Search Results

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:

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.

Ask a specific question about this device

The Inspiration ® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture.

This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.

The provided text does not contain detailed information regarding specific acceptance criteria applied to the Inspiration® Ventilator System regarding its performance with Heliox, nor does it describe a study that explicitly proves the device meets such criteria with detailed performance metrics.

However, based on the available information, we can infer the primary "acceptance criterion" being evaluated is substantial equivalence to existing devices, particularly concerning the addition of Heliox gas mixture delivery. The text focuses on demonstrating that the device operates safely and effectively with Heliox, similar to its operation with air and 100% O2, and does not introduce new safety or effectiveness concerns.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria for Heliox performance are not given, we will infer them from the safety and effectiveness claims.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "eVent Medical's bench studies of the Inspiration with high percentages of Helium." However, no specific sample size for a test set (e.g., number of test scenarios, ventilator units tested, or duration of tests) is provided.

The data provenance for the bench studies is internal to eVent Medical ("eVent Medical's bench studies"). It is implied to be prospective testing conducted by the manufacturer for this submission. The document also refers to a "review of the clinical literature on the operation of the Inspiration with Heliox," but this appears to be a separate supporting review rather than a primary study for this specific device modification.

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 text refers to "eVent Medical's bench studies," implying internal testing, but does not detail the personnel or expert involvement in establishing ground truth for these tests.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the context of "bench studies," it's likely internal verification processes were used, but no specific adjudication method (like 2+1/3+1 expert review) is mentioned, as this is typically more relevant for clinical image interpretation or diagnostic device studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size

No, an MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a continuous ventilator system and its ability to deliver Heliox.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing mentioned, "eVent Medical's bench studies," appears to be standalone testing of the device's performance characteristics (e.g., FIO2 accuracy, ability to deliver Heliox without anoxic mixtures). There is no mention of "human-in-the-loop" performance testing for this specific modification, although the overall device is used with human operation.

7. The Type of Ground Truth Used

For the "bench studies," the ground truth would be based on instrumentation and reference measurements of FIO2, gas mixture composition, and potentially other ventilator parameters, established through validated laboratory methods. For the claim that "Heliox poses no increased health risk," the ground truth is derived from a review of clinical literature.

8. The Sample Size for the Training Set

The document describes software modifications and bench studies for a ventilator, not a machine learning or AI-based diagnostic device that typically requires a "training set" in the context of model development. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here and is not provided.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no training set in the AI/ML sense described here. The "ground truth" for the device's overall design and software development would be established through engineering specifications, regulatory guidelines, and internal validation processes.

Ask a specific question about this device