{"data":{"id":"us/21-cfr-876.1050","jurisdiction":"us","citation":"21 CFR 876.1050","heading":"Endoscopic transhepatic venous access needle.","body":"(a) Identification. An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) The patient-contacting components of the device must be demonstrated to be biocompatible.\n(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.\n(3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.\n(4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.\n(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:\n(i) Needle crumple testing;\n(ii) Tensile testing;\n(iii) Dimensional verification for all components; and\n(iv) Simulated use testing.\n(6) Labeling must include the following:\n(i) Instructions for use, including specific instructions regarding device preparation;\n(ii) The recommended training for safe use of the device; and\n(iii) A shelf life for any sterile components.","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 B—Diagnostic 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":"107dcf4174aa5623090c3991155cd8b05cae4e8c87bef7e7206706f85350408f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.9","next":"us/21-cfr-876.1075"},"notice":"GroundRules: Original legal text. Not legal advice."}