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U.S. Department of Health and Human Services

Advisory Committees

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Obstetrics And Gynecology Devices Panel - January 24-25, 2000

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met on January 24 and 25, 2000 to discuss two agenda items.

On January 24, 2000, the Panel considered a PMA from Mallinckrodt/Nellcor Perinatal Business for its N-400 Fetal Oxygen Saturation Monitoring System, a first-of-a-kind intrapartum fetal pulse oximeter. The N-400 is indicated for labor management of singleton fetuses at term, adjunctive to fetal heart rate monitoring to permit the safe continuation of labor during non-reassuring fetal heart rate patterns.

The panel considered Nellcor’s prospective RCT of 1010 women that randomized laboring women with a non-reassuring fetal heart rate tracing into one of two groups, a test group using the new fetal pulse oximeter and a control group using conventional fetal monitoring. A specified management matrix defined how fetal oxygen saturation was to be used in face of the non-reassuring fetal heart rate tracing. The study’s primary outcome measure was the C-section rate for non-reassuring fetal status (NRFS), and the study hypothesis was that this rate would be significantly reduced in the test group. The RCT showed that 1) C-sections for NRFS decreased in the test group, 5% (23/508) compared to 10% (51/502) in the control group. However, unexpectedly, the study also showed an increase in the C-section rate for dystocia in the test group, 19% (94/508) compared to 9% (43/502). The overall C-section rate was not different between the test and control groups. Nellcor provided several possible explanations for this unexpected finding.

The Panel considered several discussion questions relevant to the PMA:

  • the accuracy of fetal O2 saturation measurement itself
  • the 30% saturation threshold, defined in the management matrix used for the study, above which intervention may be delayed even with a non-reassuring fetal heart rate tracing
  • C-section rates observed in the study
  • Device safety
  • Device labeling and training materials
  • Post-approval studies

Following these deliberations, the Panel recommended approval of the PMA, on a 10-1 vote, subject to the following conditions:

  1. Labeling changes, including the Indications for Use, addition of certain warnings and precautions. As well as a definition of physician skills needed for device use; and
  2. Focused post-approval surveillance, immediately following market launch of the device, particularly to assess the C-section rates at clinical sites where the device is used. The Panel also wanted such postmarket assessment to track the frequency of device use and its relation to infection rates, incidence of dystocia, length of time the sensor registered less than 30%, use of epidural anesthesia, adequacy of labor, and neonatal outcomes.

On January 25, 2000, the Panel considered CDRH’s draft guidance document on resorbable adhesion barriers used in the abdomen and pelvis for reduction and prevention of adhesions following surgery. Prior to panel deliberations, an industry group representing manufacturers of adhesion barrier products presented comments on the draft document. The Panel provided several recommendations to FDA regarding:

  • Use of surrogate endpoints (e.g., adhesion incidence, extent, severity, scoring systems for adhesions) versus clinical endpoints (e.g., infertility, chronic pelvic pain, small bowel obstruction)
  • premarket versus postmarket study of clinical endpoints
  • extrapolation of data for a) de novo to reformed adhesions, b) gynecologic models to general surgery, and c) site-specific application to alternative sites in the abdominopelvic cavity
  • appropriate methods for masking a trial
  • laparoscopy versus laparotomy indications
  • Data on the potential of an adhesion barrier product to enhance infection

CDRH will consider the Panel's recommendations, as well as comments received during the public comment period, in order to refine and improve the draft guidance.

Contact: Elisa Harvey, Ph.D., DVM, Executive Secretary,
301-594-1180, x 141

Transcripts may be purchased from: (written only)

Miller Reporting
507 C Street, NE
Washington, DC 20002
(202) 546-6666 (voice) (202) 546-1502 (fax)

or

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

Executive Summary may be purchased from: (written request only)

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)