(98 days)
The Vascular Solutions Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The Pronto extraction catheter is a dual lumen catheter with related accessories. The extraction lumen allows for the aspiration and removal of emboli/thrombi 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 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 fluotoscopic visualization. Two visible markers are located on the shaft of the catheter to provide guidance to the user concerning the relative position of the Pronto and the associated guide catheter. The catheter is a monoral design with a distal flexible region and a proximal stiff region. The catheter has an approximate outer diameter of 0.065 inches, allowing delivery through standard 6Ft. 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, in increments of 15 cm. The proximal end of the catheter incorporates a standard luct adapter to facilitate the attachment of the catheter to the included extension line, stopcock, and syringe. A 74 micron filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of thrombus.
The provided documents are a 510(k) summary for the Vascular Solutions Pronto Extraction Catheter. However, this is for a modification of an already marketed device (K032763). The summary explicitly states: "No clinical evaluations of this product for this use have been conducted." and "No performance standards have been developed under section 514 for this device."
Therefore, based on the provided text, I cannot provide a table of acceptance criteria or a study proving the device meets acceptance criteria, as such information is not present for this specific submission (K042937).
The document is an administrative correction (dated 2021) to an original 510(k) letter from 2005 (K042937), which itself seems to be for a device modification. The 2005 letter explicitly states "No clinical evaluations of this product for this use have been conducted." for this specific submission.
Here's a breakdown of what can be inferred from the provided text, regarding the lack of the requested information for this specific 510(k) submission:
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Table of acceptance criteria and the reported device performance: Not provided. The submission states that "No performance standards have been developed under section 514 for this device." and "No clinical evaluations of this product for this use have been conducted."
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Sample size used for the test set and the data provenance: Not applicable, as no clinical evaluations were conducted for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical evaluations were conducted for this submission.
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Adjudication method for the test set: Not applicable, as no clinical evaluations were conducted for this submission.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an embolectomy catheter, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used: Not applicable, as no clinical evaluations were conducted for this submission.
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The sample size for the training set: Not applicable, as no clinical evaluations were conducted for this submission (and it's a physical device, not an AI model requiring a training set).
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How the ground truth for the training set was established: Not applicable, as no clinical evaluations were conducted for this submission.
In summary, the provided 510(k) submission (K042937) for the Pronto Extraction Catheter (a device modification) explicitly states that no clinical evaluations were conducted, and no performance standards have been developed. Therefore, none of the requested information regarding acceptance criteria, study details, or clinical performance can be extracted from this document for this specific filing.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).