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The DSS Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The DSS Balloon Catheter is a flexible catheter that is intended to dilate the sinus ostia. The device is compatible with commonly used accessories including standard guide wires, guide cannulas and inflation devices. Catheter working length is from 25cm up to 140cm and is available in both over-the-wire (large diameter balloons) and rail configurations (small diameter configurations).

The distal end of the catheter includes a balloon that expands to known diameters and lengths at specific pressures. The balloon has radiopaque markers to assist with radiographic positioning. The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from either a rapid exchange style distal port just proximal to the balloon (small diameter configurations) or through the central lumen back to the proximal hub (large diameter configurations) and through the distal tip. The DSS Balloon Catheter is supplied sterile and intended for single use.

This FDA 510(k) summary for the Dillard Sinuplasty System (DSS) Balloon Catheter does not contain the detailed acceptance criteria and study information typically found in a clinical study report for device performance. This document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Indications for Use: The DSS Balloon Catheter is intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, it's specifically for dilating sinus ostia and spaces associated with the maxillary sinus.
• Fundamental scientific technology.
• Important performance specifications.
• Non-clinical performance testing: This includes dimensional verification, balloon rated burst pressure, balloon fatigue, balloon inflation and deflation, catheter joint bond strengths, and biocompatibility testing.

The document states that "No new questions of safety or effectiveness were identified during device testing," which implies that the device met internal design specifications and safety requirements as demonstrated by these tests. However, it does not provide:

• A table of acceptance criteria and reported device performance with specific numerical values. The listed performance tests are categories, not specific criteria or results.
• Clinical study details: This includes sample size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or details on ground truth establishment for either training or test sets. This device appears to have been approved based on substantial equivalence and non-clinical bench testing, not a clinical trial demonstrating specific performance metrics against clinical outcomes or expert consensus.

Therefore, for the specific questions asked, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document lists performance tests conducted (e.g., Balloon Rated Burst Pressure (RBP), Balloon Fatigue) but does not state the specific acceptance criteria (e.g., "RBP must be > X psi") or the actual reported performance values.
2. Sample sized used for the test set and the data provenance: Not applicable as no clinical test set for performance against human or clinical outcome ground truth is described. The tests mentioned are non-clinical, bench-top tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert ground truth for a clinical test set is described.
4. Adjudication method 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 device is a manual surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" would be established engineering specifications and physical properties of the materials and device. For example, for "Dimensional Verification," the ground truth is the engineering drawing specification.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) summary, which establishes substantial equivalence, often through bench testing and comparisons to predicate devices, rather than comprehensive clinical performance studies involving human subjects and specific acceptance criteria for diagnostic accuracy or clinical outcomes.

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