(90 days)
The device indications for use are as follows: 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 Intra Aortic Balloon catheter comes with a catheter tray and an introducer tray. The catheter tray contains: a 9Fr. 40cc IAB catheter, airway tubing w/female luer fitting, 6" pressure tubing with stopcock, a 3 way stopcock, a 60cc syringe, an optional Datascope or Arrow adaptor, 36" pressure tubing, and a male luer lock cap. The accessory tray contains; a percutaneous tearaway introducer, 8" or 11" introducer dilators, 18 gauge angiography needle, and two 150cm floppy J guidewires.
The provided text describes a 510(k) summary for the Bard 9Fr., 40cc. RediGuard and TaperSeal balloons. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain information about a study proving device performance against specific acceptance criteria for a medical device that would typically involve AI or software.
The document explicitly states:
"The Bard RediGuard and TaperSeal IAB catheters were subjected to biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A, and to the FDA's current guidelines on IAB testing. All testing was successfully completed."
This indicates that the performance data for this submission is related to biocompatibility and general IAB testing, not to the kind of performance metrics (sensitivity, specificity, AUROC, etc.) typically associated with AI-powered devices or diagnostic tools.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: No such criteria or reported performance (beyond "successfully completed" biocompatibility) are mentioned for the purpose of a clinical or performance study demonstrating efficacy through metrics like sensitivity or specificity.
- Sample size used for the test set and the data provenance: Not applicable as there's no mention of a test set for performance evaluation in the context of AI or advanced diagnostic capabilities.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable as there is no mention of an algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
This 510(k) submission is for a medical device (intra-aortic balloon catheters) that appears to be a physical product without a stated AI component or advanced diagnostic software requiring performance evaluation against such criteria. The "Performance Data" section focuses on biocompatibility, which is a different type of testing.
§ 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.