{"data":{"id":"us/21-cfr-876.4100","jurisdiction":"us","citation":"21 CFR 876.4100","heading":"Flushing and storage solution for vascular autografts at room temperature.","body":"(a) Identification. A flushing and storage solution for vascular autografts at room temperature is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Clinical data must evaluate adverse events associated with clinical use of the device. Devices indicated for vascular grafts for coronary artery bypass graft surgeries must include an evaluation of the incidence of major adverse cardiac events, vein graft occlusion, and mortality.\n(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:\n(i) Maintenance of cell viability and structural integrity of vascular conduits during storage at the labeled temperature and storage duration; and\n(ii) Evaluation of visible and non-visible particulates in the final mixed solution.\n(3) Shelf life testing must demonstrate the stability of the device's chemical components over the identified shelf life.\n(4) The device must be demonstrated to be biocompatible.\n(5) Performance data must demonstrate the sterility of the device.\n(6) Labeling must include:\n(i) The maximum storage duration for vascular autografts in the solution;\n(ii) A description of all additives or supplements that are added at the point of care;\n(iii) The need for visual inspection of the solution for particulate matter prior to use;\n(iv) A statement regarding the duration of stability of the final solution after preparation;\n(v) A summary of the non-clinical performance testing that supports use of the device as a flushing and storage solution for vascular autografts; and\n(vi) A summary of the clinical data that supports use of the device as a flushing and storage solution for vascular autografts.","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 E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-10-07/title-21.xml","current_through":"2026-10-07","vintage":"","retrieved_at":"2026-10-09T05:45:50Z","sha256":"194fc60083843d19bdd2abd3ea8a71d38d24d27389eaba152231faccc48909f7","source_id":"us-cfr","stale":false,"prev":"us/21-cfr-876.4020","next":"us/21-cfr-876.4270"},"notice":"GroundRules: Original legal text. Not legal advice."}