(a) Identification. A prostate lesion documentation system is a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.
(2) Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(5) Methods and instructions for reprocessing of any reusable components must be properly validated.
(6) The labeling must include specific information needed to ensure proper use of the device.
