(304 days)
intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufacutered by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.
The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. The difference between predicate sterilizer controls and the Access controls is that the Access controls are provided with more modern microprocessor/software. and interactive graphic touch screen operator interface. The chamber vessel and piping remain unchanged.
Here's an analysis of the provided text in the context of device acceptance criteria and studies, specifically noting what information is not present for this particular submission.
It's important to understand that the provided text (K954736) describes a submission for sterilizer controls, and the regulatory pathway chosen (510(k) Pre-market Notification) for this type of device often relies on demonstrating substantial equivalence to a predicate device, rather than extensive clinical efficacy studies akin to those for diagnostic AI devices.
Analysis of K954736 for Acceptance Criteria and Study Information
The provided text describes the MDT Biologic Company ACCESS (Powerclave) sterilizer controls, which are an upgrade to an existing microcomputer control system for hospital steam sterilizers.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Evidence/Mechanism |
|---|---|---|---|
| Performance Requirements | ANSI/AAMI ST-8 - 1994 American National Standard for Hospital Steam Sterilizers | The product is designed to meet these requirements. | Manufacturer's claim of design conformance. |
| Safety Standards | UL-544 (Medical and Dental Equipment) | The product is designed to meet these requirements. | Manufacturer's claim of design conformance. |
| Safety Standards | CSA C22.2 (Canadian Electrical Code, Part II: Safety Standards for Electrical Equipment) | The product is designed to meet these requirements. | Manufacturer's claim of design conformance. |
| Safety Standards | IEC 601.1 (now IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance) | The product is designed to meet these requirements. | Manufacturer's claim of design conformance. |
| Vessel Design & Construction | Section VIII of the ASME pressure vessel code | Vessels are designed and constructed to this code; each vessel is certified. | Manufacturer's claim; certification. |
| Substantial Equivalence | To Castle Microcomputer Control (K820783) | Believed to be substantially equivalent. | Comparison highlighting the upgrade of microprocessor/software and touch screen, with unchanged chamber vessel and piping. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided. The submission explicitly states, "No clinical testing is required for this submittal." This indicates that a traditional "test set" in the context of clinical or performance data (as one would expect for an AI/diagnostic device) was not used or required for this particular regulatory pathway. The reliance is on engineering standards, safety compliance, and substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. As no clinical testing or performance study with a "test set" was conducted, there were no experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. No test set requiring expert adjudication was utilized.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. The submission explicitly states "No clinical testing is required for this submittal." MRMC studies are typically for evaluating the impact of a diagnostic aid on human reader performance, which is not relevant for a sterilizer control system.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable / Not Provided in the typical sense. While the system (microprocessor/software) operates autonomously, a "standalone study" in the context of AI/diagnostic device performance isn't described. The performance is assessed against engineering standards and functional requirements of a sterilizer, not against human interpretation or clinical outcomes of a diagnostic nature. The controls themselves are a standalone system (not human-in-the-loop in their primary function), but their "performance" is demonstrated through compliance with standards, not through clinical trials.
7. The Type of Ground Truth Used
- Not Applicable / Not Provided in the typical sense of a diagnostic device. For this device, "ground truth" would relate to the successful and consistent sterilization of items as defined by the associated performance standards (ANSI/AAMI ST-8) and the accuracy of the control system in maintaining those parameters. Compliance with these standards serves as the implicit "ground truth" for its functional performance.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This device is a control system for a sterilizer. It uses microprocessor/software but is not an AI/machine learning device that would typically have a "training set" in the sense of learning from data to make predictions or classifications. Its programming likely follows deterministic logic and control algorithms based on established sterilization principles.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As there's no indicated "training set" for AI/ML, this question doesn't apply. The "ground truth" for the design and programming of such a control system would be derived from the scientific principles of sterilization and the requirements of the standards like ANSI/AAMI ST-8.
Summary for K954736:
This submission is for an upgrade to a sterilizer control system. The regulatory pathway (510(k)) focuses on demonstrating substantial equivalence to an existing predicate device and conformance to relevant engineering and safety standards. As explicitly stated, no clinical testing was required or performed. Therefore, many of the questions related to clinical study design, test sets, ground truth establishment, and expert involvement for AI/diagnostic devices are not applicable to this particular submission. The "proof" of meeting acceptance criteria comes from the manufacturer's attestation of design and construction according to established standards and the comparison to an already cleared predicate device.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).