(100 days)
Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam.
The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following:
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Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)
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Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs)
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Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)
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Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)
Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam.
The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following:
-
Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)
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Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs)
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Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)
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Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)
The provided text is related to an FDA 510(k) clearance for a steam sterilizer (Lexa MINI), not a device that involves AI/ML, human readers, or a test set with ground truth established by experts.
Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the given document. These are typical requirements for evaluating the performance of AI/ML-driven medical devices, which the Lexa MINI sterilizer is not.
§ 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).