(165 days)
The W&H Lisa Water Steam Sterilizer is designed for pressurized steam sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous and hollow loads.
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This document is an FDA 510(k) clearance letter for the W&H Lisa Steam Sterilizer. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed premarket submission summary.
The provided text only lists the operational parameters for the sterilization and test cycles of the device, which are part of its intended performance but not necessarily the "acceptance criteria" as you defined them in the context of a study demonstrating device performance against specific metrics.
Therefore, I cannot provide the requested information from the given input. The document is primarily a regulatory clearance, not a performance study report.
§ 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).