October 24, 2012: Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
|CDRH||October 24, 2012||8:00 a.m. to 6:00 p.m.|
Hilton Washington DC North/Gaithersburg,
On October 24, 2012, the committee will discuss, make recommendations, and vote on a premarket approval application supplement to expand the indications for use of the Selenia Dimensions 3D System with C-View Software Module, sponsored by Hologic, Inc.
The Selenia Dimensions 3D System is currently approved for breast cancer screening and diagnosis. The screening exam can consist of field digital mammography (FFDM) alone or the combination of FFDM with digital breast tomosynthesis (DBT).
The new C-View Software Module can generate synthetic 2D images from the DBT data. Hologic requests to expand the indications for use to allow the combination of DBT with synthetic 2D images to be used as another exam option for breast cancer screening.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/default.htm. Scroll down to the appropriate advisory committee meeting link.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 15, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 5, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 9, 2012.
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- Shanika Craig,
Center for Devices and Radiological Health,
Food and Drug Administration,
10903 New Hampshire Ave.,
Bldg. 66, rm. 1613,
Silver Spring, MD 20993,
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product area
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
October 24, 2012: Meeting Materials FDA Generated
October 24, 2012: Meeting Materials Non-FDA Generated
Table of Contents(PDF - 120KB) Sponsor Executive Summary(PDF - 2.2MB) Glossary of Terms(PDF - 346KB) SSED(PDF - 460KB) Draft C-View CD Label(PDF - 118KB) Post Approval Study(PDF - 208KB) Draft C-View User Instructions(PDF - 653KB) Protocol 09 03 Rev 04 (Image Acquisition Protocol)(PDF - 541KB) Protocol 11 02 Rev 02 (Reader Study Protocol)(PDF - 100KB) Referenced Literature: Dorfman et al 1992(PDF - 12KB) Referenced Literature: Gur et al 2010(PDF - 14KB) Referenced Literature: Gur et al 2011(PDF - 342KB) Referenced Literature: Hendrick 2010(PDF - 400KB) Referenced Literature: Hendrick et al 1997(PDF - 10KB) Referenced Literature: Hills et al 2008(PDF - 22KB) Referenced Literature: NRC(PDF - 9KB) Referenced Literature: Obuckowski 2010(PDF - 14.7MB) Referenced Literature: Obuchowski 2006(PDF - 11KB) Referenced Literature: Pisano et al 2005(PDF - 14KB) Referenced Literature: Rafferty et al 2007(PDF - 8KB) Referenced Literature: Rosenberg et al 2006(PDF - 14KB) Referenced Literature: Skaane et al 2001(PDF - 342KB) Referenced Literature: Smith et al 2004(PDF - 39KB) Referenced Literature: Tabar et al 2001(PDF - 36KB) Sponsor Presentation: Oct. 24, 2012(PDF - 9.9MB)