(442 days)
The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.
The New Aera Tidal Assist Ventilation (TAV) system comprises a small, lightweight, wearable, battery-powered ventilator, TAV-C100, and a nasal pillow interface, TAV-NP10. The system is intended to connect to an air or oxygen source and supports three modes of delivery:
- Tidal Assist mode, a breath-activated ventilation assist mode in which the delivered gas from the source entrains additional room air at the nasal pillows interface, delivering it under positive pressure during the patient's inhalation to assist breathing;
- Conserve mode, a breath-activated delivery mode used to conserve oxygen consumption when using a cylinder with regulator; and
- Constant mode, presenting a continuous 1 – 5 LPM flow of oxygen to the patient.
For the Tidal Assist mode, the user may select one of five flow delivery settings, corresponding to a delivered minute volume of approximately 1 - 5 LPM.
For the Conserve mode, the user may select one of five pulse delivery settings, corresponding to an equivalent gas flow rate of approximately 1 - 5 LPM.
For the Constant mode, the user may select one of five flow delivery settings, corresponding to a delivered gas flow rate of approximately 1 - 5 LPM.
The TAV system is battery operated, running from a single AA alkaline battery. Under typical usage, battery life is ~ 14 days; a low battery alert activates when battery life is less than 2 days under typical usage.
The system has a simple user interface, comprising: - a mode selection button;
- buttons to increase or decrease the delivered flow rate;
- a button to turn the device on and off, and to temporarily silence any alarms;
- LED indicators for the current delivery mode, flow setting, and low battery and alarm conditions; and
- an audible buzzer used to alert the user to an alarm condition.
The device has two pneumatic ports: - an inlet port, used to connect the regulated gas source to the device, and
- an outlet port, used to connect the device to the patient interface.
Lastly, the device has a bypass valve, used to deliver a constant 2 LPM gas flow rate to the patient in the event of a system failure.
The provided text describes the New Aera Tidal Assist™ Ventilator (TAV™) System and its substantial equivalence to a predicate device, the Breathe Technologies – NIOV Ventilator (BT-V2S).
Here's the breakdown of the acceptance criteria and the study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for performance metrics with specific numerical targets. Instead, it compares the proposed device's features and performance to a predicate device (BT-V2S) and a reference device (Chad Evolution Model OM-900) to demonstrate substantial equivalence. The "acceptance criteria" are implied by the similarity to the predicate device and meeting general performance specifications and standards.
| Feature | Predicate (BT-V2S) | Proposed Device (TAV System) | Status (Implicit Acceptance) |
|---|---|---|---|
| Device Classification | Class II/ONZ | Class II/ONZ | Met (Identical) |
| Prescription Device | Yes | Yes | Met (Identical) |
| Indications for Use | Similar to proposed device (volume assist for spontaneously breathing adults with respiratory insufficiency, continuous applications in institutional/home care, trained personnel/caregivers under physician) | Similar to predicate device | Met (Similar) |
| Patient Population | Spontaneously breathing adults (minimum tidal volume 3.5cc/kg PBW) | Spontaneously breathing adults (minimum tidal volume 3.5cc/kg PBW) | Met (Similar) |
| Environments of Use | Home and institutional settings | Home and institutional settings | Met (Similar) |
| Technical Method | Light-weight, portable, electronically timed/controlled volume assist ventilator; delivers bolus 50-250ml blended with ambient air; two components: ventilator & patient interface | Light-weight, portable, electronically timed/controlled volume assist ventilator; delivers bolus 50-250ml blended with ambient air; three components: regulator adapter, ventilator & patient interface | Met (Similar) |
| Method of Flow Control | Electronically controlled proportional valve | Electronically controlled proportional valve | Met (Identical) |
| Delivered Gas | Oxygen or air | Oxygen or air | Met (Identical) |
| Gas Supply Compatibility | DISS 1240 connection | DISS 1240 connection and other compatible regulated oxygen or air sources | Met (Compatible/Broader) |
| Patient Interface | Interface with large opening(s) for spontaneous breathing, pressurized nozzles for entrainment | Interface with large opening(s) for spontaneous breathing, pressurized nozzles for entrainment | Met (Similar mechanism) |
| Trigger Sensitivity | User adjustable fixed pressure setting | Preset relative flow trigger setting with signal artifact correction | Met (Equivalent performance demonstrated by testing) |
| Initiation of Bolus | At onset of inhalation | At onset of inhalation | Met (Identical) |
| Bolus Delivery Phase | During inhalation | During inhalation | Met (Identical) |
| Oxygen Bolus Size | 50 to 250ml | 50 to 250ml | Met (Identical) |
| Breath Rate | Up to 40 breaths/minute, patient triggered | Up to 40 breaths/minute, patient triggered | Met (Identical) |
| Additional Delivery Modes | Not offered | Capable of delivering pulsed-dose oxygen (Conserve Mode) & continuous flow oxygen (Constant Mode) | Exceeds (Improved functionality not raising new concerns) |
| Total Delivered Volume | Up to 1,150 ml (max 18 cmH2O) | Up to 1,150 ml (max 18 cmH2O) | Met (Identical) |
| Backup Mode | Yes | Yes | Met (Identical) |
| Backup Rate | 3 LPM or 12 breaths/min | 3 LPM or 12 breaths/min | Met (Identical) |
| Alarms | High/Low Source Pressure, High/Low Delivery Pressure, High Circuit Pressure, High PEEP, High Temp, System Fault, Breath Time Out, Low/High Breath Rate, Low Battery | Pressure regulation system, High/Low Flow Alarm, System Fault, Breath Time Out, Low/High Breath Rate, Low Battery | Met (Similar and adequate) |
| Battery Alarm | Low Battery ( |
§ 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).