(42 days)
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 medical device, the Vascular Solutions Pronto V3™ Extraction Catheter, and its FDA 510(k) clearance (K052232).
Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (typically based on predicate device performance or relevant consensus standards) | Reported Device Performance (from non-clinical testing) |
|---|---|
| Suitable for intended use: removal of fresh, soft emboli and thrombi from arterial systems. | Confirmed suitability for intended use through "assessments of the design verification" and "biocompatibility assessments." |
| Design verification (e.g., catheter dimensions, material properties, functionality) | "Testing conducted included assessments of the design verification of the Pronto V3 Extraction Catheter." |
| Biocompatibility | "Biocompatibility assessments" were conducted. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission indicates "No clinical evaluations of this product have been conducted."
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical testing was performed and therefore no ground truth was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical testing was performed and therefore no adjudication was necessary.
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:
- Not applicable. This device is a catheter, not an AI or imaging diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a catheter, not an AI or imaging diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and in-vitro test results confirming the physical and functional properties of the device met predetermined design requirements. No clinical ground truth (e.g., expert consensus, pathology, or outcomes data) was used.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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).