(74 days)
SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79.
This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about specific acceptance criteria or the study used to prove the device met those criteria. The letter acknowledges the submission and declares the device substantially equivalent to a predicate device based on the information provided by the applicant.
Therefore, I cannot extract the requested information 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).