§ 884.4350 Fetal head elevator.

(a) Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of patient-contacting components of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted. (ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted. (iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted. (5) Labeling must include the following: (i) Contraindication for use in the presence of active genital infection; (ii) Specific instructions regarding the proper placement and use of the device; and (iii) A shelf life.