(75 days)
Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to a health care setting where low and intermediate level disinfection of hard, non-porous surfaces is required. It is intended to be used in a dental office as an instrument ultrasonic cleaning solution. In order to disinfect, a contact time of 10 minutes at 69°F / 20°C is required.
This product may be used to pre-clean or decontaminate of critical or noncritical medical devices prior to sterilization. Must be followed by appropriate terminal sterilization or high-level disinfection process.
Pro-Portion is a broad spectrum, multi-purpose ready to use, effective cleaner and disinfectant for use on the surfaces of inanimate objects. Pro-portion will efficiently clean and disinfect, when used as directed, such items as laminated counter tops, dental units, dental instruments, lights, and other inanimate surfaces, including those made of plastics (such as: polycarbonate, polyvinylchloride, polypropylene and polystyrene), nonporous vinyl and upholstery, stainless steel, painted surfaces, Plexiglas, glass, and other hard non-porous surfaces.
The provided text is a 510(k) summary for a phenolic cleaner/disinfectant called Pro-Portion. It outlines the product's physical characteristics, intended use, and ultimately states that the FDA found it substantially equivalent to legally marketed predicate devices.
However, the document does not contain information about acceptance criteria, a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the performance of a device in terms of clinical or diagnostic outcomes.
This document is for a disinfectant, which is a chemical product rather than a diagnostic or therapeutic medical device that would typically involve a "study" with "acceptance criteria" for performance metrics like sensitivity or specificity. The "performance characteristics" mentioned refer to its efficacy as a cleaner and disinfectant against microorganisms, which are typically evaluated through standardized microbiological tests, not studies involving human subjects or expert consensus on interpretations.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as that information is not present in the provided text for this type of product.
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.