(53 days)
The Cannula is indicated for
· the non-surgical removal of thrombi or emboli from vasculature.
· aspiration of contrast media and other fluids from 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) System is a single use-over-wire catheter- based system that facilitates the removal of thrombus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA System is comprised of six main components packaged together:
- a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip
- . AlphaVac Sheath
- . AlphaVac Obturator
- 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 within the waste bag for disposal. Target vessels for 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 ~20° (AlphaVac 25F/C20) and ~180° (AlphaVac 25F/C180) angled configurations.
The provided text is a 510(k) summary for the AlphaVac Multipurpose Mechanical Aspiration (MMA) System. It details information typically included in a regulatory submission for medical devices to prove substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria for device performance studies, nor does it describe a study that explicitly demonstrates the device "meets" those acceptance criteria in the way a clinical trial or a performance study with defined endpoints would.
Instead, the document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization, and a comparison of technological characteristics with a predicate device. It briefly mentions "Previous animal studies also contributed to demonstrating substantial equivalence," but no details on the study design, acceptance criteria, or results are provided.
Therefore, many of the requested pieces of information cannot be extracted from the provided text. I will address the points that can be inferred or explicitly stated.
Acceptance Criteria and Device Performance for AlphaVac Multipurpose Mechanical Aspiration (MMA) System
The provided 510(k) summary does not explicitly list acceptance criteria in terms of specific performance thresholds for a study designed to prove the device meets those criteria. Instead, it outlines a series of tests performed to support substantial equivalence to a predicate device (FlowTriever Retrieval/Aspiration System). The "reported device performance" is described as successfully meeting "all specified design and performance requirements" for these non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria are not provided, this table will summarize the types of tests performed and the general outcome as stated in the document.
| Test Category | Acceptance Criteria (Not explicitly stated as numerical values) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | (Assumed to be internal design specifications) | Met all specified design and performance requirements for: |
| - Dimensional Testing | ||
| - Visual Inspection | ||
| - Tensile Testing | ||
| - Stiffness Testing | ||
| - Cannula and Funnel Actuation | ||
| - Distal Cannula Shape Manipulation | ||
| - Bend Angle | ||
| - Hub Rotation | ||
| - Distal Tip Functionality | ||
| - Kink Resistance | ||
| - Radiopacity | ||
| - Torque | ||
| Functional/Operational | (Assumed to be internal design specifications) | Met all specified design and performance requirements for: |
| - Flushability | ||
| - Product Interface (Compatibility) Testing | ||
| - Leak Testing | ||
| - Siphoning Testing | ||
| - Fluid Volume Removal | ||
| - Handle Lock Testing | ||
| - Pressure Testing | ||
| - Handle Pull Force | ||
| - Human Factors Evaluation/Usability Evaluation | ||
| - Simulated Use | ||
| Biocompatibility | (Per ISO 10993 requirements) | Met requirements for cytotoxicity, sensitization, systemic toxicity, |
| pyrogenicity, and hemocompatibility. | ||
| Sterilization/Shelf Life | (Per internal protocols and regulatory standards) | Confirmed packaging integrity, sterility, and distribution cycle; |
| withstood extreme distribution/environmental conditions maintaining integrity and sterility. |
2. Sample size used for the test set and the data provenance:
The document refers to "comprehensive bench testing" and "previous animal studies." However, no specific sample sizes for these tests are provided. Data provenance is not explicitly stated beyond "performed by AngioDynamics and independent test houses" for sterilization/shelf life and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document describes non-clinical engineering and biological tests, not a clinical study with expert-established ground truth. Human Factors/Usability Evaluation was performed, which would typically involve users, but the details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a diagnostic device requiring adjudication of interpretations.
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:
Not applicable. This is not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical aspiration device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO, FDA guidance). For biocompatibility, it's ISO 10993 standards. For animal studies, the ground truth would be based on physiological observations and post-mortem analysis.
8. The sample size for the training set:
Not applicable. This refers to a medical device's non-clinical performance and substantial equivalence, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).