Search Results
Found 1 results
510(k) Data Aggregation
(303 days)
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
The Belfort-Dildy Obstetric Tamponade System (OTS) 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 OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.
The Belfort-Dildy Obstetric Tamponade System (OTS) 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 Belfort-Dildy Obstetric Tamponade System (OTS) is supplied sterile in peel open pouches for one time use to a single patient.
The provided text describes a medical device, the Glenveigh™ Belfort-Dildy Obstetric Tamponade System (OTS), and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven system.
This document details the regulatory submission for the Belfort-Dildy OTS, which is a physical medical device. The "performance data" section states that "Design verification performance test results demonstrate that the Belfort-Dildy Obstetric Tamponade System performs its intended use and is equivalent to the Bakri predicate device." It also mentions "Bench testing versus the predicate Bakri device has demonstrated that the Belfort-Dildy Obstetric Tamponade System is functionally equivalent to the Bakri predicate device and that any minor differences do not affect safety or effectiveness."
Because this is not a study of an AI or diagnostic device that would typically have metrics like sensitivity, specificity, or reader accuracy, many of the requested fields are not applicable.
Here's an attempt to answer the questions based on the provided text, noting where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "materials that come in direct contact with the patient have a long history of use in catheter manufacture and are demonstrated to be biocompatible through testing according to ISO 10993-1." |
| Functional Equivalence to Predicate Device (Cook Bakri Postpartum Tamponade Balloon) | "Bench testing versus the predicate Bakri device has demonstrated that the Belfort-Dildy Obstetric Tamponade System is functionally equivalent to the Bakri predicate device and that any minor differences do not affect safety or effectiveness." |
| Performs Intended Use | "Design verification performance test results demonstrate that the Belfort-Dildy Obstetric Tamponade System performs its intended use." |
| Equivalent to Predicate Devices (Cook Bakri, Frontline Medical, Utah Medical BT-Cath) regarding fundamental scientific technology, intended use, materials, mechanisms, and technological characteristics. | "The Belfort-Dildy Obstetric Tamponade System is substantially equivalent to other legally marketed post partum tamponade balloons with the same fundamental scientific technology, same intended use as the original, predicate devices, equivalent materials, same mechanisms and equivalent technological characteristics." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of patient data, but rather bench testing and design verification of a physical medical device.
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. "Ground truth" in the context of expert consensus on data is not relevant to this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on bench testing against predicate devices and design verification performance testing, demonstrating functional equivalence and performance for intended use. Biocompatibility was established through testing according to ISO 10993-1.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
Page 1 of 1