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510(k) Data Aggregation

    K Number
    K212037
    Device Name
    SancDam Latex Oral Dam
    Manufacturer
    Sanctuary Health Sdn. Bhd.
    Date Cleared
    2022-03-28

    (271 days)

    Product Code
    MSC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K091769
    Why did this record match?
    Device Name :

    SancDam Latex Oral Dam

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

    The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

    Device Description

    The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area. The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm). The SancDam™ available in 4 different flavors and colors versions as listed below: Pink Strawberry, Green Mint, Yellow Vanilla, Purple Grape.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the SancDam™ Latex Oral Dam. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence.

    Based on the provided text, the device in question is a Latex Oral Dam, which is a physical barrier used during oral/vaginal and oral/anal sex to reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.

    The document does not describe an AI/ML-driven device or study parameters that align with the request for information on acceptance criteria and study proving device meets acceptance criteria for such a device. The tests performed are standard non-clinical bench tests for a latex barrier device.

    Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a physical medical device, not a software or AI-based one.

    No information provided in the document covers the following requested points:

    • A table of acceptance criteria and reported device performance for an AI/ML device.
    • Sample sizes, data provenance, number of experts, adjudication methods, or ground truth types related to an AI performance study.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Training set details for an AI model.

    The document focuses on non-clinical testing for a physical latex product and comparison to a predicate device for substantial equivalence, not on the performance of an AI/ML algorithm.

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