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The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive medical devices in healthcare facilities. .

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6minute exposure at 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

• The extensive treatment of EPA potable water consists of: *
  • 1. Pre-filtration through two pre-filters:
    • · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
    • · Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
  • 2. UV Irradiation:
    • · During transit through the UV Water Treatment Chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
  • 3. 0.1 micron filtration:

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• The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment system, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM IE Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects ensure thorough circulation of the sterilant solution and rinses.

The acceptance criteria and study proving the device meets these criteria are detailed below, based on the provided text for the SYSTEM 1E Liquid Chemical Sterilant Processing System.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System and its sterilant, S40 Sterilant Concentrate. The evaluation is a substantial equivalence determination based on comparison to predicate devices, supported by non-clinical and clinical tests.

1. Sample Size used for the test set and the data provenance:

   • Simulated-Use Test: The document mentions "Simulated-Use Test Meets efficacy requirement. ≥ 6 log10 reduction Geobacillus stearothermophilus spores." However, the exact sample size (number of devices, test runs) for these simulated-use tests is not explicitly stated.
   • Clinical In-Use: "No surviving microorganisms on representative medical devices tested." The number of "representative medical devices" is not specified.
   • Device Material Compatibility: Tested "finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles." This implies a sample size of at least one flexible endoscope and one rigid device, subjected to these cycle counts.
   • Data Provenance: The document does not explicitly state the country of origin of the data. Given STERIS Corporation is based in Mentor, OH, USA, and the submission is to the FDA, it is highly likely the studies were conducted in the USA. The studies are prospective in nature, as they are specifically conducted to demonstrate the efficacy and safety of the new device for regulatory clearance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. For sterilization efficacy studies, the "ground truth" is typically established by laboratory methods (e.g., enumeration of surviving microorganisms after exposure to sterilant) which are objectively measurable, rather than through expert consensus. Experts would be involved in designing and executing these studies and interpreting results, but not necessarily "establishing ground truth" in the sense of consensus on an image or clinical finding.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretations (e.g., radiology image readings). This type of method is not applicable to the objective microbial inactivation or material compatibility tests described for this sterilant system.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with or without AI assistance, which is irrelevant for a device that performs automated sterilization. The studies here are focused on the device's intrinsic ability to achieve sterilization and material compatibility.

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

   • Yes, a standalone performance evaluation was done. The entire premise of the document describes the performance of the SYSTEM 1E Processor and S40 Sterilant Concentrate as a fully automated system for liquid chemical sterilization (an "algorithm only" in the context of device function). The efficacy claims (sporiciadal, fungicidal, virucidal, bactericidal, tuberculocidal, simulated-use, clinical in-use, material compatibility) are all based on the device's performance without human intervention in the sterilization process itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used for efficacy claims is based on microbiological assays (e.g., colony-forming unit counts for log reduction) and physicochemical measurements (e.g., temperature, concentration, filter integrity, visual inspection for material changes/damage).
   • Specifically:
     • Sterilization Efficacy: Direct measurement of microbial inactivation (log reduction) for various microorganisms (Bacillus subtilis, Clostridium sporogenes, Geobacillus stearothermophilus, Trichophyton mentagrophytes, Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa, Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1, Mycobacterium terrae). This is a direct, objective method.
     • Residue Reduction/Biocompatibility: Likely analytical measurements of residual chemicals and cytotoxicity tests.
     • Material Compatibility: Visual and functional inspection of devices after multiple cycles.

7. The sample size for the training set:

   • Training sets are primarily associated with machine learning or AI algorithm development. Since this device is an automated chemical sterilizer, there is no "training set" in the context of AI. The development process would involve iterative design, testing, and refinement, but not in the sense of a machine learning training set.

8. How the ground truth for the training set was established:

   • As there is no AI "training set," this question is not applicable. The underlying scientific principles and performance parameters for chemical sterilization are established through decades of microbiology and engineering research, which guide the design and testing of such devices.

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