Search Results

The RayFlow catheter is intended to be used in adults (patients aged 22 years and older) for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature. The RayFlow is not intended to be used in the neurovasculature.

The RAYFLOW infusion catheter is a rapid exchange (RX) double lumen catheter with a series of holes and a radiopaque marker on its distal part. The outer lumen along the entire length of the catheter is used to inject fluids (saline, medication or contrast media) through the holes. The inner RX lumen is dedicated to the passage of a 0.014" quidewire facilitating the progression of the RAYFLOW catheter through the arteries. Four holes are located between the outer lumen and the surface of the catheter, allowing infusion of fluids into the blood resulting in a homogeneous mixing. Two holes located between the outer and inner lumen of the RAYFLOW catheter allow the measurement of the injected solution temperature by a specific pressure/temperature guidewire (Abbott PressureWire™ X Guidewire) at the moment the solution enters the artery. The hub is standard sized and compatible with any automated pump injector used for the continuous infusion of saline/liquid at room temperature. The RAYFLOW is provided sterilized with ethylene oxide. This device is for a single use only and packed in individual unit. A mandrel is inserted into the inner lumen to protect the integrity of the device.

The provided text is a 510(k) Premarket Notification for the RayFlow catheter, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical bench testing and adherence to recognized standards. It explicitly states that the device does not involve artificial intelligence (AI) and therefore, the acceptance criteria and study design elements typically associated with AI/ML-driven medical devices (such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in machine learning, and human reader performance with AI assistance) are not applicable.

The "acceptance criteria" for this device are its performance in various bench tests, demonstrating that it meets the requirements of relevant ISO and ASTM standards, and that any differences from predicate devices do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text:

Device: RayFlow Catheter
Device Type: Continuous flush catheter, intravascular diagnostic catheter, percutaneous catheter.
Intended Use: Introduction of interventional devices and infusion of diagnostic or therapeutic agents into the coronary vasculature in adults (22 years and older). Not for neurovasculature.

1. A table of acceptance criteria and the reported device performance:

Since this is a non-AI device relying on bench testing, the acceptance criteria directly relate to meeting the specifications of recognized standards. The document summarizes the performance by stating the device "showed no sign of leakage," "is able to advance through a coronary anatomical model," "is conform to ISO 10555-1," and that all biocompatibility tests were passed. Precise numerical acceptance criteria and reported values for each test are typically detailed in the full test reports (e.g., TR 20-014, not provided here), which are summarized in this 510(k) document.

Ask a specific question about this device