Search Results

STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear® Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear® Technology
• · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator (BI) /Process Challenge Device (PCD) is a selfcontained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRAD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2ºC.

The STERRAD VELOCITY BI/PCD can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.

The STERRAD VELOCITY BI/PCD consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.

The STERRAD VELOCITY BI/PCD has the same a-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K182404. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.

The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI/PCD and is used to distinguish between the positive and negative responses.

The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI/PCD to obtain the final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.

There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.

The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.

The STERRAD VELOCITY Reader of the subject device has the same hardware and uses same fundamental scientific technology as the predicate device cleared under K182404. Only the algorithm for fluorescence reading has been modified in the subject device to reduce the fluorescence readout time from 30 minutes to 15 minutes.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes for the test sets in each study. It mentions that:

• For "Hydrogen Peroxide Dose Response and Sterilization Verification," "Design evaluation and Performance Qualification for Periodic Testing," "Verification of Reduced Incubation Time," and "Verification of BI Holding Time," the device's performance was evaluated by reanalyzing fluorescence results and data collected from previously submitted studies using the modified algorithm. No additional sterilization cycles were performed for these specific re-evaluations. This suggests the data provenance is retrospective, using previously gathered data.
• The original provenance of the data used for the reanalysis (e.g., country of origin) is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The studies primarily involve analytical testing against established biological and chemical indicators, rather than expert interpretation of medical images or other data requiring clinical expertise.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are based on analytical measurements (fluorescence readings, growth/no growth, chemical indicator changes) and adherence to set criteria. There is no mention of a human adjudication process for interpreting results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system used for monitoring sterilization, not a diagnostic AI system that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are essentially standalone performance evaluations of the STERRAD VELOCITY BI/PCD and Reader. The modified algorithm's ability to accurately read and interpret the biological indicator's fluorescence (without human intervention in the interpretation process) is the core of the verification. The reader automatically determines and displays the result ("Positive" or "Negative").

7. The type of Ground Truth Used:

The ground truth used in these studies is primarily biological/chemical reference standards and established scientific principles:

• Biological model: For periodic testing, the BI's resistance is compared to a "biological model," which represents the most difficult item routinely processed.
• Sterile BIs (growth and fluorescence): The "growth" outcome of the Geobacillus stearothermophilus spores (or lack thereof) after incubation, and the corresponding fluorescence, serve as the biological ground truth for assessing sterilization effectiveness.
• Chemical indicator changes: The color change of the chemical indicator (from red/pink to yellow/orange/brown dots) provides a chemical ground truth for exposure to hydrogen peroxide.
• 7-day incubation spore growth results: For verifying reduced incubation time, the rapid fluorescence results are compared against the longer, traditional 7-day visual assessment of spore growth, which is a well-established method for confirming biological indicator results.

8. The Sample Size for the Training Set:

This information is not provided. Given that the modification was an update to an existing algorithm based on reanalysis of previous data, and the device is a biological indicator reader rather than a deep learning AI, a distinct "training set" in the context of machine learning might not be applicable or explicitly documented in this way. The algorithm's development would have likely involved extensive testing and refinement, but the specific size or methodology for a formal "training set" is not detailed here.

9. How the Ground Truth for the Training Set was Established:

As with the training set size, the specific methodology for establishing ground truth for any potential "training set" for algorithm development is not detailed. However, it can be inferred that the ground truth would have been established through controlled experiments involving the exposure of biological indicators to varying levels of hydrogen peroxide and subsequent traditional incubation and growth assessment (e.g., the 7-day incubation method mentioned). The previous K182404 submission would have contained details on the initial algorithm's development and associated ground truth.

Ask a specific question about this device