(522 days)
The Fisher & Paykel Healthcare MR850 Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas, to reduce condensation. They are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier. The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.
The MR850 Humidifier is a Respiratory Gas Humidifier (heated pass-over type) according to 21 CFR §868.5450. Heat is used to provide evaporated water content to dry breathing gases. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.
The MR850 has a thermoplastic enclosure with dimensions of 140 mm high × 135 mm wide × 173 mm deep, and weighs 2.8 kg. A heater plate is positioned in the top of the unit, where the enclosure rim and finger guard allow a humidification chamber to be added. Temperature probe and heater wire connection sockets are on the right side of the unit. A serial data interface port is located in the underside of the unit, with a mounting bracket at the back of the device.
The unit controls and displays are located on the front panel. Controls consist of power, operating mode and alarm mute buttons. A setup / alarm display indicates if a part of the equipment is incorrectly installed, or type of alarm condition occurring.
Accessories for the MR850 Humidification chambers, breathing circuits, electrical adaptors and temperature / flow probes.
The chamber slides on to the heater plate and contains the water supply for adding humidity to breathing gases. The breathing circuit transports gases to the patient, and includes sections for connection from ventilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. Heated wires in the inspiratory and expiratory limbs prevent condensation. The electrical adaptor supplies power to the heated wires. The temperature / flow probe has sensors at the chamber and patient airway ends of the inspiratory section for heater control.
The MR850 Humidifier has two operating modes. Intubated Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37 ℃ (body temperature). Mask Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31 °C. The MR850 Humidifier monitors temperature, flow parameters and equipment integrity, in order to maintain stable performance conditions. It will also notify the user of high delivered temperature. inadequate delivered humidity, or incorrect equipment set-up conditions.
The provided text describes the 510(k) summary for the MR850 Respiratory Humidifier, which is a regulatory submission to the FDA. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in a clinical trial report.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated in this type of regulatory summary. The information provided is high-level and focused on general compliance and safety/effectiveness demonstrations.
However, I can extract the available information and indicate where details are not provided in this specific document.
Acceptance Criteria and Device Performance (Based on provided text)
The document primarily states that the MR850 Humidifier meets the requirements of various standards and demonstrates safety, effectiveness, and performance. Specific quantitative acceptance criteria or reported performance values are not detailed in a table format. Instead, the general compliance is asserted.
| Acceptance Criterion (Inferred from compliance statements) | Reported Device Performance (Summary from text) |
|---|---|
| Safety: Meets electro-medical and EMC standards. | Meets IEC 60601-1, IEC 60601-1-2, UL 2601-1, and 1993 FDA Reviewer Guidance for Premarket Notification Submissions. Complies with ISO 8185 and ASTM F1690 (USA) particular standards for Humidification Systems (with exceptions for clauses 51.6.2 and 51.7). |
| Effectiveness/Performance: Provides required temperature and humidification output. | Clinical verification studies demonstrated the humidifier was able to provide required temperature and humidification output across a variety of respiratory gas therapies. Shows ability to provide effective humidity levels. |
| User Interaction: Low user intervention, reduced susceptibility to user error. | Required a low level of user intervention and had reduced susceptibility to user error factors. |
| Technological Equivalence: Equivalent to predicate devices in key aspects. | Equivalent to MR730 and HC500 Humidifiers in type, configuration, power usage, performance (same temperature and humidity output), control method, and materials. Equivalent to 7200 Ventilator in heated-wire flow-sensing technology. |
| Hazard Introduction: Modified components do not introduce further hazards. | Modified technological components fulfilled their purpose of safety and effectiveness improvements and did not introduce further hazards to user or patient. |
Detailed Study Information (Based on provided text):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text. The document refers to "Clinical verification studies" but does not give details about the number of patients or duration of these studies.
- Data Provenance: Not specified explicitly. The clinical verification studies were likely conducted internally or by contracted organizations associated with Fisher & Paykel Healthcare. The context implies these are prospective clinical evaluations rather than retrospective data analysis, given they are "verification studies."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. Clinical verification studies would typically involve medical professionals, but their number and specific qualifications (e.g., specific specialties, years of experience) are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text. Adjudication methods are specific to studies involving expert review and interpretation, which are not directly detailed here.
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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:
- This is not applicable and not mentioned in the text. The MR850 Humidifier is a physical medical device (humidifier), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of an algorithm. The device itself (the humidifier) has "standalone" performance in its function as a humidifier. The document states:
- "Non-clinical testing of the MR850 Humidifier has been carried out covering... functional verification, and performance capacity and accuracy."
- "Clinical verification studies on the MR850 Humidifier demonstrated the safety, effectiveness and performance of the device."
- This implies the device was tested for its inherent performance without continuous human intervention during operation, as would be expected for a medical device.
- This is not applicable in the context of an algorithm. The device itself (the humidifier) has "standalone" performance in its function as a humidifier. The document states:
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Clinical verification studies," the ground truth for effectiveness would likely be based on:
- Measured temperature and humidity levels: Comparing device output to established physiological requirements for humidified respiratory gases (e.g., 37 °C for intubated mode, 31 °C for mask mode).
- Patient outcomes/physiological parameters: Assessing patient comfort, respiratory status, or prevention of airway irritation/desiccation.
- For safety, ground truth would involve:
- Adverse event reporting: Observing for any patient harm or device malfunction.
- Compliance with electrical/thermal safety standards: Measured against documented safety limits.
- The document mentions "performance capacity and accuracy" in non-clinical tests, suggesting quantitative measurements against specifications.
- For the "Clinical verification studies," the ground truth for effectiveness would likely be based on:
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The sample size for the training set:
- This information is not provided in the text. The MR850 is a hardware device with embedded control algorithms (e.g., PID algorithm). The "training set" concept is typically relevant for machine learning models, which are not the primary focus of this device's regulatory review. If "training" refers to iterative design and testing during development, the specific size of data used in such iterations is not documented here.
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How the ground truth for the training set was established:
- This information is not provided and is generally not applicable in the context of a traditional hardware humidifier's regulatory summary. The device's "ground truth" (i.e., correct operational parameters) would be based on established medical and engineering principles, physiological requirements for respiration, and relevant international standards. The PID algorithm would be tuned based on engineering control theory and empirical testing to achieve desired temperature and humidity outputs.
§ 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).