(166 days)
The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.
The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.
The test pack consists of multiple layers of paper cards with a SporView Rapid Read Biological Indicator, chemical process indicators and load record card. The load record card is used to record the detailed information from the sterilization cycle.
The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.
The provided text describes the regulatory clearance for the "SporView Rapid Read Biological Indicator SteamPlus Test Pack." The document includes a summary of non-clinical performance data, which outlines the acceptance criteria and the results of the study conducted to demonstrate the device's performance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Test Pack Performance | All test packs have complete kill in a 270°F (132°C) pre vacuum steam sterilization cycle for an exposure time of 4 minutes. |
| Resistance Performance | The test pack has resistance greater than or equal to the AAMI Towel Pack. |
| Resistance (vs. self-contained BI) | The test pack has resistance greater than the self-contained biological indicator itself. |
| Chemical Indicator Performance | Testing to confirm process indicators contained in the test pack perform as intended per the FDA Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the country of origin of the data. It also does not specify if the data was retrospective or prospective. The "Summary of Non-Clinical Performance Data" implies prospective testing as it describes performance testing conducted to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to a biological indicator device. Biological indicators are evaluated based on their ability to show the presence or absence of viable microorganisms after a sterilization process, not on expert interpretation of images or other subjective assessments. The "ground truth" for a biological indicator is the objective determination of microbial growth or no growth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation by multiple human readers (e.g., in medical image analysis). For a biological indicator, the outcome (growth or no growth) is an objective biological response.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a biological indicator for sterilization monitoring, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent in its design and biological response, not in an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a biological indicator is the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is determined by observing microbial growth (or lack thereof) in a controlled incubation process. For the "complete kill" criteria, the ground truth is the absence of microbial growth, indicating a successful sterilization cycle. For resistance testing, the ground truth relates to the time/temperature exposure required to inactivate the spores.
8. The sample size for the training set
This information is not applicable. The device is a physical biological indicator, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, the device does not involve a training set.
§ 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).