(21 days)
The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.
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The provided text describes a 510(k) summary for the Cardeon® Aegis™ Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report with performance metrics.
Here's an analysis of the information available, structured according to your request, with a necessary acknowledgement of missing data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the Cardeon® Aegis™ Catheter does not explicitly state specific numerical acceptance criteria for performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The performance is assessed through "product testing" to show that the modified device "functions as safely and effectively as previously approved devices."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: substantial equivalence to predicate devices in terms of safety and effectiveness) | "Results of product testing demonstrated that the modified Aegis Catheter functions as safely and effectively as previously approved devices." |
| Biological compatibility | Tested (mentioned in "Product Testing") |
| In vitro performance | Tested (mentioned in "Product Testing") |
| In vivo performance | Tested (mentioned in "Product Testing") |
| Device performance characteristics (e.g., flow pattern, rate of arterial return) | Differences between the Aegis Catheter and other devices "do not alter or diminish the rate of arterial return required during cardiopulmonary bypass." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "product testing" without these specifics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The submission does not mention the use of experts to establish ground truth for a test set in the context of this 510(k) summary. The evaluation appears to be based on engineering and biological testing, comparing the device against established performance characteristics of predicate devices, rather than an expert-driven assessment of diagnostic accuracy.
4. Adjudication Method for the Test Set
As no expert-based ground truth establishment is described, there is no mention of an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic devices where human reader performance is a key metric. The Aegis Catheter is a surgical device, and its evaluation focuses on its physical and biological performance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of a "standalone" algorithm performance is not applicable here as the Aegis Catheter is a physical medical device, not an algorithm. The "Product Testing" mentioned would be considered the standalone performance evaluation of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance relies on engineering specifications, direct measurements of physical properties (e.g., flow rate), and biological compatibility testing to ensure it meets the requirements for its intended use and is comparable to predicate devices. It is not an "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device. The ground truth essentially is that the device performs its intended mechanical and biological functions safely and effectively as demonstrated through testing.
8. The Sample Size for the Training Set
As this is a physical medical device and not an AI/ML algorithm that requires training data, there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of Device and Study Focus:
The K024058 submission for the Cardeon® Aegis™ Catheter is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The "study" described is a series of "product testing" efforts, including biocompatibility, in vitro, and in vivo performance tests. These tests were conducted for both the original and modified Aegis devices to confirm that the modified device's performance aligns with the original and other marketed devices. The level of detail on specific test parameters, sample sizes, and quantitative results is typical for a 510(k) summary (i.e., often not fully elaborated in the public summary document). The FDA's decision to grant substantial equivalence indicates that the information provided (which would have been more detailed in the full submission, not just the summary) was sufficient to meet their requirements.
§ 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).