(609 days)
For use in sterilizing dental and surgical instruments such as extractor forceps with sirrated handles, IRIS scissors, and convex mirrors and handles, with all legally marketed models of MDT Harvey Chemiclaves, when use of chemiclave solution is indicated, and used according to the chemiclave cycle parameters, ( 132°C, 20 -27 psi, for 20 minutes per cycle). Not for use in water or steam type sterilizers
Vapophene - Chemical autoclave solution
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vapophene - Chemical autoclave solution," but it does not detail any performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. It only states that the device is "substantially equivalent" to legally marketed predicate devices.
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.