(159 days)
The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.
Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable. The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism. The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.
The provided text describes a 510(k) premarket notification for the Marquest SCT 3000 Heated Humidifier. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics of a device, especially not one using AI or machine learning. Therefore, I cannot fully complete the requested table and sections.
Here's an analysis based on the provided document, highlighting why certain questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics for the new SCT 3000 Heated Humidifier in the way a study for a diagnostic AI device would. Instead, it relies on comparison to predicate devices, indicating equivalency in function and safety features.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated as AC) | Reported Device Performance (as presented in the document) |
|---|---|---|
| High Temperature Alarm | Distal Temperature > 1 degree C of Set Temp. (for SCT 3000) | Meets or exceeds; set at > 1 degree C (compared to predicate's > 2 degrees C) |
| Low Temperature Alarm | Distal Temperature |
§ 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).