(59 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.
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.
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- 0.1 micron filtration:
- · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.
The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate.
The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.
The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.
The provided document is a 510(k) Pre-Market Notification for the SYSTEM 1E Liquid Chemical Sterilant Processing System (K190104) and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System (K190104). This submission describes modifications to the S40 Sterilant Concentrate used with these systems, specifically the addition of a second supplier for a proprietary component of the concentrate.
The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (K180342 for SYSTEM 1E and K173256 for SYSTEM 1 endo). As such, the studies described are verification tests for the modified component of the sterilant rather than a full stand-alone performance study of the entire device.
Here's the breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For S40 Sterilant Concentrate with alternate source of a proprietary component:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility of S40 Sterilant Concentrate with alternate source of a proprietary component | Medical devices shall be non-cytotoxic after exposure to S40 Sterilant Concentrate containing the alternate source of a proprietary component | Pass |
| Stability of S40 Sterilant Concentrate with alternate source of a proprietary component | S40 Sterilant Concentrate shall meet acceptance criteria after 6-months of storage. | Pass |
Study Details:
The document clearly states that "New testing was performed to evaluate the modified device," specifically referring to the change in the supplier for a component of the S40 Sterilant Concentrate. The provided tables are comparison tables with predicate devices, indicating that the overall system performance (effectiveness as a sterilant) for the proposed device is considered "identical" to the predicate devices which had already demonstrated efficacy through extensive testing. The new testing is therefore focused on verifying that the change in sterilant component supplier does not negatively impact the established performance.
For the Biocompatibility and Stability Tests (Table 3 on pages 16 and 28):
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the biocompatibility or stability tests regarding the alternate component.
- Data Provenance: The studies were "new testing" performed to evaluate the modified device, implying prospective testing for this specific change. The country of origin for the data is not specified, but the submission is to the US FDA, so it's likely part of US-based regulatory activities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as these are laboratory-based physical/chemical/biological tests rather than expert interpretation of medical images or clinical data.
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Adjudication method for the test set:
- Not applicable; these are objective laboratory tests with pre-defined pass/fail criteria.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a liquid chemical sterilizer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device for sterilization, not an algorithm. The "standalone" performance is implied by the "Pass" results of the biocompatibility and stability tests of the sterilant itself. The overall sterilization efficacy of the SYSTEM 1E and SYSTEM 1 endo Processors using S40 Sterilant is established through prior predicate device clearances and the underlying efficacy claims of the sterilant (e.g., sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal activity, and simulated-use tests, summarised in the comparison tables as "Meets efficacy requirements").
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the new tests: The ground truth is laboratory-determined objective measurements against pre-defined regulatory and performance standards for biocompatibility (non-cytotoxicity) and chemical stability.
- For the overall device's sterilization efficacy (as implied by the identical comparison with predicate devices): This would have been established through a combination of in vitro microbiological assays (e.g., AOAC methods for sporicidal, fungicidal, bactericidal activity), in vitro virucidal testing (EPA method), simulated-use tests, and clinical in-use studies. The references to specific methods (e.g., AOAC Official Method 966.04) indicate standardized laboratory protocols are the ground truth.
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The sample size for the training set:
- Not applicable in the context of this 510(k) submission, as it's not an AI/machine learning device.
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How the ground truth for the training set was established:
- 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.