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The EDDY™ Intravascular Infusion Catheter is intended for general Intravascular use, including neuro, peripheral, and coronary vasculature. The catheter is intended to be flow tracked in order to access distal tortuous vasculature. Once the subsclective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications oulined by the manufacturer.

The device is a single lumen device which facilitates distal vascular access. The catheter is available in two shaft sizes. The larger shaft size models incorporate a 2.7F proximal shaft with a 2.2F flexible distal shaft and a distal internal diameter of .019". The smaller shaft size models incorporate a 2.4F proximal shaft with a 1.7F flexible distal shaft and a distal internal diamcter of .013". The catheter is available in usable shaft lengths from 135 to 165cm, in 5cm increments.

The catheter is intended to be flow tracked, but may accommodate steerable hydrophilic guidewires of < . 016" for the larger shaft size models. The EDDY™ is available in straight and bulb tip configurations. Radiopaque markers at the distal tip and the mid-shaft bond facilitate fluoroscopic visualization of the device. The proximal end of the infusion catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The distal end of the catherer is steam shapeable as are other flow tracked catheters currently on the market. A white ink proximal mark is located 100cm from the tip of the catheter to indicate when the stylet is to be removed during insertion of the infusion catheter into the guide catheter.

The outer surface of the EDDY™ catheter is coated with a hydrophilic coating system, except for the proximal 30cm of shatt. The device will be provided sterile, and is intended for one procedure use only (disposable).

The provided text is a 510(k) summary for the EDDY™ Intravascular Infusion Catheter. This document describes the device, its intended use, and briefly mentions testing performed to demonstrate its safety and effectiveness for regulatory clearance (FDA 510(k)). It is not a clinical study report describing the performance of an AI/ML device.

Therefore, the information requested regarding acceptance criteria and a study proving device performance (specifically for an AI/ML context with details like sample size, ground truth, expert opinions, MRMC studies, etc.) cannot be extracted from the provided text.

The provided text focuses on:

• Device Description: What the EDDY™ Intravascular Infusion Catheter is, its dimensions, and how it works.
• Intended Use: For general intravascular use, flow tracking, and targeted infusion of materials.
• Testing Mentioned (but not detailed): Shaft burst pressure, tensile, infusion rate, tip flexibility, torque testing, coating durability and lubricity, biocompatibility, and "in vivo studies." These are engineering and biocompatibility tests typically performed for medical devices, not performance evaluation of an AI system.
• Substantial Equivalence: The primary conclusion is that the EDDY™ catheter is substantially equivalent to existing predicate devices.

In summary, the provided document does not contain the information requested about acceptance criteria and a study proving performance in the context of an AI/ML device.

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