§ 886.5350 Ultrasound cyclodestructive device.

(a) Identification. An ultrasound cyclodestructive device is a prescription device that reduces intraocular pressure by producing a series of lesions in the ciliary body and/or trabecular meshwork induced by high intensity focused ultrasound (HIFU) energy and that is intended for treatment of glaucoma patients who: (1) Are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery; and (2) Had failures on maximally tolerated drug therapy. (b) Classification. Class II (special controls). The special controls for this device are: (1) The clinical performance data must demonstrate an appropriate reduction in intraocular pressure in glaucoma patients who: (i) Are refractory to, or are poor candidates for, Argon laser trabeculoplasty or traditional filtering surgery; and (ii) Had failures on maximally tolerated drug therapy, and an evaluation of all adverse events observed during clinical use. (2) Non-clinical performance testing of device features and characteristics must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Ultrasound field characteristics, which must include the total acoustic power radiated by the transducer(s), the spatial distribution of the ultrasound field (including compressional and rarefactional pressure), and spatial-peak, temporal-average intensity; and (ii) Thermal and physical safety characteristics of the device. (3) Simulated use testing to validate that the device performs as intended under anticipated conditions of use, including eye movements and positioning error. (4) Analysis or testing must demonstrate electrical safety in the appropriate use environment. (5) Analysis or testing must demonstrate electromagnetic compatibility (EMC), including wireless coexistence (if applicable) in the appropriate use-environment. (6) Software verification, validation, and hazard analysis must be performed commensurate with the level of concern of the device. (7) The patient-contacting components must be demonstrated to be biocompatible. (8) Performance data must demonstrate sterility of all patient-contacting components labeled as sterile. If the device contains reusable eye-contact components, the validation tests must demonstrate adequate cleaning and reprocessing of these components. (9) Labeling must include: (i) A detailed description of the patient population for which the device is indicated for use, as well as warnings, and precautions regarding potential for device malfunction and use-error pertinent to use of the device. (ii) A detailed summary of the clinical testing, including study outcomes and adverse events. (iii) Information on how the device operates and the typical course of treatment. (iv) Description of all main components of the device including HIFU generator, transducer(s), and controls. The labeling must include the technical specifications of the device including, but not limited to, treatment frequency, total acoustic power delivered by transducer, treatment duration, treatment zone, site targeting, power requirements, weight, and physical dimensions of the device. (v) Where appropriate, validated methods and instructions for reprocessing of any reusable components. (vi) Safe-use conditions for electrical safety and electromagnetic compatibility.