Obstetrics and Gynecology Devices Panel Meeting Summary for April 22, 2002
The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on April 22, 2002 to discuss a premarket approval application (PMA P020001) from Neoventa, Inc. for their STAN® S21 Fetal Heart Monitor. The proposed indication was for planned vaginal delivery of a full term, singleton fetus in vertex presentation, with gestational age greater than or equal to 36 weeks, when:
- there is need for close fetal surveillance during labor, or
- there are maternal disorders and/or utero-placental dysfunction with potential adverse influence on fetal oxygen and nutritional supply, or
- there is deviation from the normal course of labor including induction/augmentation of labor.
The panel considered the sponsor's prospective, randomized, controlled, clinical trial, which was conducted at 3 university hospitals in Sweden. 2519 women were monitored with both STAN and conventional fetal heart rate monitoring, while 2447 women were monitored with only conventional fetal heart rate monitoring (control). The primary endpoint was metabolic acidosis, which was defined as umbilical cord arterial pH <7.05 and base deficit >12 mmol/L. Among the babies with adequate cord blood samples, 0.7% (15/2159) of the babies in the STAN arm had metabolic acidosis; 1.5% (31/2079) of the babies in the control arm had metabolic acidosis. This difference was statistically significant (p=0.02).
The panel also considered additional studies. A randomized, controlled trial was conducted in Plymouth, England during development of the device. An observational trial conducted in Gothenburg, Sweden showed reduced rates of metabolic acidosis as users became more experienced with the device.
The panel voted 6-5 to recommend that the PMA was not approvable. Panel members indicated that to put the PMA into approvable form, a randomized, controlled trial should be conducted in the U.S, because of perceived differences in (1) styles of practice between Sweden and the U.S., (2) target populations, and (3) conventions in fetal heart rate tracings. The panel also expressed concern about the importance of education on use, interpretation, and decision-making if the device were introduced in the U.S.
Contact: Joyce M. Whang, Ph.D., Executive Secretary, 301-594-1180, x127
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