QWX · Active Noise Attenuation System For Infant Incubators
General Hospital · 21 CFR 880.5405 · Class 2
Overview
| Product Code | QWX |
|---|---|
| Device Name | Active Noise Attenuation System For Infant Incubators |
| Regulation | 21 CFR 880.5405 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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.
Special Controls
In combination with the general controls of the FD&C Act, an active noise attenuation system for infant incubators is subject to the following special controls: - (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: - Testing with compatible incubator model(s) and dimensions; (A) - Attenuation performance testing simulating different infant locations and (B) orientations within the incubator; and - (C) Testing with relevant noise sources and room configurations. - Software validation, verification, and hazard analysis must be performed. (2) - Electrical safety and electromagnetic compatibility (EMC) testing must be performed for (3) any electrical components of the device. - The patient- or user-contacting components of the device must be demonstrated to be (4) biocompatible. - Labeling for the device must include: (5) - Instructions for infant placement and the expected attenuation performance of the (1) device: - (ii) Warnings regarding the risks of exposure to the potential maximum output of the device: - Methods and instructions for cleaning and disinfection; and (iii) - (iv) Identification of the incubator(s) that the device is intended to be used with.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220048 | Neoasis | Invictus Medical, Inc. | Jun 16, 2023 | DENG |
Top Applicants
- Invictus Medical, Inc. — 1 clearance
