Search Results

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

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical trials or data for algorithm validation. Instead, the performance evaluation relies on bench testing to demonstrate compliance with international standards.

• Sample Size: Not explicitly stated as a numerical sample size of devices or patient data. Testing would have involved a sufficient number of MR810 units to demonstrate compliance with the specified standards under controlled conditions.
• Data Provenance: The data is from non-clinical (bench) testing performed by Fisher & Paykel Healthcare. The country of origin for the testing is implied to be consistent with the manufacturer's location, New Zealand. The data is prospective in the sense that it was generated specifically for this submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the study did not involve human experts establishing ground truth for a clinical test set. The "ground truth" for the device's performance was established by internationally recognized engineering and medical device standards (e.g., ISO 8185), against which the device performance was measured through objective bench tests.

4. Adjudication Method for the Test Set

This section is not applicable. There was no subjective evaluation by experts that would require an adjudication method. Compliance was determined by objective measurements against predefined standard requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The MR810 System is a medical device for providing heat and humidity to respiratory gases, and its performance is evaluated through engineering and physiological standards, not human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is partially applicable in the sense that the device's performance was evaluated in a standalone manner through bench testing against established standards (ISO 8185, IEC 60601-1, IEC 60601-1-2, ISO 5367). The device's ability to achieve the specified humidity output, enthalpy, and maintain temperature controls was tested directly, without human intervention in operating the device for the purpose of the test (beyond setting up and initiating the tests). There is no "algorithm" in the sense of AI/ML models being evaluated for diagnostic accuracy, but the embedded software controls were part of the system being tested.

7. The Type of Ground Truth Used

The ground truth used was established international standards and regulatory requirements for medical humidifiers and electrical medical equipment. Specifically:

• ISO 8185:1997: Humidifiers for medical use - General requirements for humidification systems. This standard dictated the acceptable range for humidity output and enthalpy.
• IEC 60601-1: 1988 +A1:1991 +A2:1995: Medical Electrical Equipment - Part 1: General Requirements for Safety.
• IEC 60601-1-2: 2001: Medical electrical equipment. Part 1: General requirements for safety. 2. Collateral standard: Electromagnetic compatibility.
• ISO 5367:2000: Breathing tubes intended for use with anaesthetic apparatus and ventilators.

8. The Sample Size for the Training Set

This is not applicable. The MR810 System is a hardware device with embedded software for control, not a machine learning or AI-based system that requires a "training set" of data in the typical sense. The software development and tuning would have occurred during the product development cycle, but it would not be described as a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there was no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and engineering principles would be based on established physics, electronics, and engineering best practices, alongside the requirements of the aforementioned international standards.

Ask a specific question about this device