The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on May 17, 2005 , in an open session.
The panel discussed the pre-market approval application (PMA P040028) from MediSpectra, Inc. ( Lexington , MA ) for the LUMA™ Cervical Imaging System. The proposed indication was "for use as an adjunct to colposcopy in identifying high grade disease (CIN 2,3+) in patients referred to colposcopy with an ASCUS or LSIL cervical cytology test result. LUMA™ is not intended to replace colposcopy. A thorough colposcopic evaluation with identification and selection of biopsy sites must be performed independently of and prior to the viewing of the LUMA™ result."
The LUMA™ Cervical Imaging System illuminates the cervix with ultraviolet and visible light and produces a color-coded image that highlights biopsy sites on the cervix with a likelihood of identifying CIN 2/3+ disease.
The panel considered the sponsor’s two pivotal studies, which looked at the use of LUMA™ as an adjunct to colposcopy for identifying biopsy sites that are suspected to be CIN 2/3+. The first pivotal study (PS I) was a randomized, controlled, two-arm study. In one arm, biopsies were identified by colposcopy only. In the second arm, colposcopists viewed both the colposcopy and LUMA™ images while identifying biopsy sites. The second pivotal study (PS II) was a single arm study in which each patient had biopsies identified first using colposcopy only; then the LUMA™ image was viewed, and additional biopsy sites were identified. Based on histopathological analysis of the biopsies, each study assessed the impact of LUMA™ on identification of patients having CIN 2/3+.
On a 9-2 vote, the panel recommended that the MediSpectra PMA be found “not approvable.” While acknowledging the need for additional tools to help the colposcopist, the panel noted the small observed effect in the two clinical studies and cited the failure of these studies to achieve statistical significance regarding most study endpoints. The panel did not find post hoc analyses of the LSIL/ASCUS subpopulation in the study to be persuasive.
Contact: Michael T. Bailey, Ph.D., Executive Secretary, 301-594-1180, x130.
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