(248 days)
The U&U Sterilization indicator tapes and strips are designed to demonstrate that the unit or load has been exposed to a sterilization process and to distinguish between processed and unprocessed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from off yellow to Dark brown/Black.
Use the U&U Sterilization Indicator tapes and strips in steam sterilization processes described below.
- 121 ℃, 30 minutes; Gravity Steam
- 132°C , 4 minutes; Dynamic Air Removal Steam
- 135°C , 3 minutes; Dynamic Air Removal Steam
The U&U Sterilization Indicator Tape is designed for use with steam sterilization as a method of securing packs and identifying processed from unprocessed items.
The U&U Sterilization Indicator Strip is a paper strip printed with a chemical indicator ink that turns from yellow to dark brown/black when exposed to the steam sterilization process. It is designed to indicate whether steam has penetrated to the point of placement of the strip, An internal chemical indicator should be used inside each pack to be sterilized.
The provided text is a 510(k) summary for the U&U Indicator Tape and Strip, a chemical sterilization process indicator. It describes the device, its intended use, comparison to predicate devices, and non-clinical testing. However, it does not contain information about an AI/ML-based medical device study.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and study data for an AI/ML device, as the document is about a different type of medical device (chemical indicator).
Here's why the requested information cannot be found in the provided text:
- Device Type: The device is a "U&U Indicator Tape and Strip," a "Sterilization Process Indicator." These are chemical indicators that change color based on exposure to sterilization conditions. They are not AI/ML-based devices.
- Study Type: The document refers to "Non-Clinical Testing" including performance testing in a steam sterilizer, biocompatibility, storage conditions, and shelf life. This is typical testing for physical/chemical indicators, not for AI/ML algorithm validation.
- No Mention of AI/ML: There is no mention of algorithms, machine learning, artificial intelligence, datasets, human readers, or any other terms associated with AI/ML device studies.
- No Human Interpretation Component: The device's function is a direct color change, not an interpretation of complex data that would require AI or human experts for ground truth.
Therefore, I cannot fill in the table or answer the specific questions about AI/ML device studies based on 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).