(442 days)
The Trilogy Evo Universal ventilator provides continuous or intermittent pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediativ through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive ventilation.
The Trilogy Evo Universal ventilator is a microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is intended to provide continuous or intermittent ventilatory support. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It is applicable for adults and pediatric patients weighing at least 2.5 kg who require the following types of ventilatory support:
Control Modes
- A/C-PC: Assist control .
- . A/C-VC: Assist control
Spontaneous modes
- CPAP: Continuous positive airway pressure .
- PSV: Pressure support ventilation .
Mixed modes
- S/T: Spontaneous/timed ventilation .
- . SIMV-PC: Synchronized intermittent mandatory ventilation (pressure control)
- SIMV-VC: Synchronized intermittent mandatory ventilation (volume control)
In addition to the therapy modes, the Trilogy Evo Universal provides the following major functions:
- Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh ●
- Power Management of various power sources (AC, internal and detachable Li-lon batteries and ● external Pb-Acid battery)
- Physiological alarms
- . Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input
- . Bluetooth and USB Communications
- Compatibility with various patient interfaces and multiple circuit types
- Connectivity with hospital monitors ●
- . Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors
- . Ventilation with supplemental low flow oxygen or oxygen blender
The associated accessories include:
- Bacteria Filter ●
- Circuits, including Passive, Active and Dual Limb
- FiO2 Sensor ●
- . Active Exhalation Valves
- . Leak Device
- . Heat and Moisture Exchangers (HME's)
- Oximeter and Sensors
- Capnography Sensors and cable ●
- Flow Sensors
- Detachable Battery and Battery Cables ●
- Roll Stand
- Mounting Bracket .
Here's a breakdown of the acceptance criteria and study information for the Trilogy Evo Universal Ventilator, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Trilogy Evo Universal) |
|---|---|---|
| Intended Use | Continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, with or without air/oxygen blending. Intended for pediatric through adult patients weighing at least 5kg (11lbs). Oximetry Interface kit measures functional oxygen saturation and pulse rate. Used in home, hospitals, institutions, and portable applications (wheelchairs, gurneys). Invasive and noninvasive ventilation. Not a transport ventilator. | Continuous or intermittent positive pressure ventilation for individuals requiring mechanical ventilation. Intended for pediatric through adult patients weighing at least 2.5 kg. Measures, displays, records, and alarms SpO2, FiO2, CO2, and Pulse Rate data when integrated with appropriate accessories. Suitable for institutional/hospital settings and non-emergency transport settings (e.g., wheelchair). Used for both invasive and non-invasive ventilation. |
| Patient Population | Pediatrics and Adults | Pediatrics and Adults |
| Principle Of Operation | Microprocessor controlled, Electronically powered, Software driven | Microprocessor controlled, Electronically powered, Software driven |
| Performance | Met ISO 80601-2-12 requirements on essential performance of ventilators. | Met ISO 80601-2-12 requirements on essential performance of ventilators. |
| Waveform Comparison | Comparable waveform results | Comparable waveform results |
| Design | LCD screen, hard keys, and LED indicators. | Graphic user interface with LCD with touch screen. |
| Delivery method to patient | Continuous or intermittent positive pressure ventilation | Continuous or intermittent positive pressure ventilation |
| Energy Used for device | AC and DC (Battery) Power | AC and DC (Battery) Power |
| Therapy Types | Invasive and Non-Invasive Mechanical ventilation | Invasive and Non-Invasive Mechanical ventilation |
| Software | Not explicitly stated as a separate criterion, but implied under "Principle of Operation" and the software's "major" level of concern. | Software verification and validation testing performed based on product requirements, meeting FDA guidance for "major" level of concern software. All product requirements met with passing test results. |
| Biocompatibility | Not explicitly stated, but implied as a general safety requirement | Biocompatibility evaluation conducted in accordance with FDA Guidance and ISO 10993-1. Testing (cytotoxicity, sensitization, irritation, genotoxicity, implantation, extractables, condensate) found materials biocompatible. Gas pathway materials evaluated via Gas emission VOC, Inorganic gases (CO, CO2, Ozone) and PM2.5 testing. |
| General & Electrical Safety, EMC | Not explicitly stated, but implied to meet relevant standards. | Complies with AAMI/ANSI/ES 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-8:2012, ISO 80601-2-12:2011, ISO 80601-2-55:2011, ISO 80601-2-61: 2011, ISO 5356-1:2015, ISO 5367:2014. |
| Human Factors | Not explicitly stated, but implied as a general safety requirement. | Human Factors/Usability Engineering process followed IEC 62366-1 and FDA guidance. Human factors validation study indicates appropriate user operation and acceptable residual risk. |
Study That Proves the Device Meets Acceptance Criteria:
The document states that the "Trilogy Evo Universal device is as safe and as effective as the predicate device, Trilogy Series Ventilator with Oximetry (K111610) and is deemed substantially equivalent to the predicate device, Trilogy Series Ventilator with Oximetry (K111610)." This substantial equivalence is primarily established through non-clinical tests and a comparison of technological characteristics with the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a numerical sample size for the test set used in the non-clinical tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. The tests were performed on the device itself as part of the verification and validation process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number of experts used or their qualifications for establishing ground truth in the non-clinical tests. The tests rely on compliance with established standards and internal validation processes rather than expert interpretation of data like in a diagnostic study.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for the test set in the context of expert consensus, as the testing involves engineering and performance validation against predefined standards and requirements rather than subjective expert evaluation of study data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Trilogy Evo Universal ventilator. Product functionality has been adequately assessed by non-clinical tests." Therefore, there is no mention of human readers improving with or without AI assistance, as AI assistance in the diagnostic sense is not the primary function of this ventilator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not directly applicable in the traditional sense of a diagnostic AI algorithm. The device itself is a standalone medical device that performs ventilation. The "software verification and validation testing" assessed the algorithm (software) without human intervention during the automated tests. The "Human Factors" study assessed the human-in-the-loop performance from the perspective of safe and effective user interaction with the device, rather than an AI diagnostic aid.
7. The type of ground truth used:
- The ground truth for the non-clinical tests was primarily established by engineering specifications, regulatory standards (e.g., ISO, IEC), and predefined product requirements. For example:
- Performance: Compliance with ISO 80601-2-12 and "All product requirements have been met with passing test results."
- Software: Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Biocompatibility: Compliance with ISO 10993-1.
- Safety/EMC: Compliance with AAMI/ANSI/ES 60601-1 and various IEC/ISO standards.
- Human Factors: Compliance with IEC 62366-1 and FDA guidance, with validation showing appropriate user operation and acceptable residual risk.
8. The sample size for the training set:
- The document does not specify a sample size for a training set. This is because the device is a ventilator, not a machine learning model that requires a "training set" in the common sense of AI/ML software for diagnosis or prediction. The software development process likely involved various internal testing and refinement, but not a distinct "training set" like one would find in, for example, an image recognition algorithm.
9. How the ground truth for the training set was established:
- As a "training set" as commonly understood in AI/ML is not applicable here, the question of how its ground truth was established is not relevant to this document. The "ground truth" for the device's functionality was based on the performance standards and design specifications it was built to meet.
§ 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).