21 CFR 892.5727 — Phase-Changing Fiducial Marker For Radiation Therapy

Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5727

Identification

A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities. BioXmark is indicated for use to radiographically mark lung, bladder and lymph nodes in adult patients for whom it has been determined that radiographical marking of tissue for radiation treatment is indicated for their cancer treatment.

Classification Rationale

Class II (special controls). The device is granted under the De Novo process, and the probable benefits outweigh the probable risks, which can be mitigated by the use of general controls and the identified special controls.

Product Codes