(64 days)
Recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Any use of this product for procedures other than those indicated is not recommended.
The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is a multilumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The green lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
The catheter shaft gradually tapers beneath the balloon, nominally one french size. The tip is further tapered to provide a smooth interface with a Bard .035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon.
The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool.
The Bard Tru-Trac Peripheral Balloon Dilatation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters
The provided text describes a medical device, the Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheter, and its performance characteristics. However, it does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/machine learning diagnostic device. The text is a regulatory submission (510(k) summary) for a physical medical device, primarily focusing on its design, intended use, and manufacturing specifications.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) because the document does not relate to an AI-driven diagnostic.
If you have a document describing a study for an AI/ML diagnostic device, please provide it, and I will then be able to answer your questions.
§ 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).