(28 days)
The Datascope 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheter has the following indications for use:
- Refractory ventricular failure.
- Cardiogenic shock.
- Unstable refractory angina.
- Impending infarction.
- Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture.
- Ischemia related intractable ventricular arrhythmias.
- Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients.
- Septic shock.
- Weaning from cardiopulmonary bypass.
- Intraoperative pulsatile flow generation.
- Support for failed angioplasty and valvuloplasty.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery. The intra-aortic balloon is placed in the descending aorta just below the subclavian artery to provide temporary support during the following situations: Refractory ventricular failure, Cardiogenic shock, Unstable refractory angina, Impending infarction, Impending infarctions due to acute myocardial infarction, Ischemic related intractable ventricular arrhythmias, Ischemic related intractable voluncial and coronary angiography or angioplasty patients, Septic shock, Weaning from cardiopulmonary bypass, Interoperative pulsatile flow generation, Support for failed angioplasty and valvuloplasty.
The provided document describes the safety and effectiveness of Datascope's 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheters. However, it does not contain a study that presents specific acceptance criteria and detailed device performance results.
Here's a breakdown of the information available based on your request, and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The document states that the "results of in-vitro tests conducted demonstrate that the functionality and performance characteristics are comparable to the currently marketed devices" (Section F, NON-CLINICAL TESTS). This implies a comparison to predicate devices, but no specific criteria or performance metrics are listed for the new device or the predicates.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document explicitly states: "There have been no clinical evaluations of the new device" (Section G, CLINICAL TESTS). This indicates that no clinical test set was used for the new device. The in-vitro tests are mentioned but no details regarding sample size or provenance are given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided. Since there were no clinical evaluations for the new device, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. As no clinical test set was used, no adjudication method would have been required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable and not provided. The document describes a medical device (intra-aortic balloon catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not provided. The device is a physical medical instrument, not a standalone algorithm.
7. The Type of Ground Truth Used:
This information is not applicable and not provided for the new device directly. Given the statement "There have been no clinical evaluations of the new device," any ground truth would pertain to the predicate devices or general medical understanding, not a specific test set for this submission.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. As this is a medical device and not an AI or machine learning model, the concept of a "training set" in this context is not relevant.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. See point 8.
In summary:
The provided document describes a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices. The submission relies on non-clinical (in-vitro) tests to demonstrate comparability in functionality and performance characteristics. No clinical studies were performed on the new device, meaning there is no information regarding clinical acceptance criteria, device performance in a clinical setting, test set size, expert ground truth, or adjudication methods for this specific submission.
§ 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.