### SUMMARY MINUTES

### SEVENTIETH MEETING OF THE OBSTETRICS AND GYNECOLOGY DEVICES

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### ADVISORY PANEL

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**OPEN SESSION**

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**June 23, 2005**

Holiday Inn Gaithersburg

Gaithersburg, Maryland

Obstetrics and Gynecology Devices Advisory Panel Meeting

**June 23, 2005**

 

**Attendees**

**Chairperson**

Kenneth L. Noller, M.D.

Tufts University Medical School

Boston, MA

**Voting Members**

Paula J.A. Hillard, M.D.

University of Cincinnati College of Medicine 

Cincinnati, OH

Hugh S. Miller, M.D.

Arizona Health Science Center

Tucson, AZ

**Consultants**

Marcelle I. Cedars, M.D.

University of California

San Francisco, CA

Ralph B. D'Agostino, Ph.D.

Boston University

Boston, MA

Gary S. Eglinton, M.D.

The New York Hospital Medical Center of Queens

Flushing, NY

Jay D. Iams, M.D.

The Ohio State University

Columbus, OH

Julian T. Parer, M.D., Ph.D.

University of California

San Francisco, CA

Susan M. Ramin, M.D.

University of Texas-Houston Medical School

Houston, TX

Deborah A. Wing, M.D.

University of California at Irvine

Orange, CA

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## Consumer Representative

Lee Lee Doyle, M.A., Ph.D.

University of Arkansas for Medical Sciences

Little Rock, AR

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## Industry Representative

Elisabeth George

Phillips Medical Systems

Newton, MA

**Executive Secretary**

Michael T. Bailey, Ph.D.\
CDRH

**CALL TO ORDER**

**Panel Chair Kenneth L. Noller, M.D.,** called the meeting to order at
9:00 a.m. and asked the panel members to introduce themselves. **Panel
Executive Secretary Michael T. Bailey, Ph.D.,** announced there would be
no OB/GYN Devices Panel on August 15 and 16, 2005; the remaining panel
meeting dates for this year are November 15 and 16, 2005. He then read
into the record the appointment of seven temporary voting members:
Marcelle I. Cedars, M.D.; Ralph B. D'Agostino, Ph.D.; Gary S. Eglinton,
M.D.; Jay D. Iams, M.D.; Julian T. Parer, M.D., Ph.D.; Susan M. Ramin,
M.D.; and Deborah A.Wing, M.D. Dr. Bailey then read the conflict of
interest statement. The Agency had no conflicts to report.

**Sousan S. Altaie, Ph.D., Scientific Policy Advisor, Office of In Vitro
Diagnostic Device Evaluation and Safety,** gave a presentation on FDA's
Critical Path Initiative, an effort to make product development more
predictable and less costly. Critical path tools are used in the
assessment of safety to predict whether the product will be harmful; in
proof of efficacy to determine if it will have medical benefits; and in
industrialization to ensure the product is manufactured with consistent
quality.

**Colin Pollard, Chief, Obstetrics and Gynecology Devices Branch,**
welcomed the panel and noted that they would be looking at a pre-market
approval application (PMA P020001) from Neoventa Medical AB for the
STAN^®^ S31, a fetal heart monitoring system. The Panel first looked at
this system in April of 2002 in a PMA based on a large Swedish
randomized control trial (RCT) that showed positive benefit in reducing
metabolic acidosis and operative deliveries. However, the Panel voted
6-5 not to approve the device because all of the clinical data came from
Sweden and there were concerns about how the technology would transfer
to the U.S. The FDA in June of 2003 went to the company with plans for
bridging studies to examine how U.S. clinicians learned and used the
technology.

# OPEN PUBLIC HEARING

No public comments were made. Dr. Bailey read into the record a written
statement from the American College of Obstetricians and Gynecologists
(ACOG) Office of the Deputy Executive Vice President and Vice President
of Practice Activities.

ACOG's Committee on Obstetric Practice cannot endorse the STAN PMA
because of limited evidence the technology improves maternal-fetal
outcomes. The Committee is also concerned about the need to monitor
clinical training of the device. The Committee feels that if the PMA is
approved, post-marketing surveillance of all monitored cases will
require short-term neonatal outcome variables, including paired (artery
and vein) umbilical blood gas analysis.

**NEOVENTA MEDICAL AB PRESENTATION: P020001**

**Marie Marlow, President and CEO, M Squared Associates,** began the
sponsor's presentation by presenting the history of the PMA process for
the STAN^®^ device. She then introduced the other sponsor presenters as
well as additional individuals available to help answer questions.

**Lawrence D. Devoe, M.D., Chairperson, Department of Obstetrics and
Gynecology, Medical College of Georgia**, began with a discussion of the
current practice of electronic fetal monitoring (EFM) in the U.S. The
original goal of EFM was to assist clinicians in determining both
appropriate intervention, by detecting fetuses in early stages of
compromise, and appropriate nonintervention, by enabling reassurance of
fetal condition to allow for normal vaginal birth and avoid unnecessary
maternal risk. Dr. Devoe explained current issues facing obstetrical
practitioners and discussed the meta-analysis undertaken by Thacker
comparing EFM with the standard of intermittent auscultation, in some
instances abetted with fetal scalp blood sampling. The meta-analysis
concluded that EFM was positively associated with more operative
deliveries, perinatal death rates were comparable to the population
receiving intermittent auscultation, and there was a reduction in
neonatal seizures when EFM was abetted by an ancillary method. Dr. Devoe
discussed ACOG Practice Bulletin #62, which concluded that EFM has a
high false positive rate, leads to more operative deliveries, and does
not reduce cerebral palsy rates.

**Simon Grant, CEO, Neoventa Medical AB**, discussed the technical
properties and functionality of the device. STAN^®^ looks at the effect
of stress on the fetal electrocardiogram (ECG). The signal is obtained
in the same manner as with ECG, but the entire ECG complex is analyzed
rather than simply the R wave. First, a baseline must be established, a
process which can take 5-20 minutes. The system takes 30 ECG complexes
and analyzes the average. Then the device looks at the slope of the ST
segment and the amplitude of the T wave compared to the QRS and
calculates the T/QRS ratio.

One of the most important things the device looks at is a rise in the T
wave amplitude. During hypoxia, there is an adrenalin surge, aerobic
metabolism and a resulting increase in T wave amplitude, which results
in an increased T/QRS ratio. There are two kinds of ST events in this
situation: a baseline rise or an episodic rise where there is a
temporary rise in T/QRS.

Another type of ST event is biphasic, a negatively sloping ST segment.
When changes are clinically significant, an ST event is generated, and
the clinician consults the STAN Clinical Guidelines to decide how to
manage the patient.

Mr. Grant explained that STAN includes the standard functionality of an
intrapartum and electronic fetal monitor. He explained the difference in
the display of the STAN device compared to a standard monitor. The
display was adapted for use in the U.S. following recommendations of the
Panel, and a training program for U.S. clinicians was also developed.

Mr. Grant described the current use of the device in Europe. Then he
discussed the early preclinical research of the technology. These
studies demonstrated that an ST rise indicated anaerobic myocardial
metabolism and that biphasic ST indicated a reduced ability of the
myocardium to respond.

Dr. Devoe reviewed the data originally presented to the Panel in 2002.
One study of note was the Nordic Study from 1990 to 1999, which
established that the guidelines for the STAN information were able to
detect cases of metabolic acidosis. The Swedish RCT enrolled nearly
5,000 patients and showed a 54% reduction of cord metabolic acidosis and
a 19% reduction in operative deliveries. Dr. Devoe also talked about the
clinical usage trials conducted in Europe. The E.U. Clinical Study
demonstrated that the educational materials could be used effectively in
different countries and languages. The Gothenburg study also showed a
reduction in metabolic acidosis, low Apgar score, seizures, and
operative deliveries for fetal distress. Dr. Devoe then discussed the
previous Panel meetings regarding the device.

**Sue Ellen Abney, RNC, MSN, Perinatal Nurse Specialist, Medical College
of Georgia**, introduced the U.S. Educational Study. It was designed as
a bridge between the Swedish RCT and the U.S. Clinical Use Study. The
study focused on mandatory education and training including
credentialing and certification of OB physicians and midwives. Total
overall accuracy for the U.S. investigators in identifying fetal
conditions improved from about 45 to 70 percent with the addition of ST
information.

The outcomes of the educational study were used in designing the U.S.
Clinical Use Study. Investigators first completed a self-study and a
lecture followed by a certification test. Then they used the STAN^®^
monitor to gather standard EFM data and observe the ST information. They
were credentialed based on review of their cases and their understanding
of the ST analysis.

Ms. Abney discussed her own observations as the study coordinator at the
Medical College of Georgia.

**Jennifer L. Ryea, ScM, Biostatistician, Hogan & Hartson, L.L.P.**,
further discussed the U.S. Clinical Use Study. The first primary
endpoint of the study, negative predictive value (NPV) of the device, as
measured by the percent of cases with non-reassuring fetal heart rate
tracings, no indication for intervention based on ST data, and where
cord artery pH was greater than 7.12, in which a correct decision not to
intervene was made, would ensure that when no intervention was performed
there was a high probability of a normal fetal outcome.

The second primary endpoint, agreement of the U.S. clinicians with the
STAN experts, measured by positive and negative percent agreements (PPA
and NPA), would demonstrate that the U.S. clinicians could implement the
device similar to the experts.

Dr. Devoe further discussed the design and results of the U.S. Clinical
Use Study. With regard to NPV, analysis across all pH values exceeded 90
percent, well above the success criteria, and the overall agreement,
both PPA and NPA, was found to be 90 percent.

A user survey was also conducted. The majority of users found the STAN
monitor to be easy to use, and in two-thirds of the cases users felt the
device improved their ability to assess the condition of the fetus
during labor.

Three conclusions drawn from the studies were that they show a reduction
in adverse perinatal outcomes, the STAN educational program has been
successfully used in diverse cultures, and that there has been
successful technology transfer to the U.S.

Ms. Marlow first emphasized that the device would be used only in term
pregnancies as an adjunct to standard EFM. She added that other
conditions for use included planned vaginal delivery, need for close
fetal surveillance, and in cases of maternal disorders such as
utero-placental dysfunction. Contraindications for the device are
similar to those for standard EFM~~.~~

**PANEL QUESTIONS TO SPONSOR**

Dr. Noller opened up the floor for clarifying questions from the Panel
members. Dr. D'Agostino asked whether the sponsor had done an analysis
of the performance of the individual investigators. Ms. Ryea responded
that they had had completed that type of analysis and had found nothing
of concern.

Dr. Parer asked for clarification whether a non-reassuring fetal heart
rate tracing was an indication for the use of STAN, and Ms. Marlow
assured him that it was. Dr. Parer then asked whether the T/QRS ratio
was a running average. **Mihaela Golic, Product Manager, Neoventa
Medical**, responded that the ratio is not a running average but rather
the average of 30 sequential heart rate intervals. Dr. Parer further
inquired whether ST events were generated from changes in both T/QRS and
ST morphology. Mr. Grant responded that an event would be generated by
one or the other, and that the log would record which type of ST event
it was.

Dr. Iams raised concerns about the potential use of the device on
patients without any of the recognized high-risk indications since it
would potentially be used any time an internal monitoring device was
used for any reason. Dr. Devoe stated that when there is a reassuring
tracing, that tracing should be the main factor in clinical
decision-making.

**Michael Ross, M.D, M.P.H., Professor of Obstetrics and Gynecology,
UCLA School of Medicine and School of Public Health**, pointed out that
the indication for enrolling patients in the clinical use study was
placement of an internal scalp electrode, the same sort of circumstance
Dr. Iams was concerned about, and there was no demonstrated increase in
operative intervention and no cases of significant metabolic acidosis.

Dr. Iams asked for information on the NPV of all women in the clinical
use study who used the device. Dr. Ramin asked whether the device would
take 20 minutes from beginning use of the device to provide an ST
analysis. Dr. Golic responded that it would depend on the type of event
and that the maximum time needed would be 20 minutes.

Dr. Eglinton inquired about how the device would be integrated into
central monitoring systems already in place. Mr. Grant responded that
they are talking to manufacturers about integrating the technology. Dr.
Parer wondered whether there might be another explanation for the
improvement of the U.S. clinicians in the Educational Study besides that
the ST information helped them. He also wondered about the difference in
paper speed between the Swedish and U.S. systems.

**FDA PRESENTATION**

**Kathryn S. Daws-Kopp, lead reviewer,** began the FDA's presentation.
She described the history of the FDA review of the device. The sponsor
first submitted a PMA in January 2002 after the Swedish RCT was
completed. The PMA came before the Panel in April of 2002. In June of
2003 the sponsor again came before the Panel to discuss the Education
and Clinical Use studies. The current amended PMA was submitted in
February of 2005.

Ms. Daws-Kopp described the components of the STAN^®^ device. The basis
for the mechanism of action is that responses to hypoxia will show up as
changes in the ECG waveform. The three types of events of interest are
baseline T/QRS rise, episodic T/QRS rise, and biphasic ST.

One issue in particular focused on was the change from the S21 model of
the device, used in all of the clinical testing, to the S31, the subject
of the amended PMA. FDA was satisfied that the S31 would perform in the
same manner as the S21. Bioresearch monitoring and manufacturing reviews
have yet to be completed.

**Julia Carey- Corrado, M.D., OBGYN Devices Branch**, discussed the
Swedish RCT, the pivotal clinical trial for the device. For the
intent-to-treat population, this study found a statistically significant
reduction in metabolic acidosis and in operative delivery for
non-reassuring heart rate among patients monitored with both FHR plus ST
analysis compared to patient monitored with FHR alone. Regarding safety,
the Swedish RCT found no statistically significant difference in Apgars
of less than 7 at 5 minutes or in admissions to the NICU.

Dr. Corrado discussed the concerns of the Panel in 2002 and the
development and carrying out of the Educational and Clinical Use
studies. She concluded by saying that safety and effectiveness were
demonstrated by the Swedish RCT. Now the sponsor has promulgated a U.S.
version of STAN guidelines, completed two bridging studies, and created
an expanded education and training program for the device.

**Gene Pennello, Ph.D., Statistical Reviewer, Diagnostics Branch,
Division of Biostatistics**, talked about statistical design and
analysis issues. Diagnostic tests are meant to evaluate the tradeoff
between correctly detecting the condition and falsely detecting it. An
uninformative test would test positive as often when the condition was
present as when it was not.

The STAN tests positive when the clinician intervened before spontaneous
vaginal delivery and negative when the clinician does not. Because the
studies are interventional and intervention eliminates the possibility
of knowing what the outcome would have been without intervention, only
the negative predictive value, a measure of non-interventions without
the condition, can be calculated without bias. The U.S. Clinical Use
Study only looked at negative predictive value. There is some potential
bias looking at accuracy in the Educational Study.

Dr. Pennello talked about the difficulty of obtaining a correct p-value
for the percent agreement in the Education Study because of correlations
in the total pool of readings that were completed. He also discussed the
development of endpoints for the Clinical Use Study.

Dr. Pennello summarized the two U.S. studies. In the Education Study, 10
of 13 raters passed the certification test, and there was some variation
in the effectiveness of the training. In the Clinical Use Study, of the
three endpoints, only PPA was not met.

**FDA QUESTIONS AND PANEL DISCUSSION**

**1. Given the results of the Education Study, does the Panel believe
that this shows U.S. clinicians, in a classroom setting, can learn and
successfully use the STAN system? Is variation among readers in the
effectiveness of training a concern?**

Panel members were in general agreement that U.S. clinicians were shown
to be capable of using the system, but expressed some concerns about the
variation amongst the clinicians in light of the intensity of the
training. A panel member wondered whether the results of the Clinical
Use Study had been influenced by the fact that some of the clinicians
had already received training in the Educational Study. The sponsor
clarified that there was no overlap of the participants in the two
studies. A panel member pointed out that it is rare for patient monitors
to have required training regimens. Dr. Noller agreed that health care
facilities generally decide who can and cannot use such devices. One
panel member espoused the view that there should be mandatory training
for fetal heart rate monitoring and hoped that this new system would
have a certification program.

**2. The *a priori* targets for NPV and NPA were met, but the lower
bound on the 95% CI for PPA was 68% (versus the 75% target). Considering
the various analysis strategies, please discuss the clinical
implications of these findings. Does the CUS Study demonstrate that U.S.
clinicians can learn and successfully use the STAN technology in the
clinical setting?**

A panel member stated that he did believe the CUS study showed that U.S.
clinicians can learn the STAN system. The sponsor, responding to an
earlier question, stated that the NPV did not change much when women
with normal tracings were included. A panel member inquired whether any
women had interventions in spite of a normal tracing because of an ST
event. The sponsor responded that five of 291 women fit that category
and clarified that they were indeed intervened upon unnecessarily, as
verified by the cord gases. Members asked whether the fetal EKG
functions could be turned off and the device used as a standard monitor,
and the sponsor stated that it could be used in such a way. The
discussion turned to the question of the target population for the
device and whether it should be indicated only for cases with
non-reassuring fetal heart rate or for all laboring patients. A panel
member raised the issue that the device needs a 20 minute baseline so
waiting for non-reassuring fetal heart rate to develop before turning on
the device wouldn't necessarily work. Another panel member was concerned
about who would be monitored with the device and thought it was
unrealistic to expect that only high-risk patients would be. A panel
member pointed out that 80-100 percent of mothers have continuous EFM so
the question of which patients will be monitored is practically moot.
With certain exceptions, e.g. cord prolapse, there is an evolution from
normal to abnormal fetal heart rate tracings. At some point during this
evolution from normal to abnormal, the clinician begins to get
concerned. This is when it would become useful to activate the ST
analysis.

**3. Do the results from these two bridging studies conducted in the
U.S. (Education and CUS), when considered along with the previously
reviewed studies (e.g., the Swedish RCT), collectively demonstrate the
safety and effectiveness of the STAN S31 Fetal Heart Monitoring System
for its stated indication for use?**

 

A panel member stated that the studies taken together did demonstrate
safety and effectiveness, but stressed the need for an intensive and
ongoing educational program. He also suggested that perhaps a few people
in each health care facility should take the lead on maintaining
standards for use of the device. Other panel members agreed that the
device was demonstrated to be safe and effective.

 

**4. Does the panel have any comments on the labeling and instructions
for use provided by the sponsor?**

Panel members discussed the idea of "need" with regard to the
indications and acknowledged that most women monitored in this country
do not need to be. A panel member mentioned that the device might be
able to be used to increase the possibility of a safe vaginal delivery.
One panel member added that the device was also effective at reducing
acidemia. The sponsor talked about identifying centers of excellence
that can help train clinicians from other centers, and super users that
could take the lead within individual health care systems. A panel
member raised the issue of using the device in other than term
pregnancies, for which there are no data.

**5. Does the panel believe that the STAN Educational Program used for
the U.S. Clinical Use Study together with the existing Continuing
Education opportunity available on the Internet should be basic
requirements of STAN training for U.S. clinicians if the PMA is
approved?**

Panel members discussed the need for Department Chairs to require
training. Ms. George talked about sponsor monitoring of adverse events
associated with devices. The sponsor discussed the time needed for
training and the spread of the information among clinicians. A panel
member inquired about the use of the device for twins and to aid with
arrhythmias. The sponsor replied that the device could not be used with
normal twins and is useful with only certain specific arrhythmias. One
panel member raised a concern about the difficulty of interpreting the
ST data in the setting of a woman in labor. There was discussion about
whether FDA should require users of the device to be trained. A panel
member suggested there should be mandatory training because of the
potentially far-reaching impact of the device and so that hospitals
cannot skip the training to save money. Panel members agreed that there
should be mandatory training.

**6. Does the panel have any input regarding any issues that should be
addressed in a post-approval study?**

 

Panel members generally agreed that there should be tracking of the
rates of cesarean section and acidemia at the first centers to adopt the
device. One panel member suggested that a post-approval study should
look at whether clinicians are being properly trained. Another panel
member suggested that rates of use and indications for use should be
examined.

**OPEN PUBLIC SESSION**

**Thomas Frank, Perinatronics Medical Systems,** began by stating that
the panel seemed to have no doubts that the device under consideration
was intrinsically safe and clinically effective. He discussed the need
to clarify terminology. He stated that the device provided an
opportunity to monitor a new physiologic parameter for the benefit of
patients.

**FINAL FDA COMMENTS**

The FDA had no final comments.

**FINAL SPONSOR COMMENTS**

Ms. Marlow thanked the panel members for their hard work and a fair
review of the PMA.

# VOTE

Panel Executive Secretary Bailey read the voting options. Dr. Noller
asked whether there was a motion to recommend approval, approval with
conditions, or not approvable. Dr. Ramin put forth a motion to approve
the device with conditions; Dr. Wing seconded the motion. Dr. Noller
asked for motions for the individual conditions

Dr. Ramin put forth a motion that the sponsor should outline a program
to educate the clinicians who will use the device. Dr. Iams seconded the
motion. Dr. Hillard asked whether the motion was intended to include
certification, and Dr. Ramin said that it was. Drs. Parer and Cedars
stated they would like to see surveillance of the efficacy of the
training provided. The panel members discussed the sponsor's role in the
training. Dr. Noller clarified the motion to be that the sponsor be
required to develop educational materials leading to certification in
the use of the device and to present implementation plans for education
and certification to each new clinical setting. Drs. Ramin and Iams
agreed with his restatement of the motion. The motion was approved
unanimously.

Dr. Parer moved that there be a requirement for a post-approval study of
the primary study endpoints, C-section and acidemia rates following
introduction of the device. Dr. Iams offered a friendly amendment to
also include the endpoint of operative delivery. Dr. Parer accepted, and
Dr. Iams seconded the motion. Dr. Parer clarified that the study would
need to be done appropriately but left those details open. Dr. Hillard
offered as an amendment that there be an assessment of the rates of use
and indications for use. Drs. Parer and Iams agreed. Ms. George stated
that much of the data would already be collected by the hospitals, and
Dr. Noller agreed that some of the data could be obtained from the
hospitals. Dr. Noller stated that data on indications for operative
deliveries would be difficult to obtain. Dr. D'Agostino cautioned that
the burden for obtaining the data from the hospitals should be on the
sponsor. Dr. Noller said that the details of the study would be worked
out by the FDA and the sponsor. **Nancy Brogdon, Director, Division of
Reproductive, Abdominal, and Radiological Devices,** agreed and said the
FDA was most interested in knowing what data the Panel thought should be
studied.

Dr. Eglinton wondered about the difficulty of getting information on
usage rates. Dr. Noller suggested there be some allowance for whether
getting those data would be feasible. Dr. Iams suggested that the study
should look at less information, and Dr. Parer agreed. Dr. Parer
wondered what would happen if C-section and acidemia rates went up after
introduction. Ms. Brogdon stated that the PMA approval could be
withdrawn or the labeling be restricted. Dr. Doyle suggested that the
panel was essentially requiring the sponsor to obtain information on
off-label uses. Dr. Iams suggested that the potentially widespread use
of the device without informed consent justified consideration of
off-label usage. Dr. Eglinton discussed how C-section rates have gone up
during his career and wondered whether further increases could
justifiably be attributed to the device. Dr. Noller agreed. He restated
the motion as requiring the sponsor to conduct a survey on the primary
endpoints from the studies already conducted, rates of operative
deliveries, acidemia, and neonatal encephalopathy; certification of
clinicians; and indications for use and rates of use, if possible. The
motion passed with eight voting for, one against, and no abstentions.

Dr. Cedars moved for a condition that there be a change in the labeling
to say the device is an adjunct for the assessment of non-reassuring
fetal heart pattern. Dr. Parer seconded the motion but asked that the
terminology be left open. Dr. Cedars stated that the panel needed to use
the standard terminology. There was no other discussion. The motion
passed unanimously.

Dr. Eglinton put forth a motion that each device be delivered with an
education package including a textbook, a CD-ROM certification test,
credentialing materials, a test, and continuing education materials. Dr.
Iams seconded the motion. There was no discussion. The motion passed
unanimously.

Dr. Miller moved that the labeling for the device exclude twin
gestations. Dr. Iams seconded the motion. There was some disagreement on
what the sponsor had said about twins. Ms. George pointed out that the
user documentation stated that it was not possible to monitor both twins
with the fetal ECG. Dr. Miller withdrew his motion.

Hearing no more conditions, Dr. Noller called for a vote on the motion
to approve Neoventa's PMA P020001 for the STAN S31 Fetal Heart
Monitoring System with the four conditions just approved. The motion
passed unanimously.

Dr. Noller asked each panel member to state the reason for his or her
vote.

Dr. Doyle said that the device had the potential to identify fetuses in
trouble and those who were not in trouble, thus the device posed minimal
risk to the patient.

Ms. George thought the voting members had made a great decision and
reiterated that data for the post-approval study would already be
collected by parties other than the sponsor.

Dr. Wing stated that the data were convincing, that there were no safety
concerns, and that this device added a potential benefit of reducing
acidemia and operative deliveries.

Dr. D'Agostino said that the Swedish study demonstrated safety and
effectiveness, and that the bridging studies had addressed the Panel's
concerns about the use of the device in the U.S.

Dr. Iams agreed with the previous comments. He urged the FDA and the
sponsor to take seriously the task of promoting the device as being
intended to identify patients who do not require an intervention.

Dr. Miller agreed with the previous comments and was glad to have
another tool to assess the fetus.

Dr. Cedars agreed with the comments about the Swedish study and the
bridging studies.

Dr. Ramin stated that the device had been demonstrated to be safe and
efficacious, and that concerns about its use in the U.S. had been
addressed.

Dr. Hillard also agreed with the previous comments and expressed
excitement about the possibility of improving the use of existing
technologies and decreasing cesarean rates.

Dr. Parer believes that the device is safe and effective, and that the
conditions imposed would provide information about its safety and
effectiveness in the broader medical community.

Dr. Eglinton believed that the sponsor had satisfactorily demonstrated
safety and effectiveness in accordance with the law.

**ADJOURNMENT**

Dr. Noller thanked the Panel members for their preparation and adjourned
the meeting at 3:49 p.m.

 

** **

> I certify that I attended this meeting of the Obstetrics and
> Gynecology Devices Advisory Panel Meeting on May 17, 2005, and that
> these minutes accurately reflect what transpired.
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Michael Bailey, Ph.D.
>
> Executive Secretary

I approve the minutes of this meeting

as recorded in this summary.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Kenneth L. Noller, M.D.

Chairperson

> ***Summary prepared by***
>
> Eric C. Mollen
>
> Neal R. Gross & Company
>
> 1323 Rhode Island Ave., N.W.
>
> Washington, D.C. 20005
>
> \(202\) 234-4433