(156 days)
The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:
- Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs)
- CMV and IMV mode of ventilation with or without PEEP / CPAP
- Provide oxygen or a mixture of medical air and oxygen
The pNeuton mini ventilator is a small, lightweight transport ventilator designed for use on patients from neonate to pediatric in size (400 gram to 25 kg). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable inspiratory time, expiratory time and pressure is delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable from 21 to 100 percent. The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device. The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use. The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.
The pNeuton mini Ventilator is a device designed for providing ventilatory support to critically ill neonate to pediatric patients. Its acceptance criteria and proof of meeting them are detailed in the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through its specifications, which meet or exceed the requirements of relevant voluntary standards. Below is a summary of key performance characteristics and their specifications:
| Characteristic | Acceptance Criteria (pNeuton mini Ventilator Specification) | Reported Device Performance (as per non-clinical testing) |
|---|---|---|
| Maximum Working Pressure Limitation | 80 cm H2O | The device is designed for 80 cm H2O maximum working pressure. No specific deviation is mentioned, implying it met this. |
| Maximum Inspiratory Flow | 20 L/min | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. Implicitly, this includes flow. |
| Inspiratory Time Control Setting | 0.25 to 2.0 sec | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Inspiratory Time Accuracy | ± 10% | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Expiratory Time Control Setting | 0.25 to 20.0 sec | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Expiratory Time Accuracy | ± 10% | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Peak Patient Pressure Control Setting | 15 – 60 cm H2O | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Peak Patient Pressure Accuracy | ± 2 cm H2O | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Flow Rate Control Setting | 6, 8, 10, 15, 20 L/min | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Flow Rate Accuracy | ± 10% | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| CPAP Control Setting | 0 - 20 cm H2O | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| CPAP Accuracy | ± 2 cm H2O | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Oxygen Control Setting | 21 to 100% | The precision air/oxygen blender is noted as being used for neonatal ventilation due to specific requirements, implying greater accuracy than prior models. |
| Oxygen Accuracy | ± 3% | Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. |
| Monitored Pressure Parameter Range | -10 to 80 cm H2O | Performance as specified. |
| Monitored Pressure Accuracy | ± 2 cm H2O | Performance as specified. |
| High Pressure Alarm | 10 - 70 cm H2O (settable) | Performance as specified. Implicitly, this alarm range is met. |
| Environmental Operating Temperature | -15 to 49 °C (5 to 120 °F) | Passed RTCA DO-160G (Temperature Variation, Humidity, Robust Vibrations, Spray Proof) and MIL-STD-810F (Rapid decompression, Jet Aircraft Random Vibration) tests, confirming operation within and beyond listed limits. Endurance tests for 240 hours at environmental extremes. |
| Humidity | 15 to 95 percent humidity | Passed RTCA DO-160G, section 6, Humidity tests using Category A. |
| MRI Compatibility | MR Conditional 3T | Passed ASTM F2052-06e1 and ASTM F2119-07 testing using a 3 Tesla scanner. No induced displacement force, performance variance, or artifact generated. |
| Reliability/Lifespan | Not explicitly stated, but implies performance over lifetime | Operated continuously for 2,200 hours at two different clinical simulated conditions, and an additional 240 hours at environmental extremes. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Clinical testing was not performed on this device." Therefore, there is no test set in the context of human patient data. The provenance of the data is from non-clinical bench testing and simulated conditions performed by the manufacturer, Airon Corporation, presumably in the USA (where the company is based). The data is retrospective in the sense that it represents controlled lab measurements and simulations based on predefined specifications and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As clinical testing was not performed and the data is non-clinical bench testing, the concept of "ground truth" derived from expert clinical opinion is not applicable here. The "truth" or reference for performance was established by engineering specifications and recognized industry standards (e.g., ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F). The experts involved would be those who developed these standards and the engineers and technicians at Airon Corporation who conducted the tests and verified compliance. Their qualifications would be in engineering, medical device manufacturing, and testing, rather than medical clinical specialties for patient diagnosis.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used. The device's performance was judged against pre-defined engineering specifications and compliance with voluntary standards through measurement and direct verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical testing was not performed on this device." The submission relies on substantial equivalence to predicate devices and non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the non-clinical testing described represents standalone performance of the device. The pNeuton mini Ventilator is a mechanical, pneumatic device with no electronic controls or software, hence no "algorithm" in the modern AI sense. The testing verified the physical and mechanical performance of the device itself against its specifications in a controlled, simulated environment, without direct human interaction or intervention during the operational tests (e.g., the 2,200 hours of continuous operation).
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on:
- Engineering specifications: The target performance parameters (e.g., flow rates, pressure ranges, time accuracies) defined by Airon Corporation for the pNeuton mini Ventilator.
- Voluntary industry standards: Specific requirements and test methodologies outlined in standards such as ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F, and CGA V-5:2008. These standards define acceptable ranges and test environments for ventilators.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this device is a mechanical ventilator and does not involve machine learning algorithms that would typically require a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).