(219 days)
The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:
- Positive pressure ventilation .
- Assist/Control, SIMV, CPAP modes of ventilation .
The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.
The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.
The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.
This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.
The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of SVGA and Touchscreen. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC input, the internal battery, and the option of external battery pack. The ventilator operates from this source, as well as recharging the internal battery.
The provided document, K032451, is for a medical device (TBird VELA Ventilator) and details modifications to an already cleared device. It primarily focuses on demonstrating substantial equivalence to predicate devices and verifying performance requirements.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and specific ground truth methodologies for an AI device is not applicable to this submission. This document describes a ventilator, which is a hardware medical device, not an AI/ML-driven software device.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. The document states "Performance testing verified that the TBird VELA Ventilator meets its performance requirements," but does not present a table of specific acceptance criteria or quantitative performance metrics in the way one would for an AI model. The verification is at a system level for a hardware device.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to a clinical study for an AI algorithm, not the engineering performance verification of a ventilator.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This pertains to AI model evaluation, not hardware device performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI model evaluation.
- 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 pertains to AI model evaluation, specifically human-in-the-loop performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI model evaluation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This pertains to AI model evaluation.
- The sample size for the training set: Not applicable. This pertains to AI model training.
- How the ground truth for the training set was established: Not applicable. This pertains to AI model training.
The document indicates that "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States." This implies that internal engineering and functional tests were conducted to ensure the device performs as intended and meets relevant safety and effectiveness standards for a ventilator, likely against established benchmarks for similar devices. However, the specific details of these performance requirements and test outcomes are not provided in this summary.
§ 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).