(19 days)
These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.
The ULTRAFLEX™ Venous Cannula is designed for use with cardiopulmonary bypass as a venous drainage cannula. The occluder with a malleable stylet aids in positioning and placement of the cannula. The device is available in 23 and 29 Fr. diameters. The device may also include Carmeda® coating.
The provided document describes a 510(k) Premarket Notification for the ULTRAFLEX™ Venous Cannula, focusing on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed acceptance criteria and specific study designs (like MRMC, standalone algorithm performance, expert qualifications for ground truth in AI studies, etc.) is not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to already legally marketed predicate devices. The performance criteria are therefore implicitly tied to the performance and safety profiles of those predicate devices.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Design Characteristics | Same or similar to predicate devices (VC2® Venous Cannula, Bio-Medicus® Femoral Cannula and Introducer) |
| Materials | Same as predicate devices (e.g., Bio-Medicus® Femoral Cannula and Introducer) |
| Indications for Use | Same as predicate devices (e.g., VC2® Venous Cannula: venous drainage during cardiopulmonary bypass) |
| Simulated Use Testing | Demonstrated performance characteristics of modifications |
| Functional Testing | Demonstrated performance characteristics of modifications |
| Visual Testing | Performed to establish performance characteristics |
| Dimensional Testing | Performed to establish performance characteristics |
| Carmeda® Coating Performance (if applicable) | Coverage, bio-activity, and functional testing performed |
2. Sample Sizes Used for the Test Set and Data Provenance
The document explicitly states that "In vitro visual, dimensional, simulated use and functional testing was used." This indicates that the testing was primarily bench testing or laboratory-based simulation, not human clinical trials.
- Test Set Sample Size: Not specified in terms of number of human subjects or patient cases, as the testing was in vitro. The "sample size" would refer to the number of cannulas or components tested in the lab. This information is not provided.
- Data Provenance: In vitro testing, likely conducted internally by Medtronic Perfusion Systems. No country of origin for patient data (as it's not a clinical study involving patients). The study is inherently prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of information is relevant for studies involving human interpretation (e.g., diagnostic imaging studies) where expert consensus is needed to establish ground truth for a test set. For in vitro engineering and performance testing, the "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, executed by qualified engineers and technicians.
4. Adjudication Method
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers or experts interpret data and their interpretations need to be reconciled to form a definitive ground truth. This was an in vitro engineering assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study involves human readers (e.g., radiologists, pathologists) interpreting cases with and without AI assistance to measure the effect size of AI on their performance. This is not mentioned or implied by the in vitro testing described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This device is a physical medical device (cannula), not an AI algorithm. Therefore, "standalone" AI performance is not relevant.
7. The Type of Ground Truth Used
- Engineering Specifications and Performance Standards. For this type of in vitro testing, the "ground truth" for evaluating the device's performance would be derived from:
- Predicate device characteristics: The new device must meet or be comparable to the established performance of its predicate devices.
- Manufacturing specifications: Internal design and quality control specifications for geometry, material properties, and functional parameters.
- Industry standards: Relevant ISO or ASTM standards for catheters and cannulae.
- Simulated use outcomes: Expected performance under simulated physiological conditions.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a "training set." The design and manufacturing processes are based on established engineering principles and prior device experience, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is irrelevant.
Conclusion:
The submission for the ULTRAFLEX™ Venous Cannula is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices through in vitro visual, dimensional, simulated use, and functional testing. It does not involve human clinical trials or AI algorithm development, and therefore, many of the questions related to clinical study design, expert consensus, and AI performance are not applicable. The "acceptance criteria" are inherently tied to matching the safety and effectiveness profiles of the legally marketed predicate devices.
§ 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).