(86 days)
The 120 Series is intended for monitoring fetal and maternal vital signs: fetal heart rate; and maternal uterine activity, heart/pulse rate, blood pressure, and %Sp02. The device is intended for use in a hospital/clinical environment.
The proprietary name of the modified device to be introduced into interstate commerce is the 120 Series Maternal/Fetal Monitor. Common names include: 120 Series, 120 MFM.
I am sorry, but the provided text does not contain the information required to populate the acceptance criteria and study details. The document is a 510(k) summary for the Corometrics 120 Series Maternal/Fetal Monitor, which was cleared in 1997. It describes the device's intended use and compares its technological characteristics to predicate devices. However, it does not include details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of a comparative effectiveness study, which are typical for studies involving AI or complex statistical analysis for diagnostic accuracy.
The relevant section simply states: "The 120 Series has been extensively tested to meet its requirements and design." This is a general statement and does not provide specific details about the studies or acceptance criteria themselves.
Therefore, I cannot extract the requested information from this document.
§ 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).