21 CFR 880.5405 — Active Noise Attenuation System For Infant Incubators

General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5405

Identification

Active noise attenuation system for infant incubators. A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment. The Neoasis is comprised of an outside noise sensor, a control unit, two speakers, and a residual noise sensor, intended to reduce noise levels inside an infant incubator in the NICU for frequencies between 250 Hz to 1,000 Hz.

Classification Rationale

Class II (special controls). The device is classified as Class II, subject to special controls in addition to general controls, to mitigate risks including hearing loss from high device output or ineffective attenuation, infection, and adverse tissue reaction.

Product Codes