(62 days)
The Aortic Perfusion Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass. Additionally, the Aortic Perfusion Cannula can be used to occlude the ascending aorta as well as deliver cardioplegia solution to and aspirate air from the aorta.
The CHASE Aortic Perfusion Cannula is a three lumen cannula. The primary lumen is the conduit that returns oxygenated blood from the extracorporeal circuit to the ascending aorta. A second lumen allows a balloon to be inflated at the distal tip of the cannula. A third lumen delivers cardioplegia solution through orifices proximal to the balloon.
This K970914 submission for the CHASE AORTIC PERFUSION CANNULA does not contain the detailed information typically found in studies proving a device meets acceptance criteria, especially not in the context of modern AI/ML medical devices. The document is from 1997 and pertains to a physical medical device, not a software algorithm.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text. I will address the applicable sections based on the information provided, and explicitly state when information is not present or not relevant to this type of device submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device must be substantially equivalent to predicates. | Identified as substantially equivalent to the combination of Sams Aortic Arch Cannula (K770429), DLP Aortic Root Cannula (K790565), and an aortic cross clamp. This is a primary claim of the submission. |
| Materials: Materials must be identical to those used in similar devices with similar intended uses. | "All materials are identical to materials used in similar devices that have similar intended uses." |
| Sterilization: Must have a validated sterilization cycle. | "Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10-6" |
| Functional Characteristics: Must be non-differentiable from predicates. | "All functional characteristics of the Chase Medical Aortic Perfusion Cannula are non-differentiable as compared with the predicates." |
Study Details (Based on provided text)
-
Sample size used for the test set and the data provenance: Not applicable. This submission concerns a physical medical device seeking substantial equivalence, not a machine learning algorithm tested on a dataset of patient data. The "test set" in this context refers to the device itself and its components being evaluated against known standards and predicates. The provenance of such testing would be internal lab testing, not patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering and biological testing against established standards and predicate devices, not typically by expert consensus on a dataset in the way an AI algorithm's ground truth is established. The "experts" would be engineers, material scientists, and regulatory specialists.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 are used for diagnostic interpretations, not for evaluating the physical and functional properties of a perfusion cannula.
-
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 a physical device, not an AI algorithm. MRMC studies are for evaluating diagnostic performance of readers, often with and without AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device like this, the "ground truth" for its safety and effectiveness is established through:
- Material specifications: Conformance to industry standards and predicate device materials.
- Sterilization validation: Conformance to ISO/AAMI standards for sterilization.
- Functional testing: Bench testing to ensure performance parameters (e.g., flow rates, balloon inflation, cardioplegia delivery) are equivalent to predicates and fall within acceptable engineering specifications.
- Substantial equivalence: Comparison to legally marketed predicate devices to demonstrate similar intended use, technological characteristics, and safety and effectiveness profiles. This relies on the established safety and effectiveness of the existing predicates.
-
The sample size for the training set: Not applicable. There is no "training set" in the context of this traditional medical device submission.
-
How the ground truth for the training set was established: Not applicable. There is no "training set" 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).