(118 days)
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical 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 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, cleaned semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo LCS Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects.
This submission describes modifications to the processor's user interface and controller, to be introduced in Model P6900. The modifications will provide several user convenience features as compared to the originally cleared processor. Model P6800. The advantages for users include an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records. The P6900 model utilizes an updated electronic controller and suitable software, while providing cycles for liquid chemical sterilization (LCS) and system diagnostics identical to those of the original device. The modified SYSTEM 1 endo Processor, which is computer controlled and continually monitored, provides electronic documentation of each cycle. An external printer is available for printed records, if preferred.
The SYSTEM 1 endo Processor (whether Model P6800 or P6900) is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in six (6) minutes. After liquid chemical sterilant 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 STERIS SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical medical devices and their accessories in healthcare facilities. The device 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 P6900 model introduces modifications to the user interface and controller compared to its predicate device, Model P6800, including an intuitive touchscreen display, a barcode scanner, and the ability to electronically save and download cycle data for facility records, while maintaining identical processing parameters.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety Conformance and EMC | Conformance to: |
- UL 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 1: General Requirements, 3rd Edition
- UL 61010-2-040 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials, 2nd Edition
- IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use – EMC Requirements – Part 1: General Requirements | PASS |
| Cycle Performance Qualification | All cycle specifications were met for three (3) Liquid Chemical Sterilization and three (3) Diagnostic Cycles. | PASS |
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a separate "test set" in the context of typical validation studies with human readers or clinical data. Instead, for Cycle Performance Qualification, the testing involved running three (3) Liquid Chemical Sterilization cycles and three (3) Diagnostic Cycles. The provenance of this data is not explicitly stated but is presumed to be from laboratory testing conducted by the manufacturer (STERIS Corporation). The data is retrospective in the sense that it's reported after the tests were conducted for regulatory submission. Its country of origin is not specified, but the manufacturer is based in Mentor, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the device is a chemical sterilant processing system, and its performance is evaluated against engineering and microbiological specifications, not based on expert interpretation of images or other subjective data. No human experts were explicitly mentioned for establishing ground truth related to the device's operational performance in the provided summary.
4. Adjudication Method for the Test Set:
Not applicable. The qualification tests rely on objective measurements and predefined pass/fail criteria for electrical safety, cycle parameters, and software functionality, not on human adjudication of subjective data.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The STERIS SYSTEM 1 endo is a medical device sterilization system, and its effectiveness is determined by its ability to sterilize, not by human interpretation or diagnosis.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "Cycle Performance Qualification" and "Software Validation" tests, along with the Electrical Safety and EMC conformance, demonstrate the standalone performance of the algorithm (software) and the overall device. The device was tested to ensure it operates effectively and as designed (software validation) and that all cycle specifications (e.g., temperature, contact time, peracetic acid concentration) are met during the sterilization and diagnostic cycles.
7. Type of Ground Truth Used:
The ground truth used for the performance evaluation includes:
- Engineering and Safety Standards: For electrical safety and EMC (UL 61010-1, UL 61010-2-040, IEC 61326-1).
- Predefined Cycle Specifications: For cycle performance qualification (e.g., specific temperatures, contact times, chemical concentrations).
- Software Design Requirements: For software validation, ensuring the software operates as designed and effectively controls the system.
- Microbial Efficacy Data (from predicate device's S40 Sterilant Concentrate tables): Although not specifically re-tested for the P6900 device as the sterilant concentrate is unchanged, the efficacy of the sterilant (S40) itself is based on numerous in vitro and simulated use tests demonstrating sporocidal, fungicidal, bactericidal, and virucidal activity, as well as tuberculocidal activity (e.g., > 6 log10 reduction of Geobacillus stearothermophilus spores, absence of surviving microorganisms in clinical in-use tests).
8. Sample Size for the Training Set:
Training set information is not applicable to this device submission. This is a 510(k) submission for a physical medical device (sterilizer) with software modifications, not a machine learning or artificial intelligence-driven diagnostic tool that requires training data in the typical sense. The software validation ensures that the software correctly implements the predefined control logic and algorithms for the sterilization process, rather than "learning" from a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of machine learning for this device. The software functionality is based on deterministic control logic and pre-established sterilization parameters derived from extensive microbiological and engineering studies (as indicated by the numerous efficacy tests referenced in the S40 Sterilant Concentrate Comparison Table in the original submission for the predicate device, which are identical 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.