(a) Identification. A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon's direct physical control of the instrument.

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

(1) Simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use to successfully assist in the indicated surgery, including:

(i) Testing in a simulated hospital environment with an anatomically relevant model;

(ii) Compatibility testing of all indicated instruments;

(iii) Human factors/usability evaluation; and

(iv) Validation of device use by surgeons, including:

(A) The user interface and controller(s);

(B) Compatibility with the ranges of surgeon-applied forces, torques, speeds, and motion; and

(C) Time required for emergency removal of the device and associated instruments in the event of power loss or device failure.

(2) Non-clinical performance testing must demonstrate hardware and system verification, including verification of critical parameters (including minimum and maximum forces, torques, speeds, and range of motion).

(3) Software verification, validation, and hazard analysis must be performed for any software components of the device.

(4) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.

(5) All parts or components of the device that enter the sterile field must be demonstrated to be sterile.

(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(7) All patient-contacting components of the device must be demonstrated to be biocompatible.

(8) Labeling must include:

(i) Identification of compatible instruments;

(ii) A statement about any training needed prior to use of the device;

(iii) A summary of all relevant performance testing, including simulated-use testing; and

(iv) Reprocessing instructions for reusable device components.

[91 FR 57504, Sept. 10, 2026]