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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 heat-sensitive 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 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

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 A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
• · Pre-filter B 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:

· 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 device was originally cleared under K090036. Five Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, and labeling. This premarket notification introduces a new processing tray that will accommodate ultrasound endoscopes and other large flexible devices and their associated Quick Connects. Additionally, minor inconsistent statements in the cleared Indications for Use are corrected, and clarification is provided on post-processing handling and storage of critical and semi-critical medical devices.

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 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 subsystem, 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 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) 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 for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

This document is a 510(k) summary for the SYSTEM 1E Liquid Chemical Sterilant Processing System, seeking substantial equivalence to a previously cleared device (K161683). The primary changes are the addition of a new Ultrasound Processing Tray and related Quick Connects, and minor labeling updates. The document relies heavily on the predicate device's performance data, as the technological principles are largely identical.

Here's an attempt to extract the requested information based on the provided text, acknowledging that much of the "study" detail refers to previously established performance for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative clinical trial format. Instead, it describes performance characteristics and equivalency to the predicate device. The primary performance criterion is achieving sterilization.

Study Proving Device Meets Acceptance Criteria

The document states, "Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K161683)..." This indicates that the primary "study" is a demonstration of substantial equivalence to a previously cleared device. For the specific modifications introduced in this submission (new Ultrasound Processing Tray and Quick Connects), the document states: "Any new safety and efficacy concerns were addressed through verification testing."

Since this is a 510(k) submission primarily demonstrating substantial equivalence, direct clinical efficacy studies for the new model in comparison to the predicate are not detailed. Instead, the focus is on showing that the minor changes do not introduce new questions of safety or effectiveness and that the established sterilization efficacy of the previous model (K161683) still applies.

Specific Study Types Mentioned/Implied:

• Microbial Efficacy Testing: This refers to in vitro and simulated-use tests proving the sporicidal, fungicidal, bactericidal, virucidal, and tuberculocidal claims. These are likely standardized tests (e.g., AOAC Official Methods, EPA Virucidal Testing, Ascenzi Quantitative Suspension Test).
• Biocompatibility Testing: Focusing on cytotoxicity, residue reduction, and device material compatibility after repeated processing cycles.
• Verification Testing: Specifically for the new Ultrasound Processing Tray and Quick Connects, to address any new safety and efficacy concerns. This would typically involve validating fluid flow, sterilant contact, rinse effectiveness, and material compatibility for the new components and devices intended to be processed in them.

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

The document does not specify a "test set" in the context of a dataset for an AI model. This is a medical device sterilization system, not an AI/Software as a Medical Device.

• Microbial Efficacy (In vitro/Simulated-Use): The exact sample sizes for these tests are not provided in the summary, but they would typically involve established protocols for sterility testing.
• Device Material Compatibility: "testing finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles."
• Data Provenance: Not explicitly stated as "country of origin" for data, but the tests cited (AOAC, EPA, Ascenzi) are standard scientific and regulatory compliance tests. The company STERIS Corporation is based in Ohio, USA. The testing context is for regulatory approval within the USA (FDA). The nature of these tests is generally prospective in a lab setting, following predefined validated protocols.

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

This information is not applicable. The device is a sterilizing system, not an AI diagnostic tool that requires human experts for ground truth establishment on a test set of data. The "ground truth" for sterilization is the absence of viable microorganisms, determined through microbiological testing.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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 is not an AI/Software as a Medical Device, and no human reader interpretation is involved.

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 sterilizing system and does not involve AI algorithms in the sense of image interpretation or diagnostic performance. Its performance is evaluated through its ability to mechanically and chemically sterilize devices autonomously.

7. The type of ground truth used

The "ground truth" for this device is sterility, meaning the complete absence of viable microorganisms. This is established through various microbiological tests:

• Spore-kill validation: Using highly resistant bacterial spores (e.g., Bacillus subtilis, Clostridium sporogenes, Geobacillus stearothermophilus) that are considered the gold standard for sterilization efficacy.
• Absence of other microorganisms: Fungi, bacteria, viruses, and mycobacteria are also tested, demonstrating broader microbicidal activity.
• Clinical In-Use data: Demonstrating no surviving microorganisms on representative medical devices after processing.

8. The sample size for the training set

This information is not applicable. This is not an AI/Machine Learning device that requires a "training set" of data.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as #8.

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