(100 days)
The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.
The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital transport includes patient transport within the hospital or hospital-type facility.
The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.
Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.
Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.
A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.
The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
Here's a breakdown of the acceptance criteria and study information for the Newport e500 Wave Ventilator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Ventilation Control Modes | Selectable under volume control, pressure control, and volume target pressure control breath types in A/CMV, SIMV, and SPONT modes. |
| Patient Population Supported | Infant/pediatric (>20 mL) through adult patients. |
| Alarms - Standards Compliance | Meet or exceed standards of critical care ventilators and developed in compliance with ISO9703-1, ISO9703-2, and EN475. |
| Alarms - Type | Span both technical (ventilator related) and non-technical (patient related) alarms. |
| Tidal Volume Support | ≥ 20 mL |
| Intended Environments | Hospital-type, and intra-hospital transport environments. Hospital use (general care, OR, special procedures, ICU/critical care). Hospital-type use (surgicenters, sub-acute, special nursing facilities). Intra-hospital transport. |
| Overall Performance | All test results met pre-defined acceptance criteria for hardware, software, electrical safety, functional safety, EMC, packaging, and environmental testing. |
Missing Information:
The document states that "All test results met pre-defined acceptance criteria," but it does not explicitly list the specific values or thresholds for these criteria (e.g., what constitutes "meeting" a standard, or the exact ranges for performance metrics). It provides a high-level statement of compliance.
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). It describes "Comprehensive verification and validation testing," which implies laboratory or simulated testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The testing described is verification and validation, likely against engineering specifications and industry standards, not against "ground truth" established by clinical experts in the sense of diagnostic accuracy.
4. Adjudication Method for the Test Set
- This information is not provided. Given the nature of the testing described (hardware, software, electrical safety, etc.), an adjudication method by human experts for a "test set" in the context of diagnostic performance is not applicable. The device's performance was evaluated against technical specifications and safety standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done or mentioned. This type of study is relevant for AI/diagnostic devices where human readers interpret medical images or data. The Newport e500 Wave Ventilator is a continuous ventilator, not a diagnostic imaging device.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
- The document describes "Comprehensive verification and validation testing" including hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. This implies standalone testing of the device's components and overall system performance without human intervention in the loop, to ensure it meets its pre-defined specifications and safety standards. However, it's not "algorithm only" in the sense of a standalone AI model's performance being evaluated. It's the performance of the integrated device system.
7. Type of Ground Truth Used
- The "ground truth" for the testing appears to be pre-defined acceptance criteria based on:
- Engineering specifications and design requirements.
- Compliance with international standards (ISO9703-1, ISO9703-2, EN475 for alarms).
- Functional safety requirements.
- Electrical safety requirements.
- EMC (Electromagnetic Compatibility) standards.
8. Sample Size for the Training Set
- This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models that learn from data. While the ventilator is microprocessor-controlled, the document does not suggest it uses a machine learning algorithm that would require a distinct "training set" for its core functionality as described.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not indicated for this device's type of functionality in the provided text, this information is not applicable or provided.
§ 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).