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510(k) Data Aggregation
(326 days)
NEW REGULATION NUMBER: 21 CFR 884.5210
CLASSIFICATION: II
PRODUCT CODE: PNU
Background
DEVICE NAME
PNU Device Type: Pressure wedge for the reduction of cesarean delivery Class: II Regulation: 21 CFR 884.5210
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.
This is a single use, disposable, sterile device. The Hem-Avert Perianal Stabilizer (Hem-Avert) consists of three components:
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- Rigid polymer base manufactured from a polycarbonate
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- Centrally located cushioning pad composed of a laminate of polyester non- woven tape and polyethylene foam tape
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- Two lateral hook and loop adhesive strips (with liners) which provide the tension required to keep the device firmly in place during delivery.
This request pertains to the HEM-AVERT® PERIANAL STABILIZER, a medical device, and not an AI/ML device. Therefore, typical acceptance criteria and study designs relevant to AI/ML devices (e.g., ground truth established by experts, MRMC studies, standalone performance) are not applicable in their usual form.
However, I can extract the relevant acceptance criteria (special controls and risks to health) and how the device's performance was proven through clinical studies, focusing on the reduction of cesarean delivery, sterility, and biocompatibility.
Here's a summary of the acceptance criteria and the study results, rephrased to fit the structure where applicable, with explanations for non-applicability for certain AI/ML-specific questions:
Acceptance Criteria and Reported Device Performance for HEM-AVERT® PERIANAL STABILIZER
1. Table of Acceptance Criteria and the Reported Device Performance
| Identified Risk (Acceptance Criteria addressed via mitigation) | Mitigation Method | Reported Device Performance/Study Findings |
|---|---|---|
| Special Controls | ||
| 1. Biocompatibility | Biocompatibility evaluation | Results: Non-cytotoxic, non-sensitizing, and non-irritating. This was demonstrated through testing in accordance with ISO 10993-1. |
| 2. Device breakage prevention | Nonclinical performance data | Results: Static compression three-point bending testing on 5 samples showed the Hem-Avert endured a compressive load of 188N (to flattening without breaking), indicating it is designed to withstand pushing force during labor. |
| 3. Sterility validation | Performance data on sterility | Results: Device provided sterile with a SAL of 10⁻⁶ via b(4) CCI sterilization (ISO 11137:2006). Three samples had positive growth at b(4) but none at b(4), suggesting effective sterilization at the correct dose. |
| 4. Shelf life (sterility, package integrity) | Performance data on shelf life | Results: Accelerated aging studies simulating 1, 2, and 3 years, and then 5 years for a subset, demonstrated continued package integrity via visual inspection, dye penetration testing (ASTM F1929-98), and peel strength testing (ASTM F88-07). All results were acceptable, supporting a 2-year shelf life. |
| 5. Skin/tissue trauma characterization | Clinical performance data | Niagara Falls Study: Skin/tissue trauma was not reported among adverse events in the device group. |
| Dignity Health Study: Skin/tissue trauma was not reported among adverse events. However, the Dignity Health study did report a higher rate of perineal lacerations in the Hem-Avert group (35.24%) compared to the control group (21.98%), though this was a secondary endpoint and not evaluated for statistical significance. (Note: The document implicitly accepts this risk characterization, especially as it is mitigated by labeling). | ||
| 6. Labeling requirements | Labeling (specific instructions, shelf life) | The labeling complies with 21 CFR § 801.109 and includes specific instructions for proper placement and use to mitigate risks, identifies the validated shelf life, and indicates not to use if sterility is compromised. |
| Additional Risks to Health (Mitigated) | ||
| Infection (compromised sterility) | Sterilization validation, Shelf life testing, Labeling | Validated through sterilization methods and shelf life studies as described above. |
| Pain, discomfort or abnormal sensation | Labeling | The labeling includes warnings and precautions to address potential pain/discomfort from the device. Clinical studies did not report pain as an adverse event for the device group in Niagara Falls, and "pain" was not reported as an adverse event for the device group in Dignity Health. |
| Device failure (slippage) | Nonclinical performance data, Labeling | The device is designed with hook and loop adhesive strips to keep it firmly in place. Slippage was not reported as an adverse event in either clinical study. |
| Use error | Labeling | Labeling includes specific instructions on proper placement and use to minimize use error. |
| Primary Indication: Reduction of Cesarean Delivery | Clinical performance data from two studies (primary and supportive) | Niagara Falls Study: Hem-Avert group (50 patients) had a 12% cesarean rate vs. Control group (48 patients) with a 39.6% cesarean rate (p=0.0017). This was statistically and clinically significant. |
| Dignity Health Study: Among patients who reached 8-10 cm dilation, Hem-Avert group (227 patients) had a 1.76% cesarean rate vs. Control group (273 patients) with a 13.55% cesarean rate (p |
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