Search Results

MaxForce Biliary Dilatation Catheter: The MaxForce Biliary Balloon Dilatation Catheters are recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.

Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is recommended for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. The Hurricane RX Biliary Balloon Dilatation Catheter may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

MaxForce Biliary Balloon Dilatation Catheter: The MaxForce Biliary balloon dilatation catheter, styled after the Gruntzig technique, is a double lumen catheter with a non-compliant balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments as well as the Sphincter of Oddi.

Hurricane RX Biliary Balloon Dilatation Catheter: The Hurricane RX Biliary Balloon Dilatation Catheter is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

The provided document describes a Special 510(k) Premarket Notification for a modification to existing medical devices, specifically the MaxForce Biliary Balloon Dilatation Catheter and the Hurricane RX Biliary Balloon Dilatation Catheter. The primary change is the replacement of a catheter tip resin due to the discontinuation of the original material. The acceptance criteria and the study performed are focused on demonstrating that the performance of the new resin is equivalent to the old one.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for each test. The study appears to be a bench-top engineering study rather than one involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The study involved engineering tests and measurements, not subjective expert evaluation to establish ground truth from clinical data.

4. Adjudication Method for the Test Set:

Not applicable. There was no need for adjudication as the tests were objective, quantitative engineering measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is typically done for diagnostic imaging devices involving human interpretation. This document describes a physical device modification and associated engineering performance tests, not an AI or imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This is not an algorithm-based device. The tests performed are inherent to the physical characteristics and performance of the catheter.

7. Type of Ground Truth Used:

The "ground truth" for this study was established using engineering specifications and established test methods to assess the physical performance characteristics of the catheter (e.g., tensile strength, burst pressure, compatibility).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The study focuses on verifying the physical performance of the device with a new material.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device