(84 days)
The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
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This document is an FDA 510(k) clearance letter for the "Fu Hong Industries Limited Soother Teether". It determines that the device is "substantially equivalent" to legally marketed predicate devices.
The document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for medical device performance. Instead, the FDA's 510(k) process focuses on showing substantial equivalence to a predicate device, rather than requiring new clinical trials to establish safety and effectiveness from scratch for every new device.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Performance Study: The document explicitly states "substantially equivalent" rather than detailing specific performance metrics or a study. The FDA review in this context typically compares the new device's technological characteristics, materials, and intended use against a lawfully marketed predicate device.
- Device Type: This is a teether, which is a Class II device. While Class II devices have "Special Controls," the provided letter does not elaborate on them. For many Class II devices, particularly consumer-facing ones like a teether, the "substantially equivalent" determination does not typically involve the rigorous clinical performance studies (with acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) that would be associated with more complex or higher-risk medical devices (e.g., AI-powered diagnostic tools).
The provided text focuses on regulatory compliance aspects and the determination of substantial equivalence, not on a detailed performance study as you've requested.
§ 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.