| Device |
ultraviolet radiation disinfection chamber device |
| Definition |
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. |
| Physical State |
Chambered UV-C disinfection device used to achieve high level disinfection (HLD) of surfaces of semi-critical transvaginal, semi-critical transrectal and external intact skin contacting ultrasound probes. |
| Technical Method |
Microbial reduction on surfaces of medical devices using a UV-C germicidal device. |
| Target Area |
External (intact skin contacting), Transvaginal and Transrectal ultrasound probes |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SCS |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6511
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
