(41 days)
The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.
The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.
The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.
The Maximus™ System is a 2 in 1 device which combines 2 main types of therapies referred to as:
- MIE (Mechanical Insufflation-Exsufflation) Synclara®
- OLE (Oscillation and Lung Expansion) - Volara™
The modification is to add the ability to provide aerosol from the nebulizer via the Ventilator Tee adaptor during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator. All components were cleared under K192143.
The provided text describes a 510(k) premarket notification for the Maximus™ System, a noncontinuous ventilator. The submission is for a modification to an already cleared device (K192143) to add the ability to provide aerosol from the nebulizer via a Ventilator Tee adapter during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparative testing conducted, aiming to demonstrate equivalence to the predicate device. The performance metrics reported are related to aerosol delivery, specifically Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose, and Fine Particle. The acceptance criteria for these metrics were that they should be "equivalent" across different patient interfaces.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Aerosol delivery parameters (MMAD, Total Respirable Dose, Fine Particle) for the new Ventilator Tee Adaptor should be equivalent to those of already cleared patient interfaces (Mouthpiece, Face Mask). | "Testing parameters included the key particle parameters, Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose and Fine Particle, are equivalent. The comparative testing supports that the different patient interfaces are not significantly different in their delivery of aerosol." |
| No new or different questions of safety or effectiveness are raised by the modification. | "The differences presented above have not raised new or different questions of safety or effectiveness from the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or clinical cases. The testing was described as "comparative particle characterization testing comparing the following patient interfaces: Mouthpiece, Face Mask (already cleared under K192143) and delivery through the already cleared Ventilator Tee Adaptor." It was performed at "Adult flow rates (28 Lpm) and Pediatric flow rates (12 Lpm) with 1 drug at the lowest and highest set pressures (5 and 70 cmH2O)." This indicates bench testing rather than patient data.
- Data Provenance: The data is from bench testing performed by the manufacturer, Hill-Rom Services Pte Ltd. There is no mention of country of origin for the data or if it was retrospective or prospective, as it is not human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this submission is based on objective measurements from bench testing of aerosol delivery parameters, not expert human assessment.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation is based on objective measurements from bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This submission describes a modification to a medical device (ventilator) and involves bench testing of its physical performance (aerosol delivery), not a diagnostic algorithm or human interpretation task. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical device, and the testing focuses on its mechanical and delivery performance. There is no AI or algorithm involved in the direct clinical function being evaluated.
7. Type of Ground Truth Used
The ground truth is established through objective physical measurements of aerosol particle characteristics (MMAD, Total Respirable Dose, Fine Particle) using standardized test methods.
8. Sample Size for the Training Set
Not applicable. This device does not involve a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).