{"data":{"id":"us/21-cfr-878.4405","jurisdiction":"us","citation":"21 CFR 878.4405","heading":"Focused ultrasound system for non-thermal, mechanical tissue ablation.","body":"(a) Identification. This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must document the adverse event profile and characterize tissue destruction.\n(2) Animal performance testing must demonstrate that the device mechanically destroys targeted tissue while characterizing the chronic safety profile, including thermal and mechanical injury to adjacent, non-target tissue.\n(3) 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) Acoustic characterization at clinically relevant settings;\n(ii) Determination of the minimum drive voltages necessary to sustain a bubble cloud in the target tissue;\n(iii) Validation of mechanisms to prevent energy delivery that would result in adverse thermal effects;\n(iv) Availability of real-time monitoring during the procedure;\n(v) Validation that the treatment zone is limited to the defined target tissue; and\n(vi) Validation of mechanisms to prevent, pause, and terminate ablation in the event of device failure.\n(4) Performance data must support the electrical safety and electromagnetic compatibility of the device.\n(5) All patient-contacting components of the device must be demonstrated to be biocompatible.\n(6) Software validation, verification, and hazard analysis must be performed.\n(7) Human factors testing must demonstrate that the user can safely and correctly use the device.\n(8) Labeling must include the following:\n(i) A warning that focused ultrasound ablation should only be considered in patients with sufficient functional reserve to withstand the destruction of the planned volume of tissue;\n(ii) A statement that the device has not been evaluated for the treatment of any specific disease or condition; and\n(iii) A detailed summary of the clinical testing with the device.","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/2026-10-07/title-21.xml","current_through":"2026-10-07","vintage":"","retrieved_at":"2026-10-09T05:45:50Z","sha256":"6bcba39870835af62f8f5c0c7818c14c3f7eaec90cb5d7ae0e7644e382f83c0d","source_id":"us-cfr","stale":false,"prev":"us/21-cfr-878.4400","next":"us/21-cfr-878.4410"},"notice":"GroundRules: Original legal text. Not legal advice."}