(53 days)
The Coronary Ostial Perfusion Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solutions directly to the coronary arteries.
These cannulae consist of a basket style tip attached to a malleable stainless steel tube. The cannula terminates with a locking female luer fitting.
The provided text describes a medical device, the Chase Coronary Ostial Perfusion Cannula, and its safety and effectiveness relative to a predicate device. However, it does not contain a study that establishes acceptance criteria and then demonstrates the device meets those criteria. Instead, it outlines various tests and their outcomes, primarily focusing on equivalence to a predicate device and basic functional requirements.
Here's an attempt to structure the information based on your request, highlighting what is available and what is missing:
Acceptance Criteria and Device Performance Study
The provided document describes the Chase Coronary Ostial Perfusion Cannula and its functional testing results, primarily demonstrating substantial equivalence to a predicate device and meeting specific performance standards for manufacturing and sterilization. It does not detail a study designed to establish and then meet specific, quantified clinical or performance acceptance criteria in the way a diagnostic AI device might.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document, which focuses on device manufacturing and equivalence rather than a clinical performance study with specific metrics like sensitivity or specificity, "acceptance criteria" here refers to engineering and regulatory compliance points.
| Acceptance Criterion (Category) | Specific Criterion | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Non-differentiable functional characteristics compared to predicate. | "All functional characteristics of the Chase Coronary Ostial Perfusion Cannula are non-differentiable as compared with the predicate." |
| Materials | Materials identical to the predicate device. | "All material are identical to the predicate device." |
| Sterilization | Validated Ethylene Oxide sterilization cycle with SAL 10-6. | "Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10-6" |
| Leak Test | No leaks at 10 psi air. | "No leaks at 10 psi air on Chase device." |
| Luer Connections | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings. | "Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings." |
| Package Integrity | Tyvek/Polymylar passed burst test per ASTM F1140-88. | "Tyvek/Polymylar passed burst test per ASTM F1140-88." (Implied acceptance is 'passed'). |
| Shipping & Distribution Testing | Passed National Safe Transit Ass. vibration and drop tests. | "Per National Safe Transit Ass. vibration and drop tests." (Implied acceptance is 'passed'). |
| Accelerated Aging | Demonstrates a two-year shelf life. | "Two year shelf life." (Implied acceptance is 'this is the demonstrated shelf life'). |
| Substantial Equivalence | Demonstrated substantial equivalence to the Medtronic/DLP Coronary Ostial Perfusion Cannula. | "This device has been shown to be substantially equivalent to the Medtronic/DLP Coronary Ostial Perfusion Cannula." (This is an overarching regulatory acceptance criterion and the study's primary goal). |
The subsequent information requested primarily pertains to diagnostic or AI-based device studies, which is not applicable to the documentation provided for this medical cannula. The provided text outlines a regulatory submission (likely a 510(k)) that focuses on demonstrating the safety and effectiveness of a medical device by showing it is substantially equivalent to a legally marketed predicate device. This process typically involves engineering tests, material compatibility, sterilization validation, and functional comparisons, rather than a clinical trial with specific performance metrics like those for diagnostic accuracy.
Therefore, the following points cannot be addressed from the provided text:
2. Sample size used for the test set and the data provenance
- Not applicable. The document describes engineering tests, not a clinical "test set" in the context of diagnostic performance. For physical device testing (e.g., leak tests, material tests, package integrity), the sample sizes would be determined by standard engineering and statistical methods for device validation, which are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the context of expert consensus is not relevant for this type of device submission. The "ground truth" here is adherence to engineering standards and comparison to the predicate device's established characteristics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This refers to methods for resolving discrepancies in expert interpretations, which is not relevant for the type of device and study described.
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 type of study relates to diagnostic imaging or AI assistance, which is not relevant for this perfusion cannula.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI algorithm performance, which is not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is its adherence to established engineering standards, material specifications, and the validated characteristics of the predicate device. It's not based on pathology or clinical outcomes in the same way a diagnostic study would be, but rather on physical and functional equivalence to a device already deemed safe and effective.
8. The sample size for the training set
- Not applicable. This refers to AI model training data, which is not relevant for this device.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI model training data, which is not relevant for this device.
§ 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).