(85 days)
Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.
Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.
The provided text describes a 510(k) premarket notification for the Medline Vessel Cannula, focusing on its substantial equivalence to a predicate device and its compliance with non-clinical testing standards. It does not contain information about a study proving the device meets acceptance criteria in the context of typical clinical or diagnostic device performance metrics such as sensitivity, specificity, or reader studies for AI-powered devices.
The document primarily outlines:
- Substantial Equivalence: The Medline Vessel Cannula is deemed substantially equivalent to the DLP Vessel Cannulae (Medtronic, K810820). This means its technological characteristics and performance are comparable, and it's intended for the same use.
- Non-Clinical Testing: The submission includes results from biocompatibility and functional performance testing. These are primarily engineering and safety tests rather than clinical performance studies.
Therefore, many of the requested categories for a diagnostic or AI-driven device's performance study cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Sensitization | Meets ISO 10993 requirements | Meets ISO 10993 requirements |
| Irritation | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Cytotoxicity | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Intramuscular Implant | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Acute Systemic Toxicity | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Subchronic Systemic Toxicity | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Pyrogen | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Hemolysis (direct contact) | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Hemolysis (extract method) | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Complement Activation | Meets ISO 10993 requirements | Meets ISO 10993 requirements | |
| Functional Performance | Appearance | Device effectiveness | Demonstrated device effectiveness |
| Dimensions | Device effectiveness | Demonstrated device effectiveness | |
| Direction of Flow | Device effectiveness | Demonstrated device effectiveness | |
| Tensile Strength | Device effectiveness | Demonstrated device effectiveness | |
| Leakage | Device effectiveness | Demonstrated device effectiveness |
2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical, laboratory/benchtop tests, not a clinical study on a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as no clinical performance study was conducted.
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. This device is a physical medical instrument (cannula), not an AI-powered diagnostic tool.
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 these tests would be the established scientific methods and standards defined in ISO/ASTM guidelines for biocompatibility and functional testing (e.g., passing specific thresholds for toxicity, tensile strength, or leakage).
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
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).