(28 days)
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
The DLP® Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.
This document is a 510(k) Pre-Market Notification from the FDA regarding Medtronic's DLP® Silicone Coronary Artery Ostial Cannulae. It confirms the device's substantial equivalence to previously marketed predicate devices. The information provided heavily focuses on regulatory approval and comparisons to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device studies is not applicable or present in this document.
However, I can extract the information that is present concerning the device itself and the testing performed for its regulatory approval.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints for a new AI device or a software's performance metrics (e.g., sensitivity, specificity). Instead, for this medical device (cannulae), the "acceptance criteria" are implied by the performance tests conducted to ensure substantial equivalence to a predicate device after a material change. The "reported device performance" reflects the successful completion of these tests.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance (Result) |
|---|---|
| Material Strength/Integrity: | |
| Hub Tensile Pull-Off Force (Barbed Female Luer) | Pass |
| Dimensional Conformance: | |
| Dimensional Analysis (Barbed Female Luer) | Pass |
| Biocompatibility: | |
| Biocompatibility (Barbed Female Luer) | Pass |
| Biocompatibility (Silicone adhesive for ink printing) | Pass |
| Ink Adhesion: | |
| Rub Off Test (Silicone adhesive for ink printing) | Pass |
Note: The document states "The following performance tests were conducted:", but then only lists the results of those tests under the "Verification/Validation" column for the specific component changes.
2. Sample Size for Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical data for an AI/software device. The performance tests mentioned (Tensile Pull-Off Force, Dimensional analysis, Biocompatibility, Rub off test) are engineering/material tests performed on the device components. The sample size for these specific tests is not explicitly stated in this document.
Given that this is a 510(k) submission for a physical medical device (cannulae) and not a software/AI device, the concept of "data provenance (e.g. country of origin of the data, retrospective or prospective)" as it relates to patient data is not applicable here. The "data" refers to engineering test results.
3. Number of Experts and their Qualifications for Ground Truth
This information is not applicable and not provided in the document. The regulatory filing is for a physical medical device (cannulae) based on demonstrating substantial equivalence through engineering tests, not an AI/software device requiring human expert ground truth for clinical performance.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI datasets, which is not the subject of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided in the document. MRMC studies are used for evaluating the performance of imaging devices or AI algorithms interpreted by human readers, which is not relevant to this physical device submission.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable and not provided in the document. This device is a physical medical instrument, not an algorithm, so a "standalone algorithm only" performance study is not relevant.
7. Type of Ground Truth Used
For the engineering tests conducted, the "ground truth" would be established by established engineering standards, material specifications, and validated test methods. For example, the "Pass" result for tensile pull-off force indicates that the component met pre-defined strength requirements, which serve as the "ground truth" for its mechanical integrity. This is not "expert consensus," "pathology," or "outcomes data" in a clinical sense.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. A "training set" refers to data used to train an AI algorithm, which is not relevant to this physical device submission.
9. How Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document, as there is no training set for an AI algorithm.
§ 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).