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510(k) Data Aggregation

    K Number
    K193450
    Device Name
    Pre-Seed™ Fertility Lubricant
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2020-07-23

    (223 days)

    Product Code
    PEB
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K072741
    Why did this record match?
    Device Name :

    Pre-Seed™ Fertility Lubricant

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

    Pre-Seed™ Fertility Lubricant 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

    Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

    Device Description

    Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

    Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.

    AI/ML Overview

    The provided document is a 510(k) summary for the Pre-Seed™ Fertility Lubricant. It details the device's characteristics, indications for use, comparison with a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.

    Here's an analysis of the acceptance criteria and study data based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    SpecificationRecommended Acceptance CriteriaReported Performance (Pre-Seed™ Fertility Lubricant)
    Appearance/ColorHazy, colorless to slightly yellow, viscous liquidMet acceptance criteria during shelf-life testing
    OdorCharacteristic, no off odor (25 °C ± 2)Met acceptance criteria during shelf-life testing
    pH7.0-7.4Met acceptance criteria during shelf-life testing
    Osmolality260-370 mOsm/kgMet acceptance criteria during shelf-life testing
    Viscosity2800-11500 cpsMet acceptance criteria during shelf-life testing
    Total Aerobic Microbial Count (TAMC) - USP andand
    Antimicrobial Effectiveness - USPBacteria: Not less than 2.0 log reduction from the initial count at 14 days. No increase from 14 days count to 28 days. Yeast & Mold: not increase from the initial calculated count at 14 and 28 days.Met acceptance criteria during shelf-life testing
    Endotoxin
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