Hem-Avert Perianal Stabilizer
Device Facts
| Record ID | DEN160005 |
|---|---|
| Device Name | Hem-Avert Perianal Stabilizer |
| Applicant | Stetrix, Inc. |
| Product Code | PNU · Obstetrics/Gynecology |
| Decision Date | Dec 19, 2016 |
| Decision | DENG |
| Submission Type | Direct |
| Regulation | 21 CFR 884.5210 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| DEN160005 · Dec 19, 2016 | Hem-Avert Perianal Stabilizer | Stetrix, Inc. | Electronic Health Records (EHR) | The Dignity Health study used retrospective EHR data to establish a baseline cesarean delivery rate for patients delivering prior to device implementation, which was then compared to observational data from patients who received the device during routine clinical practice. | Retrospective chart review; Observational study; Routine clinical practice; EHR |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Dignity Health observational study; Observational study with retrospective baseline chart review; Follow-up/Duration: 3-month study period; Study Period: January 1, 2015 – June 30, 2015 | Women presenting for anticipated vaginal delivery; Sample Size: 500 (227 device, 273 control) plus 521 baseline retrospective patients; Number of Sites: 1 | Baseline (pre-device) and concurrent control (no device) | Cesarean section rate, duration of second stage of labor, adverse events (episiotomies and lacerations) |
Indications for Use
providing counter-pressure to the anus during vaginal childbirth, applied at 8-10 cm of dilation, to help reduce the likelihood of cesarean delivery.
Device Story
Single-use, sterile, disposable perianal stabilizer; consists of rigid polycarbonate base, polyester/polyethylene cushioning pad, and lateral hook-and-loop adhesive strips. Applied by clinician at 8-10 cm cervical dilation during labor; provides external mechanical counter-pressure to anus. Device remains in place during delivery to support perianal region; removed if interference with childbirth occurs. Output is physical support; intended to reduce cesarean delivery rates and prevent external hemorrhoids. Used in clinical labor and delivery settings. Benefits include reduced cesarean section likelihood; risks include perineal lacerations, pain, discomfort, and potential tissue trauma.
Clinical Evidence
Supported by two clinical studies. 1) Prospective, randomized, single-site study (n=98): Hem-Avert group (n=50) vs. control (n=48); cesarean rate 12% vs 39.6% (p=0.0017). 2) Observational study (n=500): Hem-Avert (n=227) vs. control (n=273); cesarean rate 1.76% vs 13.55% (p<0.0001). Secondary endpoint in observational study showed higher rate of perineal lacerations in device group (35.24%) vs control (21.98%).
Technological Characteristics
Pressure wedge providing external mechanical support. Patient-contacting materials must be biocompatible. Device must withstand mechanical forces during labor without breakage. Sterile, single-use device with defined shelf life.
Indications for Use
Indicated for women undergoing labor and vaginal delivery to provide perianal counter-pressure at 8-10 cm cervical dilation to reduce the likelihood of cesarean delivery and prevent external hemorrhoids.
Regulatory Classification
Identification
A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery.
Special Controls
In combination with the general controls of the FD&C Act, the Pressure wedge for the reduction of cesarean delivery is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) The patient contacting materials must be evaluated to be biocompatible. (2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor. (3) Performance data must validate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life. (5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma. (6) The labeling must include: (i) Specific instructions regarding the proper placement and use of the device. (ii) A shelf life.
Submission Summary (Full Text)
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### DE NOVO CLASSIFICATION REQUEST FOR HEM-AVERT® PERIANAL STABILIZER
### REGULATORY INFORMATION
FDA identifies this generic type of device as:
Pressure wedge for the reduction of cesarean delivery. A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery.
NEW REGULATION NUMBER: 21 CFR 884.5210
CLASSIFICATION: II
PRODUCT CODE: PNU
# Background
DEVICE NAME: HEM-AVERT® PERIANAL STABILIZER
SUBMISSION NUMBER: DEN160005
DATE OF DE NOVO: JANUARY 29, 2016
CONTACT: STETRIX, INC. 70 CLAY ST OAKLAND, TN 38060
### INDICATIONS FOR USE
The Hem-Avert® Perianal Stabilizer provides counter-pressure to the anus during vaginal childbirth. This counter-pressure force, applied at 8-10 cm of dilation, is intended to help reduce the likelihood of cesarean delivery. Additionally, this counter-pressure force helps prevent the occurrence of external hemorrhoids during vaginal childbirth.
### LIMITATIONS
- The Hem-Avert Perianal Stabilizer is a prescription device under 21 CFR Part 801.109.
- The Hem-Avert Perianal Stabilizer should be removed immediately if the physician feels ● the instrument in any way interferes with the childbirth process.
- Misuse or mishandling of the product may cause injury to the patient. Improper ●
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handling can render the product unsuitable for its intended use. Other probable complications may include, but are not limited to:
- Infection If the product sterility has been compromised. o
- o Pain, discomfort or abnormal sensation resulting from the presence of the instrument against the anus.
- 0 Skin/tissue trauma.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
#### DEVICE DESCRIPTION
This is a single use, disposable, sterile device. The Hem-Avert Perianal Stabilizer (Hem-Avert) consists of three components:
- 1. Rigid polymer base manufactured from a polycarbonate
- 2. Centrally located cushioning pad composed of a laminate of polyester non- woven tape and polyethylene foam tape
- 3. Two lateral hook and loop adhesive strips (with liners) which provide the tension required to keep the device firmly in place during delivery.
Figure 1 below is an image of the Hem-Avert.
Image /page/1/Figure/11 description: The image shows a medical device with hook and loop fasteners on either side of a cushioned pad base. The fasteners are white and rectangular, and they are attached to a strip of material that extends from the cushioned pad base. The cushioned pad base is gray and is located in the center of the device. The device is designed to be used to secure a medical device to a patient's body.
Image /page/1/Figure/12 description: The image shows the text "Figure 1. Hem-Avert Device". The text is in bold font and is underlined. The figure number is 1.
This De Novo request is for an expanded indication (new intended use) of providing counterpressure to the anus during vaginal childbirth, applied at 8-10 cm of dilation, to help reduce the likelihood of cesarean delivery.
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#### SUMMARY OF NONCLINICAL/BENCH STUDIES
#### BIOCOMPATIBILITY/MATERIALS
The Hem-Avert 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 ISO 10993-1: Biological evaluation of medical devices. Part 1: Evaluation and Testing. The following tests were conducted:
- Cytotoxicity
- Sensitization ●
- Irritation (Intracutaneous Reactivity) .
The results demonstrated the Hem-Avert is non-cytotoxic, non-sensitizing, and nonirritating.
### SHELF LIFE/STERILITY
peel pouch by b(4) CCI The device is provided sterile in a b(4) to achieve a sterility assurance level (SAL) of 10 . Sterilization was completed per ISO 11137:2006 using 10 samples at b(4) and 10 samples atb(4) CCI . Three samples had positive growth at b(4) and none had positive growth at b(4)
The device has a shelf life period of 2 years. To substantiate this shelf life, accelerated aging studies were completed to simulate 1, 2, and 3 years of age, utilizing 60, 60, and 65 samples respectively. After the initial accelerated aging, 10 samples from the 1, 2, and 3 year studies were further aged to simulate 5 years and tested for package integrity via visual inspection to identify obvious signs of package degradation, dye penetration testing (per ASTM F1929-98 (Reapproved 2004)), and peel strength testing (per ASTM F88-07). The results of all tests were deemed acceptable.
### PERFORMANCE TESTING - BENCH
To mitigate the risk of device breakage static compression three-point bending testing was conducted on 5 samples of the Hem-Avert. The Hem-Avert was found to endure a compressive load of 188N (to flattening without breaking). The device is designed to withstand the pushing force exerted by a woman in labor without breaking.
### SUMMARY OF CLINICAL INFORMATION
There were two clinical studies supporting this application. The Niagara Falls Memorial Medical Center study was a prospective, randomized, single-site clinical study. This study provided the primary data supporting device effectiveness. The Dignity Health clinical study was an observational, single arm study; it provided supportive information regarding effectiveness. Both studies provided information about device safety.
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# Niagara Falls Memorial Medical Center Study
The clinical investigator performed a prospective, randomized, single-site clinical study comparing the rate of cesarean delivery in patients treated with the Hem-Avert Perianal Stabilizer to a control group of patients who did not receive the device. A total of 102 patients who presented for anticipated singleton vaginal delivery were enrolled in the study. Four patients were removed from the study secondary to protocol violations (one from the device group, three from the control group). Of the remaining 98 patients, 50 were assigned to the subject device arm and 48 to the control arm.
# Primary Outcome:
- Difference in cesarean deliveries between the investigational and control groups .
# Additional Outcomes:
- Adverse events associated with delivery ●
- Duration of second-stage of labor ●
- Length of hospital stay .
# Inclusion Criteria:
Women were allowed to participate in the study if the following inclusion criteria were met:
- Patient scheduled for a vaginal delivery ●
- Patient exam indicated that delivery would be a singleton birth
- Able to provide Informed Consent
# Exclusion Criteria:
Women were excluded if any of the following criteria were encountered during the course of the study:
- Patient's prenatal information indicated that delivery would not be a singleton birth
- Patient was scheduled for an elective cesarean delivery ●
- . The patient was scheduled for a vaginal delivery with anticipated complications (i.e. breech presentation)
# Study Methodology:
All patients treated by the investigator during the course of the study were approached to determine eligibility. Block randomization (1:1) was performed using a computer-generated randomization schedule. Patient consent was performed by a member of the research team while the patient was between 1 and 5 centimeters dilated. Patient randomization occurred when subjects were between 5 and 8 centimeters dilated. Management of labor and delivery for both groups was managed in accordance with American Congress of Obstetricians and Gynecologists (ACOG) standards.
Subjects assigned to both groups began delivery in the low lithotomy position. The Hem-Avert device was placed in the device group arm once the patients reached 8-10 cm in cervical dilation.
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# Results:
- . All subjects assigned to the device group were able to be fitted with the device
- Patients assigned to the device group had a lower cesarean section rate compared to the control group; these findings were statistically and clinically significant
- . There was no statistically or clinically significant difference in the duration of the second stage of labor between groups (24.9 minutes for device group and 40.8 minutes for control)
- Skin/tissue trauma, pain, slippage, and obstruction to the treatment area were not reported among the adverse events in the clinical study
- Results are summarized in Tables 1 and 2. ●
| Table 1. Patient Demographics, Niagara Falls Memorial Medical Center Study* | | |
|-----------------------------------------------------------------------------|--------------------|------------------|
| Summary | Hem-Avert Patients | Control Patients |
| Number of Patients | 50 | 48 |
| Mean Age (Time of Delivery) | 25.0 | 25.0 |
| Minimum and Maximum Age | 14 and 36 years | 16 and 41 years |
| Mean Weight (Standard Deviation) | 180.6 (44.46) | 183.2 (43.79) |
| Number of Patients with Previous<br>Cesareans | 2 (4.0%) | 2 (4.0%) |
| Number of Previous Vaginal Births | | |
| 0 | 20 (40.0%) | 25 (52.1%) |
| 1 | 15 (30.0%) | 11 (22.9%) |
| 2 | 6 (12.0%) | 4 (8.3%) |
| 3 | 6 (12.0%) | 4 (8.3%) |
| 4 | 2 (4.0%) | 2 (4.2%) |
| 5 | 1 (2.0%) | 0 |
| 6 | 0 | 2 (4.2%) |
* There were no statistically or clinically significant differences in patient demographics.
| Table 2. Cesarean Delivery Rate by Treatment and Adverse Events | | | |
|-----------------------------------------------------------------|--------------------|------------------|---------|
| Summary | Hem-Avert Patients | Control Patients | p-value |
| Number of Patients | 50 | 48 | |
| Overall Number of Cesarean Deliveries | 6 (12%) | 19 (39.6%) | 0.0017 |
| Cesarean Rate for Patients Receiving an Epidural | 4/28 (14.3%) | 17/36 (47.2%) | 0.0072 |
| Cesarean Rate for Patients Not Receiving an Epidural | 2/22 (9.1%) | 2/12 (16.7%) | 0.6015 |
| Number of Primiparous Patients | 20 | 25 | |
| Number of Primiparous Cesarean Deliveries | 3 (15%) | 15 (60%) | 0.0022 |
| Cesarean Rate for Primiparous Patients Receiving Epidural | 2/14 (14.3%) | 14/23 (60.9%) | 0.0073 |
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| Table 2. Cesarean Delivery Rate by Treatment and Adverse Events | | | |
|------------------------------------------------------------------|--------------------|------------------|---------|
| Summary | Hem-Avert Patients | Control Patients | p-value |
| Cesarean Rate for Primiparous<br>Patients not Receiving Epidural | 1/6 (16.7%) | 1/2 (50.0%) | 0.4643 |
| Patients Experiencing Adverse<br>Events/Complications | 0 | 7 (14.6%) | 0.0053 |
| Specific Complications | | | |
| Fetal Bradycardia | 0 | 1 (2.1%) | 0.4898 |
| Hemorrhoids | 0 | 6 (12.5%) | 0.0117 |
| Right Sulcus Tear | 0 | 1 (2.1%) | 0.4898 |
# Dignity Health Clinical Study
The clinical investigator performed a single-site, observational study following the phased introduction of the Hem-Avert device into routine clinical practice. Study participants were all women who presented for vaginal delivery at Dignity Health during the 3-month study period. The investigator extracted existing data from electronic health records (baseline retrospective chart review) to compare cesarean delivery rates between women who delivered prior to the introduction of the Hem-Avert device into clinical practice and those who delivered after device implementation into clinical practice.
# Objective:
To assess whether the Hem-Avert device reduces cesarean delivery in women undergoing labor and delivery
# Primary Outcome:
- Cesarean Section rate ●
### Secondary Outcomes:
- Duration of second stage of labor
- Adverse events including episiotomies and lacerations ●
# Inclusion Criteria:
- . Patients who presented to labor and delivery for anticipated vaginal delivery during the study period
### Exclusion Criteria:
- Patients scheduled for cesarean delivery prior to labor and delivery admission
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- Failure to progress in labor prior to 8-10 cm in dilation
- Fetal indications
- Maternal indications .
- Precipitous labor ●
# Study Methodology:
The investigator performed a baseline retrospective chart review prior to the introduction of the Hem- Avert device into standard clinical practice at the study hospital. The baseline data collection and analysis were performed to identify the number of subjects who presented for planned vaginal delivery who ultimately delivered by cesarean section during a 3-month study period (January 1-March 30, 2015). After review of patient charts, it was determined that 521 subjects met the inclusion criteria (delivered during the 3-month time period). Subjects were excluded from the retrospective baseline review if 1) They were scheduled for cesarean delivery prior to admission to labor and delivery 2) There was evidence of fetal distress prior to reaching 8 cm in dilation or 3) There was failure to progress in labor prior to reaching 8 cm in dilation.
The observational study began on April 1, 2015, after completion of the baseline chart review, and was completed on June 30, 2015. All patients who presented to labor and delivery for anticipated vaginal delivery were given the opportunity to receive the Hem-Avert device (patients were not randomized into either the device or control group). All patients and physicians were given the opportunity to accept or reject the use of the device. Eligible patients had the device placed when they reached 8-10 cm of dilation. Informed consent was not obtained (nor required by IRB), as the Hem-Avert device was being used as indicated. (It was already indicated for preventing the occurrence of external hemorrhoids during vaginal childbirth.) During the 3-month study period, a total of 799 consecutive patients delivered; 790 patients presented with complete demographic data (228 patients treated with the Hem-Avert device, and 562 patients who did not receive the device). Of the 799 patients who delivered, 500 met the inclusion criteria; 227 subjects received the Hem-Avert device, and 273 subjects were placed in the control arm (no device). Duration of the second stage of labor could not be documented because of inconsistencies in documentation related to second stage onset.
# Results:
- There were no significant differences in demographics between the populations in the two study arms.
- . Among patients who reached 8-10 cm of cervical dilation, 1.76% of Hem-Avert patients had a cesarean delivery compared to 13.55% of control patients. Accordingly, the Hem-Avert patients had a statistically significantly lower incidence rate of cesarean delivery compared to the control patients (p < 0.0001).
- . Eighty patients (35.24%) who received the Hem-Avert device experienced perineal lacerations compared to 60 (21.98%) of the control patients. As the rate of perineal lacerations was a secondary endpoint, this result was not evaluated for statistical significance.
- . Skin/tissue trauma, pain, slippage, and obstruction to the treatment area were not reported among the adverse events in the clinical study.
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| Table 3. Summary of Demographic Data at Time of Delivery | | |
|----------------------------------------------------------|---------------------|----------------------|
| Characteristics | Hem-Avert® Patients | “No Device” Patients |
| Age (Years) – Number with Information | 228 | 562 |
| Mean Age | 28.1 | 29.4 |
| Minimum Age | 16 | 16 |
| Maximum Age | 44 | 45 |
| Race (Number, Percentage) | 230 | 569 |
| Caucasian | 131 (57.0%) | 307 (54.0%) |
| African American | 15 (6.5%) | 57 (10.0%) |
| Hispanic | 40 (17.4%) | 111 (19.5%) |
| Asian | 28 (12.2%) | 57 (10.0%) |
| Missing | 14 (6.1%) | 37 (6.6%) |
| Other | 2 (0.9%) | 0 (0.0) |
| Weight (lbs) | 209 | 535 |
| Mean Weight | 179 | 188 |
| Minimum | 77 | 101 |
| Maximum | 440 | 480 |
| Primiparous Patients | 99 (43.3%) | 222 (39.0%) |
| Multiparous Patients | 131 (56.7%) | 347 (61.0%) |
- Results are summarized in Tables 3 through 6. ●
Note: Of the 799 consecutive patients who delivered, demographic data were only available for 790 patients; 9 patients were excluded for incomplete demographic data.
| Table 4. Primary Endpoint: Cesarean Delivery Rate | | | |
|---------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------|--------------------------------|
| Cesarean Delivery Rate: Overall Patient Population<br>Baseline (No Device) – Control (No Device) - Investigational (Hem-Avert®) | | | |
| Summary | Baseline Patients | Control<br>(Study Patients) | Hem-Avert®<br>(Study Patients) |
| Number of Patients | 521 | 273 | 227 |
| Cesarean Deliveries | 46 (8.83%) | 37 (13.55%) | 4 (1.76%)* |
| Vaginal Deliveries | 475 (91.17%) | 236 (86.45%) | 223 (98.24%) |
* The Hem-Avert patients had a statistically significantly lower incidence rate of cesarean delivery compared to the control patients (p < 0.0001).
Note: Baseline (No Device) patients delivered prior to the Hem-Avert device into clinical practice. Control (No Device) patients delivered after Hem-Avert implementation into clinical practice.
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| Table 5. Cesarean Delivery Rate (Primiparous Patients)<br>Baseline (No Device) - Control (No Device) - Investigational (Hem-Avert®) | | | |
|-------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------|--------------------------------|
| Summary | Baseline Patients | Control<br>(Study Patients) | Hem-Avert®<br>(Study Patients) |
| Number of Patients | 237 | 106 | 97 |
| Cesarean Deliveries | 17 (7.17%) | 28 (26.42%) | 4 (4.12%) |
| Vaginal Deliveries | 220 (92.83%) | 78 (73.58%) | 93 (95.88%) |
Note: Baseline (No Device) patients delivered prior to the Hem-Avert device into clinical practice. Control (No Device) patients delivered after Hem-Avert implementation into clinical practice.
#### Secondary Endpoint: Occurrence of Perineal Lacerations
| Table 6: Perineal Lacerations Related to Delivery and Severity<br>Baseline (No Device) – Control (No Device) – Investigational (Hem-Avert®)<br>All Patient Groups Reached 8-10cm of Dilation | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------|--------------------------------|
| Categories | Baseline Period | Control<br>(Study Patients) | Hem-Avert®<br>(Study Patients) |
| Number of Patients | 521 | 273 | 227 |
| Patients Without Lacerations | 268 (51.43%) | 209 (76.55%) | 144 (63.43%) |
| Grade I Lacerations | 25 (4.79%) | 31 (11.35%) | 34 (14.975) |
| Grade II Lacerations | 49 (9.40%) | 27 (9.89%) | 42 (18.50%) |
| Grade III Lacerations | 1 (0.19%) | 1 (0.19%) | 3 (1.32%) |
| Grade IV Lacerations | 1 (0.19%) | 1 (0.19%) | 1 (0.19%) |
| Total Lacerations | 76 (14.58%) | 60 (21.98%) | 80 (35.24%) |
| No Laceration Data Available | 177 (33.97%) | 4 (1.46%) | 3 (1.32%) |
Note: Baseline (No Device) patients delivered prior to the introduction of the Hem-Avert device into clinical practice. Control (No Device) patients delivered after Hem-Avert implementation into clinical practice.
The data from the clinical studies indicate that the Hem-Avert can assist in reducing the occurrence of cesarean delivery.
#### Pediatric Extrapolation
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 Hem-Avert Perianal Stabilizer complies with the labeling requirements under 21 CFR § 801.109 for prescription devices. The labeling must include specific instructions regarding the proper placement and use of the device to mitigate the risks of skin/issue trauma, device failure, pain, and use error. The labeling must also identify the validated shelf life of the device. Additionally, the labeling should indicate that if the sterile barrier has been compromised, the device must not be used.
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# RISKS TO HEALTH
Table 7 identifies the risks to health that may be associated with use of the Pressure wedge for the reduction of cesarean delivery and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Method |
|--------------------------------------------|-----------------------------------------------------------------------|
| Skin/tissue trauma | Nonclinical performance data<br>Clinical performance data<br>Labeling |
| Device failure<br>• breakage<br>• slippage | Nonclinical performance data<br>Labeling |
| Infection | Sterilization validation<br>Shelf life testing<br>Labeling |
| Adverse tissue reaction | Biocompatibility evaluation |
| Pain | Labeling |
| Use error | Labeling |
Table 7. Identified Risks to Health and Mitigation Measures
#### SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the Pressure wedge for the reduction of cesarean delivery is subject to the following special controls:
- 1) The patient contacting materials must be evaluated to be biocompatible.
- 2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor.
- 3) Performance data must validate the sterility of the device.
- 4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life.
- 5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma.
- 6) The labeling must include:
- a) specific instructions regarding the proper placement and use of the device
- b) a shelf life.
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# BENEFIT/RISK DETERMINATION
The benefits and risks of the Hem-Avert Perianal Stabilizer are based on two clinical studies.
The probable benefits are based primarily on the Niagara Falls randomized, controlled clinical study, in which the overall rate of cesarean deliveries was 12% in the Hem-Avert patients, compared to 39.6% in the control patients. Supportive information was also provided by the Dignity Health observational study, in which 1.76% of Hem-Avert patients had cesarean deliveries, compared to 13.55% of control patients.
The Digital Health observational clinical study identified the probable risk of perineal lacerations after delivery. In the Hem-Avert device group, 80/227 (35.24%) experienced perineal lacerations after delivery (34/80 were grade I, 42/80 were grade II, 3/80 were grade III and 1/80 was grade IV), compared to 60/273 (21.98%) in the control group (31/60 were grade I. 27/60 were grade II. 1/60 were grade III and 1/60 was grade IV). In the Niagara Falls study, no patients reported adverse events.
Additional factors to be considered in determining probable risks and benefits for the Hem-Avert include:
- Infection (as a consequence of compromise to device sterility)
- Pain/discomfort ●
- Skin/tissue trauma ●
### 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 the reduction of cesarean delivery, the probable benefits outweigh the probable risks for the Hem-Avert Perianal Stabilizer. The device provides benefits and the risks can be mitigated by the use of general and the identified special controls.
### CONCLUSION
The De Novo for the Hem-Avert Perianal Stabilizer is granted and the device is classified under the following:
Product Code: PNU Device Type: Pressure wedge for the reduction of cesarean delivery Class: II Regulation: 21 CFR 884.5210
