§ 880.5405 — Active noise attenuation system for infant incubators.

§ 880.5405 Active noise attenuation system for infant incubators.

(a) Identification. An active noise attenuation system for infant incubators is a device system that captures environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.

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

(1) Non-clinical performance testing under anticipated conditions of use must demonstrate that the device performs as intended, including:

(i) Verification and validation of critical acoustic parameters, including the maximum output of the device;

(ii) Verification and validation of the attenuation performance of the device, including:

(A) Testing with compatible incubator model(s) and dimensions;

(B) Attenuation performance testing simulating different infant locations and orientations within the incubator; and

(C) Testing with relevant noise sources and room configurations.

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

(3) Electrical safety and electromagnetic compatibility testing must be performed for any electrical components of the device.

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

(5) Labeling for the device must include:

(i) Instructions for infant placement and the expected attenuation performance of the device;

(ii) Warnings regarding the risks of exposure to the potential maximum output of the device;

(iii) Methods and instructions for cleaning and disinfection; and

(iv) Identification of the incubator(s) that the device is intended to be used with.

[91 FR 46836, July 27, 2026]