Search Results

The Agilis™ NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis™ device is an 8.5 F steerable catheter introducer. The device has a small curl or medium curl at the distal tip which can deflect 90° in the counterclockwise direction and 180° in the clockwise direction. The device is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The proximal end of the device is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way store can is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheath is filled with radiopaque material for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

Instead, the document is a 510(k) summary for a medical device (Agilis NxT Steerable Introducer) and the FDA's letter granting substantial equivalence.

Here's what can be extracted from the text:

• Device Name: Agilis NxT Steerable Introducer
• Intended Use: Introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
• Comparison to Predicate: The Agilis NxT introducer has similar design, materials, and technical requirements as its predicate devices (Agilis Steerable Catheter Introducer K042623 and Livewire Electrophysiology Diagnostic Catheter K022380).
• Testing Summary: "Testing has demonstrated that the new device is substantially equivalent to the predicate devices." However, no details about this testing (what tests were done, what the results were, what acceptance criteria were used) are provided.
• Conclusion: The proposed modifications are equivalent to the predicates with respect to intended use, technological characteristics, and performance specifications.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

To answer your request, I would need a different document that details the specific performance studies conducted for the Agilis NxT Steerable Introducer, including their methodology, results, and the acceptance criteria established for those studies.

Ask a specific question about this device