Search Results

The Floppy and Intermediate guide wires and predicate devices are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 176 cm long (nominal) and have a distally attached 30 cm composite spring coil. The most distal 4 cm of the spring coil is radiopaque. The core wire and spring coils, up to and including the tip, are coated with PCP.

Despite providing detailed information on the device description, intended use, and comparison with predicate devices, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested.

The document is a 510(k) summary for a medical device (guide wires), which is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. While it mentions safety and effectiveness based on bench and biocompatibility testing, it does not quantify specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot populate the table or answer the other questions as the necessary information (acceptance criteria, reported performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth details) is absent from the provided text.

The text does mention:

• Bench testing for tensile strength, torque strength, torqueability, and tip flexibility.
• Biocompatibility tests including Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity.
• The conclusion that the devices are "safe and effective for their intended use" based on these tests.

However, it does not provide the specific acceptance values for these tests (e.g., "tensile strength must be > X N" and "device achieved Y N"), nor does it describe structured studies with defined test sets, training sets, or ground truth methodologies typically associated with assessing performance against explicit acceptance criteria.

Ask a specific question about this device

The Floppy and Intermediate guide wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are a 0.014 inch size and designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch. The guide wires are 175 cm long (nominal) and have a 30 cm radiopaque spring coil joined distally to a central stainless steel core wire. The core wire and spring coils are coated with a hydrophilic phosphorvicholine polymer.

This document is a 510(k) summary for a medical device (guide wires), not a study report. Therefore, it does not contain the information requested about acceptance criteria, study design, or performance metrics typically found in clinical studies or validation reports.

Specifically, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) is absent from this 510(k) summary.

This document describes the device, its intended use, and identifies a predicate device for substantial equivalence, which is a regulatory filing requirement, not a detailed performance study.

Ask a specific question about this device