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The Pronto V3 Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the arterial systems.

The Pronto V3 extraction catheter is a dual lumen catheter with related accessories. The extraction lumen allows for the aspiration and removal of embolic material (thrombus/debris) using the included syringe, extension line and stopcock. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate atraumatic advancement of the catheter into the blood vessel and maximize extraction of emboli/thrombi through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter is a monorail design with a distal flexible region with stiffness along the shaft tapering to a stiff proximal region. The distal segment of the catheter is coated with a hydrophilic coating to lubricate the catheter for ease of insertion. The catheter has an approximate outer diameter of 0.065 inches, allowing delivery through standard 6Fr. guide catheters. The smaller wire lumen of the catheter is able to accommodate guide wires that are ≤ 0.014" in diameter. The catheter will be available in working lengths of 40 to 145 cm with the length changes being made in the proximal rail section. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of the catheter to the included extension line, stopcock, and syringe. A 74 micrometer filter basket (not identified in the schematic below) is included for assistance in filtering the blood removed during the procedure for laboratory analysis of thrombus.

The provided text describes a 510(k) premarket notification for the Pronto V3™ Extraction Catheter, which is an embolectomy catheter. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

However, the document specifies in "Summary of Clinical Testing" that "No clinical evaluations of this product have been conducted."

Therefore, I cannot provide information on acceptance criteria or a study proving the device meets those criteria from this document, as no clinical studies were performed. The FDA's substantial equivalence determination was based on non-clinical testing and comparison to predicate devices, not on clinical performance data.

Specifically, the document states:

• "Summary of Non-Clinical Testing: Testing conducted included assessments of the design verification of the Pronto V3 Extraction Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Pronto V3 Extraction Catheter for its intended use."
• "Summary of Clinical Testing: No clinical evaluations of this product have been conducted."

Thus, the device's suitability was confirmed through design verification and biocompatibility assessments, rather than clinical trials with defined acceptance criteria and performance metrics.

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