(160 days)
The Philips OB TraceVue Obstetrical Information Management System is indicated for obstetric patients during and after pregnancy, who require monitoring in a healthcare setting. The Philips OB TraceVue provides: - Basic and advanced fetal trace alarming for both antepartum and intrapartum patients - Central monitoring of maternal alarming. - Documentation capabilities and data storage. - Viewing and alarming of patient physiologic data, at remote locations, via the healthcare facility web access (intra/internet).
The Philips OB TraceVue Obstetrical Information Management System is intended to acquire, present and store patient information and to document relevant monitor information (surveillance) of patients in the OB/GYN departments of healthcare facilities, as needed by healthcare professionals. It offers antepartum and intrapartum alarming and optional storage. It helps to monitor and chart the labor of patients. It can create awareness by alarming the user of suspicious traces and maternal parameters, but leaves the decision about what action to take to the clinician. Patient-related data can be stored to ensure a complete, permanent record of patient data. The device is a prescriptive device. US federal law restricts this device to sale by, or on the order of, a physician. Physical patient contact is not intended for the medical purpose of the device.
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Philips OB TraceVue Obstetrical Information Management System, software revision Rev.G.00. It details modifications, intended use, and substantial equivalence to predicate devices, but it does not include performance data or studies against specific acceptance criteria.
The information provided largely focuses on the regulatory submission process, device classification, and changes to the software, particularly concerning alarming capabilities and adaptation to NICHD guidelines. There is no mention of clinical studies, sample sizes, expert ground truth adjudication, or standalone performance testing for the device's functionality.
§ 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).