SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Boston Scientific Corporation % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719 JUL 27 2015 Re: K052194 Trade/Device Name: SpyGlass™ Direct Visualization Probe Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODF, FDT Dated (Date on orig SE ltr): August 10, 2005 Received (Date on orig SE ltr): August 11, 2005 Dear Mr. Lehtonen, This letter corrects our substantially equivalent letter of August 24, 2005. 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 {1} 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 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Benjamin R. Fisher -S 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} SECTION 4 INDICATIONS FOR USE 510(k) Number: To Be Determined K052194 pg. 1 of 1 Device Name: SpyGlass™ Direct Visualization Probe Indication for Use: The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. Prescription Use ☑ OR Over-The-Counter Use ☐ (Per 21 CFR 801.1091) (Optional Format 1-2-96) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Denise Buchman, Jr., MAM (Division Sign-Off) Division of General, Restorative, and Neurological Devices 000007 510(k) Number K052194 {3} Boston Scientific K052194 pg. 1 of 2 AUG 24 2005 Endoscopy SECTION 11 510(K) SUMMARY # 510(K) SUMMARY ## 1. Submitter: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 Contact: Allyson Barford Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: (508) 683-4356 Fax: (508) 683-5939 Date Prepared: July 8, 2005 ## 2. Device: Trade Name: SpyGlass™ Direct Visualization Probe Common Name: Mini-Endoscope Classification Name: Flexible Endoscope ## 3. Predicate Devices: Boston Scientific, SpyGlass Direct Visualization Probe – K050403 ## 4. Device Description: The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device is used through the SpyScope Access and Delivery Catheter (K051504) which provides stability for steering the device. The delivery catheter/probe is inserted into the working channel of a duodenoscope for entry into the duodenum for access to the indicated site. ## 5. Intended Use: The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. ## 6. Technological Characteristics: The SpyGlass Direct Visualization Probe is a modification to the predicate device and has the same technological characteristics as the predicate device. The proposed device and predicate device are fiberoptic mini-scopes used in conjunction with a mother scope to access and visualize an indicated location. C00055 {4} k052194 pg. 2 of 2 7. Performance Data: A comparison of the optical performance and image quality specifications was made between the proposed and predicate SpyGlass™ Direct Visualization Probe. Electrical safety testing was performed in accordance with industry standards. 8. Conclusion: Boston Scientific Corporation has demonstrated that the proposed SpyGlass Direct Visualization Probe is substantially equivalent to the predicate SpyGlass Direct Visualization Probe. C00056