Search Results

The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

The AXS Catalyst™ Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter shaft has a hydrophilic coating to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. It is packaged with a Rotating Hemostasis Valve (RHV), Tuohy Borst Valve with Sideport, and two peel away introducer sheaths. The RHV and Tuohy Borst valve with sideport are used for flushing, insertion of catheters, and aspiration. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the RHV or Tuohy Borst.

The provided document describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the AXS Catalyst 7 Distal Access Catheter to its predicate devices, rather than proving it meets specific acceptance criteria for a new, non-predicate device. The entire submission focuses on establishing substantial equivalence for 510(k) clearance.

Here's an analysis of the provided information, framed around the requested categories:

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

The document does not explicitly provide a table of "acceptance criteria" alongside specific numerical "reported device performance." Instead, for each test, it outlines the "Purpose" (which implicitly defines the acceptance criteria) and a "Conclusion" stating whether the device "meets acceptance criteria" or was "acceptable."

Here's a summary derived from the "Performance Data – Bench Testing" section:

Biocompatibility Testing (Table 3):

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

The document does not specify exact numerical sample sizes for each bench test conducted. It generally refers to "sample" or "test sample."

• Bench Testing: The methods described ("Prepare sample for test," "Insert sample") suggest individual samples were tested per criteria. No specific number (e.g., n=3, n=5) is given for any test.
• Animal Study: An animal study was conducted. No sample size (number of animals) is provided.
• Data Provenance: All testing appears to be prospective bench and animal testing conducted by Stryker Neurovascular. No country of origin is explicitly stated for the testing data, but the company address is in Fremont, California, USA, implying the studies were likely conducted in the USA or supervised by the US entity.
• Retrospective/Prospective: All described studies are prospective.

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)

• Bench Testing: For most bench tests, "ground truth" is typically an objective measurement against a standard or specification. Human interpretation is minimal for these.
• In-vitro Simulated Use Study: This study involved "multiple physician users." No specific number of physicians is given, nor are their qualifications (e.g., specialty, years of experience). Their role was to perform simulated procedures and evaluate device performance.
• Animal Study: The study evaluated "navigation safety" in clinically relevant vessel sizes, likely involving veterinary or medical experts for assessment, but no details are provided on their number or qualifications.

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

The document does not describe any formal adjudication method (like 2+1, 3+1 consensus) for establishing ground truth within the described studies. The bench tests rely on objective measurements and visual inspections. The "In-vitro Simulated Use Study" likely involved expert user feedback, but no formal adjudication process is outlined.

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

• MRMC Study: No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or mentioned. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a primary component of performance. The AXS Catalyst 7 is a physical medical device (catheter) for interventional procedures, not an AI diagnostic tool.
• AI Assistance: There is no mention of AI assistance in the context of this device or its studies.

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

No standalone algorithm performance study was mentioned, as this device is a physical catheter and does not involve an algorithm.

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

• Bench Testing: Ground truth for bench tests is based on objective physical measurements and adherence to engineering specifications and international standards (e.g., EN ISO 10555-1, EN 1707).
• In-vitro Simulated Use Study: Ground truth here would be the successful completion of simulated procedures, device durability, and kink resistance as observed by "multiple physician users." This is effectively expert observation and anecdotal feedback within a simulated environment.
• Animal Study: Ground truth would be the observed "navigation safety" and lack of adverse events in live animal models, determined by veterinary and/or medical experts.
• Biocompatibility: Ground truth involved laboratory analysis against established biological safety standards (e.g., ISO 10993 series) and specific test methodologies (e.g., cytotoxicity, hemolysis assays).

8. The sample size for the training set

This question is not applicable. The device is a physical medical catheter, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable, as there is no training set for this device.

Ask a specific question about this device