(56 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 > 6-log reduction of MS2 virus is delivered to the water.
- 3.0.1 micron filtration:
· The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.
The provided text is a 510(k) Summary for a medical device called the "SYSTEM 1E Liquid Chemical Sterilant Processing System." This summary primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel device. The modifications described are mainly about alternative suppliers for components and an alternative resin for the sterilant capsule, not changes to the core functionality or claims.
However, I can extract the information related to the acceptance criteria and the type of study that demonstrates the device meets these criteria, based on the provided "Summary of verification activities."
Here's the breakdown:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The modification does not change the final product release specifications (for MaxPure Filter) | Pass |
| The modification does not change the final product release specifications (for MaxPure Filter via microbial retention challenge) | Pass |
| The modification does not change the final product release specifications (for Pre-filter A and B) | Pass |
| The modification does not change the final product release specifications (for S40 Sterilant Concentrate Acid concentration) | Pass |
| The container contents are compatible with the container package and labeling (for Capsule Alternate Resin and Supplier) | Pass |
Study Details
The provided document describes verification activities rather than a full-fledged clinical study or comparative effectiveness study as would be typical for a device with clinical efficacy claims. The purpose of these activities is to ensure that the modifications (alternate suppliers for filters and sterilant capsule resin) do not negatively impact the device's established safety and effectiveness.
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Sample size used for the test set and the data provenance:
- MaxPure Filter alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-months use life." The exact number of cycles or filters tested is not specified.
- MaxPure Filter microbial retention challenge: Similar to above, "following the accumulation of liquid chemical sterilization cycles and diagnostic cycles representing 3 months use." The exact number of filters or challenges is not specified. The test was based on ASTM F838-15, which is a standard in vitro test method.
- Pre-filter A and B alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-month use life." The exact number of cycles or filters tested is not specified.
- S40 Sterilant Concentrate Acid (alternate resin for capsule): "Evaluation of the concentration of peracetic acid over the shelf life." The specific number of samples or duration of testing is not provided.
- Capsule Alternate Resin and Supplier: "Physical evaluation of compatibility of the alternate resin with container contents." The specific number of units or tests is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the U.S. FDA, it is presumed to be from studies conducted under applicable U.S. or international standards, likely at the manufacturer's facility or accredited labs. All studies appear to be retrospective for these verification activities, as they are testing components of an already-cleared device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the type of studies described. These are engineering and microbiological verification tests, not diagnostic studies requiring expert human interpretation for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as these are technical verification tests, not studies with human interpretation requiring adjudication.
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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:
- This is not applicable. The device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or imaging device used by human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is not an algorithm or AI system. Its performance is inherent in its physical and chemical processes.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the filter integrity challenge, the ground truth would be the direct measurement of microbial retention (e.g., log reduction of bacteria) using standard microbiological methods (ASTM F838-15).
- For sterilant concentration, the ground truth is the chemical assay of peracetic acid.
- For material compatibility, the ground truth is physical observation and testing of material integrity and interaction with contents.
- The "type of ground truth" here refers to established physical, chemical, and microbiological standards and measurements, not clinical expert consensus or pathology.
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The sample size for the training set:
- This is not applicable, as this device does not use machine learning or AI algorithms that require a "training set."
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How the ground truth for the training set was established:
- This is not applicable, as no training set is mentioned or implied for this device.
§ 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.