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

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

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

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

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

The S1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

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

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

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

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

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

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

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

This information is not provided in the document. The testing appears to be objective, verifying technical specifications and operational parameters, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the expected functional performance of the device and its components.

4. Adjudication method for the test set:

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

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

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

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

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

7. The type of ground truth used:

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

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

8. The sample size for the training set:

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

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

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

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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, 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.

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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 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.

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

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

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

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

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

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

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

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

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

Acceptance Criteria and Device Performance for Software Validation

Details of the Study (Software Validation)

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

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

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

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

3. Adjudication Method for the Test Set:

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

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic aids or algorithms that directly impact human interpretation (e.g., radiologists reading images). This device is a sterilizing system with software controls, not a diagnostic tool requiring human reader performance evaluation.

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

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

6. The Type of Ground Truth Used:

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

7. The Sample Size for the Training Set:

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

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

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

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