LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211967
    Device Name
    Sensual Massage, Ultra Pure
    Manufacturer
    Dreambrands, Inc.
    Date Cleared
    2021-11-09

    (138 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K191654
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sensual Massage/Ultra Pure is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

    Device Description

    Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant comprised on dimethoconol, dimethicone, and cyclopentasiloxane. This over-thecounter product is formulated to be clear, non-greasy, and odorless. The Sensual Massage/Ultra Pure lubricant is neither a contraceptive nor a spermicide.

    AI/ML Overview

    This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment for AI/ML performance evaluation is not applicable to this document.

    The document discusses the following:

    • Device Name: Sensual Massage/Ultra Pure (a personal lubricant)
    • Regulatory Class: Class II
    • Predicate Device: SILICONE Personal Lubricant (K191654)
    • Indications for Use: Moisturize and lubricate for comfortable intimate sexual activity, supplement natural lubrication, and compatibility with natural rubber latex and polyisoprene condoms (not polyurethane).
    • Performance Data: Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), shelf-life testing, and condom compatibility testing.

    The "acceptance criteria" in this context refer to the chemical and physical specifications of the lubricant and its biological and material compatibility, not performance metrics of an AI algorithm.

    Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for AI/ML test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML, as this is not an AI/ML device submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1