| Device |
biological sterilization indicator with indirect growth detection |
| Definition |
A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products. |
| Physical State |
Bacterial spores are provided in an ampoule with a separate, contained compartment of appropriate culture media. The ampoule design should segregate the spores from the culture media until incubation and facilitate contained mixing, when required, of the spores and culture media without exposing any spores to the external environment. |
| Technical Method |
The device consists of a known number of bacterial spores, with known resistance to the intended sterilization process. As the sterilization process is carried out, the surface proteins present in the spores are structurally modified and denatured. These surface spore proteins come into contact with a fluorescent dye upon the device activation and are exposed by the auto reader under UV radiation and a fluorescent substance in culture medium is detected in presence of a fluorescent dye to provide the fast readout when placed in an auto reader. The structure state of the sensor proteins as the marker decides the efficacy of the sterilization process. |
| Target Area |
The device is intended to be included with sterilization loads, within sterilization wraps, containers, pouches, trays and cassettes during sterilization cycles for which the use of this device has been validated. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | QVB |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.2806
|
|---|
| 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 |
