(277 days)
The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport.
This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O.
The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.
The Inspiration™ 71 / 51 Ventilator System provides continuous ventilation to 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 (K072950), with the following additions:
- . a GUI change to deliver a GUI similar to that of the eVolution ventilator.
- Additional monitored and trended parameters. .
- . Additional waveforms and loops.
- Additional medium and high priority alarms. .
- . Additional patient setup and default setting criteria.
- . : Integration of SNMP fields for settings, monitored and trended data.
- . Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature.
- Integration of various maneuvers
The eVent Medical Ltd. Inspiration 5i/7i Ventilator System is a continuous ventilator. The provided text outlines the device's characteristics and its substantial equivalence to previously cleared predicate devices, but it does not contain typical acceptance criteria and study data as one might expect for an AI/ML powered medical device. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and compliance with established performance standards for ventilators.
Here's a breakdown based on the provided text, aligning with the requested information to the best extent possible given the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a ventilator), "acceptance criteria" are generally tied to meeting established performance standards for medical electrical equipment and critical care ventilators, rather than statistical performance metrics like sensitivity/specificity for an AI model.
The device demonstrates performance by adhering to the following standards:
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| IEC 60601-1: 1995 (Medical Electrical Equipment, Safety) | The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with this standard. |
| IEC 60601-1-2:2004 (Medical Electrical Equipment, EMC) | The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with this standard. |
| IEC 60601-2-12:2001 (Medical Electrical Equipment, Lung Ventilators Safety) | The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with this standard. |
| ASTM F1100-90 (Standard Specification for Ventilators in Critical Care) | Performance was conducted using this standard to demonstrate the durability that the predicate ventilator met and to which compliance has been routinely accepted as requisite to any substantial equivalence claim. |
The document also provides a detailed comparison to predicate devices, showing that the Inspiration 5i/7i shares similar specifications for:
- Description: Functionally identical, with added features (GUI, monitored parameters, waveforms, alarms, setup criteria, SNMP, Capnography, maneuvers).
- Indications for Use: Expanded patient weight and tidal volume ranges (0.3kg-200kg, 5ml-2000ml) compared to the predicate's general "infant through adult" but remains within the same scope.
- Patient Types: Adult, Pediatric, Infant.
- Ventilation Modes (Volume, Pressure, VTV, Apnea backup): All listed modes are identical to the predicate.
- Settings/Controls: Similar primary and advanced settings.
- Monitoring: Includes expanded monitoring parameters compared to the predicate. Integration of Volumetric and Sidestream Capnography capability (7i model only) is a new feature, for which the predicate Hamilton G-5 Ventilator also monitors Capnography parameters.
- Electrical, Battery, Physical, and Environmental Specifications: All are identical or substantially similar to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set in the context of validating an AI/ML model with a specific sample size. The "performance" assessment is based on compliance with established engineering and medical device standards for ventilators, which typically involve testing the physical device against specified operational parameters, safety limits, and durability. Such testing would involve:
- Test Setup: Specialized test lungs, flow meters, pressure sensors, gas analyzers, and other equipment designed to simulate various patient conditions and measure ventilator performance.
- Data Provenance: The testing would be conducted in a controlled laboratory environment by the manufacturer (eVent Medical, Ltd.). The data generated would be from these laboratory tests rather than patient-derived data from specific countries or being retrospective/prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. Ground truth, in the context of AI/ML, refers to expert-labeled data used to train or evaluate models. For a ventilator, the "ground truth" for performance is defined by the technical specifications outlined in the referenced standards (e.g., how accurately a set tidal volume is delivered, or how precisely a pressure control algorithm maintains a target pressure). Performance is measured by calibrated instruments, not by expert human assessment of outputs that require subjective interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Since there is no expert labeling or subjective interpretation of results, no adjudication among experts is required. The device's performance is objectively measured against quantitative standards.
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
An MRMC comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic or interpretive AI systems where human readers (e.g., radiologists) rely on the AI's output. The Inspiration 5i/7i Ventilator System is a life-support device that directly delivers therapy, not an AI-powered diagnostic or interpretive tool that assists human decision-making in the same way.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable in the AI/ML sense. The ventilator itself operates as a "standalone" system in delivering ventilation based on its internal algorithms and controls, but this is not analogous to the standalone performance of a diagnostic AI algorithm. The device's performance stands alone in its ability to ventilate according to user settings and clinical needs, guided by its software and hardware. The evaluation of its "standalone" performance is covered by the compliance testing to the referenced standards.
7. The Type of Ground Truth Used
The "ground truth" for this device is the technical specifications and performance requirements defined by recognized medical device standards (e.g., IEC 60601-1, IEC 60601-2-12, ASTM F1100-90). The device is tested to ensure it operates within the defined tolerances and safety limits specified by these standards. This is a form of engineering or objective performance ground truth, derived from established industry requirements, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The Inspiration 5i/7i Ventilator System, as described in the submission, is a traditional medical device with software control, not an AI/ML device that undergoes a "training" phase with a large dataset. Its development involves traditional software engineering, control system design, and rigorous testing against specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As it is not an AI/ML device, there is no "training set" in the context of machine learning, and therefore no ground truth established for such a set. The design and validation relied on established engineering principles, safety standards, and performance test protocols for ventilators.
§ 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).