Search Results

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 > or equal to 6-log reduction of MS2 virus is delivered to the water.
• 3.0.1 micron filtration:
  • · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

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

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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% and rinses the load with 0.2 micron filtered water.

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

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 current submission is provided to describe a modifications for the obsolescence of the support material in the pre-filters.

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 0.1micron 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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe a modifications for the obsolescence of the support material in the pre-filters.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System. Model P6900 is a liguid chemical sterilization system, utilizing peracetic acid to process totally immersible semicritical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe a modifications for the obsolescence of the support material in the pre-filters.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The provided document describes a 510(k) premarket notification for a Liquid Chemical Sterilant Processing System. The submission is to describe a modification for the obsolescence of the support material in the pre-filters. The device is a "SYSTEM 1E Liquid Chemical Sterilant Processing System" (P6500), and "SYSTEM 1 endo Liquid Chemical Sterilant Processing System" (P6800, P6900).

The acceptance criteria and study that proves the device meets the acceptance criteria are as follows:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document states "new testing was performed to evaluate the modified device". However, it does not specify the sample size used for the performance testing with replacement pre-filters nor the data provenance (e.g., country of origin, retrospective or prospective).

3. 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. The performance testing is described for a chemical sterilant system, not an AI/diagnostic imaging device that would typically involve expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable to the type of device and testing described. The "Pass" result indicates that the device met the pre-defined performance criteria without the need for human adjudication in the context of this specific regulatory submission.

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:

This information is not applicable. The device is a liquid chemical sterilant processing system, not an AI-assisted diagnostic imaging device.

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 liquid chemical sterilant processing system, not an AI/algorithm-based device. The "Performance testing with replacement pre-filters" is a standalone test of the device's physical components.

7. The type of ground truth used:

For the performance testing of the replacement pre-filters, the "ground truth" would be the measured performance of the device against established functional and safety specifications. This is inherent in the "Performance testing" result and implies that either design specifications or predefined performance metrics (e.g., filtration efficiency, fluid flow, sterilant concentration maintenance, temperature control) were met. The document indicates that the modification "does not affect the performance of the device," implying a comparison to the performance of the original device.

For the predicate device, the provided tables (Table 1 and Table 2 details the performance of the S40 Sterilant Concentrate) describe various efficacy tests and the organisms used, which serve as the "ground truth" for germicidal claims:

• Sporicidal Activity: Bacillus subtilis, Clostridium sporogenes (in vitro)
• Fungicidal Activity: Trichophyton mentagrophytes (in vitro)
• Bactericidal Activity: Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa (in vitro)
• Viricidal Activity: Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1 (in vitro)
• Tuberculocidal Activity: Mycobacterium terrae (in vitro)
• Simulated-Use Test: Geobacillus stearothermophilus spores in a manual application (result: >= 6 log reduction)
• Clinical In-Use: No surviving microorganisms on representative medical devices tested.

8. The sample size for the training set:

This information is not applicable for this device, as it is not an AI/machine learning device that would require a training set.

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

This information is not applicable for this device.

Ask a specific question about this device

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (S1 endo) is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant concentrate, interchangeable Processing Trays/Containers, and Quick Connects.

The S1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The S1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40, 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The STERIS Corporation's SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, demonstrates substantial equivalence to its predicate device (K222615) based on non-clinical testing. The device is a liquid chemical sterilization system intended for processing immersible, reusable semi-critical medical devices and their accessories in healthcare facilities. The modifications being reviewed are limited to the use of alternative, drop-in replacement components for the control boards.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document mentions "non-clinical performance testing" and "the same methods used to verify the original design" but does not specify the exact sample size for the test set (e.g., number of sterilization cycles performed, number of control boards tested).

The data provenance is implicitly from STERIS Corporation's internal testing labs, as they designed and manufactured the device. The testing is retrospective in the sense that it's performed after the modifications were made to confirm functionality against established criteria. No external country of origin is mentioned for the testing data itself; it's generated by the manufacturer for regulatory submission in the U.S.

3. 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. The testing appears to be objective, verifying technical specifications and operational parameters, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the expected functional performance of the device and its components.

4. Adjudication method for the test set:

This information is not provided as the nature of the testing (functional verification of control boards and software) would likely involve automated system checks and predefined pass/fail criteria rather than expert adjudication of subjective results.

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 is not applicable as the device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

This is not applicable for the same reasons as #5. The device operates as an automated system; there isn't an "algorithm only" performance that would need to be separated from human interaction in the way an AI diagnostic tool might.

7. The type of ground truth used:

The ground truth used for these specific tests (related to new control boards and software) is functional criteria and predefined technical specifications. For example, a control board "fits" if it physically integrates correctly, "runs all cycles" if it successfully initiates and completes the sterilization sequence, and "runs without alarms" if no error states are triggered during operation. The software's "proper version" is a verifiable identifier, and its "proper operation of cycles and alarms" refers to its adherence to programmed logic and responses.

More broadly for the device as a sterilizer, the ultimate ground truth would be microbial efficacy (sterilization) and material compatibility, which are also stated to meet efficacy requirements based on in-vitro testing for its intended use (as described in Table 2).

8. The sample size for the training set:

This information is not applicable. The device is a physical sterilizer with a control system, not a machine learning or AI model that requires a training set. The "training" for such a system would be its design, engineering, and manufacturing processes, along with verification and validation testing.

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

This is not applicable as there is no "training set" in the context of an AI/ML model for this device. The ground truth for the device's overall function (sterilization efficacy) is established through standardized microbiological testing methods (e.g., AOAC Official Methods, simulated-use tests, clinical in-use tests as referenced in Table 2) against specific log reduction criteria for various microorganisms. For component performance (like the control boards), the ground truth is established by design specifications and functional requirements.

Ask a specific question about this device

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 > or equal to 6-log reduction of MS2 virus is delivered to the water.
• 3.0.1 micron filtration:
  • · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

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 current submission is provided to describe modifications for:

• Obsolescence and replacement of compressor ●
• Obsolescence and replacement of upper lid seal ●

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 0.1micron 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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system. utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

• Obsolescence and replacement of compressor ●
• Obsolescence and replacement of upper lid seal ●

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe the modifications for:

• Obsolescence and replacement of compressor
• Obsolescence and replacement of upper lid seal ●

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The provided document describes the STERIS SYSTEM 1E, SYSTEM 1 endo Model P6800, and SYSTEM 1 endo Model P6900 Liquid Chemical Sterilant Processing Systems. This submission is for modifications related to the obsolescence and replacement of a compressor and an upper lid seal. The document asserts that these modified devices are substantially equivalent to their predicate device (K211607).

Here's a breakdown of the acceptance criteria and study information:

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 sample size for the non-clinical testing performed. It refers to "multiple Liquid Chemical Sterilization and Diagnostic Cycles" for the material compatibility test but does not quantify "multiple". Similarly, for performance testing, it simply states "the modification does not affect the performance," without detailing the number of test cycles or units involved.

The provenance of the data is not explicitly stated beyond being "non-clinical testing" conducted by STERIS Corporation for their updated devices. It is an internal company study for regulatory submission.

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

The document does not mention the use of experts to establish ground truth for this non-clinical testing. The acceptance criteria for performance are based on the device maintaining its original performance and the specific technical standards for material compatibility and biocompatibility (ISO 10993-5, K131078, K090036). These are objective measurements rather than expert interpretations.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned as the testing is non-clinical performance and material characterization, yielding objective "Pass/Fail" results against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a liquid chemical sterilant processing system, not an AI-assisted diagnostic or imaging tool involving human interpretation. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study, in the context of AI, was not performed, nor is it applicable. The device is an automated chemical sterilization system; its performance is independently measured against specified physical and chemical parameters, not an algorithm's output. The "algorithm" here refers to the system's software controlling the sterilization cycle. The testing verifies the system's ability to maintain these controlled conditions.

7. Type of Ground Truth Used:

The ground truth for the non-clinical testing is based on objective measurements and adherence to established industry standards and previous regulatory clearances.

• Performance: The device must continue to function as intended, not being adversely affected by component changes.
• Material Compatibility: Integrity after multiple cycles, referencing K131078.
• Biocompatibility: Cytotoxicity evaluation per ISO 10993-5, Annex A, referencing K090036.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is not a machine learning or artificial intelligence device. The device's operation is deterministic based on its hardware and programmed cycles, not learned from data.

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

As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device

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 > or equal to 6-log reduction of MS2 virus is delivered to the water.
• 3.0.1 micron filtration:
  • · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

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 current submission is provided to describe modifications for:

• . Obsolescence and replacement of interface board and connector
• Obsolescence and replacement of silicone tubing ●
• S40 Sterilant Concentrate design modification ●

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 0.1micron 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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

• Obsolescence and replacement of silicone tubing
• S40 Sterilant Concentrate design modification .

The SYSTEM 1 endo Processor is an automated. self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

• Obsolescence and replacement of silicone tubing
• S40 Sterilant Concentrate design modification

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

This document is a 510(k) Premarket Notification from STERIS Corporation to the FDA regarding several Liquid Chemical Sterilant Processing Systems. It's important to understand that this document describes a sterilization device, not an AI/ML-driven diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth for training data) are not applicable to this type of medical device submission.

The acceptance criteria provided are for the functional and physical performance of a chemical sterilant processing system and its associated sterilant, not for an AI model's diagnostic accuracy.

Here's a breakdown of the requested information based on the provided document:

Device Description and Purpose:

The devices are the "SYSTEM 1E Liquid Chemical Sterilant Processing System," "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800," and "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900," along with the "S40 Sterilant Concentrate." These systems are intended for liquid chemical sterilization of cleaned, immersible, and reusable heat-sensitive medical devices (critical and semi-critical) in healthcare facilities. They utilize peracetic acid as the sterilant.

The submission is specifically for modifications to existing cleared devices (predicate K210737), primarily involving:

• Obsolescence and replacement of interface board and connector (for SYSTEM 1E)
• Obsolescence and replacement of silicone tubing (for all models)
• S40 Sterilant Concentrate design modification (for all models)

1. Table of Acceptance Criteria and Reported Device Performance

The tables below synthesize the acceptance criteria and the results as presented in the "Summary of verification activities" (Table 3 in each section of the document).

For SYSTEM 1E Liquid Chemical Sterilant Processing System (Page 15, Table 3)

For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 (Page 25, Table 3)

For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (Page 36, Table 3)

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes (e.g., number of units tested, number of cycles performed) for the functional, reliability, EMC/EMI, form and fit, physical properties, stability, or delivery tests. It simply states "Functional testing," "Reliability testing," etc., and confirms the Pass result.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as these were laboratory-based engineering and performance tests for a sterilization device, not clinical data for an AI/ML diagnostic.

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

This criterion is not applicable. The "ground truth" for this device relates to its ability to function as a sterilizer and its components meeting engineering specifications. This is established through predefined performance requirements (e.g., UL standards for electrical safety, physical property equivalence, stability of sterilant), not through expert consensus on medical images or diagnoses. Validation would be performed by engineers and quality control personnel according to established test protocols.

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

This criterion is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human readers or between AI and human reads in diagnostic studies. For a sterilization device, test results are typically objective (e.g., does it pass/fail a function test, does it meet a physical specification).

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 criterion is not applicable. This is not an AI-assisted diagnostic device. No human readers or interpretations are involved in its primary function, which is sterilization.

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

This criterion is not applicable. This is not an algorithm, but a physical medical device.

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

The "ground truth" in this context refers to the engineering and performance specifications for the device and its components. These include:

• Predefined functional requirements (e.g., device operation, sterilant delivery).
• Compliance with recognized electrical safety and electromagnetic compatibility (EMC/EMI) standards (e.g., UL 61010-1, UL 61010-2-040).
• Physical properties matching existing components.
• Chemical stability of the sterilant.

For the basic germicidal efficacy of the sterilant mentioned in the predicate device comparison (Tables 2 on pages 11-13, 22-23, and 32-34), the ground truth for microbial efficacy (e.g., "Meets efficacy requirements," "Solution is bactericidal") would be established through laboratory microbiological testing (e.g., AOAC Official Methods, EPA Viricidal Testing), which involves culturing specific microorganisms and observing their reduction or elimination after exposure to the sterilant. This is not an AI/ML-related ground truth.

8. The sample size for the training set

This criterion is not applicable. This is not an AI/ML device; there is no "training set."

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

This criterion is not applicable. There is no AI/ML training set for this device. Ground truth for its performance is established through adherence to physical and chemical engineering specifications and established microbiological testing protocols.

Ask a specific question about this device

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 > or equal to 6-log reduction of MS2 virus is delivered to the water.
• 3.0.1 micron filtration:
  • · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria. fungi and protozoa > 0.1 micron.

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

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

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 current submission is provided to describe modifications for:

• . Firmware update
• . Obsolescence and replacement of varistor

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 0.1micron 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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system. utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications for:

• Firmware update ●
• Obsolescence and replacement of varistor ●

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe the modification for obsolescence and replacement of varistor (the firmware update is not required on this model).

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The provided documentation outlines acceptance criteria and the results of a study for several STERIS Liquid Chemical Sterilant Processing Systems: SYSTEM 1E, SYSTEM 1 endo Model P6800, and SYSTEM 1 endo Model P6900. These systems utilize the S40 Sterilant Concentrate. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device (K192929), largely due to software/firmware updates and component obsolescence/replacement.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For all three models (SYSTEM 1E, SYSTEM 1 endo Model P6800, and SYSTEM 1 endo Model P6900), the testing described is limited to evaluating the impact of minor modifications (firmware update and/or varistor replacement). The core performance criteria and germicidal efficacy are based on the predicate device's established performance.

Note: The tables in the document (Table 1, Table 2 in each section concerning the systems and S40 Sterilant Concentrate) extensively compare the proposed device features and performance to the predicate device, indicating "Identical" across various parameters such as germicidal claim, exposure time, use temperature, reuse, active ingredient, mode of action, rinses, microbial efficacy (sporicidal, fungicidal, bactericidal, viricidal, tuberculocidal, simulated-use, clinical in-use), biocompatibility, residue reduction, and device material compatibility. This implies that the acceptance criteria for these aspects are the same as those met by the predicate device, and the proposed devices are considered to perform equivalently.

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

• Sample Size for Functional & Software Testing: The document does not specify the exact sample size (e.g., number of devices or test cycles) used for the software validation or functional tests with the replacement varistor. It simply states the tests were performed and passed.
• Data Provenance: The new tests (software validation and functional tests) would likely be internal studies conducted by STERIS Corporation. The data on microbial efficacy and material compatibility for the predicate device (which are claimed as identical for the proposed devices) stem from various in vitro tests and clinical in-use studies, as indicated by the listed citations (Block, Clapp et al., Maillard et al., McDonnell et al.). The country of origin for these foundational efficacy tests is not specified, but they refer to internationally recognized methods (e.g., AOAC Official Methods, EPA Viricidal Testing). These previous studies would be considered retrospective for the current submission, as they establish the performance of the predicate. The current evaluation of modifications would be prospective relative to these specific changes.

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

• The document primarily describes engineering verification and validation activities (software validation, functional testing). These types of tests do not typically involve human experts for establishing "ground truth" in the same way clinical or diagnostic studies do. Instead, the "truth" is established by adherence to design specifications, regulatory standards, and verified operational parameters.
• For the microbial efficacy (sporicidal, fungicidal, bactericidal, viricidal, tuberculocidal, simulated-use, clinical in-use), the "ground truth" implicitly relies on established microbiological methods and their respective acceptance criteria. The experts involved in the original studies for the predicate device would have been microbiologists and other scientific professionals, as indicated by the referenced scientific literature. The number and specific qualifications are not detailed in this submission.

4. Adjudication Method for the Test Set

• Given the nature of the tests mentioned (software validation, functional tests), an adjudication method (like 2+1, 3+1 often used in medical image analysis) is not applicable. These are objective engineering and performance verification tests with clear pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The device is a sterilizer, not a diagnostic imaging device typically associated with human reader performance. The improvements described are related to maintenance and software updates, not human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The device itself is a standalone system for liquid chemical sterilization; it does not involve an "algorithm" in the sense of AI performing a diagnostic task. Its performance is evaluated intrinsically through its ability to achieve sterilization (microbial kill) and maintain operational parameters. The studies verifying its efficacy (e.g., sporicidal activity, simulated-use tests) are standalone evaluations of the system's performance.

7. Type of Ground Truth Used

• For Software and Functional Testing: The ground truth is defined by the device's design specifications and regulatory requirements (e.g., correct operation of firmware, proper function after component replacement).
• For Microbial Efficacy (Predicate Device): The ground truth was established through rigorous microbiological testing using standardized methods (e.g., AOAC Official Methods, EPA Viricidal Testing). This includes:
  • Culture-based assays: Demonstrating log reduction of various microorganisms (Bacillus subtilis, Clostridium sporogenes, Trichophyton mentagrophytes, Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa, Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1, Mycobacterium terrae).
  • Simulated-use tests: Demonstrating log reduction of Geobacillus stearothermophilus spores under manual application conditions.
  • Clinical In-Use: Absence of surviving microorganisms on representative medical devices.

8. Sample Size for the Training Set

• This information is not applicable. The described devices are physical sterilizers, not AI/machine learning models that require a "training set" in the conventional sense. The "firmware update" is likely a software change to address bugs or improve existing functionality, not a re-training of a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable, as there is no "training set" for an AI algorithm.

Ask a specific question about this device

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 is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

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

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleand, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically diutes 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 0.2 micron filtered water.

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

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 current submission is provided to describe modifications for a obsolescence of the glue for creating the upper lid seal.

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 0.1micron 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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications due to obsolescence of the glue for creating the upper lid seal.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required. facilitate delivery of the sterilant use-solution and rinse water to internal channels. Table 1 compares the proposed and predicate devices.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe modifications due to obsolescence of the glue for creating the upper lid seal.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Ouick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels. Tables 1 and 2 compare the proposed and predicate devices.

The acceptance criteria and study results for the STERIS systems regarding modifications due to obsolescence of the glue for creating the upper lid seal are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The documents describe three similar devices:

• SYSTEM 1E Liquid Chemical Sterilant Processing System
• SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800
• SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

For all three models, the purpose of the submission is for modifications due to the obsolescence of the glue for creating the upper lid seal. The testing performed confirms the performance of the modified device remains equivalent to the predicate.

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

The documents do not specify a numerical sample size (e.g., number of units, number of cycles) for the non-clinical testing performed. The description refers to "multiple Liquid Chemical Sterilization and Diagnostic Cycles" for material compatibility and performance testing.

The data provenance is from non-clinical bench testing conducted by the manufacturer, STERIS Corporation, based in Mentor, Ohio, USA. The studies are prospective in the sense that they were conducted specifically to evaluate the performance of the modified device.

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

This type of submission (510(k) for a modification of an existing device) and the nature of the tests (biocompatibility, material compatibility, processor performance related to a seal) do not involve human expert interpretation of data like medical imaging. Therefore, no experts in the sense of clinicians establishing ground truth from patient data were involved or reported for these specific non-clinical tests. The ground truth is based on predefined engineering and biological acceptance criteria derived from established standards (ISO 10993-5:2009) and previous FDA clearances (K090036, K131078).

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and deterministic (pass/fail based on physical and biological measurements) rather than subjective clinical assessments requiring adjudication.

5. 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 is relevant for diagnostic devices where human reader performance with and without AI assistance is being evaluated, which is not the case for a chemical sterilant processing system.

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

Not applicable. This is a physical chemical sterilization system, not a software algorithm that performs diagnostic or analytical functions. The "performance of processor" test demonstrates the functionality of the device itself (including its automated processes), which could be considered a form of standalone performance evaluation for its intended physical function.

7. The Type of Ground Truth Used

The ground truth for these tests is based on:

• Standardized biological safety criteria: ISO 10993-5:2009 for cytotoxicity.
• Engineering specifications and integrity: Maintaining physical integrity of the seal and preventing leaks during operation, as defined by the device's design and referenced historical predicate device data (K131078).

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (a sterilant processing system) and its component modification, not an AI/ML algorithm that requires training data sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML algorithm was used.

Ask a specific question about this device

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

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe certain software modifications made after the clearance of K182827.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The provided text describes a 510(k) premarket notification for a medical device (SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900) which has undergone "certain software modifications made after the clearance of K182827" (its predicate device). The document primarily focuses on demonstrating substantial equivalence to the predicate, K182827.

The "study" referenced in the text pertains to the Software Validation of the modified device.

Here's the breakdown of the acceptance criteria and study as requested, based on the provided document:

Acceptance Criteria and Device Performance for Software Validation

Details of the Study (Software Validation)

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

   • The document states "New testing was performed to evaluate the modified device," specifically for "Software Validation," and indicates that the software was "validated."
   • However, no specific sample size (e.g., number of test cases, number of cycles) for this software validation test set is provided in the document.
   • Data Provenance: Not explicitly stated, but it would logically be controlled testing data from the manufacturer (STERIS Corporation) rather than patient or clinical data. Given the regulatory submission context, it would be considered prospective testing for the purpose of validating the software modifications. Country of origin for the data is not specified, but the submission is to the US FDA.

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

   • This information is not provided in the document. Software validation typically involves testing against pre-defined requirements and expected outcomes, which are established by software engineers and subject matter experts (SMEs). The document does not specify the number or qualifications of these individuals involved in establishing the testing parameters or reviewing the results.

3. Adjudication Method for the Test Set:

   • The document states "The software that controls the system was validated and determined to operate effectively and as designed."
   • The adjudication method is implicitly direct verification against established functional and design specifications. There is no mention of a human consensus-based adjudication method (e.g., 2+1, 3+1) as commonly seen in medical image analysis.

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 is primarily relevant for diagnostic aids or algorithms that directly impact human interpretation (e.g., radiologists reading images). This device is a sterilizing system with software controls, not a diagnostic tool requiring human reader performance evaluation.

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

   • The software validation (implied as 'algorithm only' if considering the software as the 'algorithm') was indeed done. The device's operation is automated. The validation goal was to confirm the software performs as designed and controls the system effectively.

6. The Type of Ground Truth Used:

   • The ground truth for the software validation is implicit in the design specifications and functional requirements of the software. It's based on engineering specifications and expected system behavior rather than expert consensus, pathology, or outcomes data. The "acceptance criteria" listed essentially serve as the definition of "ground truth" for the software's performance.

7. The Sample Size for the Training Set:

   • This device is a hardware system with software controls, not an AI/ML algorithm that requires a "training set" in the conventional sense (e.g., for pattern recognition or predictive modeling). Therefore, the concept of a training set as used in machine learning is not applicable here, and no information about it is provided. The software was likely developed and then validated against its specifications.

8. How the Ground Truth for the Training Set Was Established:

   • As explained above, the concept of a training set is not applicable to this device's software validation as described.

Ask a specific question about this device

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 is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

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

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

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. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate.

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 0.1micron 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 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.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The provided document is a 510(k) Pre-Market Notification for the SYSTEM 1E Liquid Chemical Sterilant Processing System (K190104) and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System (K190104). This submission describes modifications to the S40 Sterilant Concentrate used with these systems, specifically the addition of a second supplier for a proprietary component of the concentrate.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (K180342 for SYSTEM 1E and K173256 for SYSTEM 1 endo). As such, the studies described are verification tests for the modified component of the sterilant rather than a full stand-alone performance study of the entire device.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For S40 Sterilant Concentrate with alternate source of a proprietary component:

Study Details:

The document clearly states that "New testing was performed to evaluate the modified device," specifically referring to the change in the supplier for a component of the S40 Sterilant Concentrate. The provided tables are comparison tables with predicate devices, indicating that the overall system performance (effectiveness as a sterilant) for the proposed device is considered "identical" to the predicate devices which had already demonstrated efficacy through extensive testing. The new testing is therefore focused on verifying that the change in sterilant component supplier does not negatively impact the established performance.

For the Biocompatibility and Stability Tests (Table 3 on pages 16 and 28):

2. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample size for the biocompatibility or stability tests regarding the alternate component.
   • Data Provenance: The studies were "new testing" performed to evaluate the modified device, implying prospective testing for this specific change. The country of origin for the data is not specified, but the submission is to the US FDA, so it's likely part of US-based regulatory activities.

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

   • Not applicable as these are laboratory-based physical/chemical/biological tests rather than expert interpretation of medical images or clinical data.

4. Adjudication method for the test set:

   • Not applicable; these are objective laboratory tests with pre-defined pass/fail criteria.

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:

   • Not applicable. This device is a liquid chemical sterilizer, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a medical device for sterilization, not an algorithm. The "standalone" performance is implied by the "Pass" results of the biocompatibility and stability tests of the sterilant itself. The overall sterilization efficacy of the SYSTEM 1E and SYSTEM 1 endo Processors using S40 Sterilant is established through prior predicate device clearances and the underlying efficacy claims of the sterilant (e.g., sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal activity, and simulated-use tests, summarised in the comparison tables as "Meets efficacy requirements").

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

   • For the new tests: The ground truth is laboratory-determined objective measurements against pre-defined regulatory and performance standards for biocompatibility (non-cytotoxicity) and chemical stability.
   • For the overall device's sterilization efficacy (as implied by the identical comparison with predicate devices): This would have been established through a combination of in vitro microbiological assays (e.g., AOAC methods for sporicidal, fungicidal, bactericidal activity), in vitro virucidal testing (EPA method), simulated-use tests, and clinical in-use studies. The references to specific methods (e.g., AOAC Official Method 966.04) indicate standardized laboratory protocols are the ground truth.

8. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission, as it's not an AI/machine learning device.

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

   • Not applicable.

Ask a specific question about this device

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

The SYSTEM 1 endo Processor automatically 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 0.2 micron filtered water.

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

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.

This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.

The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use, or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - 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 semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The STERIS SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities. The device automatically 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 0.2 micron filtered water. The P6900 model introduces modifications to the user interface and controller compared to its predicate device, Model P6800, including an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records, while maintaining identical processing parameters.

1. Table of Acceptance Criteria and Reported Device Performance:

• UL 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 1: General Requirements, 3rd Edition
• UL 61010-2-040 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials, 2nd Edition
• IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use – EMC Requirements – Part 1: General Requirements | PASS |
  | Cycle Performance Qualification | All cycle specifications were met for three (3) Liquid Chemical Sterilization and three (3) Diagnostic Cycles. | PASS |
  | Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |

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

The provided document does not specify a separate "test set" in the context of typical validation studies with human readers or clinical data. Instead, for Cycle Performance Qualification, the testing involved running three (3) Liquid Chemical Sterilization cycles and three (3) Diagnostic Cycles. The provenance of this data is not explicitly stated but is presumed to be from laboratory testing conducted by the manufacturer (STERIS Corporation). The data is retrospective in the sense that it's reported after the tests were conducted for regulatory submission. Its country of origin is not specified, but the manufacturer is based in Mentor, Ohio, USA.

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

This information is not applicable as the device is a chemical sterilant processing system, and its performance is evaluated against engineering and microbiological specifications, not based on expert interpretation of images or other subjective data. No human experts were explicitly mentioned for establishing ground truth related to the device's operational performance in the provided summary.

4. Adjudication Method for the Test Set:

Not applicable. The qualification tests rely on objective measurements and predefined pass/fail criteria for electrical safety, cycle parameters, and software functionality, not on human adjudication of subjective data.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The STERIS SYSTEM 1 endo is a medical device sterilization system, and its effectiveness is determined by its ability to sterilize, not by human interpretation or diagnosis.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The "Cycle Performance Qualification" and "Software Validation" tests, along with the Electrical Safety and EMC conformance, demonstrate the standalone performance of the algorithm (software) and the overall device. The device was tested to ensure it operates effectively and as designed (software validation) and that all cycle specifications (e.g., temperature, contact time, peracetic acid concentration) are met during the sterilization and diagnostic cycles.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluation includes:

• Engineering and Safety Standards: For electrical safety and EMC (UL 61010-1, UL 61010-2-040, IEC 61326-1).
• Predefined Cycle Specifications: For cycle performance qualification (e.g., specific temperatures, contact times, chemical concentrations).
• Software Design Requirements: For software validation, ensuring the software operates as designed and effectively controls the system.
• Microbial Efficacy Data (from predicate device's S40 Sterilant Concentrate tables): Although not specifically re-tested for the P6900 device as the sterilant concentrate is unchanged, the efficacy of the sterilant (S40) itself is based on numerous in vitro and simulated use tests demonstrating sporocidal, fungicidal, bactericidal, and virucidal activity, as well as tuberculocidal activity (e.g., > 6 log10 reduction of Geobacillus stearothermophilus spores, absence of surviving microorganisms in clinical in-use tests).

8. Sample Size for the Training Set:

Training set information is not applicable to this device submission. This is a 510(k) submission for a physical medical device (sterilizer) with software modifications, not a machine learning or artificial intelligence-driven diagnostic tool that requires training data in the typical sense. The software validation ensures that the software correctly implements the predefined control logic and algorithms for the sterilization process, rather than "learning" from a training set.

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

Not applicable, as there is no training set in the context of machine learning for this device. The software functionality is based on deterministic control logic and pre-established sterilization parameters derived from extensive microbiological and engineering studies (as indicated by the numerous efficacy tests referenced in the S40 Sterilant Concentrate Comparison Table in the original submission for the predicate device, which are identical for this device).

Ask a specific question about this device

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 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. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.

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 0.1micron 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.

The provided text is a 510(k) Summary for a medical device called the "SYSTEM 1E Liquid Chemical Sterilant Processing System." This summary primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel device. The modifications described are mainly about alternative suppliers for components and an alternative resin for the sterilant capsule, not changes to the core functionality or claims.

However, I can extract the information related to the acceptance criteria and the type of study that demonstrates the device meets these criteria, based on the provided "Summary of verification activities."

Here's the breakdown:

Acceptance Criteria and Device Performance

Study Details

The provided document describes verification activities rather than a full-fledged clinical study or comparative effectiveness study as would be typical for a device with clinical efficacy claims. The purpose of these activities is to ensure that the modifications (alternate suppliers for filters and sterilant capsule resin) do not negatively impact the device's established safety and effectiveness.

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

   • MaxPure Filter alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-months use life." The exact number of cycles or filters tested is not specified.
   • MaxPure Filter microbial retention challenge: Similar to above, "following the accumulation of liquid chemical sterilization cycles and diagnostic cycles representing 3 months use." The exact number of filters or challenges is not specified. The test was based on ASTM F838-15, which is a standard in vitro test method.
   • Pre-filter A and B alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-month use life." The exact number of cycles or filters tested is not specified.
   • S40 Sterilant Concentrate Acid (alternate resin for capsule): "Evaluation of the concentration of peracetic acid over the shelf life." The specific number of samples or duration of testing is not provided.
   • Capsule Alternate Resin and Supplier: "Physical evaluation of compatibility of the alternate resin with container contents." The specific number of units or tests is not provided.
   • Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the U.S. FDA, it is presumed to be from studies conducted under applicable U.S. or international standards, likely at the manufacturer's facility or accredited labs. All studies appear to be retrospective for these verification activities, as they are testing components of an already-cleared device.

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

   • This question is not applicable to the type of studies described. These are engineering and microbiological verification tests, not diagnostic studies requiring expert human interpretation for ground truth.

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

   • This is not applicable as these are technical verification tests, not studies with human interpretation requiring adjudication.

4. 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 is not applicable. The device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or imaging device used by human readers.

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

   • This is not applicable, as the device is not an algorithm or AI system. Its performance is inherent in its physical and chemical processes.

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

   • For the filter integrity challenge, the ground truth would be the direct measurement of microbial retention (e.g., log reduction of bacteria) using standard microbiological methods (ASTM F838-15).
   • For sterilant concentration, the ground truth is the chemical assay of peracetic acid.
   • For material compatibility, the ground truth is physical observation and testing of material integrity and interaction with contents.
   • The "type of ground truth" here refers to established physical, chemical, and microbiological standards and measurements, not clinical expert consensus or pathology.

7. The sample size for the training set:

   • This is not applicable, as this device does not use machine learning or AI algorithms that require a "training set."

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

   • This is not applicable, as no training set is mentioned or implied for this device.

Ask a specific question about this device