MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

{0}------------------------------------------------ d > medical systems NOV - 5 2009 093187. ## 510(k) SUMMARY #### Applicant Information: a) | Date Summary Prepared | 08 October 2009 | |-----------------------------------|----------------------------------------------------------------------------------| | Sponsor/Submitter | Avantis Medical Systems, Inc.<br>263 Santa Ana Court<br>Sunnyvale, CA 94085-4511 | | Correspondent Contact Information | Amrita Sethi | | | Director of Regulatory and Quality<br>Affairs | | | Phone: 408-733-1901 x227 | | | Fax: 408-733-1847 | | | E-mail: asethi@avantismedical.com | #### b) Device Information: | Device Common Name | Endoscope | |--------------------------------------|------------------------------------------------------------------| | Device Trade & Proprietary Name | Third Eye® Retroscope® Auxiliary<br>Endoscopy System (Third Eye) | | Device Classification Name | Colonoscope (per 21CFR 876.1500) | | Device Classification Regulation | 21CFR 876.1500 | | Device Classification | Class II (special controls) | | Device Classification & Product Code | FDF, FDS, KNW, KOG | #### c) Identification of Predicate Device: The Avantis Third Eye is substantially equivalent in operation and fundamental scientific technology to its previous version cleared under K091783. #### d) Device Description Summary: The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories. {1}------------------------------------------------ Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System Ko93187 Pg 2 of 3 08 October 2009 Special 510(k) The Third Eve is designed as an auxiliary device for use with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eve Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eve then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eve Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eye Retroscope image. - Intended Use: e) The Third Eve Retroscope is intended for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes. - Discussion of Substantial Equivalence to Predicate Device: f) The Third Eve has been modified to - a) Expand the function and capabilities of the Video Processor (VP) to support both standard and High Definition (HD) colonoscopes. The modified VP displays standard and HD colonoscope images on a HD monitor. - b) Upgrade the VP with a smaller chassis to decrease the footprint and improve aesthetics. No changes in the function or capability of the VP result from these changes. No changes have been made to the disposable portions of the Third Eye system. The modified device is substantially equivalent to the cleared predicate device in fundamental design, materials, processes, sterile barrier packaging, and sterilization. All changes have been subjected to risk analysis and have been verified to meet current design specifications. Minor changes have been made to the IFU as a result of the modifications to the Video Processor. Differences between the modified Third Eye System and the predicate device have no impact on safety and effectiveness. > 263 Santa Ana Court, Sunnyvale, CA 94085 TEL: (408) 733-1901, FAX: (408) 733-1847 {2}------------------------------------------------ Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System ### 08 October 2009 Special 510(k) #### Scientific Technology a) The Third Eye® Retroscope® Auxiliary Endoscopy System includes the Retroscope, a Video Processor, Cap and accessories. Modifications made to the device and accessories did not change the fundamental scientific technology of the device. The testing described demonstrates that the differences in the device components and accessories do not raise any new or unresolved issues for safety and efficacy. #### Summary of Supporting Non-Clinical Performance Data h) Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance characteristics. Results demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended. Any statement regarding "substantial equivalence" made in this 510(k) submission and summary only relates to whether the product addressed in this submission may be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any The present submission and statements therein therefore should not be construed as Patent Office. affecting or relating to the scope of any patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing. > 263 Santa Ana Court, Sunnyvale, CA 94085 TEL: (408) 733-1901, FAX: (408) 733-1847 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is composed of three abstract shapes that resemble a person embracing another person. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Ms. Amrita Sethi Director of Regulatory and Quality Affairs Avantis Medical Systems 263 Santa Ana Court SUNNYVALE CA 94085-4511 # NOV - 5 2009 Re: K093187 Trade/Device Name: Third Eye® Retroscope® Auxiliary Endoscopy System (Third Eye) Regulation Number: 21 CFR 876.1500 . . . Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: October 8, 2009 Received: October 9, 2009 Dear Ms. Sethi: 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. 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 {4}------------------------------------------------ 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 go to http://www.fda.gov/AboutFDA/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, [signature] Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): 40093187 Device Name: Third Eye® Retroscope® Auxiliary Endoscopy System (Third Eye) Indications for Use: The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes. Prescription Use X Over-The-Counter Use - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page _ of Hémm (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.