(50 days)
This Tuttnauer autoclave is designed for use in healthcare settings for the sterilization of heat stable medical devices; wrapped solids, hollow and porous products. Sterilization of liquid loads should only be used in non-clinical applications in open or closed (but not sealed) containly si
Tuttnauer autoclave models 6990 SP-1A: 66120 SP-1A: 69150 SP-2A: 69120 L USA SP-2A; 69180 SP-2HA; and 6690 L USA SP-1V are all prevacuum autoclaves that utilize saturated steam as the sterilizing agent. Each of these autoclaves is 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.
Each of the six Tuttnauer autoclave models is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a water reservoir, a water pump, and a vacuum pump, Each autoclave is pre-programmed with twelve sterilization cycles, and each has two test programs: (1) a "Bowie & Dick Test," and (2) an "Air Leakage Test." The six autoclaves are equipped with the capability to shut down automatically. An emergency stop push button that is mounted on the front panel is an available option for customers with specific needs.
The control software, which is identical to that used in the autoclayes cleared under K032192, allows for automatic operation of all six autoclaves. The microcomputer technology employed in the autoclaves ensures that the entire cycle will operate on a fully-automatic basis. Therefore, no further intervention is necessary after setting the pre-selected parameters and starting operation of the autoclaye.
The provided text describes a 510(k) premarket notification for Tuttnauer Prevacuum Steam Heated Autoclave models, focusing on their substantial equivalence to previously cleared devices. It does not contain information about the acceptance criteria or a study that proves a device (in the context of AI/ML or diagnostic systems) meets acceptance criteria.
The information provided details a medical device (steam sterilizer) and its functional specifications, comparison to predicate devices, and testing against a standard for sterilizers (ANSI/AAMI ST8).
Therefore, I cannot fulfill your request as the required information (acceptance criteria for device performance, specific study details for proving compliance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in the provided text.
The document is a regulatory submission for a physical medical device (autoclave), not a submission for an AI/ML or diagnostic 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).