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The STERImaster Autoclave is a fast, efficient table-top unit for the sterilization of health care instruments. The STERImaster uses the internationally accepted standard of steam sterilization at a specific temperature for a specific time.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from F0 values) | Reported Device Performance (F0 values) |
|---|---|
| Sufficient F0 value for sterilization effectiveness (specific F0 values for each cycle are not explicitly stated as "criteria" but are presented as the result demonstrating effectiveness) | Solid instruments: 85.91 |
| Handpieces: 122.74 | |
| Rubber and Plastics: 29.32 |
Explanation of the Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating sufficiently high F0 values for each sterilization cycle, using Bacillus Stearothermophilus spores as the microbiological challenge. F0 value is a measure of the total lethal effect of a sterilization process, equivalent to the number of minutes at 121°C with saturated steam. Higher F0 values indicate a more effective sterilization process. While specific target F0 values are not explicitly listed as "acceptance criteria," the established steam sterilization process and the demonstration of a "large margin of safety" in spore destruction indicate that the reported F0 values are considered acceptable and sufficient for sterilization.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of devices or cycles. The study refers to "Extensive tests" and the use of Bacillus Stearothermophilus spores. The text does not specify the number of test runs or the quantity of spores used per test.
- Data Provenance: The study was conducted by "Sterilization Technical Services." The country of origin of this service is not specified in the provided text. The data is presented as a result of tests performed to determine "sterilization effectiveness," suggesting a prospective testing approach designed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for sterilization effectiveness was established by "Sterilization Technical Services" using Bacillus Stearothermophilus spores as the microbiological challenge. The text does not mention the number of human experts involved in establishing this ground truth or their specific qualifications. The ground truth here is biological (spore destruction), evaluated through established laboratory methods.
4. Adjudication Method for the Test Set
- Not applicable. The "ground truth" here is the biological outcome of spore destruction, measured by F0 values derived from the testing. There is no mention of human adjudication for the test 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
- Not applicable. This device is an autoclave (sterilizer), not an AI-assisted diagnostic or interpretative system. Therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The "performance" of the device (autoclave) is its ability to sterilize. The results presented (F0 values) are a direct measure of the autoclave's standalone performance in destroying biological contaminants. There is no human interaction required for the sterilization process itself, other than loading and initiating the cycle.
7. The Type of Ground Truth Used
- Biological Ground Truth: The primary ground truth used is the destruction of Bacillus Stearothermophilus spores. This is a widely accepted biological indicator for validating steam sterilization processes. The success of sterilization is quantified by the F0 value, which reflects the lethal effect on these spores.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical sterilizer, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm or AI. The design and parameters were likely developed through engineering principles and iterative testing, but not in the sense of a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" for this device. The physical and operational parameters of the STERImaster Autoclave were likely developed based on scientific principles of steam sterilization, engineering design, and general knowledge of effective sterilization cycles for various materials (e.g., historical data on various temperatures and times for different instrument types).
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510(k) SUMMARY FOR THE STERImaster AUTOCLAVE
Original Submission Date: Revision Date: Submitted By:
Classification Name:
Classification:
Common/Usual Name:
Trade/Proprietary Name:
August 13, 1994 August 16, 1996 SciCan. Division of Lux and Zwingenberger Ltd. 1440 Don Mills Road. Toronto. Ontario, Canada M3B 3P9 Neil McPhail, Manager Research and Development (416) 445-1600 Fax: (416) 445-2727 Sterilizer, Steam Sterilizer, Steam STERImaster Autoclave Establishment Registration Number: 8043629 Class II under 21CFR880.6880
Contact:
Predicate Device for Substantial Equivalence:
This product is similar in design, composition and function to the STATIM Cassette Autoclave@ manufactured by SciCan, Division of Lux and Zwingenberger Ltd., which was the subject of Premarket Notification No. K910241B. The STATIM is presently being marketed. The main difference between the two, besides the smaller chamber in STERImaster, is the sterilization chamber itself. The STATIM uses a two-piece cassette which is manually inserted into the unit. The STERImaster features a one-piece chamber which is automatically retracted into the unit. A seal inside the unit descends onto the chamber, forming a closed sterilization vessel. The smaller size has necessitated slightly different cycle parameters, which are described below.
Technical Description:
The STERImaster Autoclave is a fast, efficient table-top unit for the sterilization of health care instruments. The STERImaster uses the internationally accepted standard of steam sterilization at a specific temperature for a specific time. Low power requirements (110 Volts, 60 Hz, 1300 Watts) mean that the unit can be plugged into any grounded 15 Amp circuit.
The unit measures 384 mm long, 292 mm wide and 282 mm high, while the sterilization chamber measures 190 mm long, 90 mm wide and 53 mm high.
An optional printer is offered which provides a permanent record of the cycle parameters. Printed data includes date and time, cycle counter, cycle chosen, the start time of each cycle phase (described below), the temperature and pressure at 30 second intervals during the sterilization phase, and any error conditions encountered.
The STERImaster features a removable stainless-steel drawer, which holds the open-topped thin-walled stainless-steel sterilization chamber. At the sterilization cycle, the drawer automatically retracts into the insulated, lightweight laminated steel containment system. Steam enters through a small hole in the seal and exhausts through a hole at the bottom of the chamber. A microprecessor-activated valve controls the steam exhaust. The chamber is designed to distribute steam from the top to the bottom, creating a wall of sieam which moves downward, driving out trapped air. The chamber is positioned in the STERImaster at an angle, allowing condensed steam to collect in the rear comer and drain from the machine through the exhaust valve.
During operation, measured quantities of distilled water are drawn by the pump and injected, on demand, into the steam generator. The steam created here travels directly to the chamber. The steam temperature is monitored by two calibrated thermocouples; one in the chamber and one in the steam generator. The chamber thermocouple is located at the exhaust port, which is
CONFIDENTIAL 510(k) Summary for the STERImaster Autoclave
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equivalent to the drain in traditional autoclaves, and is therefore the coldest spot in the chamber. Power to the steam generator is modulated by a microprocessor-based control system, based upon the temperature in the sterilization chamber. This, and internal baffles in the steam generator, combine to ensure a supply of high-quality steam, at the correct temperature, to the sterilization chamber.
The STERImaster offers three microprocessor-controlled sterilization cycles. The first cycle sterilizes at 132°C for 3.5 minutes and is used for solid metal instruments. The second cycle sterilizes at 132°C for 5 minutes and is used for dental handpieces and hollow metal instruments of all types. The third cycle sterilizes at 121°C for 30 minutes and is used for rubber, plastic or heat sensitive instruments.
The STERImaster sterilization cycles are broken down into five phases: 1) warm-up, 2) conditioning, 3) pressurizing, 4) sterilizing, 5) venting. During the first phase, steam feeds into the chamber where it begins to purge the air through the open exhaust valve. Successive pulses of steam rapidly raise the temperature inside the chamber and drive the air out. Depending on the cycle selected, the second phase consists of a series of deep purges, during which the exhaust valve opens until the temperature falls from the sterilization temperature to 115 ℃ or 110 °C. The exhaust valve closes and the unit repressurizes to the sterilization temperature. These purges are designed to expel the remaining air from the chamber. When these purges finish, the third phase begins. Pressure and temperature inside the chamber rise, and the exhaust valve opens periodically to expel condensate. The fourth phase begins when the desired sterilization temperature is reached, and continues for the required time period during which the sterilization temperature is maintained precisely. At the end of this period, the exhaust valve opens and the pressure inside the chamber falls to atmospheric pressure. This is the fifth phase. At this point, the drawer automatically opens. The instruments can then be removed when dry and cool.
The use of a forced steam supply enables better air removal, better quality control of sterilization conditions, and less oxidation of metal instruments in the chamber. The low mass of the sterilization chamber allows it to heat quickly. Therefore, the net time spent on heat-up and cooldown is minimized, though the duration of sterilization conditions, of course is the same for all autoclaves. This benefit speeds the cycle and therefore lessens damage to instruments.
The safety and effectiveness problems which attend the STERImaster Autoclave are typical of all steam autoclaves. For example, caution must be exercised not to over-pack the autoclave, thereby inhibiting the free flow and even penetration of steam. By and large however, every error condition is detectable by the unit and will result in an incomplete cycle and a warning on the display. The pressure vessel safety aspects are less serious in the STERImaster than in other typical table top sterilizers because of its small volume and laminated steel support structure. There is no door and hinge mechanism which can fail or be partially closed, presenting the type of explosion hazards reported for pressure-cooker type autoclaves with fronthinge doors.
Relevant Standards:
Currently. there are no standards in North America related to small, table-top autoclaves of unique construction, such as the STERImaster. It is therefore necessary to examine the most important standards for larger autoclaves, and extract the safety and performance standards which apply. The STERImaster Autoclave was designed according to the AAMI Standards and Recommended Practices for Sterilization, and ST8-1988. It also conforms to UL1262 and CSA C22.2-151M, both laboratory equipment safety standards.
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Microbiological Evaluations:
Extensive tests by Sterization Technical Services using Bacillus Stearothermophilus spores as the microbiological challenge, have determined the sterilization effectiveness of each of the cycles according to the Test Protocol included in the main body of the submission. The calculated Fo values are included in the following table:
| Cycle | NominalTemperature (°C) | Time(min.) | F₀ (min.) |
|---|---|---|---|
| Solid instruments | 132 | 3.5 | 85.91 |
| Handpieces | 132 | 5 | 122.74 |
| Rubber and Plastics | 121 | 30 | 29.32 |
By using the well-established steam sterilization process, and demonstrating a large margin of safety in the destruction of Bacillus Stearothermophilus spores, it can be concluded that the STERImaster Autoclave is substantially equivalent to the STATIM Cassette Autoclave", as well as other table-top sterilizers currently on the market.
§ 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).