FDA and Optical Imaging Device/Combinations
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1 FDA and Optical Imaging Device/Combinations Neil R.P. Ogden, BME Chief, General Surgery Devices Branch 1 Division of Surgical Devices Office of Device Evaluation Food and Drug Administration New Hampshire Ave. WO 66, Room G414 Silver Spring, MD Neil.ogden@fda.hhs.gov (fax)
2 None Notice of Conflicts I currently work for FDA.
3 Disclaimer This talk represents the professional opinions of the author and is not an official document, guidance, or policy of the US government, the Department of Health and Human Services or the Food and Drug Administration, nor should any official endorsement be inferred.
4 Presentation Overview What we have done What we want to do How we can do it Considerations
5 Who does What at FDA?
6 Center for Food Safety & Applied Nutrition Center for Tobacco Products Center for Drug Evaluation & Research Center for Biologics Evaluation & Research Center for Devices & Radiological Health Center for Veterinary Medicine National Center for Toxicological Research
7 Light based Imaging and Combination products
8 Cleared Device Indications with ICG 1. For use in intra-operative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (CABG) surgery. 2. For visual assessment of blood flow and related tissue perfusion during cardiovascular surgical procedures.
9 Cleared Device Indications with ICG, continued 3. For visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgery. 4. For visual assessment of blood flow as an adjunctive method for the evaluation of flow in the native and anastomosed vessels, tissue perfusion and related tissue-transfer circulation in implanted and surrounding organs; to visualize blood flow indicative of perfusion of the donor implant prior to transplantation and to provide indication of organ function after transplantation
10 Cleared Device Indications with ICG, continued 5. For visual assessment of vessels, blood flow and related tissue perfusion with near infrared fluorescence imaging during minimally invasive surgery. 6. For visual assessment of vessels, blood flow, and related tissue perfusion with near infrared fluorescence imaging during minimally invasive robotic surgery. 7. For visual assessment of blood flow and related tissue perfusion during gastrointestinal surgery. 8. For use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, realtime depth visualization
11 Cleared Device Indications, Cont d 9. For use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. 10. Intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract; enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion. 11. The da Vinci Fluorescence Imaging Vision System is intended to provide real time endoscopic visible and near infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.
12 Presentation Overview What we have done What we want to do How can we do it Considerations
13 What Imaging Clinical Strategy? Complex issues dependent on many variables: General visualization alone Specific disease detection Combination products
14 Devices indicated for imaging specific diseases Device Indication drives data needs. Stand alone clinical data showing S&E will be needed.
15 Devices indicated for margin detection When and where is margin detection occurring?
16 Imaging Combination products Device plus drug or biologic will be reviewed together. Combination products: Complicated Likely - stand alone clinical data showing Safety & Effectiveness. If there s a predicate technical comparison.
17 Imaging Combination products, Continued Regulatory Pathway: Established Drug, same dosing, admin. Route - 510(k) or PMA. (ICG, Sodium Fluorescein) New Molecular Entity New Drug Application (NDA) New drug indication - NDA or supplements
18 Combo Product - Which Center has lead - RFD? Request For Designation (RFD) to our Office of Combination Products (OCP) will review Primary Mode of Action and how the combination achieves its Primary Intended Purpose(s) and what are the major FDA review challenges.
19 OCP Guidance Copies are available from: Office of Combination Products Food and Drug Administration WO32, Hub/Mail Room # New Hampshire Avenue Silver Spring, MD (Tel) (Fax) t.htm.
20 Informational needs for FDA device review Device Labeling Performance specifications Valid scientific evidence Tissue effects Mechanism-of-Action, like to have Clinical outcomes
21 VSE - 21 CFR (2) Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.
22 Presentation Overview What we have done What we want to do How can we do it Considerations
23 Phantoms
24 Standardization Efforts for Optical Imaging Consensus standards are corner stones for other imaging modalities, serving both the industry and the government agencies Increasing needs to standardize aspects of optical imaging - to facilitate product/clinical trial development
25 What to standardize? Optical Image calibration and performance evaluation Optical Image quality, # pixels, color rendering Optical Image size, resolution, contrast, precision Optical Image capture, CCD, ICCD, ultrasound, OCT, photoacoustic Optical Image creation
26 Summary Comments Optical imaging technology ---- non-ionizing, real-time microscopic observation An emerging field in medical applications, particularly coupled with general surgery / minimally invasive surgery Based on technologies and indications, regulated as Class I, II, and III devices Specific disease detection, e.g., cancer, in screening and for intraoperative guidance Challenges for combination products regulatory route with new drugs or approved drugs across-center efforts with CDER, CBER, and with Office of Combination Products
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28 Extra slides
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