(430 days)
The Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient. Its use is indicated whenever a physician or other healthcare provider prescribes humidification to patients receiving supplemental oxygen via oxygen tubing and nasal cannulae. This device is single patient use, non-sterile prescription device that is indicated in both hospital and homecare applications.
The Ventlab 6000 Series Humidifier is a device intended to add moisture to breathing gases for administration to a patient.
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab 6000 Series Humidifier." This document does not contain information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth as requested in the prompt.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (fir the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the FDA granted clearance based on the device's substantial equivalence to existing predicate devices, not on a new study demonstrating its performance against specific acceptance criteria. The document defines the "Indications for Use" but does not provide performance metrics.
Therefore, I cannot fulfill the request using the provided text. The requested information (acceptance criteria, study details, sample sizes, expert qualifications, ground truth methods, MRMC study, standalone performance) is not present in this 510(k) clearance document.
§ 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).