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The WOLF Thrombectomy System, 6F is indicated for the nonsurgical removal and thrombi from arterial and venous blood vessels in the peripheral vasculature.

The device is intended for single use only.

The WOLF Thrombectomy® System, 6F is comprised of two single lumen variable stiffness catheters (WOLF catheter & Devortex shaft) designed for use in removing clot from peripheral vasculature. The Devortex shaft is attached to the Devortex sleeve which when pulled, ingests the clot into the WOLF catheter. The WOLF Thrombectomy System, 6F is delivered through an access sheath that has an inner diameter of at least 0.087". Both the WOLF catheter and Devortex shaft have hydrophilic coating to facilitate tracking and reduce friction during ingestion of the clot. The Devortex shaft has one radiopaque marker band to indicate the tip of the catheter during tracking. The WOLF catheter has a distal radiopaque marker band toindicate its distal tip during tracking and pulling. The Devortex sleeve also has a radiopaque polymer cuff that allows for visualization of the weave movement during use.

The provided text is a 510(k) premarket notification for the WOLF Thrombectomy® System, 6F. While it outlines the device's indications for use, technical characteristics, and performance data from bench studies and biocompatibility testing, it does not contain information about a study proving the device meets specific acceptance criteria related to its clinical performance or an AI/algorithm component.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The WOLF Thrombectomy® System, 6F is indicated for the non-surgical removal of emboli and thrombi from arterial and venous blood vessels in the peripheral vasculature. This is identical or very similar to the predicate devices.
• Technological Characteristics: Comparison tables show similarities in regulation, product code, FDA classification, common/classification name, intended use, and general design features. Differences, like the inclusion of reloads and the absence of funnels (due to the 6F device's target vessel size), are presented as not raising new safety or effectiveness concerns.
• Performance Data (Non-Clinical): Bench studies were conducted to confirm the device performs as intended, covering durability, integrity, kink resistance, torsion/tensile strength, leak testing, simulated use, coating integrity, particulate testing, and corrosion resistance. Sterilization, transit, package integrity, and shelf-life testing were also performed.
• Biocompatibility Testing: Extensive testing per ISO-10993-1 was conducted due to the addition of colorants and a manufacturing process change.
• Animal Testing: The document states that previous pre-clinical studies for the primary and secondary predicate devices support the safety and performance of the subject device, and animal testing was not repeated for the subject device.

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance, an AI/algorithm component, or studies demonstrating such, because this information is not present in the provided 510(k) summary.

The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish de novo safety and effectiveness or specific performance metrics against clinical acceptance criteria. Had there been an AI component or a need for a clinical study to establish new performance claims, the submission would likely include an entirely different section detailing that evidence.

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