§ 876.5360 Laparoscopic gastrointestinal sizing tool.

(a) Identification. A laparoscopic gastrointestinal sizing tool is a prescription use device intended for laparoscopically measuring an extraluminal dimensional parameter of the indicated gastrointestinal organs. (b) Classification. Class II (special controls). The special controls for this device are: (1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following: (i) Trocar compatibility, which includes shaft bending force characterization; (ii) Joint strength tensile testing; (iii) Distal loop extension/retraction force characterization; (iv) Material selection analysis, which includes corrosion and visual inspection; and (v) Accuracy of the dimensional measurement. (2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Labeling of the device must include the following: (i) A statement regarding metal allergies if the device is made from metallic components; (ii) Specific instructions for proper device use including information regarding the following: (A) Inspection of device prior to use; (B) Surgical access techniques or methodologies; (C) Instructions for avoiding structural damage to vagus nerve bundle; (D) Trocar compatibility; (E) Sizing methodology; and (F) Minimum and maximum dimensional parameters that the device is capable of measuring. (iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and (iv) An expiration date.