(118 days)
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
The Multi-Stage Venous Cannula product family includes the MC2" Two-Stage Venous Cannula, OVAL MC2™ Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, and MC2X " Three-Stage Venous Cannula configurations. All Multi-Stage Venous Cannula configurations feature a wire wound polyvinyl chloride (PVC) body with side ports in the distal tip, a ported atrial basket, and a % inch (0.95cm) - ½ inch (1.27cm) connection site. The overall length of each cannula is approximately 15% inch (38.7cm). Insertion depth marks are provided to aid in positioning of the cannula during the surgical procedure. These cannulae are sterile, non-pyrogenic, disposable medical devices.
The provided text describes a medical device, the Medtronic Multi-Stage Venous Cannula, and summarizes performance and biological testing to demonstrate its substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria or a study proving the device meets specific performance targets in the format requested.
The document states: "Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device." While this confirms tests were done and criteria were met, the specific quantitative acceptance criteria and the results are not provided in the summary.
Therefore, for section 1 (Table of acceptance criteria and reported device performance), I can only list the types of tests performed, as the actual quantitative criteria and results are absent.
Here's the information based on the provided text, with limitations noted where data is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Not Detailed in Document) | Reported Device Performance (Not Detailed in Document) |
|---|---|---|
| Kink / Bend | Met pre-determined criteria | Confirmed to meet criteria |
| Collapse under negative pressure | Met pre-determined criteria | Confirmed to meet criteria |
| Tensile strength / Pull | Met pre-determined criteria | Confirmed to meet criteria |
| Biocompatibility | In accordance with EN ISO 10993-1 | Confirmed to meet EN ISO 10993-1 |
Note: The document states that "Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device." However, the specific quantitative values for these acceptance criteria and the detailed results of the device's performance against them are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is generally relevant for AI/software-based medical devices or diagnostic tools. The Medtronic Multi-Stage Venous Cannula is a physical medical device. Therefore, no experts were used to establish ground truth in this context, as the "ground truth" would be the physical properties and performance of the device under testing conditions.
4. Adjudication method for the test set
- Not applicable, as this is a physical device subject to engineering and biological performance testing, not diagnostic performance evaluation involving human observers.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- The "ground truth" in this context would be the objective measurements and standards defined for the physical and biological performance of the cannula. For example, a "kink/bend" test would have a defined failure threshold (ground truth for failure), and the device is tested against it. Similarly, biocompatibility is evaluated against established ISO standards.
8. The sample size for the training set
- Not applicable. This is a physical device undergoing performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical device undergoing performance testing, not a machine learning 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).