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The Visions PV .035 catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels.

The Visions PV .035 ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Visions PV .035 Catheter is an over-the-wire intravascular imaging catheter with a digital ultrasound transducer at the distal end. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The Visions PV .035 Catheter is introduced percutaneously or via surgical cutdown into the vascular system, and is designed to track over 0.035"-0.038" (0.89-0.97mm) guide wires.

The catheter body has markers 1 cm apart along the working length. There are 25 radiopaque (RO) markers on the distal end of the catheter, starting 1 cm from the imaging plane, with the 25th RO marker overlapping the distal-most wide inked markers (non-radiopaque) continue along the shaft, spaced 1 cm apart, middle, with wider marks indicating 5 cm intervals.

A lubricious GlyDx® hydrophilic coating is applied externally to a distal portion of the catheter. The Visions® PV .035 Catheter, catalog number 88901, catheters may only be used with the In-Vision Imaging System, Volcano s5™ or Volcano s5i™ imaging systems, or later systems. This catheter will not operate if connected to any other imaging system.

The provided text describes a 510(k) submission for the Volcano Visions® PV .035 Digital IVUS Catheter. This is a premarket notification for a medical device redesign, aiming to demonstrate substantial equivalence to a legally marketed predicate device. As such, the document does not contain a study designed to prove the device meets acceptance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating that the redesigned device is as safe and effective as the predicate device by comparing their intended use, principles of operation, and design elements, and ensuring that design changes do not negatively impact performance. The "acceptance criteria" here are implicitly related to maintaining the performance and safety standards established by the predicate device and relevant regulations.

Here's an analysis based on the provided text, highlighting what is included and what is not typically part of a 510(k) submission for a device modification of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" for clinical performance with corresponding "reported device performance" in the context of a new efficacy study. The device is a diagnostic imaging catheter, and its performance is judged against its ability to display vascular morphology and provide dimensional measurements, similar to its predicate.

The main "performance" data presented is the Acoustic Output Reporting Table for Track 3 (Page 4). This table details physical acoustic parameters of the transducer, which are critical safety and performance characteristics for ultrasound devices.

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