Obstetrics and Gynecology Devices Panel
Monday, May 21, 2001 – 1-4
OxiFirstÒ Fetal Oxygen Saturation Monitoring System, Model N-400
Panel Discussion Questions
When the FDA
approved the PMA for the OxiFirstÒ monitor (May 12, 2000), a post‑approval
study was required to assess how the use of this monitor would impact cesarean
deliveries, as well as to evaluate several other important variables within
general clinical practice. Per
FDA’s approval order, the post‑approval study should address the
· indication(s) for OxiFirstÒ sensor placement
that fetal oxygen saturation can remain below 30% before risk of fetal injury
outcomes (e.g., cord blood cases, Apgar scores, etc.)
In the PMA Supplement subject to this panel discussion,
Mallinckrodt has proposed a post‑approval study plan based on the three
A – 3‑arm multi‑center randomized trial conducted by NICHD’s
MFMU Network, with some technical consultation from Mallinckrodt
Study B – ‘General Use
Study’ sponsored by Mallinckrodt
C – ‘Dystocia Study’ conducted by some of the original OxiFirstÒ
investigators and partially underwritten by Mallinckrodt
the NIH study, the OxiFirst sensor will be placed in subjects for indications
beyond what is in the approved labeling (i.e., non‑reassuring FHR
tracing). Will the proposed NIH
study provide useful data, per the panel’s earlier recommendation, on the
currently approved indication? If
not, are there patient subsets that can be analyzed?
FSpO2 “cut‑off” specified in the OxiFirstÒ
labeling is 30%. Will the sham arm
of the NIH study provide information towards further understanding of the
validity of this cut‑off value?
the labor management protocol employed in the NIH study allow for meaningful
interpretation with respect to the management protocol in the approved labeling?
Study B – General Use Study
the nature of the clinical centers involved in the NIH study and Dystocia Study,
should the “General Use Study” target different types of
hospital settings so as to optimize the overall information gained by the
sum of the three studies?
5. What would be the appropriate overall timeframe for the conduct of this study? Is there a need for longer term tracking?
6. Are there any other improvements that can be made to the clinical protocol?
Study C – Dystocia Study
this study help elucidate the findings from the pivotal PMA study that showed
more cesarean deliveries for dystocia in the OxiFirstÒ arm?
Package for the PMA: http://www.fda.gov/cdrh/pdf/p990053.html
Dildy, G.A., McNamara, H., Nageotte, M.P., Boehm, F.H., Dellinger, E.H., Knuppel,
R.A., Porreco, R.P., Miller, H.S., Sunderji, S., Varner, M.W., Swedlow, D.B.,
“A multicenter controlled trial of fetal pulse oximetery in the intrapartum
management of nonreassuring fetal heart rate patterns,” Am J Ob Gyn 183:1049-1058, 2000.
post-approval clinical study plans (attachment 1)