# FDA Approves New Device to Help Distinguish Harmless from Pre-Cancerous Growths Colon



## JeanG (Oct 20, 1999)

The url for this article is: http://www.fda.gov/bbs/topics/ANSWERS/ANS01054.html FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding withconsistency and accuracy to questions from the public on subjects of current interest. Talk Papersare subject to change as more information becomes available.T00-61 Sharon Snider: 301-827-6242November 15, 2000 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA FDA APPROVES NEW DEVICE TO HELP DISTINGUISH HARMLESS FROM PRE-CANCEROUS GROWTHS IN COLONFDA today approved a laser system to improve a physician's ability to distinguish small harmless growths frompre-cancerous growths in the colon. The device, made by SpectraScience, Inc. of Minneapolis, uses laser light energy. The product, the OpticalBiopsy System, is operated through an endoscope and can be used during either sigmoidoscopy orcolonoscopy to evaluate polyps less than 1 cm in diameter that the physician has not already decided toremove. It is intended to be used only when physicians would not otherwise remove all visualized polyps. When used byphysicians who base removal of polyps on their visual assessment, the device helps them to decide whichpolyps should be removed and sent for microscopic examination and which can safely be left alone. It is notintended to be used as a stand-alone device and should not be used to replace the physician's judgement inthe removal of colonic polyps. The Optical Biopsy System consists of a laser source, an optical fiber, analytical software and a user-interfaceconsole. The system shines laser light through the optical fiber onto the target growth in the colon. The lightenergy is absorbed by the polyp. In response, the polyp emits light energy that is sent back through the opticalfiber, returned to the machine, and analyzed by the system software. Based on a series of computations thatare performed by the software, the system indicates whether or not the polyp is suspicious for having thepotential to become malignant. Approval of the device was based on FDA's review of clinical studies of safety and effectiveness conducted bySpectraScience and on the recommendation of the Gastroenterology and Urology Devices Panel of FDA'sMedical Devices Advisory Committee. SpectraScience studied use of the device in 101 patients with 135 polyps at five medical centers in the UnitedStates. In the study, the device increased the physicians' accuracy in correctly identifying pre-cancerous polypsfrom 82 to 96 percent. At the same time the device decreased the physicians' accuracy in correctly identifyingnon-cancerous polyps from 50 to 33 percent. Since the starting point of any particular physician's accuracy maydiffer from that of the few physicians who participated in the study, the device's effect in changing a physician'saccuracy may differ from the results shown in this study. No adverse events were reported from use of thedevice. Use of the Optical Biopsy System is restricted to physicians who have been trained in endoscopy and in theproper use of the device. FDA News Page | FDA Home Page Office of Public Affairs Web page created by tg 2000-NOV-15. [This message has been edited by JeanG (edited 11-15-2000).]


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