(513 days)
Not Found
Not Found
No
The device description and performance studies focus on a physical, mechanical device and do not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is indicated for the "prevention of external hemorrhoids during vaginal childbirth," which is a health condition, thus making it a therapeutic device.
No
The device is indicated for the prevention of external hemorrhoids, not for diagnosing them.
No
The device description clearly outlines physical components made of polymer, foam, and adhesive strips, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Hem-Avert Function: The Hem-Avert Perianal Stabilizer is a physical device applied externally to the perianal region during childbirth. Its purpose is to provide physical support and stabilization to prevent the formation of external hemorrhoids. It does not analyze any biological samples or provide diagnostic information.
The description clearly indicates a physical, external medical device used for prevention, not a test performed on a sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Hem-Avert Perianal Stabilizer is indicated for the prevention of external hemorrhoids during vaginal childbirth.
Product codes
OOA
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.
- two lateral hook and loop adhesive strips (with liners) which provide the tension required to keep the instrument firmly in place during delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perianal region
Indicated Patient Age Range
Subject is between 18 and 40 years of age, female and pregnant
Intended User / Care Setting
OBGYN physician clinics, Delivery sites
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Clinical Study
Sample size: 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.
Key results: The data from the clinical trial indicate that use of the Hem-Avert can aid in preventing the occurrence of hemorrhoids during vaginal delivery.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| 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 |
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 Tack | ||
| Conformable | ||
| Double Coated | ||
| Tape | Skin | |
| 2 | b(4) | |
| Foam medical tape | Mucosal | |
| 3 | b(4) Non- | |
| woven tape | Mucosal | |
| 4 | b(4) | May come into contact with |
| liquids that could leach material. | ||
| Should be considered in mucosal | ||
| 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)
2
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
3
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
4
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