(51 days)
The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.
The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) 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 (K151254/S001) is a 510(k) premarket notification for a modification to an existing device, the CARDIOSAVE Intra-Aortic Balloon Pump. The modification is specifically an "alternative AC/DC Bulk Senior Power Supply with an increased load driving capacity."
Because this is a submission for a minor modification (a Special 510(k)), and not a new device or a significant functional change, there is no AI or software component involved, and therefore no study addressing AI performance. The review focuses on demonstrating that the new power supply does not negatively impact the device's original validated performance.
Therefore, most of the requested information about AI acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document.
However, I can extract information related to the non-clinical tests performed for this specific modification:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Compliance with IEC60601-1-2 EMC Collateral Standard | The alternative AC/DC Bulk Senior Power Supply for the CARDIOSAVE Hybrid IABP complies with IEC60601-1-2 EMC Collateral Standard. |
| Compliance with IEC60601-1 for rough handling and movement | The alternative AC/DC Bulk Senior Power Supply for the CARDIOSAVE Hybrid IABP complies with IEC60601-1 for rough handling and movement across a threshold. |
| Compliance with Electrical Safety Tests of IEC60601-1 (including humidity soak) | The alternative AC/DC Bulk Senior Power Supply for the CARDIOSAVE Hybrid IABP complies with Electrical Safety Tests of IEC60601-1 including humidity soak. |
| Requirements specification review | Completed as part of Datascope Corp. development process. |
| Performance testing | Completed as part of Datascope Corp. development process. Results demonstrate that the functionality and performance characteristics of the alternative AC/DC Bulk Senior Power Supply is comparable to the currently marketed predicate. |
| Design validation | Completed as part of Datascope Corp. development process. The design verification and validation testing established that the CARDIOSAVE Hybrid IABP with the alternative AC/DC Bulk Senior Power Supply performs as well as the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of units tested. The testing involved compliance with standards and performance/design validation, which typically involves a representative sample of the hardware component.
- Data Provenance: Not applicable as this is hardware testing against engineering standards and requirements, not biological data. The tests were performed by "Datascope Corp." as part of their development process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is hardware safety and performance testing against engineering standards, not clinical or diagnostic ground truth establishment by medical experts.
4. Adjudication method for the test set:
- Not applicable. This is hardware safety and performance testing.
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. This document refers to a power supply modification, not an AI or software device. There are no human readers or AI involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document refers to a power supply modification, not an AI or algorithm.
7. The type of ground truth used:
- The "ground truth" here is defined by engineering standards (IEC60601-1-2, IEC60601-1) and internal performance specifications for the power supply. The device is expected to meet these predefined technical benchmarks.
8. The sample size for the training set:
- Not applicable. This is hardware testing, not machine learning.
9. How the ground truth for the training set was established:
- Not applicable. This is hardware testing, not machine learning.
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.