(495 days)
Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).
BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.
Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).
The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).
The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Not Found
The provided text does not contain information about acceptance criteria for a medical device's performance (such as sensitivity, specificity, or accuracy) or details about a study designed to prove the device meets these criteria. The document is an FDA 510(k) clearance letter for sterilization process indicators, not a performance study report for a diagnostic or AI-powered device.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details about training sets.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Details of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone performance details.
- Type of ground truth used.
- How ground truth for the training set was established.
The document focuses on the regulatory clearance for biological and chemical indicators used to monitor sterilization processes, confirming their substantial equivalence to predicate devices, and outlining applicable regulations. It does not describe a clinical performance study as one would typically find for a diagnostic or AI device.
§ 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).