(113 days)
The AngioVac Cannula is indicated for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours. The cannula is also indicated for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
The AngioVac device is a 22 Fr cannula with a balloon-actuated, expandable, funnel shaped distal tip that can be advanced through a 26 Fr sheath over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit and a commercially available pump head and bubble trap. A commercially available reinfusion camula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. When the bypass pump is started, suction is created, removing blood and debris from around the tip of the Angio Vac cannula, circulating the blood through the filter, and returns the blood to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of clot material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. The device may be used in target vessels for thrombus/embolus extraction include, but are not limited to, the illiofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA).
The provided text describes the AngioVac Cannula, its intended use, and the performance data submitted for its 510(k) clearance (K133445). However, it does not contain the detailed information necessary to fully answer your request regarding specific acceptance criteria, reported device performance metrics in a table, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training set ground truth was established.
This document is a 510(k) summary, which provides a high-level overview of the device and the basis for its substantial equivalence to predicate devices, rather than a detailed study report. It indicates that bench and animal testing were performed, but does not disclose the specific results or the methodology in detail.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "The AngioVac Cannula met all specified design and performance requirements." However, it does not enumerate these specific requirements (acceptance criteria) or the quantitative performance metrics achieved.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Bench and animal testing" but does not specify the sample sizes (e.g., number of bench tests, number of animals) or the provenance of this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. The testing involved "Bench and animal testing," which typically does not involve human expert ground truth establishment in the same way clinical imaging studies do. The document does not mention any expert review processes for the performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. As the testing involved bench and animal studies (non-clinical), adjudication methods typically seen in clinical trials or imaging studies are not applicable or mentioned.
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
- Cannot be provided. This device is a physical medical device (cannula), not an AI-powered diagnostic or decision-support system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the bench testing would likely be based on physical measurements and engineering specifications, while for animal testing it would involve direct observation of the device's function in vivo (e.g., thrombus removal, blood flow characteristics) and potentially necropsy findings. Specific details are not provided.
8. The sample size for the training set
- Not applicable / Cannot be provided. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. As above, this is a physical device, not an AI model.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).