On May 21-22, 2001, the Obstetrics and Gynecology Devices Panel met to consider 5 issues.
Monday, May 21, 2001
The Panel discussed a PMA-Supplement (P990053/S1) from Mallinckrodt Inc. (Pleasanton, CA) for a post-approval study for the OxiFirst™ Fetal Oxygen Saturation Monitoring System. The Sponsor proposed that the requirements of the FDA approval order be satisfied with data from the following set of 3 studies:
A “General Use” study sponsored by Mallinckrodt would satisfy FDA requirements that the following parameters be addressed: indications for OxiFirst™ sensor placement, Cesarean-section rates, maternal infection rates, and neonatal outcomes.
A “Dystocia Study” conducted by some of the original OxiFirst™ investigators and partially underwritten by Mallinckrodt would address the adequacy of labor.
A 3-arm multi-center randomized trial conducted by NICHD’s Maternal-Fetal Medicine Unit Network would address the duration that fetal oxygen saturation can remain below 30% before risk of fetal injury.
The Panel provided comments to FDA on all three studies. The Panel expressed concern that these studies (especially the NICHD study) could take several years to be completed, and urged that they be conducted as quickly as possible.
The Panel heard a presentation about the clinical investigation of Novatrix’s Labor Assistor System. Based on the study results, the firm decided not to pursue PMA approval. At FDA’s invitation, the firm agreed to discuss its early collaboration meetings with FDA, including a determination/agreement meeting; they also shared their investigational findings. The presentation provided the opportunity for the Panel, FDA, and the public to learn about the device and the clinical findings from the studies.
Tuesday, May 21, 2001
The Panel started the day with a 2-hour closed session.
The Panel discussed room air and/or gas emboli that have occurred during operative hysteroscopy. The Panel heard presentations from Ethicon, FDA, and the public. The Panel concluded that (a) additional research is needed to further understand the risk and (b) good clinical practice is essential for minimizing risk. The Panel recommended a number of mechanisms for heightening clinical awareness of the risk of this potentially life-threatening event.
The Panel discussed the following issues related to studies of Uterine Fibroid Embolization (UFE) devices: inclusion and exclusion criteria; study endpoints; length of follow-up; re-treatment; and labeling. Two speakers presented on behalf of the Society for Cardiovascular and Interventional Radiologists (SCVIR). The Panel provided comments to assist FDA in its development of an IDE/510(k) guidance document for artificial embolization devices for UFE.
Contact: Joyce Whang, Executive Secretary, 301-594-1180, x127
Transcripts may be purchased (written requests only) from:
Miller Reporting Company
735 8th Street, SE
Washington, DC 20003
202-546-6666 (voice)/202-546-1502 (fax)
Food and Drug Administration
Freedom of Information Staff
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice)/301-443-1726 (fax)
Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.