(91 days)
The Fisher & Paykel Healthcare 880 Respiratory Humidification System (880 System) is intended to be used to warm and humidify breathing gases delivered to spontaneously breathing patients requiring assisted breathing and / or mucosal humidification. The system is intended to be used in a hospital environment by trained healthcare providers.
The 880 Respiratory Humidification System (880 System) is designed to condition gases for patients by raising the delivered water vapor content and temperature of the gases.
The 880 System consists of the following components:
- · MR880 Respiratory Humidifier (MR880)
- · Accessories:
- a) RT241 Heated Delivery System
- b) 900MR441 Adaptor
The MR880 is an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber (chamber).
An unheated tube connects a gas source to the chamber input port. The chamber output port is connected to a heated inspiratory tube designed for exclusive use with the MR880. The gas is heated by means of a heaterwire placed internally within the heated inspiratory tube and enables the humidified gas to be transported to the patient whilst simultaneously minimizing the loss of humidity as condensation.
The MR880 controls the amount of heat provided to the chamber and the power to the heaterwire in the heated inspiratory tube via a proprietary algorithm.
Sensors external and internal to the gas path provide feedback on ambient room temperature, gas flow and gas temperature to regulate temperature and humidity delivery to the patient.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets them based on the provided text. The text is a 510(k) summary for a respiratory humidification system, which typically outlines the device, its intended use, and a comparison to a predicate device for substantial equivalence. It confirms that non-clinical testing was performed, but does not provide details of the specific acceptance criteria or the study data demonstrating how the device met those criteria.
Specifically, the document states:
- "Non-clinical testing of the 880 System has been carried out covering mechanical, electrical and thermal safety; electromagnetic compatibility, functional verification and performance."
- "The 880 System complies with requirements of IEC 60601-1-2 Electromagnetic Compatibility."
- "The MR880 has been submitted for testing to IEC 60601-1 Medical electrical equipment -General requirements for safety."
- "Testing carried out on the 880 System indicates that they meet design and performance functional requirements."
- "The proposed device meets the requirements of medical electrical equipment and respiratory humidifier standards for safety and performance."
While these statements confirm that testing was done and the device met requirements, they do not provide the detailed acceptance criteria, reported device performance metrics, or study characteristics (sample size, data provenance, ground truth establishment, expert involvement, etc.) that you requested. This information would typically be found in the actual test reports or a more detailed submission than a 510(k) summary provides.
§ 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).