(16 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/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
- Paralytics
- Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- Allergies
- Medications
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.
The provided text is a 510(k) premarket notification letter from the FDA to AirStrip Technologies, LP, concerning their AirStrip RPM I2 Support device. This document primarily focuses on the FDA's "substantial equivalence" determination and regulatory compliance requirements. It does not contain information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a clinical study report or a more detailed technical submission.
Therefore, I cannot directly extract the requested information from this document.
What the document does indicate is:
- Device Name: AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software
- Intended Use: To allow clinicians to remotely review physiologic data, waveforms, and other near real-time patient data from monitored systems using a cellular telephone or other device when not at the hospital. It is intended as a diagnostic aid, not a replacement for direct viewing of monitoring devices.
- Data Displayed: ECG Waveform, Heart Rate, 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/Cuff, Mean Arterial Pressure Invasive/Cuff, Diastolic Blood Pressure Invasive/Cuff, Vasoactive Infusions, Antiarrhythmics, Sedation, Paralytics, Laboratory Data (Blood Gas, Chemistry, Hematology, Coagulation), Allergies, Medications.
- Regulatory Class: Class II (two)
- Product Code: MWI
- 510(k) Number: K110503
- Predicate Device: Not explicitly stated in this segment, but a substantial equivalence determination implies comparison to a legally marketed predicate device.
To answer your questions, additional documentation, such as the full 510(k) submission, a clinical study report, or a user manual, would be required. This letter confirms regulatory clearance but does not detail the technical validation study performed.
§ 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).