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510(k) Data Aggregation
(139 days)
MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
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 or prevent condensation and to it 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 or unheated breathing tubes can be used to deliver the humidified gas to the patient. Heated breathing tubes 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 adapters 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 yentilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. When used with heated breathing circuits the electrical adapter from the humidifier 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. Invasive Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37 ℃ (body temperature). Non-Invasive Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31 ℃. 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, or incorrect equipment set-up conditions, and when in the invasive mode, of inadequate delivered humidity.
Here's a breakdown of the acceptance criteria and the study descriptions for the Fisher & Paykel MR850 Respiratory Humidifier, as derived from the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device must meet relevant regulatory standards for electro-medical and EMC safety. | Meets requirements of IEC 60601-1, IEC 60601-1-2, UL 2601-1, FDA Reviewer Guidance for Excerpts related to EMI (November 1993). |
| Performance: Device must provide required temperature and humidification output across various respiratory gas therapies. | Clinical verification studies demonstrated the humidifier was able to provide required temperature and humidification output across a variety of respiratory gas therapies. |
| Usability: Requires low user intervention and reduced susceptibility to user error. | Required a low level of user intervention and had reduced susceptibility to user error factors. |
| Functionality: Modified technological components must fulfill their purpose of safety and effectiveness improvements and 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. |
| Compliance with Specific Standards: Meets performance and safety requirements of ISO 8185 and ASTM F1690 (USA) for Humidification Systems. | Complies with performance and safety requirements of ISO 8185 and ASTM F1690 (USA) with the exception of clauses 51.6.2 and 51.7, and 50.2.4.1 for non-heated breathing circuits. |
| Equivalence to Predicate Devices: Equivalent to or better than predicate devices in terms of safety, effectiveness, and performance. | The MR850 is equivalent to the predicate MR850 in terms of type, configuration, power usage, performance, and control method. It uses equivalent materials and some common components. Equivalent to the predicate MR730 in terms of unheated breathing circuits. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical verification studies (test set). It only refers to "clinical verification studies" in a general sense.
The provenance of clinical data is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications. The "clinical verification studies" likely involved medical staff, but specific details are not provided.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device is a respiratory humidifier, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
The device itself is a piece of medical equipment, not an algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the typical sense for an AI device. The humidifier operates autonomously to deliver humidified gas, based on its internal controls and sensors, without requiring constant human intervention beyond initial setup and monitoring. The "performance" refers to the device's ability to maintain specific temperature and humidity levels.
7. Type of Ground Truth Used
The ground truth for the performance claims appears to be derived from direct measurements of the device's output (temperature, humidity, flow parameters) during operation, and likely observations of patient outcomes/comfort in clinical settings. The "clinical verification studies" would have assessed the device's ability to achieve intended physiological effects.
8. Sample Size for the Training Set
The concept of a "training set" is not explicitly applicable here, as this is a physical medical device, not an AI model that undergoes a training phase with a distinct dataset. The development process involved engineering, testing, and refinement, but not in the same way an AI model is trained.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" in the context of AI models is not applicable. The device's design and engineering would have been informed by established medical standards for respiratory humidification, physiological requirements for patients, and results from initial design verification and validation testing, which serve as the "ground truth" for its functional and performance characteristics.
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