Computerized Thermal Imaging, Inc.

Breast Cancer System, BCS 2100--P010035

Radiological Devices Advisory Panel

December 10, 2002


1. Clinical data


a) The data in Amendment 4 were selected retrospectively from the original PMA dataset, albeit based on lesion type analyses that were prospectively planned for in the clinical trial protocol.  Are the data from Amendment 4 applicable for the assessment and determination of effectiveness of the BCS 2100?


b) The additional data in Amendment 5 consist of 78 masses.  Are these additional data by themselves sufficient for the assessment and determination of effectiveness of the BCS 2100?


c) When combined, Amendment 4 provides 84% (412) of the masses and Amendment 5 provides 16% (78).  What is the validity of combining these data to assess and determine effectiveness of the BCS 2100? 


2. Please discuss the same questions for safety.


3. Please discuss whether safety and effectiveness has been established.  As part of this, please discuss the risk/benefit trade-off whereby a false negative results in a 6-month delay of cancer diagnosis and a true negative obviates biopsies that would otherwise turn out benign.


4. Is the proposed labeling adequate to ensure safe and effective use of the BCS 2100?  Please include in your discussion the following specific items:


a) Given that only 2 of 105 cancers were smaller than 5 mm, should the labeling specify a lower size limit for an eligible mammographic mass?  If so, what size limit?   

b) Should the labeling address lesion depth?  If so, in what way?


5. Should the labeling be revised to address any potential psychological impact of a positive mammogram, followed by a positive BCS 2100 result, on a woman who does not, in fact, have cancer (i.e., false positive)?


6. Do the above, or any other, issues


a) require resolution before approval of the PMA?


b) suggest the need for a post-market study?