(30 days)
The AC3™ Range ™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions:
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- Acute Coronary Syndrome
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- Cardiac and Non-Cardiac Surgery
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- Complications of Heart Failure
The AC3 Range IABP system is a professional use device that provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.
The AC3 Range IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels for easy transport.
The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The pump display incorporates a high-definition touchscreen with color coded icons and a keypad for system operation. The AC3 Range IABP uses software to select and maintain precise IAB catheter inflation timing and triggering based on real time physiological data from the patient. The system offers two modes of operation, (1) the AutoPilot mode, where most functions are automatically selected and controlled by IABP and (2) the Operator mode where the user has control over most settings and selections.
This document describes the AC3™ Range™ Intra-Aortic Balloon Pump (IABP), a device intended for counter-pulsation therapy in adult patients with impaired Left Ventricular (LV) Function, providing hemodynamic support.
Based on the provided text, the device is a new version of the AC3™ Series IAB Pump (K232343), and the submission is for substantial equivalence. Therefore, the study details are focused on demonstrating that the new device is as safe and effective as the predicate device, rather than establishing de novo clinical performance.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates for an AI system) and corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence to a predicate device through Mechanical and General Safety Testing.
The "acceptance criteria" implicitly are that the new device performs equivalently to the predicate and raises "no new questions of safety or effectiveness."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Identical Indications for Use | Met: The AC3™ Range™ Intra-Aortic Balloon Pump (IABP) has the same indications for use as the predicate: 1. Acute Coronary Syndrome, 2. Cardiac and Non-Cardiac Surgery, 3. Complications of Heart Failure. |
| Identical Fundamental Technologies | Met: The device description states it features identical fundamental technologies. The AC3 Range IABP system consists of two components: (1) the pump control/display module (display, touch screen, keypad) and (2) the pneumatic drive module with wheels. It also uses software for precise IAB catheter inflation timing and triggering. It offers AutoPilot and Operator modes. |
| Identical Principles of Operation | Met: The device description states it features identical principles of operation. It provides counter-pulsation therapy through volume displacement principles, supporting blood pressure and reducing cardiac work. |
| Identical Performance (Comparative) | Met: "Substantial equivalence was demonstrated through Mechanical and General Safety Testing. The results of these tests raised no new questions of safety or effectiveness and demonstrated that the subject AC3 Range IABP is substantially equivalent to the predicate device." While specific test results are not provided, the conclusion is that the performance is equivalent. |
| No New Questions of Safety or Effectiveness | Met: The conclusion explicitly states that the tests "raised no new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document only mentions "Mechanical and General Safety Testing." This typically involves bench testing, engineering evaluation, and electrical safety tests, rather than a clinical trial with a "test set" of patient data in the context of an AI/software device. Therefore, a sample size of patient data or its provenance is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. As this is not a study establishing clinical ground truth for a diagnostic or prognostic AI algorithm, there is no mention of experts establishing a ground truth for a test set. The evaluation focuses on engineering and safety equivalence.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method, as the study type does not involve human interpretation or complex clinical endpoints requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is not an AI-assisted diagnostic tool or an imaging device directly evaluated for human reader improvement. The focus is on the safety and functional equivalence of the IABP system itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
While the device uses software to select and maintain IAB catheter inflation timing and triggering, this is presented as an integral part of the device's function, not a separate standalone AI algorithm being evaluated. The "Mechanical and General Safety Testing" would encompass the performance of the integrated software as part of the overall device functionality. No separate standalone algorithm performance study is described.
7. Type of Ground Truth Used:
Ground truth, in the typical sense of clinical outcomes or expert labels, is not directly applicable. For "Mechanical and General Safety Testing," the "ground truth" would be established engineering standards, performance specifications (e.g., pressure, flow, timing accuracy), and safety requirements, against which the device's measured performance is compared.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device where a separate training set is used for algorithm development and then a test set for evaluation. The device is a medical pump system with embedded software.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. Similar to point 8, there isn't a training set for an AI algorithm in the context described in this document.
§ 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.