(59 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties: Resist kinking, collapse, and deformation that may compromise the lumen and inhibit flow. | Device is "rigid enough to resist kinking, collapse and deformation that may compromise the lumen and inhibit flow through the cannula." |
| Flow Enhancement: Proprietary distal end with balloon-activated, expandable, funnel-shaped tip to enhance flow when activated. | Tip "will enhance flow when the balloon is activated." |
| Clogging Prevention: Prevent clogging with commonly encountered undesirable intravascular material. | Tip "will prevent clogging of the cannula with commonly encountered undesirable intravascular material that occurs with the predicate devices." |
| Material/Material Removal: Facilitate en-bloc removal of undesirable intravascular material. | Tip "facilitate en-bloc removal of such material from the vascular system." |
| Connection: Proximal end can attach to a standard off-the-shelf extracorporeal circuit. | "The cannula has a proximal end that can attach to a standard off the shelf extracorporeal circuit." |
| Sterility: Shipped sterile and ready for use. | "The cannula will be shipped to the user in a sterile package and ready for use." |
| Substantial Equivalence: Technological characteristics are the same as or equivalent to the predicate device and introduce no new safety and effectiveness issues. | "The Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues when used as instructed." (Proven through bench testing and comparison to predicate device). |
| Design Control/Risk Analysis/Design Verification: Conducted in accordance with applicable internal Design Procedures, 21 CFR § 820.30, ISO 14971, QSR, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971. | "Design control, risk analysis and design verification activities... have been conducted in accordance with all applicable internal Design Procedures." "The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30." Risk analysis "identified the risks relative to the performance requirements, as specified by ISO 14971 and QSR and internal procedures for risk analysis." |
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.
§ 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).