§ 888.4560 — Intraoperative surgical angle measurement tool.

§ 888.4560 Intraoperative surgical angle measurement tool.

(a) Identification. An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of system-level accuracy and validation of procedural accuracy in simulated use.

(2) Usability testing must demonstrate that the intended user(s) can correctly use the device based on the instructions for use.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance testing must support the sterility and shelf-life of the device.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Performance data must demonstrate the electrical safety, electromagnetic compatibility, and wireless coexistence of the device.

(7) Labeling must include:

(i) A detailed summary of the device technical parameters;

(ii) Information regarding limitations of the clinical significance of the device output;

(iii) A detailed summary of the accuracy and precision of the device;

(iv) Validated methods and instructions for reprocessing of any reusable components; and

(v) The shelf-life of the device.

[91 FR 46723, July 24, 2026]