(392 days)
The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids (for non-clinical application only) in open or closed containers. It has the following automated program sterilization cycles: Program 1 (Flash - Porous), Program 2 (Flash - Nonporous), Program 3 (Wrapped - 270°F), Program 4 (Wrapped - 270°F), Program 5 (Wrapped 275°F), Program 6 (Wrapped - 250°F), Program 7 (Liquids - 250°F) For non-clinical applications only, Program 8 (Bowie-Dick Test), Program 9 (Air Leakage Test).
The Tuttnauer Model 4472 EP-1V and 5596 EP-1V Autoclaves are steam sterilizers that provide onboard steam generation capability. They are designed for sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The Tuttnauer Model 4472 EP-1V and 5596 EP-1V autoclaves are steam sterilizers that include as main components: a pressure vessel with steam jacket, heating elements, a chamber water reservoir, a water pump and a vacuum pump.
The provided text is for a 510(k) summary for a steam sterilizer (autoclave), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.
Below is a summary of the acceptance criteria and study information provided for the Tuttnauer Autoclaves.
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ANSI/AAMI ST-8) | Reported Device Performance (Tuttnauer 4472 EP-1V & 5596 EP-1V) |
|---|---|---|
| General Sterilization Efficacy | Meets all aspects of ANSI/AAMI ST-8, including physical and microbiological performance requirements for steam sterilization. | "Tuttnauer conducted validation studies in accordance with ANSI/AAMI ST8 (2001). Testing showed that the sterilizers meet all aspects of the standard, including physical and microbiological performance requirements. Successful sterilization was accomplished in all tests performed." The device provides effective sterilization of instruments. |
| Program 1 (Flash - Porous) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 270°F (270-276°F) |
| Sterilization Time: 3 minutes | ||
| Pressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig) | ||
| Maximum Load: two (2) 16 lb. unwrapped trays | ||
| Program 2 (Flash - Nonporous) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 270°F (270-276°F) |
| Sterilization Time: 10 minutes | ||
| Pressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig) | ||
| Maximum Load: two (2) 16 lb. unwrapped trays | ||
| Program 3 (Wrapped - 270°F) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 270°F (270-276°F) |
| Sterilization Time: 4 minutes | ||
| Dry Time: 30 minutes | ||
| Pressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig) | ||
| Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs | ||
| Program 4 (Wrapped - 270°F) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 270°F (270-276°F) |
| Sterilization Time: 10 minutes | ||
| Dry Time: 20 minutes | ||
| Pressure & Range: 186 kPa (186-220 kPa); 12.3 psig (12.3-17.2 psig) | ||
| Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs | ||
| Program 5 (Wrapped - 275°F) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 275°F (275-281°F) |
| Sterilization Time: 3 minutes | ||
| Dry Time: 20 minutes | ||
| Pressure & Range: 214 kPa (214-245 kPa); 16.3 psig (16.3-20.8 psig) | ||
| Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs | ||
| Program 6 (Wrapped - 250°F) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 250°F (250-256°F) |
| Sterilization Time: 30 minutes | ||
| Dry Time: 45 minutes | ||
| Pressure & Range: 103 kPa (103-128 kPa); 0.2 psig (0.2-3.9 psig) | ||
| Maximum Load: two (2) 16 lb. wrapped trays or 8 towel packs | ||
| Program 7 (Liquids - 250°F) | Per ANSI/AAMI ST8:2001 | Sterilization Temperature & Range: 250°F (250-256°F) |
| Sterilization Time: 30 minutes | ||
| Pressure & Range: 103 kPa (103-128 kPa); 0.2 psig (0.2-3.9 psig) | ||
| Maximum Load: three (3) 1 liter flasks | ||
| Program 8 (Bowie-Dick Test) | Fixed sterilization parameters for Bowie-Dick Test | Sterilization Temperature & Range: 273°F (273-274°F) |
| Sterilization Time: 3.5 minutes | ||
| Dry Time: 2 minutes | ||
| Pressure & Range: 207 kPa (207 kPa); 15.3 psig (15.3 psig) | ||
| Program 9 (Air Leakage Test) | Test for air leakage to the chamber through door seal or other seals in vacuum phase | This test is intended to test air leakage to the chamber through the door seal or any other seals. This test is performed in vacuum phase. |
(Note: The "acceptance criteria" for the specific programs are implied by successful demonstration of meeting the program parameters as part of the overall ANSI/AAMI ST-8 compliance.)
Study Details (as they pertain to an AI/ML context, if applicable):
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Sample size used for the test set and the data provenance:
- The document refers to "validation studies" and "all tests performed" in accordance with ANSI/AAMI ST-8. It does not specify a distinct "test set" in the context of AI/ML data, but rather the performance of the physical sterilizer under various load and cycle conditions as defined by the standard.
- No specific sample sizes (e.g., number of sterilization cycles, number of biological indicators) are provided, nor is the country of origin of the data explicitly stated (though it's a US company seeking US clearance, implying US-based testing or compliance with US standards).
- The studies were "validation studies," which are prospective in nature for a new device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device sterilizer, not an AI/ML diagnostic or predictive tool requiring expert ground truth for image or data interpretation. Ground truth for sterilization efficacy is typically established through established microbiological and physical testing standards (e.g., biological indicators, thermocouples).
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Adjudication method for the test set:
- Not applicable. This is a physical device sterilizer.
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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 is a physical device sterilizer.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device sterilizer.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for sterilizers is established by established microbiological destruction criteria (e.g., 10^-6 sterility assurance level for biological indicators) and physical parameters (temperature, pressure, time) as defined by standards like ANSI/AAMI ST-8.
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The sample size for the training set:
- Not applicable. This is a physical device sterilizer, not an AI/ML device trained on data. The "training" for such a device involves engineering design, manufacturing protocols, and internal testing to ensure it meets its design specifications before formal validation.
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How the ground truth for the training set was established:
- Not applicable. This is a physical device sterilizer.
§ 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).