§876.5360. Laparoscopic gastrointestinal sizing tool.
21 C.F.R. § 876.5360
Identification. A laparoscopic gastrointestinal sizing tool is a prescription use device intended for laparoscopically measuring an extraluminal dimensional parameter of the indicated gastrointestinal organs.
Classification. Class II (special controls). The special controls for this device are:
Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following:
Trocar compatibility, which includes shaft bending force characterization;
Joint strength tensile testing;
Distal loop extension/retraction force characterization;
Material selection analysis, which includes corrosion and visual inspection; and
Accuracy of the dimensional measurement.
Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.
The patient-contacting components of the device must be demonstrated to be biocompatible.
Labeling of the device must include the following:
A statement regarding metal allergies if the device is made from metallic components;
Specific instructions for proper device use including information regarding the following—
Inspection of device prior to use;
Surgical access techniques or methodologies;
Instructions for avoiding structural damage to vagus nerve bundle;
Trocar compatibility;
Sizing methodology; and
Minimum and maximum dimensional parameters that the device is capable of measuring.
Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and
An expiration date.
Notes, amendments, and revision history
Amendments
[90 FR 40730, Aug. 21, 2025]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.
Amendments
[90 FR 40730, Aug. 21, 2025]