§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.

(a) Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis. (b) Classification. Class II (special controls). The special controls for this device are: (1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Performance testing must demonstrate the sterility of patient-contacting components of the device. (6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin. (8) Labeling must include the following: (i) Instructions for use; (ii) The detection performance characteristics of the device when used as intended; and (iii) A shelf life for any sterile components.