(392 days)
Cardiogenic shock, Pre- shock syndrome, Post- infarction angina (Threatening extension of MI) Unstable refractory angina, or impending infraction, Ischemia related intractable ventricular dvsrhythmias. Septic shock syndrome, Cardiac contusion, Support for diagnostic interventional procedures including: (Cardiac Angiography, Coronary Angioplasty (PTCA), Coronary Atherectomy, Failed Mitral Valvuloplasty), Mechanical complications due to acute myocardial infraction: (Valvular stenosis - Mitral stenosis, Mitral Valve insufficiency ~ Mitral regurgitation, Ventricular Septal Defect (VSD), Papillary muscle rupture). Prophylactic support in preparation for cardiac surgery or high risk cardiac patients undergoing non-cardiac surgical procedures, Post-surgical myocardial dysfunction , Cardiac support following correction of anatomical defects, Maintenance of graft patency post-coronary bypass surgery. Pulsatile flow during cardiopulmonary bypass, Mechanical bridge to other assist devices.
The ACAT 1 IABP is the next generation of the Arrow/Kontron KAAT II Plus IABP manufactured by Arrow International. The ACAT 1 system is an advanced multi microprocessor based system that provides flexibility of operation and extended patient care capabilities, designed for in hospital and transport applications. The ACAT 1 is a completely new industrial design package from the KAAT II Plus. Several new features have been incorporated which have continued to be customer requirements or preferences. The physical design of the ACAT 1 is smaller and lighter in weight than the current KAAT II Plus design. Overall we have incorporated new updates while maintaining the current product strengths of the KAAT II Plus system which are: Unique lifetime metal bellows drive system Wide range of triggering options Continuous assessment/maintenance of helium Safe alarming system Calibrated, continuous usable Balloon Pressure Waveform Cold trap, vapor removal system Ease of use
This 510(k) summary describes a device (ACAT 1 IABP) and its substantial equivalence to previously marketed devices. However, it does not contain the information necessary to describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any of the specific points requested (Tables of acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.).
The document focuses on:
- Identifying predicate devices (Arrow International KAAT II Plus IABP, Datascope Corporation System 95 & 97 IABP, C. R. Bard, Inc. TransAct H-8000 IABP).
- Highlighting new features and design changes of the ACAT 1 compared to the KAAT II Plus, such as being smaller and lighter, while maintaining existing strengths.
- Listing the indications for use for the intra-aortic balloon pump.
- Providing the FDA's clearance letter, confirming substantial equivalence based on the provided information.
To answer your request, a different type of document, likely a test report or a clinical study report that was part of the 510(k) submission (but not included in this publicly available summary), would be needed. This 510(k) summary explicitly states that the device is "substantially equivalent" to predicate devices, which implies that the performance requirements are met by demonstrating similarity to already cleared devices, rather than necessarily performing a new study against explicit, novel acceptance criteria defined in this document. Often, for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device operates similarly to the predicate device and does not raise new questions of safety or effectiveness.
§ 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.