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The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.

The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.

The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.

The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).

The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.

This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.

The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:

• Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
• Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
• Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.

In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML device.

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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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