(119 days)
The Babycom™ is meant to be applied to a woman's abdomen during pregnancy in order to measure the fetal heart rate (FHR) as a general indicator of fetal well-being.
The Babycom™ is a fetal ultrasonic heart rate monitor that is designed to transmit and receive ultrasonic energy into and from a pregnant woman by means of continuous wave doppler echoscopy. The Babycom™ is used to represent the fetal heart rate in an immediately perceptible form, i.e., a digital display of the rate in beats per minute (bpm) and by an audible beating signal of the same rate. The Babycom™ includes a transducer module for transmitting and receiving ultrasound signals and a signal analysis, control and display module, that we refer to as the base, that carries out all the other Babycom™ functions. The Babycom™ measures the fetal heart rate by determining the doppler shift between the transmitted and received signals.
The provided text describes the K013547 submission for the Babycom™ fetal ultrasonic heart rate monitor. However, it does not contain specific information regarding a detailed study with acceptance criteria or performance metrics for the device.
The document states: "The differences between the Babycom™ and the predicate device [Fetal Dopplex II] raise no new issues of safety or effectiveness." This implies that the device's safety and effectiveness were primarily established by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a new, comprehensive clinical performance study with defined acceptance criteria.
Therefore, I cannot provide the detailed information requested in your prompt based on the provided text alone. The text focuses on the regulatory submission process and the determination of substantial equivalence.
If this information were available in the text, it would typically be found in sections describing performance testing, clinical data, or preclinical studies.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).