(10 days)
The Bard® AtlasTM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Bard® Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
The provided text describes a medical device, the Bard® Atlas™ PTA Balloon Dilatation Catheter, and its clearance process with the FDA. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the specific details required to complete your request about the study proving the device meets acceptance criteria.
The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting detailed performance study results from which acceptance criteria are derived.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The text only states that:
- "A variety of tests, assessments, and comparisons demonstrate that the Bard® Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the above-referenced predicates in terms of composition, design, intended use, and performance attributes."
This is a general statement of equivalence and does not detail the specific tests, their acceptance criteria, or the results.
To fulfill your request, specific performance study reports or clinical trial summaries would be needed.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).