(90 days)
-Refractory left ventricular failure,
-Cardiogenic or septic shock.
-Unstable refractory angina.
-Impending infarction,
-Ischemia related ventricular arrhythmias,
-Weaning from cardiopulmonary bypass,
-Support and stabilization during coronary angioplasty,
-Intraoperative pulsatile flow generation,
-Associated mechanical complications of acute myocardial infarction,
-Support and stabilization of high-risk patients undergoing general surgical procedures.
Each double lumen percutaneous TaperSeal" IAB catheter is pre-furled and has a hemostasis device attached to the catheter which may be slid down the catheter and into the insertion site as necessary in the event of excessive bleeding from the puncture site. Each TaperSeal" IAB catheter is packaged into a balloon kit that contains airway tubing, a syringe, syringe adaptor. Kontron and/or Datascope adaptor, and pressure tubing with a stopcock. The TaperSeal" IAB catheters also come packaged with an insertion kit which contains a percutaneous tear away introducer, two guidewire, an angiography needle, and a vessel dilator.
The provided text describes a 510(k) summary for the Bard TaperSeal IAB Catheters and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria as typically found in AI/ML device submissions. The document is for a medical device (intra-aortic balloon catheter), not an AI/ML device, and therefore the requested information categories (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable.
The "Performance Data" section solely states:
"Bench testing was performed to verify that the TaperSeal Catheter can withstand insertion forces associated with sheathless insertion. All testing was completed successfully."
This is a very general statement and does not provide any of the granular details requested in the prompt, such as specific acceptance criteria, reported performance values against those criteria, sample sizes, expert involvement, or ground truth methods.
Therefore, I cannot populate the requested table or provide answers to the specific questions regarding acceptance criteria and study details based on the provided text. The document is not relevant to an AI/ML device context.
§ 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.