Fr (2.3 mm) to 5.5 Fr (1.8 mm) with an atraumatic tip. The catheter is capable of accepting a 0.035 in (0.89 mm) Boston Scientific Guidewire and a 0.025 in (0.64 mm) Boston Scientific Guidewire, while injecting and/or cutting using other lumens. The sphincterotome may be placed with or without the aid of a guidewire. When connected to a monopolar current, the sphincterotome may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8 mm and larger. {1}------------------------------------------------ #### 5. Indication for Use: The Intended Use of the proposed TRUEtomeTM Sphincterotome is identical the predicate devices, Autotome TM RX Sphincterotome and Ultratome™ XL. These devices are indicated for use in the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Sphincterotome can also be used cannulate and to inject contrast medium. #### 6. Technological Characteristics: The proposed TRUEtome™ Sphincterotomes are similar in design, materials, and manufacturing processes to the predicate, Autotome ™ RX Sphincterotome (K013153) and Ultratome™ XL Sphincterotome (K930022). #### 7. Performance Data: Biocompatibility of the proposed device was confirmed via AAMI/ANSVISO 10993-1: 2009, and included Cytotoxicity, Intracutaneous Reactivitity (Irritation), Sensitization and USP Physiochemical tests. EO residual testing was done per AAMI/ANSI/ISO 10993-7: 2008 In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications. The testing included Initial Tip Orientation, Tip Bowing, Tip Bow Holding, Tip Rotation, Guidewire Passage/Compatibility, System Leakage, Tip OD, Luer to Extrusion Integrity. Electrical safety of the device has also been confirmed via IEC 60601-1:1988 A1:1991 A2:1995. #### 8. Conclusion: Boston Scientific Corporation has demonstrated that the minor device modifications to the existing predicate Autotome ™ RX Sphincterotome (K013153) are substantially equivalent to the proposed TRUEtome™ Sphincterotome. Therefore, the proposed TRUEtome™ Sphincterotome device is as safe, as effective and performs as well as the predicate device. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002 AUG 1 7 2012 Ms. Laurie Pannella Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752 K122203 Re: > Trade/Device Name: TRUEtome™ Sphincterotome Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 24, 2012 Received: July 25, 2012 Dear Ms. Pannella: 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 {3}------------------------------------------------ Page 2 - device-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 11 you doshe sportio advice 10. Jour FDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Sincerely yours, Benjamin K. Kirk Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # KIZZZO3 # SECTION 4 INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device Name: Indications For Use: To Be Determined TRUEtome™ Sphincterotome The TRUEtome™ Sphincterotome devices are indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome can also be used to cannulate and inject contrast medium. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Aonu Khan uctive, Gastro-Rena 600.013