(274 days)
The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a Water Filled Teether. It is a regulatory approval document, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, study details, or ground truth establishment.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device based on existing standards, rather than new performance studies with specific statistical outcomes.
Therefore, I cannot extract the requested information from the provided text.
§ 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.