{"data":{"id":"us/21-cfr-876.5360","jurisdiction":"us","citation":"21 CFR 876.5360","heading":"Laparoscopic gastrointestinal sizing tool.","body":"(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.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following:\n(i) Trocar compatibility, which includes shaft bending force characterization;\n(ii) Joint strength tensile testing;\n(iii) Distal loop extension/retraction force characterization;\n(iv) Material selection analysis, which includes corrosion and visual inspection; and\n(v) Accuracy of the dimensional measurement.\n(2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.\n(3) The patient-contacting components of the device must be demonstrated to be biocompatible.\n(4) Labeling of the device must include the following:\n(i) A statement regarding metal allergies if the device is made from metallic components;\n(ii) Specific instructions for proper device use including information regarding the following:\n(A) Inspection of device prior to use;\n(B) Surgical access techniques or methodologies;\n(C) Instructions for avoiding structural damage to vagus nerve bundle;\n(D) Trocar compatibility;\n(E) Sizing methodology; and\n(F) Minimum and maximum dimensional parameters that the device is capable of measuring.\n(iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and\n(iv) An expiration date.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 876—GASTROENTEROLOGY-UROLOGY DEVICES","Subpart F—Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"fa05aa8bd8d00f4c6ae5ce6be91b706b62e07e041288f96a0d6da7604c614c90","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.5340","next":"us/21-cfr-876.5365"},"notice":"GroundRules: Original legal text. Not legal advice."}