(95 days)
AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
· By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
- · 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
The AirStrip RPM software can display 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
- · Urine Output
- · Urine/Stool Mix Output
- · Systolic Blood Pressure Invasive
- · Mean Arterial Pressure Invasive
- · Diastolic Blood Pressure Invasive
- · Systolic Blood Pressure Cuff
- · Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
- · Vasoactive Infusions
- · Antiarrhythmics
- · Sedation
- · Paralvtics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- · Allergies
- · Medications
AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
This document is a 510(k) premarket notification letter from the FDA to AirStrip Technologies. It primarily concerns the AirStrip RPM Epiphany Adapter (also referred to as AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software), which is classified as a Physiological Patient Monitor (No Alarms).
The letter indicates that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. However, this document does not contain any performance study data, acceptance criteria, or details of a study proving the device meets acceptance criteria.
The Indications for Use section (page 2) describes what the software is intended to do, such as displaying physiological and other patient information from other medical devices to clinicians remotely. It lists various types of data that can be displayed (e.g., ECG waveform, heart rate, blood pressure, laboratory data).
Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document is a regulatory approval letter, not a clinical study report or a technical performance specification.
§ 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).