HEM-AVERT PERIANAL STABILIZER

DEN090011 · Plexus Biomedical, Inc. · OOA · Jan 13, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: DEN090011
• Device Name: HEM-AVERT PERIANAL STABILIZER
• Applicant: Plexus Biomedical, Inc.
• Product Code: OOA · Obstetrics/Gynecology
• Decision Date: Jan 13, 2011
• Decision: DENG
• Submission Type: Post-NSE
• Regulation: 21 CFR 884.5200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Hem-Avert Perianal Stabilizer is indicated for the prevention of external hemorrhoids during vaginal childbirth.

Device Story

Single-use, sterile, disposable perianal stabilizer; used during labor and delivery. Composed of rigid polycarbonate base, polyester non-woven/polyethylene foam cushioning pad, and lateral hook-and-loop adhesive strips. Applied by clinician at 8-10 cm dilation to provide external mechanical support to perianal region. Device remains in place during delivery to prevent external hemorrhoid formation by mitigating pressure. Removed immediately if interference with childbirth process occurs. Benefits include reduction in hemorrhoid incidence during vaginal birth.

Clinical Evidence

Prospective clinical study (n=176 enrolled, 86 in efficacy analysis). Compared Hem-Avert (n=34) to control (n=52). Primary endpoint: prevention of external hemorrhoids during vaginal delivery. Results: 100% success rate (34/34) in Hem-Avert group vs 75% (39/52) in control group (p=0.0012). Bench testing confirmed device withstands 188N compressive load.

Technological Characteristics

Materials: medical grade polycarbonate base, polyester non-woven tape, polyethylene foam tape. Mechanical principle: external pressure wedge. Dimensions/form factor: single-use disposable instrument with adhesive fixation. Sterilization: sterile (SAL 10^-6) via Tyvek peel pouch. No electrical, electromagnetic, or MR components.

Indications for Use

Indicated for the prevention of external hemorrhoids during vaginal childbirth in pregnant females aged 18-40 scheduled for single-birth vaginal delivery. Contraindicated for patients with pre-existing hemorrhoids (other than low grade), previous rectal surgery, anal fissures, lacerations, or documented allergy to device materials.

Regulatory Classification

Identification

A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.

Special Controls

In combination with the general controls of the FD&C Act, the Hem-Avert Perianal Stabilizer is subject to the following special controls:

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are:(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) The labeling must include specific instructions regarding the proper placement and use of the device. (3) The device must be demonstrated to be biocompatible. (4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use. (5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.

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:

Hemorrhoid prevention pressure wedge. A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.

#### NEW REGULATION NUMBER: 21 CFR 884.5200

CLASSIFICATION: II

PRODUCT CODE: OOA

#### BACKGROUND

DEVICE NAME: HEM-AVERT PERIANAL STABILIZER

SUBMISSION NUMBER: DEN090011

DATE OF DE NOVO: AUGUST 18, 2009

- CONTACT: DAVID BLURTON CHIEF EXECUTIVE OFFICER PLEXUS BIOMEDICAL, INC. 70 CLAY STREET, SUITE 2 OAKLAND, TN 38060
#### REQUESTER'S RECOMMENDED CLASSIFICATION: II

#### INDICATIONS FOR USE

The Hem-Avert Perianal Stabilizer is indicated for the prevention 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 handling can

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render the product unsuitable for its intended use. Other potential complications may include, but are not limited to:

- · Infection If the product sterility has been compromised.
- · Pain, discomfort or abnormal sensation resulting from the presence of the instrument against the anus.
- · Skin irritation.

#### PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

### DEVICE DESCRIPTION

This is a single use, disposable, sterile instrument. The Hem-Avert™ Perianal Stabilizer consists of three components:

- 1. rigid polymer base manufactured from a medical grade polycarbonate
- centrally located cushioning pad composed of a laminate of medical grade polyester non-2. woven tape and medical grade polyethylene foam tape
- 3. two lateral hook and loop adhesive strips (with liners) which provide the tension required to keep the instrument firmly in place during delivery.

The cushioning pad and adhesive strips are manufactured from materials commonly associated with medical instruments and used in medical procedures.

#### SUMMARY OF NONCLINICAL/BENCH STUDIES

| Material | Description | Contact |
|----------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 1 | b(4)<br>Hi Tack<br>Conformable<br>Double Coated<br>Tape | Skin |
| 2 | b(4)<br>Foam medical tape | Mucosal |
| 3 | b(4) Non-<br>woven tape | Mucosal |
| 4 | b(4) | May come into contact with<br>liquids that could leach material.<br>Should be considered in mucosal<br>contact. |

# BIOCOMPATIBILITY/MATERIALS

Cytotoxicity (ISO Elution Method; ST-7221) - This study was based on the ISO 10993: Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity: in vitro Methods guidelines. The test article was described as the Hem-Avert Perianal Stabilizer Device. An extract of the test articles was prepared using b(4)

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# b(4)

Following incubation, the cultures were examined microscopically to evaluate cellular characteristics and percent cell lysis. The testing showed no signs of cytotoxicity.

Irritation (Intracutaneous Reactivity) - This study was based on the ISO 10993: Biological Evaluation of Medical Device, Part 10: Tests for Irritation and Sensitization. The test article was described as the Hem-Avert Perianal Stabilizer Device. b(4)

Observations for erythema and edema were made at 24, 48 and 72 hours. The testing showed no evidence of significant irritation from the material tested in this study.

Sensitization (GPMT) - This study was based on ISO 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Delayed Type Hypersensitivity. The test article was described as the Hem-Avert Perianal Stabilizer Device. b(4)

Following a

recovery period (14 days), test and control animals received a challenge patch of the appropriate test article extract or reagent control for 24h. Results of the study showed no signs of sensitization following use of saline or oil device extracts.

# SHELF LIFE/STERILITY

The device is provided sterile by b(4) to achieve a sterility assurance level (SAL) of 106. Sterilization validation was tested using 10 samples b(4) samples b(4) Three samples had positive growth b(4) y and none had positive growth alb(4) The bioburden was applied by direct transfer of 0 (4) b(4) ) for at least 14 days. The device is packaged using Tyvek peel pouch.

# ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

Electromagnetic and electrical concerns do not apply to this device.

# MAGNETIC RESONANCE (MR) COMPATIBILITY

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MR compatibility does not apply to this device as it is not intended to be used in an MR environment.

#### SOFTWARE

This device does not include software.

#### PERFORMANCE TESTING - BENCH

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. While bench testing cannot show that the device can stay in place during labor, .results from the clinical study demonstrated that the device stays in place during labor. See "Summary of Clinical Information" below.

### SUMMARY OF CLINICAL INFORMATION

### Primary Objective:

- Evaluate the safety and efficacy of the Hem-Avert as a method of preventing the occurrence of hemorrhoids during delivery
#### Sites:

- OBGYN physician clinics (n=4) .
- Delivery sites (n=3)

#### Subjects:

- 176 subjects enrolled in study ●
- 101 subjects (61 control and 40 test subjects) completed study
- 86 subjects (52 control and 34 test subjects) in efficacy analysis (Note: subjects with ● pre-existing hemorrhoids were excluded)

#### Inclusion criteria:

- Subject is between 18 and 40 years of age, female and pregnant
- Subject is scheduled for vaginal delivery
- Subjects' pre-natal examination indicates that this is to be a single birth delivery ●

#### Exclusion criteria:

- Subject weighs less than 130 pounds at time of delivery
- Subject has hemorrhoids other than low grade
- Subject has had previous rectal surgery (e.g., hemorrhoidectomy) ●
- Subject has lacerations or anal fissures
- Subject has a documented allergy to the instrument's materials
- . Subject's scheduled for vaginal delivery with anticipated complications (such as breech presentation)
- Subject is unable to understand and sign the informed consent form
- . Subject is a prisoner

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Note: One 17 year old patient and two patients with weights below 130 lbs. were included in the study, which are considereddeviations to inclusion criteria. These deviations were approved through deviation requests.

# Continuation criteria:

- Dilation at 8-10 centimeters and there was no evidence of crowning prior to the initial . visual examination.
- The presence of hemorrhoids (other than low grade) was not observed by the physician at the time of visual examination (ten centimeter dilation).
- The presence of lacerations or anal fissures was not observed by the physician at the time of visual examination.
- . The subject was able to complete the vaginal birth process (did not deliver by Cesarean section)
- The subject did not receive an episiotomy as part of the delivery process ●
- The delivery did not result in multiple births
- The delivery did not result in a still birth
- The delivery did not involve complications such as failure to progress, shoulder dystocia or delivery requiring vacuum or forceps
- The subject's perineum is < 2 cm or instrument does not seat properly ●

# Study Procedure:

- Screening visit obtain medical history, sign informed consent ●
- Physical examination at time of admission for delivery ●
- Placement of instrument – when dilated 8-10 cm
- Follow-up examination and data collection prior to discharge from hospital ●

Table 1 below describes subject accounting within the study.

| Summary | Treatment Group | | All Subjects |
|------------------------------------------------------|-----------------|---------|--------------|
| | Hem-Avert | Control | |
| Screened | | | 202 |
| Randomized | 87 | 89 | 176 |
| Randomized with Existing External<br>Hemorrhoids | 10 | 7 | 17 |
| Randomized with Prevention Possible | 77 | 82 | 159 |
| Excluded from Analysis | 43 | 30 | 73 |
| - C Section | 11 | 19 | 30 |
| - Episiotomy | 4 | 6 | 10 |
| - Perineum <2 cm | 3 | 0 | 3 |
| - Delivery Complications (Instrument<br>Not Applied) | 4 | 0 | 4 |
| - Protocol Not Followed | 1 | 0 | 1 |
| - Subject Crowning | 1 | 0 | 1 |

Table 1: Clinical Study Results

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| - Delivery at Non-study Hospital | 5 | 1 | 6 |
|------------------------------------------------------------------|----|----|----|
| - Delivered After Hours/Over<br>Weekend/Investigator not Present | 8 | 0 | 8 |
| - Subject Withdrew Consent | 1 | 0 | 1 |
| - Subject Delivered Too Quickly | 4 | 3 | 7 |
| - Study Discontinued Before Delivery | 1 | 1 | 2 |
| Total Included in Efficacy Analysis | 34 | 52 | 86 |

### Results:

Table 2 describes subject demographics.

| Table 2: Demographics | | | |
|-----------------------|---------------|---------------|---------|
| | Hem-Avert | Control | P-value |
| Number of Subjects | 34 | 52 | |
| Age (years) | | | |
| Mean (Std) | 25.3 (4.53) | 23.6 (4.55) | 0.0712 |
| Median | 24.5 | 23.0 | |
| Min, Max | 18, 34 | 17, 35 | |
| Weight (lbs) | | | |
| Mean (Std) | 186.4 (33.91) | 188.0 (37.62) | 0.8841 |
| Median | 174.5 | 180.0 | |
| Min, Max | 129, 274 | 121, 276 | |
| Previous Pregnancies | | | |
| Yes | 25 (73.5%) | 32 (61.5%) | 0.3511 |
| No | 9 (26.5%) | 20 (38.5%) | |

Table 3 describes the device effectiveness results.

| Summary | Hem-Avert® | Control | P-value |
|-------------------|-------------|------------|---------|
| Efficacy Subjects | 34 | 52 | |
| Success | 34 (100.0%) | 39 (75.0%) | |
| Failure | 0 | 13 (25.0%) | 0.0012 |
| Total | 34 | 52 | |

The data from the clinical trial indicate that use of the Hem-Avert can aid in preventing the occurrence of hemorrhoids during vaginal delivery.

#### LABELING

The Hem-Avert Perianal Stabilizer complies with the labeling requirements under 21 CFR 807.87(e) and prescription device requirements under 21 CFR § 801.109. The device labeling bears the following: "Caution: Federal law restricts this device to sale by or on the order of a physician."

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# RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of hemorrhoid prevention pressure wedge and the measures necessary to mitigate these risks.

| Identified Risk | Mitigation Method |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Skin/tissue trauma (e.g., rectal and/or<br>anal trauma, necrosis, thinning,<br>abrasion, laceration to the perineum,<br>vulvar hematoma, sloughing) | Nonclinical analysis and testing<br>Clinical information<br>Labeling |
| Device failure (e.g., material failure,<br>slippage) | Nonclinical analysis and testing<br>Labeling |
| Device failure – obstruction to the<br>treatment area caused by inability to<br>remove the instrument quickly | Device description<br>Labeling |
| Infection | Labeling |
| Adverse tissue reaction | Biocompatibility |
| Pain | Nonclinical analysis and testing<br>Biocompatibility |

#### SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the Hem-Avert Perianal Stabilizer is subject to the following special controls:

- 1. The sale, distribution, and use of this device are restricted to prescription use in accordance with 801.109 of this chapter.
- 2. The labeling should include specific instructions regarding the proper placement and use of the device.
- 3. The device should be demonstrated to be biocompatible.
- 4. Mechanical bench testing of material strength should demonstrate that the device will withstand forces encountered during use.
- 5. Safety and effectiveness data should demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery.

#### CONCLUSION

The de novo for the Hem-Avert Perianal Stabilizer is granted and the device is classified under the following:

Product Code: OOA Device Type: Hemorrhoid prevention pressure wedge Class: II Regulation: 21 CFR 884.5200