Search Results

The ebb Complete Tamponade System is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

The ebb Complete Tamponade System is a disposable, multiple lumen catheter attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The device consists of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation/deflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The device may be retained in position for up to 24 hours in the post-operative mode of treatment. The ebb Complete Tamponade System is supplied sterile in peel open pouches for one time use to a single patient.

This document describes a Special 510(k) notice for a modified medical device, the ebb Complete Tamponade System. It's a re-submission for a device that already has a predicate (K150573). The modification is specifically the addition of a UV Band around the proximal and distal ends of the vaginal and uterine balloons.

The information provided focuses on demonstrating that the modified device is substantially equivalent to its predicate, meaning the changes do not introduce new questions of safety or effectiveness. As such, the study described is a performance test to validate the modification, not a clinical trial to establish initial efficacy or performance against a broader set of acceptance criteria in a clinical setting.

Therefore, many of your requested points regarding clinical study design, ground truth, expert opinions, and comparative effectiveness are not applicable to this type of submission. The document primarily reports on bench testing to ensure the modified component maintains or improves strength.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Sample size: Not explicitly stated. The document mentions "the modified devices" and "none of the modified devices failed," implying multiple units were tested.
• Data provenance: Bench testing (laboratory environment), not country of origin of clinical data or retrospective/prospective human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This was a bench test focused on the mechanical strength of the device, not a diagnostic or treatment device requiring expert clinical ground truth. The "ground truth" was the physical performance of the device under stress.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As this was a bench test, there was no clinical adjudication process involving human reviewers. Performance was measured by defined physical parameters (e.g., failure under stress).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic or therapeutic device requiring human reader improvement studies. It is a physical medical device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this performance study was determined by physical stress testing where the operational limits and failure points of the device were observed and measured under controlled laboratory conditions, particularly focusing on cyclic physiologic pressures.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

Ask a specific question about this device