§ 876.1530 Endoscopic light-projecting measuring device.

(a) Identification. An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest. (b) Classification. Class II (special controls). The special controls for this device are: (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: (i) Visualization during the procedure; (ii) Ease of procedure as reported by the intended user; and (iii) User acceptability of imaging time. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Accuracy validation; (ii) Endoscope compatibility testing; (iii) Battery life testing; (iv) Durability testing; and (v) Light safety testing. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Software verification, validation, and hazard analysis must be performed. (5) Electrical, thermal, and mechanical safety testing must be performed. (6) Performance testing must demonstrate electromagnetic compatibility of the device in the intended use environment. (7) Methods and instructions for reprocessing reusable components must be validated. (8) Labeling must include: (i) Device technical parameters, including a description of the accuracy of the device; (ii) Information regarding endoscope compatibility; (iii) Warning for light hazards and protection for patient and operator; and (iv) Validated reprocessing instructions.