(68 days)
Vacuum Extractor Cup used in child birth
The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called "The Tulip Cup" and its comparison to an existing device, Mityvac. It mentions a survey of physicians indicating an improvement was needed in vacuum products, but it does not provide details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, or any studies demonstrating the device meets specific acceptance criteria in a structured scientific manner.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).