(84 days)
The SYSTEM IE Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive 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 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
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- The extensive treatment of EPA potable water consists of:
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- Pre-filtration through two pre-filters:
- · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
- · Pre-filter 2 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.
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- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. .
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- The extensive treatment of EPA potable water consists of:
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. Following this initial clearance the FDA was notified of a second qualified supplier of an ultraviolet light water treatment subsystem providing equivalent water treatment performance, safety, and effectiveness to that described within K090036. This modification was subsequently cleared under K101409. Software updates were cleared in K102462 and additions to that file.
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 the 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 0.1 micron 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. peracetic acid, is combined with inert ingredients 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 ensure thorough circulation of the sterilant solution and rinses.
This 510(k) summary describes modifications to the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System, which is a liquid chemical sterilization system. The submission focuses on verification activities performed to ensure that software modifications do not affect the safety or effectiveness of the device.
Here's the breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided document describes verification activities related specifically to software modifications.
| Test | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|
| Software Verification / Code Walk-Through | Only targeted modifications were implemented to the device software. | Pass |
| Software Validation | Only targeted modifications were implemented to the device software and modifications work as intended. | Pass |
Note: This submission does not include performance data for the primary sterilization function (e.g., microbial efficacy), as the changes are software-related and deemed not to affect critical performance parameters. The previous clearances (K090036, K101409, K102462) would contain such performance data for the core sterilization capabilities.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or performance data for the software modifications. The verification activities for software typically involve testing on the modified software rather than a distinct "test set" of medical images or patient data. Therefore, details like country of origin or retrospective/prospective nature are not applicable to the software verification described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This information is not applicable because the study described is for software verification, not for medical image analysis or diagnostic performance where expert ground truth is typically established.
4. Adjudication Method for the Test Set
N/A. An adjudication method is not applicable as the described activities are software verification and validation, not a study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on software modifications to an existing sterilization device, not on comparative effectiveness of human readers with or without AI assistance for interpretation tasks.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense, a standalone algorithm performance was assessed for the software. The "Software Verification" and "Software Validation" activities evaluate the modified software's functionality independently. However, this is in the context of controlling a sterilization process, not performing a diagnostic or interpretive task that would typically be associated with AI standalone performance studies.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the software verification, the "ground truth" would be the functional specifications and design documents for the software. The acceptance criteria essentially define what the "correct" and "intended" behavior of the software modifications should be. The "Pass" results indicate that the software's behavior matched these predefined specifications.
8. The Sample Size for the Training Set
N/A. This document describes software modification verification, not a machine learning or AI model development that requires a training set.
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set for an AI model described in this document, the method for establishing its ground truth 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.