(430 days)
The balloon pump is an electromechanical system used to drive intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The Belmont NGPBP System is a light and compact portable system, designed to facilitate balloon pumping at the patient's bedside. The portable balloon pump is a reliable, safe, and effective system designed especially for ease of operation and transportation. The Belmont NGPBP is made up of eight major functional elements: Operator Interface, Signal Acquisition and Display, Triggering and Assist Timing, Pneumatics: Pump Drive System, Pneumatics: Volume Control System, Pneumatics: Shuttle Gas System, System surveillance, Power System.
The provided text describes a Premarket Notification 510(k) Summary for the Belmont Model NGPBP Intra-Aortic Balloon Pump, comparing it to a predicate device, the Belmont Model PBP Intra-Aortic Balloon Pump. The document outlines the device's technical characteristics, intended use, and nonclinical tests conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Belmont NGPBP) |
|---|---|
| Ability to fully inflate and deflate commercially available intra-aortic balloons. | Compared well with the Belmont PBP. Fully inflated and deflated balloons from Bard Cardiac Assist Products, Arrow International, Bard (St. Jude Medical), and Datascope Corporation (nominal volumes 30, 34, 40, 50cc) at static pressure 90 mm Hg and heart rates of 60 and 125 BPM. |
| Appropriate triggering and timing of balloon inflation and deflation from ECG waveform. | Accurately and properly synchronized the inflate/deflate cycle with the patient's heart for a variety of normal and abnormal rhythms with variable heart rate. Maintained proper triggering from ECGs with normal sinus rhythms (30-200 BPM). |
| Performance in presence of ECG artifacts, pacing spikes, and arrhythmias with variable heart rate. | Responded by deflating during PVCs. Pumped acceptably during Atrial Fibrillation (holding inflation until the next R-wave). Triggered properly during Ventricular Tachycardia, erratic rates with Ventricular Fibrillation, and A-Paced rhythms. Responded well to baseline shift, baseline noises, wide QRS, and tall T-wave. |
| Safe operation in the presence of artifacts/interference (fail-safe mechanism). | If the unit could not track the ECG and trigger appropriately in the presence of artifact and interference, the balloon remained deflated, and an alarm was activated. |
| Activation of alarms and cessation of pumping for unsafe conditions. | The Surveillance System activates audible tones, deflates the balloon, and stops further inflation until the source of the alarm is eliminated. An alarm message is displayed. Most alarm conditions require user to restart pumping. |
| Automatic restart for specific conditions (loss of trigger, noisy ECG). | Pumping restarts automatically when the problem (loss of trigger, noisy ECG signal) is eliminated. |
| Ability to trigger from arterial pressure waveform in synchrony with cardiac cycle. | Capable of appropriate trigger balloon inflation and deflation from arterial pressure waveform. (This is mentioned in the conclusion as a common capability with the predicate device, but specific test results for AP triggering aren't detailed as extensively as ECG in section 11.b.) |
| Identification of unsafe balloon and internal conditions (disconnection, overfilling, leakage, etc.). | The Gas Surveillance System uses helium pressure, air drive pressure, and vacuum to determine unsafe balloon and internal conditions including balloon disconnection, overfilling, gas leakage, kinked catheter, and slow deflation. Internal Self Checks determine system malfunctions. |
| Functional equivalence to the predicate device (Belmont PBP) in core functional elements and operation. | The two systems perform identical functions and contain identical eight major functional elements. The NGPBP compared well with the PBP in inflation/deflation tests and triggering/timing under various clinical conditions. The conclusion explicitly states the NGPBP is "substantially equivalent" to the PBP in intended use and core performance capabilities. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: Not explicitly stated as a numerical sample size of patients or recordings. The tests were performed with:
- "Commercially available Balloons" from various manufacturers (Bard, Arrow, Datascope) covering nominal volumes of 30, 34, 40, and 50cc.
- "ECGs with normal sinus rhythms with heart rates of 30-200 BPM."
- Simulated "PVCs, Atrial Fibrillation, Ventricular Tachycardia, erratic rate with Ventricular Fibrillation, and A-Paced" rhythms.
- Simulated "baseline shift, baseline noises, wide QRS, and tall T-wave."
- Data Provenance: The study appears to be retrospective or simulated in nature, utilizing various types of commercially available balloons and simulated/pre-recorded ECG waveforms representing different clinical conditions. There is no mention of prospective patient data or data from specific countries of origin. The testing involves "compar[ing] well with the current IABP," suggesting controlled testing environments rather than direct patient trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The testing described focuses on the device's functional performance against known or simulated physiological conditions. There is no mention of expert review or labeling of a test set.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Since there's no explicitly stated "test set" in terms of clinical images or patient data that would require interpretation or labeling by human experts, there is no mention of an adjudication method. The testing largely involves objective measurements of device response to simulated inputs (e.g., triggering accuracy, inflation/deflation cycles).
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
- No. This document describes the nonclinical (benchtop) performance evaluation of an intra-aortic balloon pump, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance effect size is not applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, indirectly. The entire nonclinical testing described (Section 11) assesses the "algorithm only" performance of the Belmont NGPBP in an automated or simulated environment. The device's ability to "appropriately trigger balloon inflation and deflation" and "synchronize the inflate/deflate cycle" based on various inputs (ECG, AP waveforms) is essentially its standalone algorithmic performance in detecting and responding to physiological signals. The "automatic mode" of the NGPBP also represents an "algorithm only" operation where the system analyzes signals and determines optimal timing with minimum user input.
7. The Type of Ground Truth Used
- The ground truth for the nonclinical tests appears to be known physiological parameters and simulated clinical conditions.
- For inflation/deflation: The ground truth is the expected full inflation/deflation of balloons of known volumes at specified heart rates and pressures.
- For triggering/timing: The ground truth is the accurate and synchronized response to simulated "normal" ECG rhythms (e.g., normal sinus rhythm within 30-200 BPM) and "abnormal" rhythms or artifacts (e.g., PVCs, Atrial Fibrillation, T-waves, baseline noise) where the appropriate device action (trigger, deflate, alarm) is known.
- For safety alarms: The ground truth is the presence of simulated unsafe conditions (e.g., balloon disconnection, gas leakage, kinked catheter, artifact/interference) that should correctly activate alarms.
8. The Sample Size for the Training Set
- Not applicable / Not mentioned. This device does not appear to utilize machine learning or AI in a way that requires a separate "training set" in the conventional sense (i.e., for a supervised learning model). The device's operational logic and control algorithms would be based on established physiological principles and engineering design, not on "learning" from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not mentioned. As there is no explicit training set for AI/ML, the concept of establishing ground truth for it does not apply. The device's functional parameters and safety mechanisms are designed and verified against established medical knowledge and engineering standards.
§ 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.