§ 888.1600 Bone indentation device.

(a) Identification. A bone indentation device is a device that measures resistance to indentation in bone. (b) Classification. Class II (special controls). The special controls for this device are: (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation. (3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must demonstrate: (i) The sterility of the patient-contacting components of the device; and (ii) Validation of reprocessing instructions for any reusable components of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life. (7) Software verification, validation, and hazard analysis must be performed. (8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (9) Labeling must include: (i) Instructions for use; (ii) Validated methods and instructions for reprocessing of any reusable components; (iii) A shelf life for any sterile components; (iv) Information regarding limitations of the clinical significance of the device output; and (v) A detailed summary of the accuracy and precision of the device.