(21 days)
The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
The NanoCross catheter is an over-the-wire (OTW) coaxial lumen percutaneous transluminal angioplasty (PTA) balloon catheter compatible with 0.014"guidewires with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.
The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 4 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.
The provided text describes the 510(k) summary for the NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study measuring clinical performance or AI algorithm accuracy.
Therefore, many of the requested categories for AI/clinical studies are not applicable to this type of regulatory submission. The information below will detail what is available in the provided text.
1. A table of acceptance criteria and the reported device performance
The document lists "bench testing" and "biocompatibility testing" as the studies performed to support substantial equivalence. The acceptance criteria for these tests are implicitly that the device performs "similarly to the predicates" and "met all acceptance criteria." Specific quantitative acceptance criteria or detailed device performance metrics are not provided in this summary.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Met acceptance criteria for all bench tests | "The NanoCross Elite catheter met all acceptance criteria for the bench testing with results similar to the predicates." |
| Biocompatibility per ISO 10993-1 for short duration contact with blood ( |
§ 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).