contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. An implantable transprostatic tissue retractor system is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(2)Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3)Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life.
(4)Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(iii)Resistance-to-degradation testing must be conducted.
(5)Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment.
(6)In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: