(617 days)
Not Found
Not Found
No
The device description and performance studies focus on a physical, inflatable balloon device and its mechanical function. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to facilitate delivery of the fetus during a Caesarean section, contributing to a therapeutic outcome by reducing complications for both mother and fetus.
No
The device is an inflatable balloon used to elevate the fetal head to facilitate delivery during a Caesarean Section. It is a therapeutic device designed for intervention and treatment, not for diagnosing conditions or diseases.
No
The device description clearly outlines multiple hardware components including a silicone balloon, base plate, silicone tube, two-way tap, and syringe.
Based on the provided information, the Fetal Pillow is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Fetal Pillow's Function: The Fetal Pillow is a physical device used during a surgical procedure (Caesarean Section) to mechanically elevate the fetal head. It does not analyze or examine any biological specimens. Its purpose is to facilitate a surgical maneuver, not to provide diagnostic information based on in vitro testing.
The description clearly outlines a mechanical device used for a surgical intervention, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age >37 weeks.
Product codes
PWB
Device Description
The Fetal Pillow is an inflatable balloon device which consists of the following components:
- Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
- Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
- Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation.
- Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
- Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.
The Fetal Pillow is a single use, disposable, sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary of Nonclinical/Bench Studies:
-
Biocompatibility/Materials: The Fetal Pillow includes materials that have direct patient contact for less than 24 hours. Tested for Cytotoxicity, Sensitization, and Vaginal Irritation. Results: non-cytotoxic, non-sensitizing, and nonirritating.
-
Shelf Life/Sterility: 2-year shelf life. Sterilized by ethylene oxide (EtO) to achieve a sterility assurance level (SAL) of 10^-6. Accelerated aging study simulated 3 years of aging. Package integrity testing was conducted to confirm the sterile barrier properties are maintained.
-
Performance Testing - Bench: Evaluated overall device functionality, mechanical performance, and material integrity. Sample size not explicitly stated for individual tests but implied for all samples.
- Leakage: Device inflated to 300cc and evaluated for leakage. Acceptance: No fluid leakage after 2 min.
- Leakage under pressure: Device inflated to 300cc and subjected to 43.5psi pressure for 10 min. Acceptance: No fluid leakage after 10 min.
- Joint Disconnection Strength: 2kg mass attached to luer port, device suspended from balloon for 2 min. Acceptance: Support 2 kg. for 2 min. without damage.
- Stretching/Distortion of balloon: Device inflated to 300cc, internal balloon pressure measured every 15 sec for 2 min. Acceptance: Inflate evenly without distension, pressure maintained for 2 min.
- Maximum Pressure resistance: Device attached to pressure gun and inflated until balloon failure. Acceptance: No leakage at a balloon pressure of 72.5psi.
- Deflation Reliability: Device inflated to 180cc or 300cc, tap opened, time to empty recorded. Acceptance: Time to empty 1000cc, Need for blood transfusion, 5 minute APGAR 24 hours, Neonatal sepsis, Neonatal death.
- Key Results: Major uterine incision extensions significantly lower in FP group (6 [5%] vs. 39 [32.5%], RR 0.23 (0.11 to 0.48)). Total time for CS, incision to delivery interval, need for blood transfusions and length of hospital stay were lower in FP group. Intra-operative blood loss >1000cc was less common in FP group (4.2% vs. 21.7%).
-
Reanalysis of the randomized controlled trial data:
- Compared Fetal Pillow group (N=120) vs. Non Fetal Pillow, Hand Push Method group (N=40).
- Key Results: Extensions of uterine incisions significantly less common in FP group (10 (8.3%) vs. 23 (57.5%), Chi-squared Test p-value P1000 mL (1 (0.8%) vs. 15 (37.5%)), and mean length of stay (3.93 days vs. 5.30 days) in FP group.
-
Retrospective cohort study (Brisbane, Australia): Compared Fetal Pillow or hand-push method for full-dilatation Caesarean deliveries.
- Sample Size: 160 patients (91 Fetal Pillow, 69 Hand-push).
- Outcome Measures:
- Maternal: Estimated blood loss, Need for blood transfusion, Uterine angle extension, Duration of stay in hospital.
- Neonatal: 5-minute Apgar score below 7, Cord arterial pH, Admission to neonatal intensive care unit, Need for endotracheal intubation.
- Key Results: Fetal Pillow group showed lower mean intra-operative blood loss (273 +/- 145 vs. 403 +/- 199), shorter duration of postpartum hospital admission (77.9 +/- 19.6 hr vs. 97.8 +/- 27.6 hr), and higher mean cord arterial pH (7.24 +/- 0.06 vs. 7.19 +/- 0.09). No clinically meaningful differences for 5-min Apgar score 1000 mL, Need for blood transfusion, Length of post-operative hospital stay.
- Key Results: No difference in outcomes of interest with Fetal Pillow use when maternal BMI, fetal weight, and use of epidural in labor were taken into account.
Overall Conclusion of Clinical Studies: Use of the Fetal Pillow results in a reduction in clinically significant uterine incision extensions, as well as fewer observed cases of blood loss > 1000 mL and less need for blood transfusions. No fetal or maternal injuries attributed to Fetal Pillow use in randomized controlled trial or retrospective cohort study.
Key Metrics
-
Randomized control trial (India):
- Major uterine incision extensions (Grade 2-3): FP Group 5% vs. Non-Pillow Group 32.5%. RR 0.23 (0.11 to 0.48).
- Blood loss > 1000 mL: FP Group 4.2% vs. Non-Pillow Group 21.7%.
- Blood transfusions: FP Group 3.3% vs. Non-Pillow Group 18.3%.
- Total Time taken for Lower Segment Caesarean Section: FP Group 32.7 +/- 4.3 min vs. Non-Pillow Group 53.9 +/- 10.3 min.
- Incision to delivery interval: FP Group 176.5 +/- 14.0 sec vs. Non-Pillow Group 297.2 +/- 27.1 sec.
- Hospital stay in days: FP Group 3.9 +/- 0.80 vs. Non-Pillow Group 5.0 +/- 1.2.
- 5 minutes APGAR score ≤ 3: FP Group 0.8% vs. Non-Pillow Group 6.7%.
- Admission to NICU: FP Group 10.8% vs. Non-Pillow Group 17.5%.
- Duration of NICU stay >24 hours: FP Group 23.1% vs. Non-Pillow Group 57.1%.
-
Reanalysis of RCT (FP vs. Hand Push Method):
- Extension of uterine incision: FP Group 8.3% vs. Hand Push Method 57.5% (Chi-squared Test p-value P1000 mL: FP Group 0.8% vs. Hand Push Method 37.5%.
- Mean Length of stay in Hospital: FP Group 3.93 days vs. Hand Push Method 5.30 days.
-
Retrospective cohort study (Australia):
- Estimated blood loss: Fetal Pillow Method 273 +/- 145 vs. Hand-push Method 403 +/- 199.
- Duration of hospital stay: Fetal Pillow Method 77.9 +/- 19.6 hr vs. Hand-push Method 97.8 +/- 27.6 hr.
- Cord arterial pH: Fetal Pillow Method 7.24 +/- 0.06 vs. Hand-push Method 7.19 +/- 0.09.
- 5-min Apgar score
§ 884.4350 Fetal head elevator.
(a)
Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.
(ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.
(iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted.
(5) Labeling must include the following:
(i) Contraindication for use in the presence of active genital infection;
(ii) Specific instructions regarding the proper placement and use of the device; and
(iii) A shelf life.
0
DE NOVO CLASSIFICATION REQUEST FOR FETAL PILLOW
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Fetal head elevator: A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.
NEW REGULATION NUMBER: 21 CFR 884.4350
CLASSIFICATION: II
PRODUCT CODE: PWB
BACKGROUND
DEVICE NAME: Fetal Pillow
SUBMISSION NUMBER: DEN150053
DATE OF DE NOVO: November 18, 2015
Safe Obstetrics Systems, Ltd. CONTACT: Berkley Townsend 150 Hutton Road Shenfield, Essex CM15 8NL United Kingdom
INDICATIONS FOR USE
Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age >37 weeks.
LIMITATIONS
- The Fetal Pillow is a prescription device under 21 CFR Part 801.109.
- The Fetal Pillow should not be used in the presence of active genital infection, as it could increase the risk of ascending infection.
- . The safety and effectiveness of Fetal Pillow has not been established in the following:
- In women who have had a previous Caesarean Section o
- In women with a pregnancy less than 37 weeks o
- Multiple gestations o
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PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Fetal Pillow is an inflatable balloon device which consists of the following components:
- Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal ● head.
- . Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
- . Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation.
- . Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
- Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate . balloon with saline solution.
The Fetal Pillow is a single use, disposable, sterile device.
Figure 1 below is an image of the Fetal Pillow.
Image /page/1/Figure/10 description: The image shows a "Fetal Pillow" with several labeled components. A 60cc syringe is connected to a two-way tap and a 100 cm long silicone tube. The tube is connected to a silicone dome that is inflated to 60cc and has a silicone base with a maximum thickness of 4mm.
Figure 1. Fetal Pillow
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SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Fetal Pillow includes materials that have direct patient contact for less than 24 hours. The complete device in its final. finished form was subjected to biocompatibility testing in accordance with the FDA guidance document, Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The following tests were conducted to assess biocompatibility of the device:
- Cytotoxicity ●
- . Sensitization
- . Vaginal Irritation
The results demonstrated the Fetal Pillow is non-cytotoxic, non-sensitizing, and nonirritating.
SHELF LIFE/STERILITY
The device is provided sterile in a Tyvek peel pouch by ethylene oxide (Et() sterilization to achieve a sterility assurance level (SAL) of 10 °. Sterilization was completed per ISO 11135-1:2014. Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices, using the EtO (b) (4) (b) (4) Testing was also performed to ensure the levels of ethylene oxide and ethylene chlorhydrin (ECH) sterilant residuals post degassing met the acceptance criteria in ISO 10993-7.
The device has a shelf life period of 2 years. To substantiate this shelf life, an accelerated aging study was completed to simulate 3 years of aging, and package integrity testing was conducted to confirm the sterile barrier properties are maintained throughout the duration of the shelf life. Aged samples were assessed via visual inspection of the aged Tyvek packaging and seal strength testing. The results demonstrated that the packaging is adequate to maintain the sterility of the device for the proposed shelf life.
Functional testing was conducted on real-time aged samples of two years. Real time aged devices were evaluated in the following tests (see Performance Testing below):
- Leakage ●
- Leakage under pressure ●
- Joint disconnection
- Stretching and distortion of balloon ●
- Maximum pressure resistance ●
- Deflation reliability ●
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- Inflation pressure under force (Safe Pressures Test) .
The results of the shelf life testing demonstrated that the subject device maintains its performance specifications throughout a shelf life of two years.
PERFORMANCE TESTING - BENCH
Bench testing was conducted to evaluate overall device functionality, mechanical performance, and material integrity. Table 1 provides a description of all bench testing conducted, acceptance criteria, results, and sample size.
| Test Parameter | Test Method | Acceptance Criteria |
|---|---|---|
| Leakage | Device inflated to 300cc and | |
| evaluated for leakage | Device must not exhibit any | |
| fluid leakage after 2 min. | ||
| Leakage under | ||
| pressure | Device inflated to 300cc and | |
| subjected to 43.5psi pressure for 10 | ||
| min., then evaluated for leakage | Device must not exhibit any | |
| fluid leakage after 10 min. | ||
| Joint | ||
| Disconnection | ||
| Strength | 2kg mass attached to the luer port | |
| and the device was suspended from | ||
| the balloon for 2min. (tensile stress) | Device must be able to support | |
| 2 kg. of weight for 2 min. | ||
| without any damage | ||
| Stretching/ | ||
| Distortion of | ||
| balloon | Device inflated to 300cc and | |
| measured internal balloon pressure | ||
| every 15 second for 2min. | Device must inflate evenly | |
| without distension in any | ||
| direction. Pressure must be | ||
| maintained for 2min. period | ||
| Maximum | ||
| Pressure | ||
| resistance | Device attached to a pressure gun | |
| and inflated until balloon failure | Device must not exhibit | |
| leakage at a balloon pressure | ||
| of 72.5psi | ||
| Deflation | ||
| Reliability | Device inflated to 180cc or 300cc | |
| and tap was opened. Time taken for | ||
| device to empty was recorded. | Time to taken to completely | |
| empty must be less than 2min. | ||
| Inflation | ||
| pressure under | ||
| force | The device was subjected to | |
| 80mmHg pressure and inflated from | ||
| 60cc to 300cc. Inflation pressure | ||
| was measured at 60, 120, 180, 240, | ||
| and 300cc fill volume increments. | Device inflation pressure must | |
| remain below 142mmHg for | ||
| all fill volumes. |
Table 1. Fetal Pillow Bench Testing
All samples met the acceptance criteria for each test. The test results demonstrate the Fetal Pillow has adequate performance characteristics for its intended use.
SUMMARY OF CLINICAL INFORMATION
There were two primary clinical studies to support this application. The Indian randomized control trial was a prospective study of 240 patients carried out in West Bengal, India. The Australian retrospective cohort study was a retrospective study of 160 patients carried out in Brisbane, Australia. Differences between the patient populations in both studies, as well as
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differences in standard of care clinical practices, necessitated additional information to support the safety and effectiveness of the Fetal Pillow in the US. In order to address concerns regarding differences in the study populations and standard of care clinical practices, the De Novo request included additional real-world data collected from a 75 patient study conducted at Wishaw Hospital in Scotland, as well as a reanalysis of the randomized controlled trial data.
Randomized control trial of elevation of fetal head with a fetal pillow during caesarean delivery at full cervical dilation (West Bengal, India)
This prospective randomized controlled trial was carried out in two teaching hospitals in India and compared the use of the Fetal Pillow with other methods of delivery in a second stage Caesarean Section (CS). A total of 240 patients who required a CS in second stage of labor were enrolled into the study. Thirteen patients were excluded from the study due to: lack of informed consent (n=4), previous caesarean (n=2), breech presentation (n=2) and suspected chorioamnionitis (n=5).
Primary Outcome Measure
- Major uterine incision extensions (grade 2-3) ●
Secondary Outcome Measures
- Total time taken for CS
- Incision to delivery interval
- Difficulty with delivery of fetal head ●
- Duration of hospital stay ●
- Blood loss >1000cc
- Need for blood transfusion
- 5 minute APGAR 24 hours ●
- . Neonatal sepsis
- Neonatal death
Inclusion Criteria
- Ability to give informed consent
- CS at full dilation
- CS after failed instrumental delivery ●
Exclusion Criteria
- Presence of active genital infection
- Chorioamnionitis ●
- Breech presentation ●
- Previous Caesarean Section ●
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- Pregnancy less than 36 weeks ●
- Inability to give informed consent
Study Methodology
All patients were informed about the trial when admitted to the labor ward. Patients who were able to give informed consent if requiring a CS at full dilation were included in the study. Participants were randomized 1:1 into two parallel groups: the Fetal Pillow group (FP group) and the non-Fetal Pillow group (NFP group).
CS was carried out using the standard technique and the Fetal Pillow was inserted and inflated prior to performing the CS.
Results
The two groups were similar in terms of their baseline characteristics (Table 2).
| Variable | FP Group N= 120 | NFP Group N= 120 |
|---|---|---|
| Maternal age, y (range) | 22.1 + 2.6 (18-28) | 22.8 + 2.0 (18-33) |
| Maternal weight, kg | 55.6 +4.6 | 54.8 +4.9 |
| Parity: n | ||
| 0 | 82 [68.3%] | 84 [70%] |
| 1 | 33 [27.5%] | 27 [22.5%] |
| 2 | 5 [4.2%] | 7 [5.8%] |
| 3 | 0 | 2 [1.7%] |
| 1st Stage of Labor, hrsa | 7.8 +0.7 | 7.6 +0.6 |
| Augmentation of Labor | 79 [65.8%] | 80 [66.7%] |
| 2nd Stage of Labor, hrsb | 1.9 +0.3 | 1.9 +0.3 |
| Pregnancy duration, wk | 38.9 +1.0 | 39.0 +1.0 |
| Indication for CS | ||
| Failed progress | 88 [73.3%] | 82 [68.3%] |
| Failed instrumental | 20 [16.7%] | 21 [17.5%] |
| Fetal distress | 12 [10.0%] | 17 [14.2%] |
| Station of head | ||
| 0 | 2 [1.7%] | 2 [1.7%] |
| 1 | 46 [38.3%] | 50 [41.7%] |
| 2 | 72 [60.0%] | 68 [56.7%] |
| Position of head | ||
| Occipito Anterior | 48 [40%] | 60 [50%] |
| Occipito Transverse | 33 [27.5%] | 27 [22.5%] |
| Occipito Posterior | 39 [32.5%] | 33 [27.5%] |
| Birth weight, kg | 2.85 + 0.26 | 2.87 + 0.31 |
Table 2. Baseline characteristics
4Data available for 89 patients in FP group and 92 in NFP group, because some were transferred from other hospitals already in labor
b Data available for 90 patients in FP group and 95 in NFP group, because some were transferred from other hospitals already in labor
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There were no differences in characteristics between the two groups.
Major extensions of uterine incisions were significantly lower in the FP group (Table 3). Total time for CS, incision to delivery interval, need for blood transfusions and length of hospital stay were lower in the FP group. The intra-operative blood loss >1000cc was more common in the NFP group (Table 3).
| Variable | Fetal Pillow Group N= 120 | Non-Pillow Group N= 120 |
|---|---|---|
| Total Time taken for Lower Segment | ||
| Caesarean Section, min | $32.7 \pm 4.3$ | $53.9 \pm 10.3$ |
| Incision to delivery interval, sec | $176.5 \pm 14.0$ | $297.2 \pm 27.1$ |
| Difficulty with delivery of fetal head | ||
| Very difficult | 2 [1.7%] | 26 [21.7%] |
| Difficult | 5 [4.2%] | 21 [17.5%] |
| Moderately easy | 11 [9.2%] | 3 [2.5%] |
| Easy | 57 [47.5%] | 31 [25.8%] |
| Very easy | 45 [37.5%] | 39 [32.5%] |
| Pre-operation Hemoglobin, g/dL | $10.3 \pm 0.6$ | $10.3 \pm 0.5$ |
| Post-operation Hemoglobin, g/dL | $9.6 \pm 0.5$ | $9.0 \pm 0.8$ |
| Uterine extensions* | 12 [10%] | 43 [35.8%] |
| Grade of uterine extensions | ||
| I | 6 [50%] | 4 [9.3%] |
| II | 3 [25%] | 12 [27.9%] |
| III | 3 [25%] | 27 [62.7%] |
| Major uterine extensions (Grade 2-3)** | 6 [5%] | 39 [32.5%] |
| Blood loss > 1000 mL: n [%] | 5 [4.2%] | 26 [21.7%] |
| Blood transfusions: n [%] | 4 [3.3%] | 22 [18.3%] |
| Hospital stay in days: mean [s.d.] | $3.9 \pm 0.80$ | $5.0 \pm 1.2$ |
| Re-laparotomy: n [%] | 0 | 4 [3.3%] |
Table 3. Maternal outcomes
*RR 0.37 (0.22 to 0.63), **RR 0.23 (0.11 to 0.48)
Table 4. Neonatal outcomes
| Variable | Fetal Pillow Group
N= 120 | Non-Pillow Group
N= 120 |
|---------------------------------|------------------------------|----------------------------|
| 5 minutes APGAR score ≤ 3 | 1 [0.8%] | 8 [6.7%] |
| Admission to NICU | 13 [10.8%] | 21 [17.5%] |
| Duration of NICU stay >24 hours | 3 [23.1%] | 12 [57.1%] |
| Neonatal sepsis | 0 | 4 [3.3%] |
| Neonatal death | 0 | 3 [2.5%] |
Reanalysis of the randomized controlled trial data
Randomized Control Trial data was reanalyzed to study the maternal and fetal outcomes in the hand push group from the Non Fetal Pillow group vs. the Fetal Pillow group. The patients in the
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control group were delivered using three different methods, depending on the preference of the surgeon and difficulty encountered during delivery. These methods were: the normal abdominal delivery method, hand push from below method, and reverse breech extraction method.
Results
Mode of delivery in the Non Fetal Pillow group (n=120)
-
- 40 women were delivered using the hand push method
-
- 12 women were delivered using a reverse breech extraction method
-
- 68 women were delivered using the normal abdominal delivery method
Table 5. RCT reanalysis: Fetal Pillow Group vs. Non Fetal Pillow Group with Hand Push Method (Controls n=40) for Maternal outcomes
| | Fetal Pillow Group
N= 120 | Non Fetal Pillow, Hand Push Method
Group N= 40 |
|--------------------------------------------------|------------------------------|---------------------------------------------------|
| Mean Incision to
Delivery time (sec.) | 176.5 | 278.0 |
| Extension of uterine incision* | | |
| Yes | 10 (8.3%) | 23 (57.5%) |
| No | 110 (91.7%) | 17 (42.5%) |
| Total Time taken for
Caesarean Section (min.) | 32.7 | 55.3 |
| Blood loss >1000 mL | 1 (0.8%) | 15 (37.5%) |
| Mean Length of stay in
Hospital (days) | 3.93 | 5.30 |
*Chi-squared Test p-value P37 weeks ●
Exclusion criteria
- Multiple pregnancies
- Intrauterine fetal death
- Major congenital abnormalities
Results
Of 361 Caesarean deliveries performed at full dilation during the study period, clinicians documented the use of a Fetal Pillow in 91 deliveries and use of the hand-push method in 69. The observed values for the Fetal Pillow group show lower mean intra- operative blood loss, a shorter duration of postpartum hospital admission, and higher mean cord arterial pH (Table 7). There were no clinically meaningful differences observed for 5-min Apgar score 1000 mL ●
- Need for blood transfusion ●
- Length of post-operative hospital stay ●
Results
There was no difference observed in outcomes of interest with the Fetal Pillow use in this analysis when maternal BMI, fetal weight, and use of epidural in labor were taken into account.
Table 8. Maternal BMI & Distribution of Maternal Outcomes in Women Treated with the Fetal Pillow
| | Maternal BMI >=30
N = 38 | Maternal BMI 1000 mL | 4 (10.5%) | 5 (13.5%) |
|-------------------------------------------|------------|------------|
| Blood transfusion
Yes | 1 (2.6%) | 1 (2.7%) |
| No | 37 (97.4%) | 36 (97.3%) |
| Mean Length of stay in
Hospital (days) | 3.18 | 3.02 |
| Table 9. Fetal Weight and Distribution of Maternal Outcomes in Women Treated with the | ||
|---|---|---|
| Fetal Pillow |
| | Fetal weight ≥ 3500g
N = 53 | Fetal weight 1000 mL | 8 (15.1%) | 1 (4.5%) |
| Blood transfusion | | |
| Yes | 2 (3.8%) | 0 |
| Mean Length of stay in
Hospital (days) | 3.15 | 3.00 |
Table 10. Epidural Use and Distribution of Maternal Outcomes in Women Treated with the Fetal Pillow
| | Epidural Used
N = 54 | No Epidural Used
N = 21 |
|-------------------------------------------|-------------------------|----------------------------|
| Mean Incision to Delivery
time (mins) | 5.22 | 4.52 |
| Extension of uterine incision | | |
| Yes | 14 (25.9%) | 10 (47.6%) |
| No | 40 (74.1%) | 11 (52.4%) |
| Blood loss | | |
| >1000 mL | 5 (9.3%) | 4 (19.0%) |
| Blood transfusion | | |
| Yes | 0 | 2 (9.5%) |
| Mean Length of stay in
Hospital (days) | 3.11 | 3.10 |
In summary, the data from the clinical studies indicate that use of the Fetal Pillow results in a reduction in clinically significant uterine incision extensions, as well as fewer observed cases of blood loss > 1000 mL and less need for blood transfusions.
PEDIATRIC EXTRAPOLATION
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In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
The Fetal Pillow complies with the labeling requirements under 21 CFR 807.87(e) and prescription device requirements under 21 CFR § 801.109. The device labeling includes physician labeling, Instructions for Use, and package labeling and bears the following: "Caution: Federal law restricts the use of this device by or on the order of a physician." The labeling also includes pertinent information regarding instructions for proper placement and use of the device, a contraindication for use in the presence of active genital infection, and a shelf life.
RISKS TO HEALTH
Table 11 below identifies the risks to health that may be associated with use of the Fetal Head Elevator and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Measures |
|---|---|
| Adverse tissue reaction | Biocompatibility evaluation |
| Infection | Sterilization validation |
| Shelf life testing | |
| Labeling | |
| Fetal injury due to device failure | Non-clinical performance testing |
| Shelf life testing | |
| Labeling | |
| Maternal injury due to device failure | Non-clinical performance testing |
| Shelf life testing | |
| Labeling | |
| Use error | Labeling |
Table 11. Identified Risks to Health and Mitigation Measures
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the fetal head elevator is subject to the following special controls:
-
- The patient-contacting components of the device must be demonstrated to be biocompatible.
-
- Performance data must demonstrate the sterility of patient-contacting components of the device.
-
- Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
-
- Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
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- Reliability testing of device deployment and retrieval under relevant use a. conditions must be conducted.
- Testing of the maximum force applied to the fetal head in an anatomic model b. must be conducted.
- Testing of uniform application of the elevator mechanism on the fetal head must C. be conducted.
-
- Labeling must include the following:
- a. Contraindication for use in the presence of active genital infection;
- b. Specific instructions regarding the proper placement and use of the device; and
- c. A shelf life.
BENEFIT/RISK DETERMINATION
The risks of the device are based on nonclinical bench testing, as well as data collected in the clinical studies described above. There were no fetal or maternal injuries attributed to Fetal Pillow use in either the randomized controlled trial or retrospective cohort study. In the supplemental data, one subject experienced a small second degree laceration during insertion of the Fetal Pillow, where the physician found it difficult to insert the device due to a very low fetal head (+3 station).
The probable benefits of the device are also based on data collected in the clinical studies described above. The probable benefit of Fetal Pillow is a reduction in clinically significant uterine incision extensions. In the Indian randomized control trial, major uterine incision extensions occurred in 6 (5.0%) women in the Fetal Pillow group and 39 (32.5%) in the control group. Other clinically relevant benefits include fewer cases of blood loss > 1000 mL and less need for a blood transfusion. Additionally. newborns in the Fetal Pillow group were less likely to be admitted to the NICU or require admission for more than 24 hours.
Additional factors to be considered in determining probable risks and benefits for the Fetal Pillow include: Supplemental data suggest that maternal BMI, fetal weight, and epidural use do not impact the performance of the Fetal Pillow. In addition, reanalysis of the RCT data using a comparator delivery group consistent with US practice standards supports the benefits of the Fetal Pillow.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, the data support that for elevation of the fetal head and facilitation of delivery of the fetus in women requiring a Caesarean Section at full dilation, or those requiring a Caesarean Section after a failed instrumental vaginal delivery at a gestational age ≥37 weeks, the probable benefits outweigh the probable risks for the Fetal Pillow. The device provides benefits and the risks can be mitigated by the use of general and the identified special controls.
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CONCLUSION
The De Novo request for the Fetal Pillow is granted and the device is classified under the following:
Product Code: PWB Device Type: Fetal head elevator Class: II Regulation: 21 CFR 884.4350