(59 days)
The HC234 CPAP Humidifier is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA) by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification to this therapy relieves the drying and irritation to the patient airways that may arise from use of a CPAP system.
The HC234 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.
The HC234 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier.
The HC234 is comprised of two functional units. One is a motorised fan assembly that provides positive air pressure, and is controlled by software. The fan output is ducted to a humidification chamber at the front of the device.
The second functional unit of the HC234 is a heated passover humidifier. The water is contained in the humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects to the patient breathing tube. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions.
The provided text is a 510(k) summary for the HC234 CPAP Humidifier and does not contain information on acceptance criteria or a study proving the device meets those criteria in a way that would allow for the detailed table and study specifics requested.
Specifically, the document states:
- "Non-clinical testing of the HC234 CPAP Humidifier has been carried out covering mechanical, electrical, and electromagnetic compatibility, functional verification, and performance."
- "The HC234 is designed to meet the requirements of the IEC 60601-1 general electromedical and IEC 60601-1-11, and UL 60601-1. It complies with performance and safety requirements of ISO 8185 standard for humidifiers."
- "Clinical verification studies on the HC234 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device."
Since clinical studies were not required and only non-clinical testing for compliance with standards was performed, an acceptance criteria table detailing specific performance metrics (like sensitivity, specificity, accuracy) and a study report with details like sample size, ground truth, expert opinions, or MRMC studies for device performance as typically seen for AI/diagnostic devices are not available in this document.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document focuses on regulatory compliance with established standards (IEC, UL, ISO) rather than a comparative performance study with explicit acceptance criteria and results against those criteria.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).