(26 days)
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 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (S1 endo) 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 S1 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 S1 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 S1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.
The STERIS Corporation's SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, demonstrates substantial equivalence to its predicate device (K222615) based on non-clinical testing. The device is a liquid chemical sterilization system intended for processing immersible, reusable semi-critical medical devices and their accessories in healthcare facilities. The modifications being reviewed are limited to the use of alternative, drop-in replacement components for the control boards.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Use of new control boards: | |
| New control boards must fit. | Pass (demonstrated by testing) |
| New control boards must run all cycles. | Pass (demonstrated by testing) |
| New control boards must run without alarms. | Pass (demonstrated by testing) |
| Software confirmation test: | |
| Ensure proper software version. | Pass (demonstrated by testing) |
| Ensure proper operation of cycles. | Pass (demonstrated by testing) |
| Ensure proper operation of alarms. | Pass (demonstrated by testing) |
2. Sample size used for the test set and the data provenance:
The document mentions "non-clinical performance testing" and "the same methods used to verify the original design" but does not specify the exact sample size for the test set (e.g., number of sterilization cycles performed, number of control boards tested).
The data provenance is implicitly from STERIS Corporation's internal testing labs, as they designed and manufactured the device. The testing is retrospective in the sense that it's performed after the modifications were made to confirm functionality against established criteria. No external country of origin is mentioned for the testing data itself; it's generated by the manufacturer for regulatory submission in the U.S.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing appears to be objective, verifying technical specifications and operational parameters, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the expected functional performance of the device and its components.
4. Adjudication method for the test set:
This information is not provided as the nature of the testing (functional verification of control boards and software) would likely involve automated system checks and predefined pass/fail criteria rather than expert adjudication of subjective results.
5. 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 as the device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable for the same reasons as #5. The device operates as an automated system; there isn't an "algorithm only" performance that would need to be separated from human interaction in the way an AI diagnostic tool might.
7. The type of ground truth used:
The ground truth used for these specific tests (related to new control boards and software) is functional criteria and predefined technical specifications. For example, a control board "fits" if it physically integrates correctly, "runs all cycles" if it successfully initiates and completes the sterilization sequence, and "runs without alarms" if no error states are triggered during operation. The software's "proper version" is a verifiable identifier, and its "proper operation of cycles and alarms" refers to its adherence to programmed logic and responses.
More broadly for the device as a sterilizer, the ultimate ground truth would be microbial efficacy (sterilization) and material compatibility, which are also stated to meet efficacy requirements based on in-vitro testing for its intended use (as described in Table 2).
8. The sample size for the training set:
This information is not applicable. The device is a physical sterilizer with a control system, not a machine learning or AI model that requires a training set. The "training" for such a system would be its design, engineering, and manufacturing processes, along with verification and validation testing.
9. How the ground truth for the training set was established:
This is not applicable as there is no "training set" in the context of an AI/ML model for this device. The ground truth for the device's overall function (sterilization efficacy) is established through standardized microbiological testing methods (e.g., AOAC Official Methods, simulated-use tests, clinical in-use tests as referenced in Table 2) against specific log reduction criteria for various microorganisms. For component performance (like the control boards), the ground truth is established by design specifications and functional requirements.
§ 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.