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510(k) Data Aggregation
(139 days)
These devices are intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart.
These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.
The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae (2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also available separately for user convenience. The user assembles the components into the final product configuration immediately prior to use. The assembled device diverts oxygenated, arterial blood from the patient's aorta directly to one or two coronary arteries, thereby providing perfusion of an ischemic area of the heart during cardiac surgical procedures
The Medtronic AortoCoronary Shunt and Arteriotomy Cannulae are medical devices intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart during cardiac surgical procedures. The provided 510(k) summary outlines the non-clinical performance data used to assert substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Negative (non-toxic) results in a battery of tests per ISO 10993-1. | - Cytotoxicity (MEM Elution Method): Negative results- Sensitization (Guinea Pig Maximization Method): Negative results- Intracutaneous Reactivity (in rabbits): Negative results- Acute Systemic Toxicity (in mice): Negative results- Genotoxicity (Ames Salmonella typhimurium / Escherichia coli Mutation Reversion Method): Negative results- Hemocompatibility (material-mediated Hemolysis and Thrombogenicity): Negative results |
| Tensile and Hydrostatic Burst Testing | Acceptable strength and integrity of all device segments. | Yielded acceptable results on all segments of the fully assembled AortoCoronary Shunt. |
| Resistance to Fluid Flow | Capable of delivering blood to target coronary arteries at flow rates higher than normally observed. | Demonstrated that the product is capable of delivering blood to target coronary arteries at flow rates that are higher than are normally observed in those coronary arteries. Evaluated for both Arteriotomy Cannulae alone and the fully assembled AortoCoronary Shunt. |
| Resistance to Kinking and Damage due to Clamping | Acceptable resistance to kinking and damage. | Yielded acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance data, meaning these are laboratory or bench tests, not tests on human subjects. Therefore, the concept of a "test set" with human data is not applicable in this context.
- Sample Size: Not explicitly stated for each test (e.g., number of devices tested for tensile strength). However, the document implies that a sufficient number of samples were tested to demonstrate acceptable performance for each criterion.
- Data Provenance: The tests are explicitly described as "non-clinical" performance data, conducted in a laboratory setting. Country of origin of data is not specified but is implicitly associated with the submitter, Medtronic Cardiac Surgical Products, Grand Rapids, MI, USA. The data is prospective in the sense that the tests were conducted specifically to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this involves non-clinical bench testing, the concept of "ground truth" established by medical experts (e.g., radiologists) for a test set is not relevant. The "ground truth" here is the physical and biological characteristics measured by the laboratory tests against established scientific and regulatory standards (e.g., ISO 10993-1).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies or clinical trials to resolve discrepancies in expert opinions. For non-clinical bench testing, the results are typically quantitative measurements or qualitative observations directly compared against pre-defined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, not on comparing the effectiveness of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This submission is for a physical medical device (AortoCoronary Shunt and Arteriotomy Cannulae), not for an artificial intelligence/machine learning algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is based on:
- International Standards: Specifically, ISO 10993-1 for biocompatibility.
- Engineering Principles and Benchmarks: For functional tests like tensile strength, burst pressure, fluid flow resistance, and kinking resistance, the ground truth is established by physical measurements and comparison against expected physiological performance (e.g., flow rates higher than normally observed in coronary arteries) and engineering specifications for device integrity.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device. The tests described are for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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