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The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CARDIOSAVE IABP (Hybrid Model) is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IABPs.

This document is a 510(k) Pre-Market Notification for a modification to an existing device, the CARDIOSAVE Intra-Aortic Balloon Pump (Hybrid Model). The modification involves adding a new Top Protection Cover.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data or a specific number of units used for testing the Top Protection Cover. The testing appears to be focused on engineering verification of the physical modification itself, rather than clinical performance on a sample of patients.

• Sample Size: Not explicitly stated as a number of devices or clinical cases. The testing would likely involve a representative number of units to prove the effectiveness of the cover.
• Data Provenance: The document does not mention data provenance in terms of country of origin or retrospective/prospective studies. This is expected given the nature of the modification (a physical cover) and the type of testing performed (engineering verification).

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

This information is not applicable as the study described is an engineering verification for a physical modification, not a clinical study requiring expert assessment for ground truth determination.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. Adjudication methods are typically used in clinical trials or studies where human interpretation or decision-making is being evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The modification is a physical cover, not a software algorithm or a device requiring human interpretation for its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable as the device is an Intra-Aortic Balloon Pump, which is a physical device with electromechanical functions, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the engineering design requirements and safety standards for a medical device and its components. The device needs to prove that the new Top Protection Cover effectively prevents liquid spills from entering the unit and causing malfunction or damage, and that it does not negatively impact the existing performance of the IABP.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring model training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set. The "ground truth" in the development process would be established by the design specifications, risk assessment, and regulatory requirements for the device and its modification.

Summary of the Study:

The study performed was focused on design verification testing for a new Top Protection Cover on an existing CARDIOSAVE IABP (Hybrid Model). The primary goal of the cover is to protect against liquid spills.

The manufacturer, Datascope Corp., completed the following activities:

• Risk Assessment: To ensure the modification does not introduce new risks.
• Verification Testing: To confirm the cover meets its intended protective function and does not alter the IABP's performance.

The conclusion is that the modification does not impact the performance characteristics of the predicate device, does not introduce any new risks, and does not raise any new questions of safety and effectiveness. The design verification testing established that the device with the new cover performs the same as the predicate device. No clinical testing was deemed necessary due to the nature of the modification.

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