(784 days)
The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a PMH 5000 Heated Humidifier for Respiratory Therapy. This document is a regulatory approval for a medical device that adds moisture and warms breathing gases for patients.
It does not contain information about acceptance criteria, device performance metrics, or study design for an AI/ML-driven device. The text is a formal letter confirming that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory pathway for hardware-based medical devices.
Therefore, I cannot extract the requested information regarding AI/ML device performance and study details from this document. The questions you've asked are applicable to AI-driven diagnostic or prognostic devices, not a respiratory gas humidifier.
§ 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).