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The Pronto™ Short Extraction Catheter is indicated for:

• the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system.
• the removal/aspiration of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

The Pronto Short 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 syringes, guidewire, and extension line with 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 vessels or synthetic grafts and to maximize extraction of thrombus through the extraction lumen. Incorporated within the catheter distal tip is a non-blood contacting radiopaque marker for fluoroscopic visualization. The catheter has an approximate outer diameter of 0.078 inches, allowing delivery through standard 6Fr introducer sheath. The catheter is an over the wire design. The smaller (wire) lumen of the catheter is able to accommodate guide wires that are ≤0.018" in diameter. The catheter will be available in working lengths of 40 to 65 cm. The proximal end of the catheter incorporates a y-junction luce adapter to facilitate the attachment of the catheter to the included extension line, stopcock, and two syringes. A 74 um filter basket and a 0.018"/80cm straight guidewire (not identified in the schematic below) are included for assistance in the thrombus removal procedure. The filter basket can be used to filter the blood removed during the procedure for laboratory analysis of thrombus. The straight guidewire will be provided packaged and sterile from Galt Medical (K021990). The Pronto Short is provided sterile and is intended for single use only.

This document is a 510(k) premarket notification for the Vascular Solutions Pronto™ Short Extraction Catheter. It outlines the device's description, intended use, and a summary of non-clinical testing. Crucially, it states that no clinical evaluations of this product have been conducted. Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria from the provided text.

Based on the available information:

• No acceptance criteria are explicitly stated in terms of performance metrics. The submission relies on demonstrating substantial equivalence to predicate devices through non-clinical testing.
• No study proving the device meets acceptance criteria is documented. The document explicitly states "No clinical evaluations of this product have been conducted."

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing, rather than presenting a study against specific performance-based acceptance criteria for this particular device.

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the device. The "acceptance" is based on demonstrating substantial equivalence through design verification and biocompatibility.
   • Reported Device Performance: The document only states that "The results of this battery of tests confirmed the suitability of the Pronto Short Extraction Catheter for its intended use." No specific performance data (e.g., aspiration flow rates, clot removal efficiency percentages) from these non-clinical tests are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified for the non-clinical testing.
   • Data Provenance: Not specified for the non-clinical testing. It's safe to assume it's laboratory-based testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. The "test set" in this context refers to non-clinical design verification and biocompatibility assessments, not a clinical study requiring expert ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. As above, this pertains to non-clinical testing, not a clinical study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. The document explicitly states "No clinical evaluations of this product have been conducted." Furthermore, this device is a physical catheter, not an AI-assisted diagnostic tool, so an MRMC study related to AI would be irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. For non-clinical testing, ground truth would relate to engineering specifications, material properties, and biological safety standards, not clinical ground truth.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable. There is no "training set."

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