(123 days)
The Vessel Cannula is indicated for use during open-heart surgery to perfuse fluid into vein grafts.
The Vessel Cannula has stepped barbs at its tip and female luer fitting.
The provided documentation does not contain information about acceptance criteria and a study proving the device meets those criteria, as it is a 510(k) submission for a non-AI/ML medical device (a vessel cannula). The device's safety and effectiveness are established through substantial equivalence to a predicate device, not through performance metrics or clinical trials in the way an AI/ML device would be.
Therefore, most of the requested fields are not applicable to this submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence | Substantially equivalent to the Cobe Labs Vessel Cannula (K760624) |
| Materials | All materials identical to the predicate device. |
| Sterilization | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ |
| Functional Testing | Non-differentiable from the predicate device due to exact same fit, form, and material composition. |
| Package Integrity | Tyvek/Polymylar passed burst test per ASTM F1140-88 |
| Shipping & Distribution | Passed National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging | Two-year shelf life |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as this is a physical medical device, not an AI/ML system. There is no "test set" in the context of data for an algorithm.
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):
Not applicable.
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 consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's safety and effectiveness relies on its physical and functional equivalence to a legally marketed predicate device, and the results of standard engineering and materials testing (e.g., sterilization validation, burst tests).
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).