(28 days)
The Arrow Rediguard® 9Fr. 50cc Intra-Aortic Balloon Catheters IAB-R950-U is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
The device is a dual lumen perculaneously inserted Intra-Aortic IAB catheter, 9 Fr. in size, with two independent non-communicating lumens. The outer lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. The IAB is timed to inflate in the aorta during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart. resulting in increased blood supply to the heart muscle arid decreased work load for the left ventricle. The Arrow RediGuard® catheter is available in a 9Fr. 50cc volume, and is identical in appearance and function to the predicate devices.
I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Arrow Rediguard® 9Fr. 50cc Intra-Aortic Balloon Catheters IAB-R950-U) and not a clinical study report.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of a multi-reader multi-case study.
The document primarily focuses on demonstrating substantial equivalence to predicate devices, listing indications for use, and describing the device's technical characteristics for regulatory approval purposes. It mentions "laboratory tests" but does not detail their methodology, acceptance criteria, or results in the context of human reader performance or AI capabilities.
§ 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.