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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.

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Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").

The provided text [K092486](https://510k.innolitics.com/search/K092486) describes a device for "Cardiopulmonary Bypass Tubing and Accessories." This is a mechanical device, not an AI/ML-driven software device. Therefore, the questions about acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth definitions, and training set information are not applicable.

The document indicates that substantial equivalence was determined based on non-clinical performance data and no clinical tests were performed. The non-clinical tests focused on connection strength and system integrity to verify the integrity of the fittings and the assembled system.

Here's the information that can be extracted relevant to acceptance criteria and performance for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only broadly states "Connection strength and system integrity testing was performed to verify the integrity of the fittings and the assembled system." It does not specify quantitative acceptance thresholds (e.g., minimum burst pressure, tensile strength limits) or detailed reported values, only that the tests were performed and the integrity verified.

2. Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical evaluation of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing typically involves engineering specifications and direct measurement, not expert clinical consensus in the way an AI model would be evaluated.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this physical medical device, the "ground truth" for the non-clinical tests would be established engineering specifications and performance benchmarks for connection strength and system integrity of similar predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The Vortex Cannula is intended for use as a venous drainage cannula during extracorporeal bypass for up to 6 hours.

The Vortex Cannula is a wire reinforced, ranging from 22 to 26 French, device that is of appropriate stiffness and flexibility so that it can be manipulated throughout the vascular svstem. The cannula is rigid enough to resist kinking, collapse and deformation that may compromise the lumen and inhibit flow through the cannula. The cannula has a proprietary distal end with a balloon activated, expandable, funnel-shaped tip that willenhance flow when the balloon is activated and will prevent clogging of the cannula with commonly encountered undesirable intravascular material that occurs with the predicate devices and facilitate en-bloc removal of such material from the vascular system. The cannula has a proximal end that can attach to a standard off the shelf extracorporeal circuit. The cannula will be shipped to the user in a sterile package and ready for use.

The provided text describes a 510(k) summary for the Vortex Cannula. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device. The information provided focuses primarily on non-clinical bench testing and adherence to design control and risk analysis standards, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories related to clinical trials, ground truth, and AI-specific metrics will not be applicable or available in this document.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device." This indicates the use of in vitro or mechanical testing, not a clinical test set from human subjects. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) and sample size for a "test set" in the context of patient data is not applicable here. The "test set" would refer to the specific units of the device and predicate device used in the bench testing. No specific number of devices tested is provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth, in the context of clinical studies, typically refers to expert diagnoses or pathological findings. The testing described is non-clinical bench testing, not involving human expert assessment of clinical data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert consensus on clinical data. Since this was non-clinical bench testing, such methods are not relevant.

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. An MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess AI's impact on their performance. The Vortex Cannula is a physical medical device, not an AI diagnostic tool, and the provided document describes non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The Vortex Cannula is a physical device, not an algorithm. Standalone performance refers to the accuracy of an AI model independently.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing would be the objective measurements obtained during the bench testing (e.g., flow rates, resistance to kinking, visual assessment of clogging, observation of material removal, successful attachment). The performance of the predicate device would also serve as a benchmark for comparison.

8. The Sample Size for the Training Set

Not applicable. A "training set" refers to data used to train machine learning models. This document describes a physical medical device and its non-clinical testing, not an AI product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

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