(199 days)
The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
Teething Ring – Water or Gel Filled
This document is a 510(k) premarket notification for a Teething Ring - Water or Gel Filled. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way medical device AI/software studies typically do.
The FDA 510(k) clearance process for this type of device (a physical teething ring) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring specific performance studies with quantitative metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot provide the requested information because it is not present in the provided text. The document is primarily a regulatory clearance letter and an "Indications For Use" statement.
§ 872.5550 Teething ring.
(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.