(265 days)
The Verify® SCBI 275F 3-10 is a self-contained biological indicator that may be used for installation testing and routine monitoring of steam sterilizers. The Verify® SCBI 275F 3-10 provides independent confirmation that sterilization conditions were achieved during the following cycles:
| TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|
| 275°F (135°C) | Gravity Flash | 3 minutes |
| 275°F (135°C) | Prevacuum | 3 minutes |
| 275°F (135°C) | Gravity | 10 minute |
| 275°F (135°C) | Gravity Flash | 10 minutes |
The proposed Verify® SCBI 275F 3-10 is a self-contained biological indicator intended for use in steam sterilization processes. The proposed Verify® SCBI 275F 3-10 consists of a plastic shell containing Geobacillus stearothermophilus spores and an ampoule of culture media.
This 510(k) premarket notification was submitted to expand the Indications For Use for the biological indicator to include 275°F (135°C) steam sterilization for 3 minute Prevacuum and 10 minute Gravity and Gravity Flash cycles.
The provided text describes a 510(k) premarket notification for the STERIS Verify® SCBI 275F 3-10, a self-contained biological indicator. It details the device's intended use and claims that performance testing was conducted to validate its use in various steam sterilization cycles. However, the document does not provide detailed acceptance criteria or a comprehensive study plan with the specific information requested, such as sample sizes for test and training sets, data provenance, expert ground truth details, or MRMC study results.
Based on the information available:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance testing was conducted to validate the SCBI for use in the steam sterilization cycles included in the indications for use section. The results support the use of sterilization cycles and confirm that the SCBI meets the current requirements of FDA guidance and relevant industry standards."
This indicates that acceptance criteria would be tied to the "current requirements of FDA guidance and relevant industry standards" for biological indicators, which typically involve demonstrating a certain level of spore kill and resistance to the sterilization process. However, the specific numerical acceptance criteria (e.g., D-value, Z-value, sterility assurance level) and the reported device performance against those criteria are not explicitly stated in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 as this is a biological indicator for sterilization, not a diagnostic device requiring expert interpretation of images or data. Performance is measured by the destruction of microbial spores.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is a biological indicator for sterilization, not a diagnostic device requiring human adjudication.
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 as this is a biological indicator for sterilization, not an AI-assisted diagnostic device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a biological indicator for sterilization, not an algorithm. The performance of the biological indicator is assessed directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a biological indicator, the "ground truth" would be the direct measurement of spore viability (or lack thereof) after exposure to sterilization conditions. This is typically determined through standard microbiological culture techniques. The document does not explicitly detail the exact methodology but implies standard BI validation methods.
8. The sample size for the training set
This information is not provided in the document. (Note: For biological indicators, "training set" is not a standard term as it is for machine learning. The testing involves validating the performance of the physical indicator itself.)
9. How the ground truth for the training set was established
This information is not provided in the document. (As in point 8, "training set" ground truth is not a standard concept for this type of device.)
Summary of available study information from the document:
- Study Name/Description: "Performance testing was conducted to validate the SCBI for use in the steam sterilization cycles included in the indications for use section." (Page 2, Section 5)
- Purpose: To validate the Verify® SCBI 275F 3-10 for use in 275°F (135°C) steam sterilization for 3-minute Gravity Flash and Prevacuum cycles, and 10-minute Gravity and Gravity Flash cycles.
- Conclusion: "The results support the use of sterilization cycles and confirm that the SCBI meets the current requirements of FDA guidance and relevant industry standards." (Page 2, Section 5)
- Device Performance Claim: The device is identical in components, design, materials, and manufacturing specifications to its predicates, except for expanded indications for use.
- Data Provenance: Not specified, but implied to be validation testing performed by the manufacturer, STERIS Corporation. (The document is a 510(k) submission from STERIS).
Missing Information:
Crucially, the document is a regulatory submission summary and does not contain the detailed study protocols, raw data, or specific statistical analyses that would provide concrete acceptance criteria, sample sizes, and detailed performance metrics beyond a statement of compliance. These details would typically be found in the full submission, but not in this publicly available summary.
§ 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).