Search Results
Found 1 results
510(k) Data Aggregation
(137 days)
Elation Pulmonary Balloon Dilation Catheter
The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.
The Pulmonary Balloon Catheters are multi-lumen catheters with a dilation balloon on the distal tip. The catheters have two extension legs with luer connectors on the proximal end. The catheter is designed to pass through the working channel of a bronchoscope and accept a 0.035 in (0.89 mm) X 260 cm guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon.
The dilation balloon will be available in a 7.5F catheter with a length of 1.5 cm and in one additional balloon diameter of 4mm range that will be added to the current range from to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopague marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon.
The provided text is a 510(k) summary for the Elation™ Pulmonary Balloon Dilation Catheter. It outlines the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain a study that explicitly establishes acceptance criteria and then proves the device meets those criteria through a detailed performance study as would be seen in a clinical trial.
Instead, the document details a series of non-clinical, bench-top tests designed to show that the modified device (with a smaller balloon diameter and shorter length) performs equivalently to its predicate. The text states "All tests passed the predetermined acceptance criteria," but it does not list these specific criteria or provide detailed results from a study proving this. It also mentions a "design validation study... with porcine lungs to demonstrate the safety of dilation of smaller (6mm diameter or below) bronchi," but no specific data or acceptance criteria for this study are provided.
Therefore, many of the requested items cannot be fully answered from the provided text.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Balloon Length | (Implied: Within design specifications) | Tests passed predetermined acceptance criteria. |
| Balloon Diameter | (Implied: Within design specifications) | Tests passed predetermined acceptance criteria. |
| Burst Pressure | (Implied: Withstand specified pressure without bursting) | Tests passed predetermined acceptance criteria. |
| Pressure Cycling | (Implied: Maintain integrity over 10 cycles) | Tests passed predetermined acceptance criteria. |
| Leak Testing | (Implied: No leaks detected) | Tests passed predetermined acceptance criteria. |
| Material Attachment | (Implied: Secure attachment) | Tests passed predetermined acceptance criteria. |
| Tip Tensile | (Implied: Withstand specified tensile force) | Tests passed predetermined acceptance criteria. |
| Proximal Tensile | (Implied: Withstand specified tensile force) | Tests passed predetermined acceptance criteria. |
| Wire Tensile | (Implied: Withstand specified tensile force) | Tests passed predetermined acceptance criteria. |
| Design Validation (Porcine) | (Implied: Demonstrate safety of dilation in |
Ask a specific question about this device
Page 1 of 1