---
kind: "section"
citation: "21 C.F.R. § 888.4560"
title: "21"
number: "888.4560"
heading: "Intraoperative surgical angle measurement tool."
url: "https://uscodex.org/cfr/21/888.4560"
---

# §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.**

## Notes

### Amendments

[91 FR 46723, July 24, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[91 FR 46723, July 24, 2026]