(286 days)
The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP , ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (
The provided text describes a 510(k) summary for the "MAM Twister" Fluid-Filled Teething Ring. It outlines the device's technical characteristics and how it meets various safety standards.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bacteriological | USP / ASTM F963 section 4.3.6.1 | Meets | Meets |
| Cleanliness of products used in toys | ASTM F963 section 4.3.6.3 | Meets | Meets |
| Ban of lead-containing paint | 16 CFR 1303 | Meets | Meets (, ASTM F963, 16 CFR regulations, CPSIA, EN 71 series) define objective criteria for acceptable performance. |
8. The Sample Size for the Training Set
Not applicable. This is a physical device undergoing non-clinical safety and performance testing against predefined standards, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved in the evaluation of this device. The standards themselves serve as the "ground truth" for the non-clinical tests.
§ 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.