(126 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 Intraoperative pulsative now generals of acute myocardial infarction Associated mechanical computations of actions in action in the many of any ical procedures.
Each Intra Aortic Balloon catheter comes with a catheter tray and an introducer tray. The catheter tray contains: a 9Fr. 30cc 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 does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document is a 510(k) Summary for a medical device (Bard 9Fr., 30cc. RediGuard and TaperSeal Intra-Aortic Balloons), which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Here's what the document does include:
- Device Description and Intended Use: Details about the intra-aortic balloon catheters and their clinical applications.
- Comparison to Predicate Device: A table (Table VI-I) highlighting that the new device has the "Same" indications for use, contraindications, packaging, and sterilization as the predicate device. This is crucial for demonstrating substantial equivalence, not performance against specific criteria.
- Performance Data (G): It 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 some testing was done (biocompatibility, and IAB-specific testing per FDA guidelines), and it was "successfully completed." However, it does not provide any specific acceptance criteria, numerical performance results, or details about the studies themselves (e.g., sample size, ground truth, experts).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with quantifiable acceptance criteria.
§ 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.