(62 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 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.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software validation per IEC 62304 | The firmware was validated and determined to operate effectively and as designed. | Pass |
| Functional test with replacement varistor | The modification does not affect the operation of the device (or ensures operation). | Pass |
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.
§ 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.