(52 days)
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:
- 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%").
- 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.
§ 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).