(25 days)
The SYSTEM 1E 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°C, 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.
- The extensive treatment of EPA potable water consists of:
- 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. - 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. - 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.
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 K 101409.
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 IE 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 document describes a Special 510(k) Premarket Notification for modifications to the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. The modifications primarily concern device software.
Here's an analysis of the acceptance criteria and study information provided:
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Table of Acceptance Criteria and Reported Device Performance:
Test Acceptance Criteria Reported Performance 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 Pass Machine Validation Targeted modifications do not affect the performance of the device Pass -
Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the traditional sense for evaluating an AI model. This submission is for modifications to a physical sterilization system's software, not an AI/ML device. The "tests" mentioned are verification and validation activities for software and machine performance. The data provenance is not applicable as this is a device modification, not a study involving patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of expert consensus, pathology, or outcomes data, is typically for diagnostic or prognostic AI models. This submission is about a sterilizer's software update. The "ground truth" for the acceptance criteria is implicitly defined by the system's intended function and pre-established engineering specifications. -
Adjudication method for the test set:
Not applicable. There's no mention of a human adjudication process for resolving disagreements in "ground truth" for a test set, as this is a software/machine validation. -
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 is not a comparative effectiveness study involving human readers or AI assistance. It's a regulatory submission for a modification to a sterilizer. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of AI algorithms. The "software" in question runs within the SYSTEM 1E Processor, an automated, self-contained device. The software's performance is standalone in the sense that it controls the machine, but it's not a standalone diagnostic or predictive algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these tests relates to engineering requirements and the system's operational specifications. For example, for "Software Verification," the ground truth is whether "only targeted modifications were implemented." For "Machine Validation," the ground truth is whether "targeted modifications do not affect the performance of the device" according to its established sterilization and functional parameters. This would be based on design specifications, functional requirements, and performance data from the machine itself. -
The sample size for the training set:
Not applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML 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.