Search Results

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

The Cannula is intended for use in the venous system.

The Handle is indicated as a vacuum source for the AlphaVac MMA 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), and Right Heart (Atrium (RA)). The device is provided in ~85° (AlphaVac F1885) angled configuration.

The provided document is a 510(k) Premarket Notification from the FDA for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. It describes the device, its indications for use, and the studies performed to demonstrate its substantial equivalence to a predicate device.

There is no information in this document related to any AI/ML model, ground truth, expert readers, or retrospective/prospective studies on patient data. This document focuses on the mechanical and functional performance of a medical device (aspiration catheter) and its substantial equivalence to a predicate device.

Therefore, I cannot provide a response that includes information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device. The request specifically asks for details pertinent to AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.), which are not present in this document.

The document outlines the following performance data to support substantial equivalence for the device itself (not an AI/ML component):

Acceptance Criteria and Device Performance (Mechanical/Functional Device)

The document states that "Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AlphaVac MMA F1885 System met all specified design and performance requirements below."

The acceptance criteria are implied to be the successful demonstration that the device performs according to its design and functional requirements. The reported device performance is that it "met all specified design and performance requirements."

Non-Applicable AI-Specific Information from the Document:

The following points are not addressed or are not applicable based only on the provided text, as the document describes a mechanical medical device, not an AI/ML system:

• Sample size used for the test set and data provenance: No information on patient data test sets as it's a mechanical device.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a mechanical device.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance for a physical medical device (aspiration catheter) based on a demonstration of substantial equivalence through bench testing, biocompatibility, and sterilization validation, not an AI/ML product.

Ask a specific question about this device