21 CFR 880.6511 — Ultraviolet Radiation Disinfection Chamber Device
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6511
Identification
An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation. The Germitec Chronos® is an automated medical device consisting of a sealed disinfection chamber, incorporating multiple UV-C lamps and reflective walls, indicated for use in a healthcare environment to achieve a high-level disinfection of surfaces of external, transvaginal, and transrectal ultrasound probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, and the probable benefits outweigh the risks, which can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SCS | Ultraviolet Radiation Disinfection Chamber Device | 2 | 2 |
Special Controls
SCS — Ultraviolet Radiation Disinfection Chamber Device
In combination with the general controls of the FD&C Act, the ultraviolet radiation disinfection chamber device is subject to the following special controls:
De Novo Order DEN230067
