(300 days)
SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is a single-use device 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. The test pack consists of a selfcontained 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. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
The test pack consists of a selfcontained 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. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
The provided text is a 510(k) clearance letter from the FDA for the SteriTec Smart-Read Biological Test Pack. It does not contain information about the acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.
The document discusses:
- The device name and model number.
- The regulation number and name.
- The regulatory class.
- The product code.
- The date of the submission and receipt.
- The determination of substantial equivalence to a legally marketed predicate device.
- General controls provisions of the Act that apply to the device.
- Contact information for various FDA divisions.
- The intended indications for use of the device, which is a biological test pack for steam sterilizers.
This biological test pack is a physical device used to verify sterilization conditions, not an AI/ML algorithm or software. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment relevant to AI/ML devices is not present in this document.
§ 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).