(364 days)
The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues.
This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 lb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician.
The eVolution 3e ventilator system is a class IIb medical device to be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.
The eVolution 3e Ventilator utilizes dual valve technology and three hot wire flow sensors for precise breath delivery and lower work of breathing. The eVolution 3e is an electrically powered microprocessor-controlled software-driven ventilator with an electrically controlled exhalation valve. The eVolution 3e is available in two configurations; one version of The eVolution 3e utilizes an integrated high performance internal gas source (blower) and the second version of the eVolution 3e utilizes outside compressed air source and does not utilize a blower.
The eVolution 3e Ventilator is intended for continuous and intermittent mechanical ventilation for pediatric to adult patients (5 kg or more) requiring respiratory support in various healthcare settings.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria in a quantitative table with corresponding device performance metrics for specific clinical or technical outcomes. Instead, it relies on demonstrating substantial equivalence to a predicate device (eVent Inspiration™ Ventilator System K072590) by comparing technical characteristics and compliance with recognized standards.
The "Comparison Parameter" table serves as the primary document for demonstrating equivalence, highlighting features that are "same as" or have minor differences that do not raise new questions of safety or effectiveness. For example:
| Comparison Parameter | Predicate Device (Inspiration Ventilator System K072590) | eVolution Ventilator System |
|---|---|---|
| Vt (Inspiratory Tidal Volume) | 5 to 2000 ml | 50 - 2000 ml |
| Ti (Inspiratory Time) | 0.1 to 10 sec | 0.2 - 5.0 sec |
| PEEP | 0 to 50 cmH2O | 0 to 40 cmH2O |
| O2 (FiO2) | 21 - 100% | 21 - 100% |
| Operating temperature | 10 to 40 °C | 5-40 °C |
| Operating humidity | 10% - 80% | 15% - 95% |
The overall acceptance criterion is demonstrating that the eVolution 3e Ventilator is as safe and effective as the predicate device by showing:
- Same intended use.
- Similar technological characteristics, or differences that do not raise new questions of safety or effectiveness.
- Performance data demonstrating compliance with recognized consensus standards.
2. Sample Size Used for the Test Set and Data Provenance
The provided text focuses on engineering and performance testing against standards, rather than clinical trials with patient data. Therefore, there isn't a "test set" in the sense of patient data.
- Sample size for test set: Not applicable in the context of clinical patient data. Performance testing would have involved multiple identical devices and defined test conditions as per the standards listed.
- Data Provenance: Not applicable for patient data. The provenance of the performance data stems from engineering tests conducted in a laboratory setting to verify compliance with industry standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The assessment for this device is based on demonstrating technical equivalence and compliance with established engineering and safety standards (e.g., IEC, ASTM). There is no "ground truth" established by clinical experts in the context of diagnostic accuracy for this type of device.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic device requiring human expert adjudication for ground truth. The compliance with standards would be evaluated by qualified test engineers and quality assurance personnel.
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. The eVolution 3e Ventilator is a life-support device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a ventilator, a physical medical device, not an algorithm or software-only system. Its performance is inherent to its mechanical and software functions, which are always "standalone" in their operation (though used by humans).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is compliance with established international and national consensus standards for medical electrical equipment and critical care ventilators. Specifically:
- IEC 60601-1: 1995 (General Requirements for Safety)
- IEC 60601-1-2:2004 (Electromagnetic compatibility)
- IEC 60601-2-12:2001 (Particular requirements for the safety of lung ventilators. Critical care ventilators.)
- EPA Method TO-15 (Determination of Volatile Organic Compounds (VOCs) In Air) - This might be related to material safety or off-gassing, not direct functional performance.
- ASTM F1100-90 (Standard Specification for Ventilators Intended for Use in Critical Care)
The device's performance parameters (e.g., tidal volume accuracy, pressure control, oxygen delivery accuracy, alarm limits) are measured against the specifications and limits defined within these standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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).