(89 days)
The VERIFY® Spore Test Strip for S40 Sterilant is intended to provide users with a means to assess spore kill by S40 sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.
The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 36 in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the liquid chemical sterilant processor. The transfer clip thus holds the Spore Test Strip in a fixed location during a processing cycle in the STERIS Liquid Chemical Sterilant Processing System and enables aseptic transfer of the strip from the processor into the growth media vial after the cycle ends.
For use, the Spore Test Strip is removed from the glassine envelope and secured using the transfer clip in the SYSTEM 1E Liquid Chemical Sterilant Processing System or SYSTEM 1 endo Liquid Chemical Sterilant Processing System along with the items to be liquid chemically sterilized. The liquid chemical sterilization cycle is initiated. At the end of the full cycle, the Spore Test Strip is removed and placed into the vial of growth medium for incubation under the specified conditions that will promote spore growth for at least 24 hours. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail.
The Spore Test Strip is incubated at 55-60°C for a minimum of 24 hours, but may be incubated for up to 7 days. The shelf life is 12 months when stored at 2-24℃ and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
The current submission makes no changes to the strip itself; only the indications for use are changing to encompass the VERIFY Spore Test Strip's broader use in more than one STERIS automated liquid chemical sterilant processing system (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.
The provided text describes the 510(k) premarket notification for the VERIFY® Spore Test Strip for S40® Sterilant. This device is a biological indicator designed to assess the effectiveness of liquid chemical sterilization processes. It is important to note that this is not an AI/ML device, and therefore, several requested categories are not applicable.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Table 1 & 2) |
|---|---|
| Population | |
| • At manufacture | $\geq$ 1.5 x 105 cfu/strip |
| • After wash-off (end of cycle) | $\geq$ 1.0 x 105 cfu/strip |
| Resistance (at 1635 ppm PAA) | |
| • D-value | 12-26 sec |
| • Survival Time | $\geq$ 38 seconds |
| • Kill Time | $\leq$ 239 seconds |
| Reduced Incubation Time | 24 hours |
| Simulated Use | PASS |
| Stability of Media Color | PASS |
| Shelf Life | PASS (for 12 months) |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical testing was performed for "Simulated Use", "Stability of Media Color", "Reduced Incubation Time", and "Shelf Life for 12 months." However, the specific sample sizes used for these tests are not provided in the document.
Regarding data provenance:
- Country of Origin: Not explicitly stated, but the submission is to the U.S. FDA by STERIS Corporation located in Mentor, Ohio, USA. It can be inferred that the testing likely occurred in the USA.
- Retrospective or Prospective: The testing described (simulated use, stability, reduced incubation time, shelf life) appears to be prospective laboratory-based testing designed to validate the device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a biological indicator, not an AI/ML diagnostic device that requires expert interpretation of images or other complex data. The "ground truth" for its performance is established through microbiological methods and chemical analysis of the sterilant's effect on spores, rather than expert consensus on complex medical data.
Therefore, this question is not applicable in the context of this device.
4. Adjudication method for the test set
As the "ground truth" for this device is based on objective microbiological and chemical measurements (e.g., spore kill, population counts, D-values, color change indicating growth), an adjudication method involving multiple human experts is not applicable or described. The results (PASS/FAIL, numerical values) are determined by laboratory assays.
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 question pertains to AI/ML devices involving human readers. The VERIFY® Spore Test Strip is a biological indicator, not an AI/ML device.
Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question pertains to AI/ML devices. The VERIFY® Spore Test Strip is a biological indicator, not an AI/ML device. While its performance is "standalone" in the sense of being an automated indicator, it does not involve an algorithm generating a diagnostic output without human input in the way a medical AI would. Users visually interpret the media color.
Therefore, this question is not applicable in the context of an AI algorithm.
7. The type of ground truth used
The ground truth used for this device is based on microbiological viability testing and chemical resistance characteristics.
- Spore Kill: Demonstrated by the absence of growth (no color change) in the culture medium, indicating that the targeted 5-log reduction of Geobacillus stearothermophilus spores was achieved.
- Population Counts: Directly measured in colony-forming units (CFU/strip).
- Resistance Characteristics (D-value, Survival Time, Kill Time): These are experimentally determined values that quantify how resistant the spores on the strip are to the sterilant under specific conditions.
- Stability of Media Color: Objective observation of the indicator color over time.
8. The sample size for the training set
This device is not an AI/ML device that requires a training set. Its performance characteristics are inherent to its biological and chemical design, validated through laboratory experiments.
Therefore, this question is not applicable.
9. How the ground truth for the training set was established
This device is not an AI/ML device that requires a training set.
Therefore, this question is not applicable.
§ 880.6887 Spore test strip.
(a)
Identification. The spore test strip consists of a carrier or strip with a known number of spores, at least 5 log10 per strip, of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip after the specified predetermined incubation period indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores on the test strip which is 5 log10 spores/strip; it does not confirm the expected full performance of the liquid chemical sterilant processing cycle because full performance is a 6 log10 spore kill in a full liquid chemical sterilization cycle.(b)
Classification. Class II (special controls). The special controls for this device are:(1)
Spore strip characterization. (i) Population of viable spores on strip shall be a minimum of 5 log10 after physical wash off of spores from the strip by exposure to liquid chemical sterilant in the liquid chemical sterilant processing system, which should be validated over the claimed shelf life.(ii) The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life.
(iii) The spore strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash off. Bacteriostasis of the spore strip materials should be evaluated.
(iv) Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life.
(2)
Simulated Use Testing. Simulated use testing should demonstrate performance of spore test strip in liquid chemical sterilant/high level disinfectant under worst case in use conditions over the claimed shelf life.(3)
Labeling. Labeling should specify appropriate instructions, warnings, cautions, limitations, and information relating to viable spore population, resistance characteristics, and interpretation of a “no growth” result.