(267 days)
Terragene® Bionova® Hyper Biological Indicator (BT98) is a self-contained biological indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of Plasma or Vaporized Hydrogen Peroxide sterilization processes in the following systems:
-Sterrad® 100S Sterilization System.
-Sterrad® NX Sterilization System (Standard and Advanced Cycles).
-Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced Cycles).
-Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo Cycles).
-Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo Cycles).
-V-Pro@ S2 Low Temperature Sterilization System (Fast, Non Lumen and Flexible Cycles).
-V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen. Lumen and Flexible Cycles).
Terragene® Bionova® BT98 has Hyper Rapid readout at 5 minutes at 60 ℃.
Terragene® Bionova® Hyper Auto-reader Incubator (BHY) incubates at 60 °C and reads the Terragene® Bionova® Hyper SCBIs at the times prescribed in the User Manual.
Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) incubates at 60 °C and reads the Bionova® SCBIs at the times prescribed in the User Manual.
Not Found
The provided text is related to a 510(k) premarket notification for sterilization process indicators and auto-reader incubators. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA clearance letter and an "Indications for Use" statement, not a scientific study report.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth type, or training set details) from the provided text.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).