(174 days)
This device is intended to be used by clinicians for the following purposes:
- To view the near real-time waveforms remotely
- To remotely review other standard or critical near real-time patient data from the monitored system
- To provide a request for remote consultation regarding a patient's waveform or other data
This device software can display the following the physiologic data captured by other medical devices:
- ECG Waveform
- Heart Rate Monitored
- Respiratory Rate
- Oxygen Saturation
- Intracranial Pressure
- Central Venous Pressure
- Pulmonary Capillary Wedge Pressure
- Cardiac Index
- Cardiac Output
- Cerebral Perfusion Pressure
- Systolic Blood Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Blood Pressure Invasive
- Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the Airstrip ONE Web Client, a cardiac monitor. This document primarily focuses on FDA's determination of substantial equivalence and does not contain specific details about acceptance criteria for device performance or the study that proves the device meets those criteria.
The information typically found in such a study (acceptance criteria, sample size, ground truth establishment, expert qualifications, etc.) is not present in this regulatory letter. This letter is a formal communication from the FDA stating that the device has been cleared for marketing based on its substantial equivalence to a legally marketed predicate device, and it outlines the regulatory obligations of the manufacturer.
Therefore, I cannot extract the requested information from the provided text.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).