(323 days)
The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.
Indications for Use:
Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:
- Unstable refractory angina .
- Impending infarction ●
- Post Infarction Angina or Threatening Extension of Myocardial Infarction .
- Refractory ventricular failure .
- Mechanical complications because of myocardial infarction ●
- Cardiogenic shock .
- Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
- Ischemic related intractable ventricular arrhythmias .
- Septic shock .
- Interoperative pulsatile flow generation
- Weaning from cardiopulmonary bypass .
- Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
- Prophylactic support in preparation for cardiac surgery .
- . Post-surgical myocardial dysfunction
- Cardiac Contusion .
- Mechanical bridge to other assist devices ●
- Cardiac support following correction of anatomical defects ●
- Support for failed angioplasty and valvuloplasty
The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases.
The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:
Acceptance Criteria and Device Performance Study
The iPulse Intra-Aortic Balloon Pump Console's acceptance criteria primarily revolved around demonstrating equivalence to two legally marketed predicate devices: the Datascope CS100 Intra-Aortic Balloon Pump (K031636) and the Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Predicate Equivalence) | Reported Device Performance (iPulse Console) | Relevant Section for Performance |
|---|---|---|
| Intended Duration of Use: Temporary use, approx. ≤ 30 days | Temporary use, Approx. ≤ 30 days | Table 1 |
| IAB Catheter Tested: 8F, 40 cc | 8F, 40 cc | Table 1 |
| IABP Drive System: Electro-pneumatic with replaceable helium cylinder | Electro-pneumatic with replaceable helium cylinder | Table 1 |
| User Interface/Display Type: Laptop | Laptop | Table 1 |
| Maximum Beat Rate: ≥ 185 BPM (based on lower predicate) | 200 BPM | Table 1 |
| Trigger Signals Accepted: ECG, Aortic pressure | ECG, Aortic pressure | Table 1 |
| Console Size (on Cart): Comparable dimensions to predicates | 30"Hx23"Wx11"D | Table 1 |
| Console Weight: Comparable weight to predicates | 126 lbs | Table 1 |
| Voltage Requirement: 120/240 Vac | 120/240 Vac | Table 1 |
| Battery Type: Sealed Lead Acid | Sealed Lead Acid | Table 1 |
| Battery Runtime (minimum): ≥ 2.0 hours (based on lower predicate) | 2.5 hours | Table 1 |
| Safety and Effectiveness: Equivalent to predicates | Safe and effective | Section g & h |
| Performance and Reliability: In accordance with FDA guidance | Demonstrated equivalence to 2 predicate IABP consoles | Section g |
| Software Verification: Compliance with applicable standards | Demonstrated compliance | Section g |
| Electrical Standards (EMI, EMC, Electrical Safety): Compliance with applicable standards | Demonstrated compliance | Section g |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a "test set" in terms of patient data or a specific number of devices tested for comparative performance. The pre-clinical testing mentioned involves "laboratory tests" which are typically in-house engineering and performance evaluations.
- Sample Size: Not specified in terms of number of devices or clinical cases. The testing was conducted on the iPulse IABP Console itself.
- Data Provenance: The testing was "pre-clinical laboratory testing" conducted by ABIOMED, Inc. (manufacturer). There is no mention of country of origin for any external data, and it is entirely retrospective in the sense that it's a report of completed internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this device's performance relies on engineering specifications, adherence to functional requirements, and comparison to the published specifications and performance characteristics of predicate devices. There is no mention of human expert evaluation in establishing a "ground truth" for the device's technical performance in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable, as there was no "test set" requiring adjudication by human experts in a clinical context. The "adjudication" for the device's performance was an assessment against established engineering and regulatory standards and comparison to predicate device specifications.
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. This device is an Intra-Aortic Balloon Pump Console, not an AI-powered diagnostic tool requiring a MRMC study for human reader performance. Its effectiveness is measured by its mechanical and electrical performance in assisting the heart, not by improving human interpretation of medical images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (hardware and embedded software) that operates in conjunction with human operation (human-in-the-loop is inherent to its use in a clinical setting). It is not solely an "algorithm" in the sense of an AI model being evaluated for standalone diagnostic performance. The pre-clinical testing did evaluate its standalone technical performance against specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for evaluating the iPulse IABP Console's performance was:
- Engineering specifications and functional requirements: The device was tested against its design specifications for parameters like maximum beat rate, battery runtime, drive system, etc.
- Regulatory standards: Compliance with applicable electrical standards (EMI, EMC, Electrical Safety) and software verification methods.
- Predicate device performance: The performance of the iPulse console was specifically compared to the Datascope CS100 and Arrow AutoCAT2, aiming for "equivalence" in performance and reliability. FDA guidance for IABP catheters and consoles was also referenced.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device, not a machine learning model that requires a training set and corresponding ground truth.
§ 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.