(153 days)
The treated article controls the growth of bacteria, fungus, and algae providing the antimicrobial surface is regenerated with the continuous use of a Sterisil water pre-treatment product. The Sterisil treated article is intended to be used with distilled, deionized, or reverse osmosis water. Efficacy for tap water has not been determined. This product is not intended to provide sterile water.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Sterisil® Antimicrobial Tubing and Bottle). It confirms that the device is substantially equivalent to a predicate device and can be marketed.
This document does not contain any information regarding:
- Acceptance criteria for performance.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
Therefore, I cannot fulfill your request based on the provided input. The letter focuses on regulatory clearance, not on detailed study performance metrics.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.