(120 days)
The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracopereal bypass for up to 6 hours.
The AngioVac Cannula is a venovenous cannula with a nitinol basket reinforced, self-expandable funnel shaped distal tip collapsed using an over-sheath that can be advanced through a 26 Fr sheath and over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit, an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. The funnel tip is actuated by advancing the AngioVac Cannula out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip angle. Once optimal flow rate is achieved, the AngioVac Cannula is advanced under image guidance towards the undesirable intravascular (i.e. thrombus or emboli) until it is engaged, suctioned into the cannula and removed from the vasculature. The blood is then circulated though the filter and returned to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of thrombus and embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA). The device is provided in ~20° (AngioVac C20) and ~180° (AngioVac C180) angled configurations.
This document is a 510(k) summary for the AngioVac Cannula, a medical device. It does not describe a study that uses AI or machine learning models. Therefore, it is impossible to extract information about AI/ML specific acceptance criteria, test set, training set, or expert adjudication as requested in the prompt.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments.
However, I can provide the acceptance criteria and performance data that are present in the document for the AngioVac Cannula, even though they are not related to AI/ML performance.
Acceptance Criteria and Reported Device Performance (Non-AI/ML)
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Functional Performance | Tensile Testing | Met all specified design and performance requirements. |
| Stiffness Testing | Met all specified design and performance requirements. | |
| Aspiration Strength | Met all specified design and performance requirements. | |
| Cannula Actuation | Met all specified design and performance requirements. | |
| Distal Cannula Shape Manipulation | Met all specified design and performance requirements. | |
| Bend Angle | Met all specified design and performance requirements. | |
| Hub Rotation | Met all specified design and performance requirements. | |
| Distal Tip Functionality | Met all specified design and performance requirements. | |
| Kink Resistance | Met all specified design and performance requirements. | |
| Sheath Flushability | Met all specified design and performance requirements. | |
| Flow Rate | Met all specified design and performance requirements. | |
| Product Interface (Compatibility) Testing | Met all specified design and performance requirements. | |
| Physical/Dimensional | Radiopacity (presence of markers on distal tip) | Radiopaque markers on distal tip to assist tip visualization. |
| Dimensional Testing | Met all specified design and performance requirements. | |
| Visual Inspection | Met all specified design and performance requirements. | |
| Biocompatibility | Cytotoxicity (ISO 10993 Part 1) | Performed with acceptable results. |
| Sensitization (ISO 10993 Part 1) | Performed with acceptable results. | |
| Systemic Toxicity (ISO 10993 Part 1) | Performed with acceptable results. | |
| Genotoxicity (ISO 10993 Part 1) | Performed with acceptable results. | |
| Hemocompatibility (ISO 10993 Part 1) | Performed with acceptable results. | |
| Irritation (ISO 10993 Part 1) | Performed with acceptable results. | |
| Sterilization/Shelf Life | Packaging Integrity, Sterility, Distribution Cycle Tests | Confirmed suitability of sterile packaging to protect and maintain sterility within stated shelf life. |
Information Not Applicable or Not Found (Due to Non-AI/ML Nature of the Device/Study):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this device does not involve an AI/ML model with a test set of data. The performance data refers to bench test results.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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): The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for device performance and biocompatibility.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the Document's Conclusion:
The study submitted (non-clinical testing) demonstrates that the proposed AngioVac Cannula is substantially equivalent to the predicate device (AngioVac Cannula, cleared via K142593) based on functional performance, physical characteristics, biocompatibility, and sterilization/shelf life data. The differences in technological characteristics (addition of 180° angled configuration, different distal funnel tip design with embedded nitinol basket actuated by sheath) were addressed through comprehensive bench testing, which AngioDynamics states met all specified design and performance requirements.
§ 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).