(29 days)
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:
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- 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.
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- 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:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance testing with replacement compressor | The modification does not affect the performance of the device. | Pass |
| Performance testing with replacement upper lid seal | The modification does not affect the performance of the device. | Pass |
| Material Compatibility of upper lid seal | The upper lid seal maintains integrity after multiple Liquid Chemical Sterilization and Diagnostic Cycles in accordance with methods disclosed in K131078. | Pass |
| Biocompatibility of upper lid seal | The upper lid seal meets the acceptance criteria for cytotoxicity in ISO 10993-5, Annex A in accordance with methods disclosed in K090036. | Pass |
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.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.