(76 days)
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. 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/Stoo! 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
- · Paralytics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coaqulation
- · Allergies
- · Medications
Counter-Indications
Ocamer manageno intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use the hour when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
This document is a 510(k) clearance letter for the AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software. It informs AirStrip Technologies, LP that their device has been found substantially equivalent to legally marketed predicate devices and can be marketed.
However, this document does not contain information about:
- Acceptance criteria or reported device performance
- Sample sizes or data provenance for test sets
- Number or qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
- Standalone (algorithm-only) performance studies
- Type of ground truth used
- Training set sample size
- How ground truth for the training set was established
The letter focuses on regulatory approval and specifies the intended use of the device, which is to display physiological and other patient information from existing medical devices and patient information systems to clinicians remotely. It clarifies that AirStrip RPM is a diagnostic aid, not a replacement for direct viewing of monitoring devices.
Therefore, I cannot provide a table of acceptance criteria or details of a study that proves the device meets specific performance criteria based on the provided text. The document is a regulatory approval, not a scientific study report.
§ 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).