{"data":{"id":"us/21-cfr-878.4371","jurisdiction":"us","citation":"21 CFR 878.4371","heading":"Irrigating wound retractor device.","body":"(a) Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.\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 and evaluated for particulate matter.\n(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.\n(3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.\n(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:\n(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;\n(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;\n(iii) Characterize the forces required to deploy the device;\n(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;\n(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and\n(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.\n(5) The labeling must include or state the following information:\n(i) Device size or incision length range;\n(ii) Method of sterilization;\n(iii) Flammability classification;\n(iv) Non-pyrogenic;\n(v) Shelf life; and\n(vi) Maximum flow rate and suction pressure.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical 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":"d9a1265e666807bb0050eaa8c066c61b018399a638617bacd8f24a6cece505cd","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4370","next":"us/21-cfr-878.4380"},"notice":"GroundRules: Original legal text. Not legal advice."}