(135 days)
MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.
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The provided text is a 510(k) summary for the UltraMIST System, a low energy ultrasound-generated mist device used for wound cleansing and maintenance debridement. This document is a regulatory approval letter from the FDA and does not contain the information requested regarding acceptance criteria, study details, or performance data of the device.
Therefore, I cannot provide a response to your request as the necessary information is not present in the given document.
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.