(160 days)
The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using a continuous or 'intermittent non-invasive ventilator system or a continuous gas flow system.
The MR810 System is intended for non-invasive therapies only. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive ventilation is beneficial to prevent drying of the patient airways.
The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.
The Fisher & Paykel Healthcare MR810 System is designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
The MR810 System consists of the following components:
- . MR810 Respiratory Humidifier
- Accessories: .
- O Breathing circuit (i.e. 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit)
Note: The 900MR810 and 900MR810E breathing circuits have identical heated inspiratory limbs, however the 900MR810E also includes an expiratory limb (unheated) and a Y-piece (which connects the inspiratory and expiratory limbs).
- O Humidification chamber (as cleared in K934140 and K913368).
The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element which transfer heat to the water in a humidification chamber and control power to the heated inspiratory limb of the breathing circuit.
A dryline tube (part of the breathing circuit) transports respiratory gases from a gas source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.
The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube of the 900MR810 and 900MR810E breathing circuits is electrically heated by means of a heaterwire placed internally to the tube, which is controlled by the MR810 respiratory humidifier.
The MR810 respiratory humidifier also includes a built-in heaterwire adaptor. The heaterwire adaptor makes an electrical connection with the heated inspiratory limb of the breathing circuit for the purpose of powering the heated limb. The heater wire adaptor incorporates an ambient (room) temperature sensor and a chamber temperature sensor. The heaterwire adaptor also includes an embedded LED to visually indicate that the heated breathing circuit has been connected correctly.
The expiratory limb of the breathing circuit transports expired gas from the patient when a return flow of expired gases from the patient to the gas source is required (the 900MR810E Adult Dual Limb Breathing Circuit should be used as it includes an expiratory limb).
The Fisher & Paykel Healthcare MR810 System is a respiratory gas humidifier designed to condition respiratory gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Feature | Requirement (Acceptance Criteria) | MR810 Performance (Reported) | Comment |
|---|---|---|---|
| Humidity Performance | ≥ 10 mg/L (as required by ISO 8185:1997 for all humidification systems, non-invasive use) | > 10 mg/L (Flow: 5 to 60 L/min) | Meets requirement |
| Humidity Performance (Invasive Use) | ≥ 33 mg/L (as required by ISO 8185:1997 for invasive use) | Not applicable (MR810 is for non-invasive use only) | N/A |
| Enthalpy |
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).