(452 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 Respiratory Humidifier is designed to condition gases for patients by raising the delivered water vapor content and temperature of the gases.
It consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a chamber. A tube connects gas to the chamber input. Another tube connects to the chamber output and enables the humidified gas to be transported to the patient. Depending on the chosen configuration, these tubes may be electrically heated, by means of a heater-wire placed internally to the tubes, to minimize the loss of humidifier will control the amount of heat provided. An electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit and incorporates protection circuitry to prevent voltage and current transients on the heater-wire.
Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.
The MR850 Respiratory Humidifier differs from the predicate device by the addition of a new version of software (version 7.25) which includes a humidity compensation feature to the normal heater plate control mode of the modified device. This feature enables the chamber output set temperature to be increased (via a proprietary algorithm) to increase the relative humidity at the patient airway probe position. This is a risk mitigator against specific foreseeable misuse as identified in the Hazard Analysis of the MR850.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MR850 Respiratory Humidifier (K110019):
The provided 510(k) summary for the MR850 Respiratory Humidifier lacks detailed information about specific acceptance criteria and the comprehensive study that proves the device meets them, especially in the context of clinical performance or human-in-the-loop studies. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing related to humidity and enthalpy.
However, based on the information available, we can extract the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Meeting humidity limits as established in ISO 8185 | "The testing confirmed that the modification to software had no impact on the MR850 meeting the humidity limits...as established in ISO 8185." |
| Meeting enthalpy limits as established in ISO 8185 | "The testing confirmed that the modification to software had no impact on the MR850 meeting the...enthalpy limits as established in ISO 8185." |
| Maintaining the same performance as the predicate device | "The modified MR850 Respiratory Humidifier...has: The same performance." (This is a claim of substantial equivalence, implicitly stating its performance meets or exceeds the predicate's standards). |
| Software modification (version 7.25) to act as a risk mitigator against foreseeable misuse | "This feature enables the chamber output set temperature to be increased (via a proprietary algorithm) to increase the relative humidity at the patient airway probe position. This is a risk mitigator against specific foreseeable misuse..." |
| Resolution of factory test issues | "This modification does involve a revision of the software to version 7.25 which will enable...the resolution of factory test issues." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any test sets, nor does it provide information about the provenance (country of origin, retrospective/prospective) of the data. The testing mentioned appears to be laboratory-based engineering performance testing ("Humidity Performance Testing," "Enthalpy Testing," "Humidity Control Performance Testing") rather than clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The testing described is technical performance testing against an international standard (ISO 8185), not a comparison against expert-established ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no mention of a human-reviewed test set requiring adjudication.
5. 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
No. This device is a respiratory humidifier, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's software (version 7.25) includes a "humidity compensation feature" via a "proprietary algorithm." The "Humidity Control Performance Testing" would inherently evaluate the standalone performance of this algorithm in controlling humidity output according to the device's design and the relevant ISO standard. However, the document does not elaborate on the specific methodology or results of this standalone algorithm performance beyond stating it met the limits.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing cited is the established limits and specifications within the ISO 8185 standard for respiratory gas humidifiers. This is a technical, rather than a clinical, ground truth.
8. The sample size for the training set
Not applicable. As this device is a hardware humidifier with embedded software for control, there is no mention of a "training set" in the context of machine learning. The software modification is for a control algorithm, not a learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in this context.
§ 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).