(25 days)
The e360 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. Intra-hospital transport includes patient transport within the hospital or hospital-type facility
The Newport e360 Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (≥20 mL) through adult patients. Front panel controls allow trained operators to select ventilation controls for 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. When fully charged, the internal battery provides approximately 45 minutes of power. The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
This document is a 510(k) summary for the Newport e360 Ventilator. The information provided focuses on the device's description, intended use, and general testing, rather than a detailed study proving performance against specific acceptance criteria in a clinical context. Therefore, many of the requested categories about clinical study design and outcomes cannot be fully addressed from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Hardware Performance | Met pre-defined acceptance criteria (implicit) |
| Software Performance | Met pre-defined acceptance criteria (implicit) |
| Electrical Safety | Met pre-defined acceptance criteria (implicit) |
| Functional Safety | Met pre-defined acceptance criteria (implicit) |
| EMC (Electromagnetic Compatibility) | Met pre-defined acceptance criteria (implicit) |
| Packaging | Met pre-defined acceptance criteria (implicit) |
| Environmental | Met pre-defined acceptance criteria (implicit) |
| Alarm System Performance | "The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995)." |
Explanation: The document states, "Comprehensive verification and validation testing was performed with the Newport e360 Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria." However, it does not provide specific numerical or qualitative acceptance criteria for these categories, nor does it detail the specific performance results for each. It only states that the criteria were met. The alarm system's performance is specifically mentioned as meeting or exceeding critical care ventilator standards and FDA guidance.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in this document. The testing described is verification and validation, which often involves engineering and regulatory tests, not necessarily a "test set" in the context of clinical data for AI/ML performance.
- Data Provenance: Not applicable. This document describes testing for a ventilator device, not an AI/ML algorithm that relies on patient data for its performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert-established ground truth from clinical data. The "ground truth" for a ventilator's performance is typically defined by engineering specifications, regulatory standards, and physical measurements.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes.
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. This document describes a medical device (ventilator) and its engineering-based verification and validation, not an AI-assisted diagnostic or interpretive system that would be subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not a study of an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance would be based on:
- Engineering Specifications: Designed performance parameters.
- Regulatory Standards: Compliance with FDA Draft Reviewer Guidance for Ventilators (1995) and other relevant industry standards for medical devices (e.g., electrical safety, EMC).
- Physical Measurements and Testing: Verification of output pressures, volumes, modes, alarm thresholds, etc., using specialized equipment.
8. The sample size for the training set
- Not applicable. This is not an AI/ML system requiring a training set from data.
9. How the ground truth for the training set was established
- Not applicable.
§ 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).