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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:

1. 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.
2. 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.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable as there is no mention of an algorithm being trained.
9. 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.

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