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U.S. Department of Health and Human Services

Advisory Committees

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Obstetrics and Gynecology Devices Panel - August 29, 2006

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on August 29, 2006, in an open session.

The panel discussed the pre-market approval application (PMA P050003) from Mirabel Medical Systems, Inc. (Austin, TX) for the T-Scan™ 2000 ED. The proposed indication for this device is:

The T-Scan™ 2000 ED is indicated for use as a complement to clinical breast examination (CBE) in asymptomatic women who are 30 to 39 years of age with a negative clinical breast exam and a negative family history for breast cancer. The device detects electrical impedance changes in breast tissue that are associated with an increased risk of breast cancer. A positive T-Scan™ result provides physicians with additional information to guide a recommendation regarding further breast examination, e.g., mammography or ultrasound. The T-Scan evaluates women’s risk of breast cancer at the time of the exam (current risk) and not lifetime risk.

The T-Scan™ 2000 ED is proposed as a pre-screening device to select normal asymptomatic women who might have an increased risk of breast cancer and therefore be considered for further diagnostic study by analyzing differences in electrical impedance of breast tissue.

The panel considered the sponsor’s pivotal study. The study had two arms: arm one assessed Sensitivity by testing an enriched population that included biopsy positive women in the 30-45 year age group. The second arm assessed Specificity by testing normal 30-39 year old subjects.

On a unanimous vote (10-0), the panel recommended that the Mirabel Medical Systems, Inc. PMA be found “not approvable.” While acknowledging the need for additional tools to help physicians screen for breast cancer in women 30-39, the panel noted issues of concern regarding device sensitivity, the size and population of the study, number of cancers detected in study patients, and risks associated with additional screening events.

Contact: Michael T. Bailey, Ph.D., Executive Secretary, 301-594-1180, x130.

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The Food and Drug Administration
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