(395 days)
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.
Typical applications:
Metal Medical Instruments (Unwrapped) Metal Medical Instruments (Wrapped) Glassware (Unwrapped) Hand Pieces (Pouches)
The electronic control has four pre-programmed sterilization cycles.
The four pre-programmed sterilization cycles are for:
Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes
Cycle 2: Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes
Cycle 3: Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes
Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes
The Astell Scientific range of UMB benchtop steam sterilizers are designed to offer convenience and flexibility in the sterilization of medical and surgical instruments.
Instruments for sterilization include wrapped and unwrapped Metal Medical instruments, unwrapped Glassware and pouched dental hand pieces.
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. Autoclaves/sterilizers heat water to generate steam as the sterilization agent, producing steam in the chamber to create a gravity displacement, pulsed dynamic air removal sterilization environment.
Steam sterilization is a widely used sterilization process due to its versatility and speed. The sterilizers include as its main components a pre-programmed electronic control module, autofill water reserve, electronic heaters and an auto-drain sterilization chamber.
The free-steaming phase of the sterilization process incorporates a 20-minute dynamic air removal program pulsing at low; 1200 mbar/ high;1600 mbar
The autoclaves are equipped with multiple safety features. The door contains a safety locking mechanism that does not permit operation unless the door is closed and locked, and does not permit the door to be opened until the internal chamber pressure is no greater than 100mbar above atmospheric pressure. Additional safety features include an automatic safety shutoff to prevent the chamber overheating; two (2) thermostats; one to detect overheating of the heaters and one to prevent opening of the door if the chamber temperature is unsafe to do so (80 °C). There is also a safety valve for the pressure vessel.
A touch screen digital display with a user log, data archiving for up to 5000 cycles and multiple user access levels and multi-level password protection is used for precision control and monitoring purposes.
The differences between the UMB Autoclaves/Sterilizers in this submission is the chamber volumes:
UMB 220 (Total volume 33 Litres) UMB 230 (Total volume 43 Litres) UMB 240 (Total volume 63 Litres)
There is an optional printer available to record cycle parameters.
Only United States Food and Drug Administration cleared accessories such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes should be used with this Autoclave.
The provided document is a 510(k) premarket notification for a medical device (Astell UMB 220, 230, 240 Autoclaves/Sterilizers). This document primarily focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Tuttnauer EZ Plus Series Autoclaves), rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI device or a device with complex performance metrics like diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria and a study proving device performance (especially those related to AI, human readers, ground truth, and training data) are not applicable to this type of submission. The document outlines technical performance standards and safety criteria that the device must meet, and then demonstrates through non-clinical testing and comparison that it achieves these.
Here's how to interpret the document in the context of your request:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a sterilizer are not typically framed in terms of metrics like sensitivity or specificity, but rather in meeting established physical and microbiological performance standards for sterilization. The study proving these criteria are met is the non-clinical testing conducted according to recognized standards.
Table of Acceptance Criteria (based on relevant standards) and Reported Device Performance:
| Acceptance Criteria (from ANSI/AAMI ST55:2010 and other standards) | Reported Device Performance (Astell UMB series) | Notes |
|---|---|---|
| Sterilizer Temperature Control (e.g., within -0°C and +3°C of target) | Passed for both 121°C and 134°C cycles | Demonstrated compliance with 5.4.3 of ANSI/AAMI ST55:2010. |
| Biological Performance of Sterilizers (ability to kill target microorganisms) | Passed | Demonstrated compliance with 5.5 of ANSI/AAMI ST55:2010. This is the core proof of sterilization efficacy. |
| Mechanical Air Removal (effective removal of air from the chamber) | Passed | Demonstrated compliance with 5.6 of ANSI/AAMI ST55:2010, which indicates effective steam penetration. |
| Moisture Retention (items sufficiently dry after cycle) | Passed | Demonstrated compliance with 5.7 of ANSI/AAMI ST55:2010. Important for preventing recontamination. |
| Electrical Safety (e.g., per IEC 61010, IEC 61010-2-040) | Compliant (through gap analysis reports and self-certification) | Testing conducted to demonstrate safety with electrical components as per the standard. |
| Electromagnetic Compatibility (EMC) (e.g., per IEC 61326) | Compliant (through gap analysis reports) | Device does not interfere with or is not affected by other electronic devices. |
| Application of Risk Management (per BS EN ISO 14971) | Compliant (through self-certification validated by Notified Body) | Process in place to identify, evaluate, and control risks associated with the device. |
| Application of Usability (per IEC 62366) | Compliant (through self-certification validated by Notified Body) | Designed for safe and effective use by operators. |
| Software Life Cycle Processes (per IEC 62304) | Compliant (through self-certification validated by Notified Body) | Software development and maintenance follows recognized standards. |
| Functional Equivalence to Predicate Device (e.g., design, components, safety features, sterilization cycles) | Similar/Same across multiple parameters (Tables 1, 2, 3A, 3B, 4, 5) | Demonstrated by direct comparison tables against the predicate device (K111736). |
Study Information (as applicable to a sterilizer 510(k))
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Sample size used for the test set and the data provenance:
- The "test set" here refers to the sterilizer units themselves and the test loads used within them. The document does not specify an exact number of units or test cycles beyond stating that "All testing was conducted in accordance with the requirements of AAMI/ANSI ST55:2010 inclusive of physical and microbiological performance requirements."
- Data Provenance: The testing was conducted by Astell Scientific (the manufacturer) and certified by a Notified Body (SGS). The standards applied are international (ANSI/AAMI, IEC, BS EN, ISO). This is non-clinical lab testing. The data is prospective, in the sense that the tests were specifically performed to demonstrate compliance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable. "Ground truth" for a sterilizer's performance is established by the physical and microbiological tests outlined in standards like AAMI/ANSI ST55:2010. These involve:
- Physical: Temperature probes, pressure sensors, timers, etc., to verify cycle parameters.
- Microbiological: Use of biological indicators (BIs) containing resistant spores (e.g., Geobacillus stearothermophilus) which are processed in the sterilizer. The "ground truth" of successful sterilization for BIs is validated by absence of growth after incubation under controlled laboratory conditions, indicating spore kill.
- The "experts" involved would be microbiologists and engineers who design and execute these tests, and the auditors/certifiers from SGS who verify compliance with the standards. Their qualifications are inherent in their roles within testing labs and notified bodies for medical devices.
- This concept is not directly applicable. "Ground truth" for a sterilizer's performance is established by the physical and microbiological tests outlined in standards like AAMI/ANSI ST55:2010. These involve:
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Adjudication method for the test set:
- Not applicable in the sense of human reader adjudication. Test results (e.g., temperature/pressure readings, bacterial growth/no growth in BIs) are objective and determined by laboratory protocols.
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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 device is an autoclave/sterilizer, not an AI-powered diagnostic or assistive tool. There are no "human readers" in the context of its performance evaluation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the autoclave has an electronic control system, it doesn't perform diagnostic functions or involve an "algorithm" in the sense of AI. Its performance is evaluated as a complete electromechanical system via the physical and microbiological tests mentioned.
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The type of ground truth used:
- Scientific Standards and Objective Measurement: The ground truth for a sterilizer's performance is ultimately derived from the established scientific principles of sterilization (time, temperature, pressure, steam saturation) and empirically proven methods for demonstrating microbial inactivation. This is primarily established through:
- Physical parameters: Direct measurement (e.g., temperature, pressure, time) and comparison against specified acceptance limits.
- Microbiological indicators: The known resistance of specific bacterial spores and the absence of their growth after a sterilization cycle.
- Scientific Standards and Objective Measurement: The ground truth for a sterilizer's performance is ultimately derived from the established scientific principles of sterilization (time, temperature, pressure, steam saturation) and empirically proven methods for demonstrating microbial inactivation. This is primarily established through:
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI models, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is irrelevant.
In summary, this 510(k) submission details non-clinical laboratory testing and comparisons to predicate devices to prove the safety and effectiveness of a steam sterilizer against recognized performance and safety standards, rather than through a clinical study involving human users or AI performance metrics.
§ 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).