(168 days)
This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.
The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient). The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.
The VORTRAN® GO2VENT™ is a powered emergency ventilator. The device was found substantially equivalent to its predicate device (VORTRAN® Automatic Resuscitator (VAR-Plus), K041473) based on non-clinical performance data and material biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance:
The device's acceptance criteria are based on compliance with the following standards:
- ASTM Designation: F 920 - 93 (Reapproved 1999): "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."
- ISO 10651-5: "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators."
The table below summarizes some key operational characteristics of the device and how they compare to the predicate, demonstrating that the new device meets the same specifications:
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Maximum Inspiratory Flow | 40 L/min | 40 L/min |
| Ventilatory Frequency | Auto-adjusting to lung capacity | Auto-adjusting to lung capacity |
| Peak Pressure Range | 10 - 45 cm-H2O | 10 - 45 cm-H2O |
| PEEP | 2 - 9 cm-H2O | 2 - 9 cm-H2O |
| Required Source Pressure | 50 psig | 50 psig |
| Dead Space | 4 ± 3 mL | 4 ± 3 mL |
| Inspiratory Resistance | 3 ± 1 cm-H2O / L / sec | 3 ± 1 cm-H2O / L / sec |
| Expiratory Resistance | 3 ± 1 cm-H2O / L / sec | 3 ± 1 cm-H2O / L / sec |
| High Pressure Pop-off | Yes, 60 cm H2O | Yes, 60 cm H2O |
| Visual or Audible Indication of High Pressure | Yes | Yes |
| FiO2 Delivery (50% setting) | 50% FiO2 by entraining room air | 50% FiO2 by entraining room air |
| FiO2 Delivery (>85% setting) | FiO2 of >85% (100% O2 supply) | FiO2 of >85% (100% O2 supply) |
In addition, specific modifications were tested:
- MR Conditional: The new beryllium-copper springs were tested according to ASTM F2052 and verified as MR Conditional for a static magnetic field of 3-Tesla or less, and a spatial gradient magnetic field of 10,000-gauss/cm or less.
- New Entrainment Connectors: All testing data showed that the change in the knobs for FiO2 delivery did not degrade performance and the device delivers the required specifications.
- New Beryllium-Copper Springs: Tested for performance and fatigue.
2. Sample size used for the test set and the data provenance:
The document concerns non-clinical performance testing only. There is no specific "test set" sample size in terms of clinical data or patient cases mentioned. The testing was conducted on the device itself and its components. The data provenance is from non-clinical laboratory testing performed by the manufacturer and a third-party (Shellock MR Testing for MR Conditional verification). The data is retrospective in the sense of comparing the new device against previously documented performance of the predicate device and established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this was a non-clinical device performance and material compatibility study, not an expert-driven ground truth establishment for a diagnostic or AI algorithm.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical device performance testing against established standards and predicate device specifications, not a clinical trial requiring adjudication of patient outcomes or interpretations.
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:
No. This is not an AI-enabled device; it is a powered emergency ventilator. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm, but a medical device.
7. The type of ground truth used:
The ground truth for the device's performance is compliance with established engineering and medical device standards (ASTM F 920-93 and ISO 10651-5) and the performance specifications of the predicate device. Material compatibility was assessed against materials used in previously cleared devices.
8. The sample size for the training set:
Not applicable, as this is hardware medical device. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, no training set or ground truth in the context of machine learning.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).