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

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

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

• The extensive treatment of EPA potable water consists of:

• 1. Pre-filtration through two pre-filters:
  • · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
  • · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
• 2. UV Irradiation:
  • · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 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 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 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 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.

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The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

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

• The extensive treatment of EPA potable water consists of:

1. Pre-filtration through two pre-filters:

• · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
• · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.

2. UV Irradiation:

• During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.

3. 0.1 micron filtration:

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

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Five Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, and labeling. This premarket notification introduces a new processing tray that will accommodate ultrasound endoscopes and other large flexible devices and their associated Quick Connects. Additionally, minor inconsistent statements in the cleared Indications for Use are corrected, and clarification is provided on post-processing handling and storage of critical and semi-critical medical devices.

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

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

Study Proving Device Meets Acceptance Criteria

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

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

Specific Study Types Mentioned/Implied:

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

7. The type of ground truth used

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

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

8. The sample size for the training set

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

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

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

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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 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.

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

• The extensive treatment of EPA potable water consists of:

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

Not Found

This document is an FDA 510(k) clearance letter for the STERIS System 1E Liquid Chemical Sterilant Processing System. It does not contain information about acceptance criteria or specific study details proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory clearance, not a technical report detailing performance criteria and study results.

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

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

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

• The extensive treatment of EPA potable water consists of:
  • 1. Pre-filtration through two pre-filters:
    • · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
    • Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
  • 2. UV Irradiation:
    • · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
  • 3. 0.1 micron filtration:
    • · The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

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

The device was originally cleared under K090036. Following the initial clearance the FDA was notified of a second qualified supplier of an ultraviolet light water treatment subsystem providing equivalent water treatment performance, safety, and effectiveness to that described within K090036. This modification was subsequently cleared under K101409. Minor revisions to software that did not alter cycle parameters were cleared under K102462 and K113520.

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

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific SYSTEM IE Quick Connects, if required, facilitate delivery of the liquid chemical sterilant use-solution and rinse water to internal channels.

The provided document describes a 510(k) premarket notification for a modification to the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. This document focuses on demonstrating that the modifications to the device do not affect its safety or effectiveness, rather than a de novo study of the entire device's performance against clinical endpoints. Therefore, many of the requested fields regarding extensive studies are not applicable or cannot be extracted from this specific 510(k) summary.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes verification activities related to specific hardware and software modifications. It does not mention a "test set" in the context of clinical or large-scale performance evaluation using data. The tests focus on confirming that the modifications themselves do not negatively impact the device.

• Sample Size: Not applicable in the context of a "test set" for performance evaluation against ground truth. The "sample" would be the modified components or software itself undergoing specific engineering verification.
• Data Provenance: Not applicable. The "data" comes from internal engineering and quality testing of the modified device components and software.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the original SYSTEM 1E, and the tests aim to ensure the modifications do not deviate from that. This is not a study requiring expert clinical adjudication.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study. It's a 510(k) clearance for device modifications, focusing on maintaining substantial equivalence to a predicate device, not on improving human reader performance.

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

Yes, in a way. The tests reported (Biocompatibility, Processor Performance, Software Verification, Software Validation, Machine Validation) are essentially standalone in that they assess the device's technical specifications and function without direct human interaction or interpretation in a clinical diagnostic setting. The device (STERIS SYSTEM 1E) is an automated liquid chemical sterilant processing system.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria is based on the established performance and safety specifications of the predicate SYSTEM 1E Liquid Chemical Sterilant Processing System (K090036 and subsequent modifications under K101409, K102462, K113520). The studies described here verify that the implemented modifications do not alter this existing profile.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. It's a physical medical device.

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

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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