(221 days)
The STATIM 5000 Cassette Autoclave is a table-top steam sterilizer designed for the reprocessing of reusable instruments in a clinical setting. The STATIM 5000 has four microprocessor-controlled, pre-programmed cycles. The first cycle operates at 132 °C for 3.5 minutes and is used for light loads of up to 0.5 kg solid stainless steel instruments free from deep cavities or holes, for example, scalers, forceps or scissors. The second cvcle operates at 132 °C for 6 minutes and is for up to 1.5 kg of stainless steel instruments, such as those described above, and instruments of more complex construction, such as handpieces, wrapped in paper/paper or paper/plastic-film packs. The third cycle operates at 121 °C for 35 minutes and is for up to 0.4 kg of rubber, plastic or heat-sensitive items, for example, plastic mouth mirrors, suction tips or impression travs. The fourth cycle is designed for up to 1.5 kg of unwrapped stainless steel instruments, such as those described above, and instruments of more complex construction, such as handpieces.
The STATIM 5000 Cassette Autoclave is considered a fast, efficient table-top unit for the sterilization of health care instruments. The STATIM 5000 uses the conventionally accepted parameters of saturated steam at temperatures of 132 °C and 121 °C for specific times depending on the cycle selected. The STATIM 5000 features a removable stainless steel cassette, which, when inserted into the insulated steel receptacle, forms the sterilization chamber. The cassette consists of a lid (including user-replaceable seal) and a tray. Sockets at the rear of the cassette connect to a steam line and exhaust valve upon insertion into the insulated receptacle. The cassette seal distributes steam from the rear of the cassette to the front, creating a wall of steam to remove air through the exhaust socket. The cassette is positioned to allow condensed steam to collect and drain through the exhaust socket to the exhaust valve. During operation, distilled water is pumped according to the control algorithm into the steam generator. The saturated steam produced by the steam generator travels to the cassette through the steam socket. The steam temperature is monitored by two calibrated thermocouples, one located in the cassette chamber and the other in the steam generator. The cassette chamber thermocouple is located at the exhaust socket. Power to the steam generator is modulated by a microprocessor based control system in order to maintain the temperature in the cassette chamber. This process, along with internal baffles in the steam generator, ensure a supply of saturated steam at the appropriate temperature into the cassette chamber. The STAT/M 5000 has four microprocessor controlled sterilization cycles. Each of the cvcles includes six phases: 1) warm-up, 2) conditioning, 3) pressurizing. 4) sterilizing, 5) venting and 6) air-drying. There is an optional built-in printer which provides a record of the cvcle parameters.
Here's a breakdown of the acceptance criteria and study information for the STATIM 5000 Cassette Autoclave based on the provided text:
Acceptance Criteria and Device Performance
Physical Evaluation
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1. Saturated steam is present in the sterilization chamber during the sterilization phase of each cycle. (a) | Demonstrated (tested according to BS3970-1990. 1990. Section 12.2). |
| 2. Sterilization temperature throughout the chamber is controlled to within -1/+3 °C of the specified temperature. (b) | Demonstrated (tested according to ANSI/AAMI ST8-1988 Sections 3.4.1 and 3.4.2). |
| 3. Sterilization exposure timing is accurate to within 5% of the stated time. (c) | Demonstrated (tested according to ANSI/AAMI ST8-1988 Section 3.4.3). |
| 4. Temperature indicator and recorder accuracy is within ±1 °C. (d) | Demonstrated (tested according to ANSI/AAMI ST8-1994 Section 4.4.1.3). |
| 5. Calculated pressure accuracy during the sterilization phase of each cycle is within ±15 kPa. (e) | Demonstrated (tested according to AAMI ST55 (Nov. 1995 Draft ) Section 4.4.4.1). |
Microbiological Evaluation
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1. Culture media evaluated for sterility, volume control, and growth promotion of low numbers of Bacillus Stearothermophilus spores. | Found to be acceptable. |
| 2. All spore strips had at least 1.0 X 10⁶ spores per strip. | Verified. |
| 3. Test instruments inoculated with a spore suspension mixed with 10% sheep blood containing at least 1 X 10⁶ spores per inoculum. Spore recovery method yielded at least 1 X 10⁶ spores per test instrument for those not submerged in broth. | Verified. |
| 4. No spore survivors at exposure times greater than 5 seconds at sterilization temperature for Unwrapped, Heavy Duty Unwrapped, and Wrapped Cycles (D-value, Half-Cycle, and Total Kill Endpoint Determination not possible due to rapid kill). Simulated use testing with inoculated instruments for these cycles shows no regular spore survival. | Data indicated no spore survivors could be expected at exposure times greater than 5 seconds at the sterilization temperature for the Unwrapped, Heavy Duty Unwrapped and the Wrapped Cycles. Simulated use testing showed no regular spore survival in test handpieces in the Wrapped and Heavy Duty Unwrapped Cycles (loads: single handpiece to 68) and no regular spore survival with solid test instruments in the Unwrapped Cycle (loads: single instrument to 86). |
| 5. For Rubber and Plastics cycle, D-value of 0.187 minutes for a full 0.4 kg load. No spore strip survivors after 5.5 minutes of exposure at sterilization temperature. Simulated use testing with inoculated instruments shows no survivors after 17 minutes of exposure at sterilization temperature. | Worst case load (0.4 kg) for Rubber and Plastics cycle had a D-value of 0.187 minutes. No spore strip survivors found after 5.5 minutes of exposure at the sterilization temperature. Simulated use testing showed no survivors after 17 minutes of exposure at the sterilization temperature. |
| F₀ Values (Calculated Minimum) | Unwrapped Instruments: 43.1 min (132 °C, 3.5 min) |
| Wrapped Instruments: 73.8 min (132 °C, 6 min) | |
| Heavy Duty Unwrapped Instruments: 73.8 min (132 °C, 6 min) | |
| Rubber and Plastics: 34.2 min (121 °C, 35 min) |
Study Details
Based on the provided text, the studies conducted are related to the performance validation of a medical sterilization device (autoclave). This is a type of engineering and microbiological validation, not a study directly involving human readers or interpretation of data. Therefore, many standard AI/medical device study fields (like expert adjudication, MRMC studies, training set details) are not applicable to this type of device and study description.
Here's a breakdown of the applicable information:
2. Sample Size Used for the Test Set and Data Provenance
- Physical Evaluation: Not specified in terms of distinct "samples" like patients or images. The tests were performed on the device itself under various conditions and cycles.
- Microbiological Evaluation:
- Spore Strips: "all spore strips had at least 1.0 X 10⁶ spores per strip." (Quantity of strips not specified, but implied to be sufficient for testing.)
- Inoculated Test Instruments: "at least 1 X 10⁶ spores per inoculum" for various instruments.
- Wrapped and Heavy Duty Unwrapped Cycles: "loads ranging from a single handpiece to 68 handpieces."
- Unwrapped Cycle: "loads ranging from a single instrument to 86 instruments."
- Rubber and Plastics Cycle: "full load of instruments weighing 0.4 kg" (number of instruments not specified, but load weight is).
- Data Provenance: Not explicitly stated, but implicitly from in-house laboratory testing conducted by SciCan or a contracted testing facility for the purpose of this 510(k) submission. These are prospective validation tests specific to the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This study is a performance validation of a sterilizer, not a diagnostic device requiring expert interpretation of results. The "ground truth" is established by direct measurement (e.g., temperature, pressure) and scientific microbiological principles (e.g., absence of spore growth).
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
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 is a sterilizer, not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device operates as a standalone automated sterilizer. Its performance is evaluated directly. There is no "algorithm only" in the sense of an AI model to be contrasted with human performance. The device's operation is dictated by its programmed microprocessor control system, and its performance (sterilization efficacy) is what was tested.
7. The Type of Ground Truth Used
- Physical Evaluation: Direct measurements of physical parameters (temperature, pressure, timing) against established engineering standards and specifications.
- Microbiological Evaluation: Absolute sterility (absence of viable bacterial spores) as determined by standard microbiological culture techniques, using Bacillus Stearothermophilus as a biological indicator. This represents a definitive biological outcome.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI model that undergoes a "training phase" in the conventional machine learning sense. The device's operation is based on pre-programmed cycles and physical principles of steam sterilization.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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).