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The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to provide separated perfusion of the arch and distal thoracic aorta with temperature differential, if desired.

The Cobra Catheter is an externally communicating device in limited contact with circulating blood.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cobra™ Catheter, structured according to your request:

Acceptance Criteria and Device Performance

The provided 510(k) summary focuses heavily on demonstrating substantial equivalence to predicate devices rather than clearly defined numerical acceptance criteria for the Cobra™ Catheter itself. The text implies that the acceptance criteria are met if the device demonstrates:

• Biological compatibility, non-toxicity, and safety for limited contact (up to 6 hours) with circulating blood.
• Structural integrity.
• Key device functionality.
• Ease of use.
• Adequate venous oxygen saturation delivery.
• Preservation of cerebral autoregulation (implied by differential temperatures).

However, no specific quantitative thresholds or numerical targets are provided for these criteria. The "reported device performance" is descriptive and comparative.

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document mentions "clinical studies" including "Feasibility and randomized clinical studies" and "und case" (likely a typo for "one case" or "study case"). However, no specific numerical sample sizes are provided for these clinical studies.
• Data Provenance: The document does not explicitly state the country of origin. Given the applicant is Cardeon Corporation in Cupertino, CA, and the FDA is the reviewer, it's highly probable the studies were conducted in the United States. The studies were prospective as they were conducted to demonstrate the safety and effectiveness of a new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not provided in the document. The studies are described in terms of "clinical studies" and "standard surgical techniques," implying a clinical setting, but details on expert involvement for ground truth establishment are absent.

4. Adjudication Method:

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done as described. This device is a medical catheter, not an imaging or diagnostic AI device that typically involves human readers interpreting data. The comparison is between the new device's performance and predicate devices, or between the device and standard clinical practices/outcomes, rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone AI algorithm performance study was not done. The Cobra™ Catheter is a physical medical device, not an AI algorithm. Its performance is evaluated through in vitro, in vivo, and clinical studies of its physical function and clinical impact, not through an algorithm's output.

7. Type of Ground Truth Used:

• For the in vitro and in vivo tests, the ground truth was likely established through direct measurement against engineering specifications and biological response assessments (e.g., cell viability, clotting, inflammation).
• For the clinical studies, the ground truth was based on clinical outcomes and physiological measurements such as "adequate venous oxygen saturation" and "differential temperatures indicating the preservation of cerebral autoregulation." This constitutes outcomes data and physiological markers monitored during surgical procedures.

8. Sample Size for the Training Set:

• This information is not applicable/not provided because the Cobra™ Catheter is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable/not provided as there is no AI training set involved for this physical device.

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The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

Not Found

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."

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.

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The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.

The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit.

The provided text describes the Cardeon® Ascending Balloon Cannula (ABCTM) and its regulatory clearance (K022042). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or data provenance as requested.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study with quantitative acceptance criteria and detailed performance data.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific force limits, flow rates, failure rates thresholds). The general "acceptance criteria" are implied to be that the device functions "as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
• Reported Device Performance:
  • "Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
  • This is a qualitative statement of equivalence, not specific quantitative performance data against defined criteria (e.g., "burst pressure > X mmHg", "flow rate > Y L/min with

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The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

Not Found

The provided text is a 510(k) summary for the Cardeon Aegis Catheter. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed acceptance criteria and a human-readability study as would be typical for AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available or applicable in this document. This document describes a traditional medical device (a catheter), not a software or AI/ML device, so the requested format does not align with the information provided.

However, I can extract the following based on the available text:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the format of a table with specific performance metrics and acceptance criteria. The submission states that "Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as predicate devices." This is a general statement of performance rather than specific, quantifiable acceptance criteria.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/not provided. The submission refers to "product testing," which included "biocompatibility, in vitro and/or in vivo performance." However, specific sample sizes, study methodologies (retrospective/prospective), or data provenance are not detailed as they would be for an AI/ML device's test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/not provided. 'Ground truth' in the context of an AI/ML device typically refers to expert-labeled data. For a physical device like a catheter, performance is assessed through engineering tests and potentially animal or human clinical trials, where 'ground truth' doesn't fit the same paradigm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided. This refers to consensus-building among experts for labeling data, which is not relevant for this type of device submission.

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/not provided. MRMC studies are specific to AI-assisted diagnostic or interpretive devices, which this catheter is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to AI algorithm performance without human intervention, which is irrelevant for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. As mentioned, the concept of 'ground truth' in this context doesn't align with AI/ML device evaluation. The assessment of this catheter's safety and effectiveness would rely on engineering specifications, biocompatibility testing results, and comparison to predicate devices' established safety and performance profiles.

8. The sample size for the training set: Not applicable/not provided. This device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable/not provided.

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The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

The provided text does not contain detailed information about specific acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for the Cardeon Aegis™ Catheter in the way requested in the prompt. The document is a 510(k) summary and an FDA clearance letter, which typically focus on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with the requested metrics.

The document states:

• Substantial Equivalence: "The determination of substantial equivalence was also based on an Product Testing: assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as a predicate devices."
• Performance Claim: "Differences between the Aegis Catheter and other devices do not alter or diminish the rate of arterial return required during cardiopulmonary bypass."

However, it does not provide the granular details requested in the prompt about specific acceptance criteria or the study that proved the device met them. It generally states that testing demonstrated safety and effectiveness compared to predicate devices.

Therefore, I cannot fully populate the requested table and answer all the questions based on the provided text.

Based on the provided text, here is what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Note: The document emphasizes substantial equivalence to predicate devices and general statements about biocompatibility and performance rather than specific, quantitative acceptance criteria that would typically be found in a detailed study report.

Study Details

1. Sample sizes used for the test set and the data provenance: Not specified in the provided text. The document mentions "in vitro and in vivo performance" testing but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified in the provided text. This type of information is typically related to diagnostic devices or image analysis, not physical medical devices like catheters, where "ground truth" might be established through direct measurement or observation during testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for performance testing of a physical medical device like this catheter.
4. 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 study type is for AI/diagnostic devices and involves human readers assessing cases. The Cardeon Aegis™ Catheter is a physical device for perfusion.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This study type is for AI/diagnostic devices. The Cardeon Aegis™ Catheter is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in the context of "ground truth" as typically defined for AI/diagnostic devices. For this type of device, "ground truth" would likely refer to objective measurements of flow rates, pressure, material integrity, and biocompatibility observed during in vitro and in vivo testing, often compared against established medical standards or predicate device performance.
7. The sample size for the training set: Not applicable. Training sets are for machine learning algorithms. The Cardeon Aegis™ Catheter is a physical medical device.
8. How the ground truth for the training set was established: Not applicable.

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