(182 days)
The following are the indications for use for the System 96 Intra Aortic Balloon Pump:
- Refractory Ischemia
- Myocardial Infarction
- Preoperative Hemodynamic Stability
- Weaning from Cardio Pulmonary Bypass
- Refractory Ventricular Failure
- Cardiogenic Shock
- Unstable Refractory Angina
- Septic Shock
- Angioplasty Support
- Intraoperative Pulsatile Flow Generation
Any other uses are not recognized by Datascope Corporation as bonafide.
Datascope System 96 Intra-Aortic Balloon Pump (IABP)
This document is an FDA 510(k) clearance letter for the Datascope System 96 Intra-Aortic Balloon Pump (IABP). It states that the device is substantially equivalent to a predicate device and can be marketed.
However, the provided text DOES NOT contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The document is a regulatory approval, not a scientific study report. It indicates that the device has met the FDA's requirements for substantial equivalence, but it does not detail the specific performance metrics or the studies used to demonstrate those metrics.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. To get this information, you would need to access the actual 510(k) submission from Datascope Corporation (K965236) to the FDA, which would contain the technical data and performance studies.
§ 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.