(21 days)
The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.
The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 20-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.
The provided document is a 510(k) premarket notification decision letter from the FDA to Merit Medical Systems, Inc. regarding the Advocate PTA Catheter. It outlines the regulatory classification, intended use, and substantial equivalence to predicate devices.
Crucially, this document is for a physical medical device (a catheter for angioplasty), not a software or AI-based medical device. Therefore, the specific questions related to AI/software performance, such as acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, are not applicable to the information contained within this document.
The document explicitly states: "No Safety or Performance testing is required to establish the safety and efficacy of the subject device." This is because the device is being marketed as substantially equivalent to existing predicate devices (Pirouette 014, 018, and 035) with "no technological differences" and manufactured by the "same Manufacturer who makes the identical device under the Pirouette name." The only difference noted is the naming and labeling of the product.
Therefore, I cannot provide the requested information based on this document. The questions you posed are relevant for AI/software medical devices, which typically require extensive validation studies to demonstrate performance.
§ 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).