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510(k) Data Aggregation

    K Number
    K092781
    Device Name
    MAM TWISTER
    Manufacturer
    MAM INTERNATIONAL AG
    Date Cleared
    2010-06-23

    (286 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K052105
    Why did this record match?
    Device Name :

    MAM TWISTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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 (

    AI/ML Overview

    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

    CharacteristicsStandardAcceptance CriteriaReported Device Performance
    BacteriologicalUSP / ASTM F963 section 4.3.6.1MeetsMeets
    Cleanliness of products used in toysASTM F963 section 4.3.6.3MeetsMeets
    Ban of lead-containing paint16 CFR 1303MeetsMeets (, 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.

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