(14 days)
AirStrip OB® is intended to be used by Obstetricians for the following purposes
To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device
To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time
To review the current Labor and Delivery patient census list
Provide a request for remote consultation regarding a fetal heart tracing
To remotely review other standard or critical real-time numeric data from Labor and Delivery
Not Found
This document is a 510(k) premarket notification acceptance letter for the AirStrip OB Remote Data Viewing software. It acknowledges the substantial equivalence of the device to legally marketed predicate devices.
However, the provided text does not contain acceptance criteria for the device, nor a study proving it meets such criteria.
The document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to existing devices and can therefore be marketed. It lists the "Indications for Use" for the AirStrip OB® Remote Data Viewing software, which describe how the device is intended to be used by obstetricians, but these are not performance acceptance criteria.
Therefore, I cannot provide the requested information from the given input.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).