Search Results

The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.

The Percu-Pro™ GuideWire is constructed of a stainless steel core wire The proximal end of the core and is finished with a PTFE jacket. The coil covered distal end of the core is tapered to a ribbon tip to increase flexibility and is finished with a silver brazed ball tip. The guidewire is provided sterile and is a single use device.

The provided 510(k) summary for the Percu-Pro™ GuideWire (K094062) describes pre-clinical safety and performance testing but does not include acceptance criteria or a study with specific performance metrics for the device itself against established criteria. Instead, it states that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices."

The submission focuses on demonstrating substantial equivalence to predicate devices (TechDevice Guidewire K053251 and TFX Guidewire K963320) based on "intended use, design, materials, technology, and performance," asserting that "There are no differences between devices which would raise new issues of safety or effectiveness."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study proving the device meets those criteria, as such information is not present in the provided document.

However, I can extract information about the pre-clinical testing conducted, which supports the safety and performance claims for substantial equivalence:

Pre-Clinical Safety and Performance Testing Information (from the 510(k) Summary):

• Type of Testing: Biocompatibility and hemocompatibility, tensile strength, torque strength, resistance to fracture, torqueability, and tip flexibility.
• Methodology: Conducted "in accordance with protocols based on the requirements of industry standards and guidance documents."

Missing Information (Not available in the provided document):

1. Table of Acceptance Criteria and Reported Device Performance: Not specified.
2. Sample Size for Test Set and Data Provenance: Not specified for any performance testing.
3. Number of Experts and Qualifications for Ground Truth: Not applicable, as performance testing against specific criteria is not detailed.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable (this is a medical device, not an AI diagnostic tool).
6. Standalone Performance Study (Algorithm only): Not applicable (this is a medical device, not an AI algorithm).
7. Type of Ground Truth Used: Not applicable, as performance testing against specific criteria is not detailed.
8. Sample Size for Training Set: Not applicable (this is a medical device, not an AI algorithm).
9. How Ground Truth for Training Set was Established: Not applicable.

Ask a specific question about this device