(108 days)
The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-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 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 current submission is provided to describe certain software modifications made after the clearance of K182827.
The SYSTEM 1 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 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 provided text describes a 510(k) premarket notification for a medical device (SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900) which has undergone "certain software modifications made after the clearance of K182827" (its predicate device). The document primarily focuses on demonstrating substantial equivalence to the predicate, K182827.
The "study" referenced in the text pertains to the Software Validation of the modified device.
Here's the breakdown of the acceptance criteria and study as requested, based on the provided document:
Acceptance Criteria and Device Performance for Software Validation
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The software that controls the system was validated and determined to operate effectively and as designed. | Pass |
Details of the Study (Software Validation)
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Sample Size Used for the Test Set and Data Provenance:
- The document states "New testing was performed to evaluate the modified device," specifically for "Software Validation," and indicates that the software was "validated."
- However, no specific sample size (e.g., number of test cases, number of cycles) for this software validation test set is provided in the document.
- Data Provenance: Not explicitly stated, but it would logically be controlled testing data from the manufacturer (STERIS Corporation) rather than patient or clinical data. Given the regulatory submission context, it would be considered prospective testing for the purpose of validating the software modifications. Country of origin for the data is not specified, but the submission is to the US FDA.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Software validation typically involves testing against pre-defined requirements and expected outcomes, which are established by software engineers and subject matter experts (SMEs). The document does not specify the number or qualifications of these individuals involved in establishing the testing parameters or reviewing the results.
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Adjudication Method for the Test Set:
- The document states "The software that controls the system was validated and determined to operate effectively and as designed."
- The adjudication method is implicitly direct verification against established functional and design specifications. There is no mention of a human consensus-based adjudication method (e.g., 2+1, 3+1) as commonly seen in medical image analysis.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic aids or algorithms that directly impact human interpretation (e.g., radiologists reading images). This device is a sterilizing system with software controls, not a diagnostic tool requiring human reader performance evaluation.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- The software validation (implied as 'algorithm only' if considering the software as the 'algorithm') was indeed done. The device's operation is automated. The validation goal was to confirm the software performs as designed and controls the system effectively.
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The Type of Ground Truth Used:
- The ground truth for the software validation is implicit in the design specifications and functional requirements of the software. It's based on engineering specifications and expected system behavior rather than expert consensus, pathology, or outcomes data. The "acceptance criteria" listed essentially serve as the definition of "ground truth" for the software's performance.
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The Sample Size for the Training Set:
- This device is a hardware system with software controls, not an AI/ML algorithm that requires a "training set" in the conventional sense (e.g., for pattern recognition or predictive modeling). Therefore, the concept of a training set as used in machine learning is not applicable here, and no information about it is provided. The software was likely developed and then validated against its specifications.
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How the Ground Truth for the Training Set Was Established:
- As explained above, the concept of a training set is not applicable to this device's software validation as described.
§ 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.