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The Cannula is indicated for:
· the non-surgical removal of thrombi or emboli from the vasculature
· aspiration of contrast media and other fluids from the vasculature

The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.

The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:

• . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
• AlphaVac Sheath (22F)
• AlphaVac Obturator (17F) ●
• AlphaVac Handle .
• . Waste Bag and Tubing

The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. The device is provided in ~85° (AlphaVac F1885) angled configuration.

The provided text describes the 510(k) summary for the AngioDynamics AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. While it details the device and its intended use, it does not explicitly provide information on acceptance criteria for an AI/ML-based medical device, nor does it present a study proving the device meets AI/ML specific acceptance criteria. This document describes a traditional medical device (a catheter system) and its performance through bench testing and a clinical trial.

Therefore, I cannot extract the requested information about AI/ML acceptance criteria and a study proving the device meets them from the provided text.

Here's why and what information is available:

• Device Type: The AlphaVac MMA F1885 System is described as a "single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot." This is a physical, mechanical medical device, not an AI/ML software device.
• Performance Data (K): This section refers to "Comprehensive bench testing (integrity and functional performance)" and lists various engineering and mechanical tests (Dimensional Testing, Tensile Testing, Fluid Volume Removal, etc.). These are typical tests for a physical medical device.
• Clinical Testing (L): This section describes the APEX-AV trial, a multicenter pivotal study to assess the use of the device in subjects with acute intermediate-risk pulmonary embolism. The primary safety endpoint was the rate of major adverse events (MAEs), and the primary effectiveness endpoint was the reduction in RV/LV ratio. These are standard clinical trial endpoints for a physical medical device.

To answer your request, if this were an AI/ML device, the information would typically include:

1. AI/ML Specific Acceptance Criteria: Metrics like sensitivity, specificity, AUC, F1 score, precision, recall, positive predictive value (PPV), negative predictive value (NPV), often with specific thresholds (e.g., "Sensitivity must be >= 90%").
2. Study Design for AI/ML Evaluation:
   • Test Set Details: Sample size, data provenance (e.g., patient demographics, imaging modalities, data type like CT scans, X-rays), and whether it was retrospective or prospective.
   • Ground Truth Establishment: Number and qualifications of experts, the adjudication method (e.g., 2+1, 3+1 for consensus), and the nature of the ground truth (e.g., expert consensus, pathology, clinical outcomes).
   • MRMC Study: Whether a multi-reader multi-case study was performed, and its findings on human reader improvement with AI assistance.
   • Standalone Performance: Specific metrics for the algorithm-only performance.
   • Training Set Details: Sample size and how ground truth was established for the training data.

Since this document pertains to a mechanical medical device, none of the above AI/ML specific details are present.

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The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Aventus Thrombectomy System is intended for use in the peripheral vasculature.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:

• Aspiration Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister
    The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
    The Aspiration Catheter includes an atraumatic radiopaque Distal Tip with angled aspiration orifice for directional aspiration and navigation without a dilator, a dedicated navigation catheter lumen with integrated Navigation Catheter, a dedicated infusion lumen for injection of fluids, and a Handle designed to navigate within the vasculature. The Aspiration Catheter shaft incorporates a metallic reinforcement made of stainless steel, an inner liner and polymeric jacket material with variable stiffness.
    The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

The provided text describes a 510(k) premarket notification for the Aventus Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a clinical or AI performance context.

The document does not contain information related to AI/software performance, human reader studies, or explicit acceptance criteria for such an AI system. It primarily details the physical and functional characteristics of a medical device (a thrombectomy catheter) and its non-clinical performance testing (biocompatibility, sterilization, bench testing, and animal studies).

Therefore, I cannot provide the requested information, which pertains to the performance validation of an AI/software device. The provided text describes the regulatory filing for a physical medical device, not an AI or software product.

Based on the provided text, the device is a physical medical device (Aventus Thrombectomy System), not an AI/software product. Therefore, the requested information (AI acceptance criteria, human reader studies, ground truth establishment for AI, etc.) is not present in the document.

The document details the following performance data, which are typical for physical medical devices seeking 510(k) clearance:

• Biocompatibility Testing: Successful completion per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility). This demonstrated no risk of negative interaction with patients.
• Sterilization Testing: Successful completion per ISO 14937:2009, with a demonstrated SAL of 10^-6. Bacterial endotoxins test (BET) also confirmed meeting pyrogen limit specifications.
• Distribution, Packaging and Shelf-Life Testing: Successful completion of distribution testing and accelerated aging simulating a six-month shelf-life, demonstrating integrity of the sterile barrier and preservation of properties.
• Performance Testing - Bench: Design verification testing demonstrated physical and functional requirements were met. Specific tests included: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Pouch Seal Visual Inspection and Bubble Test, Pouch Seal Strength, Compatibility Testing, Torque Transmission Testing, Kink Testing, Kink and Torque to Failure, Simulated-Use.
• Performance Testing – Non-Clinical (GLP Animal Study): A GLP animal study demonstrated the system could be used safely in a chronic large animal study and met all pre-defined study endpoints.

The document does not describe any acceptance criteria or studies related to AI/software performance, such as sensitivity, specificity, human reader performance, or ground truth derived from expert consensus/pathology. Thus, I cannot populate the table or answer the specific questions about AI/software validation.

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