Agenda

Radiological Devices Panel Meeting

 

February 3, 2004

 

Purpose of the Meeting - To discuss, make recommendations and vote on a premarket approval application (PMA P030012) for a computer aided detection device that assists a physician in identifying solid nodules in CT images of the lung.

 

Closed Session

 

8:30 – 8:35                  Call to order– Minesh P. Mehta, M.D.   

8:35 – 9:00                  Briefing on Current Investigational Devices - Robert A. Phillips, Ph.D. and RADB Staff

 

Open Session

 

9:00 – 9:20                  Call to order and the Panel Introduction – Minesh P. Mehta, M.D.

                                    FDA Introductory Remarks - Robert J. Doyle, Executive Secretary  

                                    Update on FDA Radiology Activities - Robert A. Phillips, Ph.D.    

 

 

Open Public Hearing

 

9:20 – 9:50                  Open Public Hearing: interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.   

                                                 

Open Committee Discussion

 

9:50 – 10:00                Charge to the Panel - Minesh P. Mehta, M.D.

 

10:00 – 10:40              Overview of Contemporary ROC Methods – Robert F. Wagner, Ph.D.

 

10:45 – 11:45              Presentations on P030012 by sponsor

 

Introduction – Kathy O’Shaughnessy, PhD

Current Clinical Practice – Heber MacMahon, MD

Device Description and Clinical Trial Introduction – Ronald Castellino, MD

Clinical Study – Dave Miller

User Experience – Pablo Delgado, MD

Summary – Kathy O’Shaughnessy, PhD

 

11:45 - 12:45               Lunch                       

 

 

12:45 – 1:45                Presentations on P030012 by FDA

 

-                      PMA Overview -  Robert Phillips, Ph.D.

                                    -    Clinical Background - William Sacks, Ph.D., M.D

                                    -    Clinical Results -  Nicholas Petrick, Ph.D.

                                    -    PMA Review Summary - William Sacks, Ph.D., M.D

 

1:45 – 2:15                  Reports by Panel Lead Reviewers

                                  

                                   -    David Stark, M.D.

                                   -    Brent Blumenstein, Ph.D.

 

2:15 – 2:30                  Presentation of FDA Questions

 

2:30 – 2:45                  Break

 

2:45 – 3:45                  Panel Discussion

 

Open Public Hearing

 

3:45 – 4:15                  Open Public Hearing: interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  

 

Open Committee Deliberations

 

4:15 – 4:30                  Panel Recommendation(s) and vote

 

4:30                             Adjourn