(105 days)
The 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 fluoroscopic visualization. The catheter is a monorail design with a distal flexible region and a proximal stiff region. The distal portion of the catheter is coated with Tween (Polysorbate 80); this coating is to lubricate the catheter for ease of use. 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 luer 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.
Here's a breakdown of the acceptance criteria and study information for the Vascular Solutions Pronto™ Extraction Catheter, based on the provided documents:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it indicates that the device met its intended use through non-clinical testing and benchmarking against predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance |
|---|---|---|
| Intended Use | Removal of fresh, soft emboli and thrombi from arterial vessels. | The device performs as intended for its indicated use. |
| Material Biocompatibility | Biocompatible with the human body. | Biocompatibility assessments were conducted and confirmed suitability. |
| Design Verification | Mechanical and physical characteristics meet design specifications. | Design verification assessments were conducted and confirmed suitability. |
| Safety | No undue risks during use. | The device is considered substantially equivalent to predicate devices, implying similar safety profiles. |
| Performance | Effective in blood vessel navigation and thrombus/emboli extraction. | The catheter's design (rounded distal tip, sloped opening, coating, guide wire compatibility, and outer diameter) facilitates advancement and maximizes extraction. |
| Sterility | Not explicitly stated, but implied for an invasive device. | Not explicitly stated in the provided text. |
| Shelf Life | Not explicitly stated, but implied for a medical device. | Not explicitly stated in the provided text. |
Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed quantitative performance metrics against pre-defined acceptance criteria. The "reported device performance" above is inferred from the overall claim of suitability and substantial equivalence.
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document explicitly states: "No clinical evaluations of this product have been conducted."
- Data Provenance: Not applicable, as there were no clinical studies. The non-clinical testing would have been conducted in a laboratory setting by the manufacturer, Vascular Solutions, Inc. (USA).
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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 studies were performed requiring expert ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical studies were performed.
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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 physical medical device (catheter), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device. It does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the non-clinical testing, the "ground truth" would have been specifications, engineering standards, and the physical properties of materials, rather than clinical ground truth types.
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The sample size for the training set:
- Not applicable, as no clinical studies or machine learning algorithms were involved.
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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).