Search Results

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The Mullins X™ catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.

The balloons of the MULLINS X™ PTA Catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.

The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.

The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

The provided document is a 510(k) premarket notification for a medical device (NuMED Mullins X PTA Catheter), which primarily focuses on demonstrating substantial equivalence to a predicate device based on manufacturing specifications, materials, and intended use. It does not contain information about clinical studies, device performance in terms of efficacy or diagnostic accuracy, or specific acceptance criteria and their achievement through studies in the way a diagnostic AI device submission would.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth adjudication, MRMC studies, standalone performance, or training set details. This document describes a medical device for a physical intervention (PTA catheter), not a diagnostic algorithm or AI system.

I reiterate that the provided text does not contain any information about acceptance criteria or studies proving device performance related to diagnostic accuracy, AI, or human reader improvement.

The document does mention:

• Biocompatibility Testing: Materials used are the same as previously approved devices (K931009, K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results are on file at NuMED, Inc.
• Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and results are kept on file at NuMED, Inc.

However, these are general statements about compliance and are not the type of detailed performance studies asked for in the user's prompt (which implies a diagnostic or AI-driven device context).

Ask a specific question about this device