(64 days)
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M-Series CPAP & Heated Humidifier System also includes the flex therapy feature cleared in K052110 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. The design of the humidifier has been adapted to be powered from DC. Like its predicate, the REMstar Pro M-Series CPAP & Heated Humidifier System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.
I am sorry, but the provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or the study design (test set size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth establishment, or training set size) as requested in your prompt.
The document states:
- "Design verification tests were performed on the Respironics REMstar Pro M-Series CPAP & Heated Humidifier System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, it does not specify what those acceptance criteria were, how the device performed against them, or any of the details about the underlying study that would typically prove these criteria were met. The document focuses on establishing substantial equivalence based on intended use, operating principle, technology, and manufacturing process, and notes that modifications had no impact on safety and effectiveness.
Therefore, I cannot populate the table or provide answers to the specific questions about the study that proves the device meets the acceptance 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).