Search Results

The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.

The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working length of 100 cm) biocompatible, flexible, radiopaque, dual lumen catheter with a 6F, C shaped tip. The shaft utilizes a braided wire design with multiple Pebax durometer extrusions reflowed over PTFE liner. The distal tip includes radiopaque marker bands for visibility under fluoroscopy. The larger lumen accommodates an 0.035" guidewire and other interventional devices; the smaller lumen allows a 0.014" guidewire to exit the catheter at the curve to provide stabilization of the catheter. The hub, with Luer fittings, is compatible with standard syringes and is leak proof. The hub is marked to identify the lumens.

The Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter (K201076)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state numerical sample sizes for most of the tests. It typically refers to "All devices" or "Devices" met the criteria.

• Physician Simulated Use: Two physicians used "subject and predicate devices." The number of devices used by each physician is not specified.
• Functionality/Stabilization: "Subject and predicate devices were tested."
• Shelf Life Testing: "Devices were subjected to all testing post 6 month accelerated aging."
• Packaging Testing: Implies sufficient packages were tested to ensure compliance.
• Biocompatibility Tests: These tests follow ISO standards, which typically specify sample sizes for biological evaluations. The document does not provide the specific numbers of samples tested, but states that the tests were performed per the referenced ISO standards. For instance, the "4-Hour Thrombogenicity Study in Canine" would involve a number of animal subjects.

The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond the fact that these were laboratory and simulated use studies conducted as part of the device's development and premarket notification. These are assumed to be prospective studies conducted specifically for this regulatory filing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Physician Simulated Use: "Two physicians" were actively involved in judging the performance of the device in a simulated use model. Their specific qualifications (e.g., years of experience, specialty) are not detailed in this document.

For other performance tests like visual inspection, dimensional measurements, buckle, flexibility, torque, leakage, flow rate, tensile strength, and particulate tests, the "ground truth" is established by adherence to recognized national and international standards (e.g., ISO, ASTM) and the device's own internal specifications. The experts are implied to be qualified technical personnel carrying out these standardized tests.

4. Adjudication Method for the Test Set:

• Physician Simulated Use: The two physicians "deemed the performance of the subject device acceptable." This suggests a consensus or agreement among the two on the acceptability of the device's performance, but no formal adjudication method like 2+1 or 3+1 is described. For the objective metrics (e.g., retropulsion), direct measurement provided the "ground truth."
• For the vast majority of the other tests (e.g., visual, dimensions, mechanical, biocompatibility), the adjudication method is based on meeting the quantitative or qualitative criteria of the referenced ISO/ASTM standards or the device's internal specifications. There is no mention of a multi-observer adjudication process for these tests; rather, they are objective measurements or pass/fail assessments against established criteria.

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:

This information is not applicable to the Aqure Medical, Inc. Anchor Dual Lumen Guidewire Catheter. This device is a physical medical instrument (a guidewire catheter), not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

This information is not applicable for the same reason as point 5. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for most of the tests is established through a combination of:

• Objective Measurements: For aspects like dimensions, contrast flow rate, tensile strength, and some biocompatibility metrics (e.g., p-value for PTT).
• Pass/Fail Criteria based on Established Standards: Adherence to ISO, ASTM, and EN standards for physical, mechanical, chemical, and biological properties.
• Expert Opinion/Acceptability: For the physician simulated use, the "acceptable" performance was a qualitative judgment by the physicians.
• Comparative Performance to Predicate: For certain aspects like retropulsion and thrombogenicity, the performance was compared directly to predicate devices and found to be superior or equivalent, respectively.

8. The Sample Size for the Training Set:

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The term "training set" is generally used for data used to train AI algorithms. For a physical device, development typically involves prototypes, iterative design, and testing, but not a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

Ask a specific question about this device