(513 days)
The Hem-Avert Perianal Stabilizer is indicated for the prevention of external hemorrhoids during vaginal childbirth.
This is a single use, disposable, sterile instrument. The Hem-Avert™ Perianal Stabilizer consists of three components:
- rigid polymer base manufactured from a medical grade polycarbonate
- centrally located cushioning pad composed of a laminate of medical grade polyester non-woven tape and medical grade polyethylene foam tape
- 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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: HEM-AVERT PERIANAL STABILIZER
Intended Use: Prevention of external hemorrhoids during vaginal childbirth.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the Special Controls and the Results section of the clinical study, we can infer the primary performance acceptance criteria and how the device performed against them.
| Acceptance Criterion (Inferred from Special Controls/Clinical Study Objective) | Reported Device Performance (from Clinical Study) |
|---|---|
| Biocompatibility: Device must be demonstrated to be biocompatible. | Passed: Cytotoxicity, Irritation, and Sensitization studies showed no signs of cytotoxicity, significant irritation, or sensitization. Materials commonly associated with medical instruments were used. |
| Mechanical Strength: Device must withstand forces encountered during use (e.g., pushing force during labor). | Passed: Bench testing showed the Hem-Avert could endure a compressive load of 188N to flattening without breaking. Clinical study demonstrated the device stayed in place during labor. |
| Safety and Effectiveness: Device must prevent hemorrhoids in women undergoing spontaneous vaginal delivery. | Passed: Clinical study showed 100% success (no hemorrhoids) in the Hem-Avert group (34 subjects) versus 75% success in the Control group (39 out of 52 subjects). (p-value = 0.0012) |
| Sterility: Device must be provided sterile. | Passed: Sterilization validation achieved a sterility assurance level (SAL) of 10^-6, with no positive growth in tested samples. |
| Labeling Compliance: Labeling must include specific instructions and comply with prescription device requirements. | Passed: Stated that labeling complies with 21 CFR 807.87(e) and 21 CFR § 801.109, and includes the "Caution: Federal law restricts this device..." statement. Specific instructions regarding placement and use are also required by special controls. |
| Risk Mitigation: Identified risks (Skin/tissue trauma, Device failure, Infection, Adverse tissue reaction, Pain) must be mitigated. | Addressed: Nonclinical analysis, testing (biocompatibility, mechanical), and labeling are cited as mitigation methods for various risks. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (Clinical Study Efficacy Analysis):
- Hem-Avert (Treatment) Group: 34 subjects
- Control Group: 52 subjects
- Total for efficacy analysis: 86 subjects
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the FDA, suggesting a US context.
- Retrospective or Prospective: Prospective. The study involved subject enrollment, screening, randomization, device placement during delivery, and follow-up examinations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The text does not specify the number of experts (physicians) involved in establishing the ground truth (presence/absence of hemorrhoids) during the clinical study.
- Qualifications of Experts: The study was conducted at "OBGYN physician clinics" and "Delivery sites." Physicians at these sites would be qualified OBGYN doctors responsible for labor, delivery, and postpartum assessment.
4. Adjudication Method for the Test Set
- The text does not explicitly describe an adjudication method beyond the physician's observations during "follow-up examination and data collection prior to discharge from hospital" to determine the presence of hemorrhoids. It implies that the treating physicians made the assessment. There's no mention of independent reviewers or a consensus process for the clinical outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a physical medical device (perianal stabilizer), not an AI algorithm or imaging diagnostic tool that would typically involve human readers interpreting results with or without AI assistance. Therefore, there is no effect size reported for human readers improving with AI vs. without AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- N/A (Not Applicable). As mentioned above, this is a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device itself (Hem-Avert) operates standalone in its mechanism of action by providing mechanical support; there is no "human-in-the-loop" once it's placed, beyond the physician's initial placement and decision to use it. The clinical study did evaluate its standalone performance (the device's effect in preventing hemorrhoids compared to no device).
7. Type of Ground Truth Used
- Expert Clinical Observation. For the efficacy endpoint (prevention of hemorrhoids), the ground truth was established by the physician's visual examination and assessment after delivery to determine the presence or absence of hemorrhoids. This is based on clinical signs and symptoms, observed by a medical professional.
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI. Performance was evaluated in a clinical trial, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, the question of how its ground truth was established is not relevant.
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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:
-
- 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
-
- 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)Hi TackConformableDouble CoatedTape | Skin |
| 2 | b(4)Foam medical tape | Mucosal |
| 3 | b(4) Non-woven tape | Mucosal |
| 4 | b(4) | May come into contact withliquids that could leach material.Should be considered in mucosalcontact. |
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 ExternalHemorrhoids | 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 (InstrumentNot 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/OverWeekend/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/oranal trauma, necrosis, thinning,abrasion, laceration to the perineum,vulvar hematoma, sloughing) | Nonclinical analysis and testingClinical informationLabeling |
| Device failure (e.g., material failure,slippage) | Nonclinical analysis and testingLabeling |
| Device failure – obstruction to thetreatment area caused by inability toremove the instrument quickly | Device descriptionLabeling |
| Infection | Labeling |
| Adverse tissue reaction | Biocompatibility |
| Pain | Nonclinical analysis and testingBiocompatibility |
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:
-
- The sale, distribution, and use of this device are restricted to prescription use in accordance with 801.109 of this chapter.
-
- The labeling should include specific instructions regarding the proper placement and use of the device.
-
- The device should be demonstrated to be biocompatible.
-
- Mechanical bench testing of material strength should demonstrate that the device will withstand forces encountered during use.
-
- 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
§ 884.5200 Hemorrhoid prevention pressure wedge.
(a)
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.(b)
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.