(120 days)
The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. Signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the BirthTrack System, primarily focused on its substantial equivalence to predicate devices and regulatory compliance.
It outlines the device description, intended use, and compliance with performance standards and recognized standards. However, it does not present a table of acceptance criteria, reported device performance against those criteria, details of a specific study, sample sizes, data provenance, ground truth establishment, or any information regarding multi-reader multi-case studies or standalone algorithm performance.
The document mainly focuses on regulatory approval and substantial equivalence with existing devices, rather than detailed performance evaluation against specific, quantified acceptance criteria.
§ 884.2800 Computerized Labor Monitoring System.
(a)
Identification. A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.(b)
Classification. Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.