§ 876.5360. Laparoscopic gastrointestinal sizing tool.
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/us/cfr/t21/s§ 876.5360·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [90 FR 40730, Aug. 21, 2025]
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§ 876.5360
Laparoscopic gastrointestinal sizing tool.
Fed. Reg.×1
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