§ 890.5870 Non-invasive bone growth stimulator.

(a) Identification. A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use. Imaging data must demonstrate fusion at the treatment site. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Critical performance and safety characteristics of the device, considering the operational modality of the device, must be verified and validated to ensure: (i) Intended design outputs are delivered to the patient; (ii) Thermal safety and thermal reliability; (iii) Signal characteristics are within safe physiologic limits; and (iv) Device reliability is consistent with the expected use-life. (3) Patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Labeling comprehension testing must demonstrate the patient can correctly use the device based solely on reading the instructions for use. (7) Labeling for the device must include the following: (i) Warning against use on compromised skin or when there are known skin sensitivities; (ii) Appropriate warnings for patients with implanted medical devices; (iii) A detailed summary of the supporting clinical data, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (iv) A clear description of the device; (v) Instructions on appropriate usage, duration, and frequency of use; (vi) Instructions for maintenance and safe disposal; (vii) Validated instructions for appropriate cleaning of any reusable components; (viii) Specific warnings regarding user burns, electrical shock, and skin irritation; and (ix) The risks and benefits associated with use of the device when used as intended.