(73 days)
The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.
The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices. The IABP 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.
The provided text is a 510(k) summary for the CS100/CS100i and CS300 Intra-Aortic Balloon Pumps. It states that the device is substantially equivalent to a predicate device and includes information about modifications made to the device. However, it explicitly states that there was no clinical evaluation of the modified device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, and ground truth, as these details are typically derived from clinical studies or extensive performance testing, which were not conducted for the modified device described in this document.
The document only notes that:
- The changes consist of a revised blood detection software function.
- "Performance data" claims that "The results of the tests conducted demonstrate that the modified CS100/CS100i and CS300 Intra-Aortic Balloon Pumps perform as intended."
- "Datascope Corp. development process required that the following activities be completed...: Requirements specification review, Performance testing, Design verification and validation."
Without a clinical study, there are no specific acceptance criteria for performance metrics that would typically involve human-in-the-loop performance or comparison against a gold standard established by experts.
In summary, based on the provided text, the device's substantial equivalence was determined without a clinical study, meaning the details requested (acceptance criteria, performance, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance) are not available within this document.
§ 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.