This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: STAN® S31 Fetal Heart Monitor
Manufacturer: Neoventa Medical AB
Address: Ågatan 32, SE-431 35 Mölndal, Sweden
Approval Date: November 1, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020001a.pdf
What is it? The STAN® S31 Fetal Heart Monitor is new type of fetal monitor that uses the fetal electrocardiogram (ECG) obtained through a fetal scalp electrode during labor to help the doctor or midwife decide whether to allow the mother to continue to labor or to intervene and deliver the baby.
How does it work? The STAN® S31 monitor looks for changes in the fetal ECG that suggest the fetus is not adapting to the stress of labor.
When is it used? The STAN® S31 monitor is used when there is concern that the fetus might be at increased risk for metabolic acidosis.
What will it accomplish? The STAN® S31 monitor will help the doctor or midwife decide when the fetus can no longer tolerate the stress of labor and needs to be delivered.
When should it not be used? The STAN® 31 monitor should not be used in the following situations:
- when fetuses are not identified as high risk;
- when, prior to application of the monitor, the fetal heart rate suggests that the fetus has already been injured;
- when a fetal scalp electrode should not be placed (e.g., mother has HIV/AIDS or hepatitis, fetus has a blood clotting abnormality);
- when labor is progressing rapidly and delivery is likely to occur before the necessary STAN® ECG information can be established (first 20 minutes of STAN® monitoring);
- when the mother is receiving electrical nerve stimulation therapy for pain control; and
- when it has already been decided that the baby should be delivered immediately.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020001