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510(k) Data Aggregation

    K Number
    K210242
    Device Name
    Astroglide X Silicone Personal Lubricant
    Manufacturer
    BioFilm Inc.
    Date Cleared
    2021-04-28

    (89 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K141913
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal 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 condoms. This product is not compatible with polyisoprene and polyurethane condoms.

    Device Description

    Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.

    AI/ML Overview

    The provided text describes the acceptance criteria and a study for the Astroglide® X Silicone Personal Lubricant.

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Specification)Reported Device Performance
    AppearanceClearClear
    OdorCharacteristicOdorless
    Viscosity225 to 350 centipoise225 to 350 centipoise
    Total yeast/mold count (USP <61>)<10 cfu/mL<10 cfu/mL
    Total aerobic microbial count (USP <61>)<100 cfu/mL<100 cfu/mL
    Absence of Pathogenic Organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) (USP <62>)AbsentAbsent
    Water activity (USP<1112>)< 0.3 Aw< 0.3 Aw
    Condom CompatibilityCompatible with natural rubber latex condomsCompatible with natural rubber latex condoms only
    Shelf-Life3 years3 years
    Biocompatibility (Cytotoxicity)Non-cytotoxicNon-cytotoxic
    Biocompatibility (Sensitization)Non-sensitizingNon-sensitizing
    Biocompatibility (Irritation)Non-irritatingNon-irritating
    Biocompatibility (Systemic Toxicity)Not systemically toxicNot systemically toxic

    Note: The "Reported Device Performance" column reflects that the device met the stated specifications/criteria, as confirmed by the "Summary of Non-Clinical Performance Testing" section.

    2. Sample size used for the test set and the data provenance

    The document does not specify a distinct "test set" in the context of a clinical trial or a specific number of samples for each non-clinical test. The testing described is non-clinical performance testing.

    • Sample Size: Not explicitly stated for each test. The document refers to "the subject lubricant" being tested.
    • Data Provenance: Not explicitly stated. The tests are non-clinical (laboratory-based) and conducted according to international standards (ISO, ASTM, USP). There's no mention of country of origin for data or if it's retrospective/prospective in a clinical sense.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This section is not applicable. The evaluations are based on internationally recognized laboratory test methods (ISO, ASTM, USP), not expert consensus on individual cases or ground truth derived from clinical experts.

    4. Adjudication method for the test set

    This section is not applicable. The evaluations are based on objective laboratory test results against defined specifications, not on human interpretation requiring adjudication.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    This section is not applicable. This document pertains to the regulatory submission of a personal lubricant, not an AI-powered diagnostic device, so an MRMC comparative effectiveness study is irrelevant.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    This section is not applicable. This document pertains to the regulatory submission of a personal lubricant, not an AI-powered algorithm.

    7. The type of ground truth used

    The "ground truth" for the device's performance is established by objective measurements against predetermined specifications and international standards. This includes:

    • Physical property measurements (viscosity, appearance, odor, water activity).
    • Microbiological testing (total yeast/mold count, aerobic microbial count, absence of specific pathogens).
    • Biocompatibility testing results (cytotoxicity, irritation, sensitization, systemic toxicity) as per ISO 10993.
    • Condom compatibility testing results as per ASTM D7661-10.
    • Shelf-life testing results as per ASTM F1980-16.

    8. The sample size for the training set

    This section is not applicable. There is no "training set" as this is a physical medical device (personal lubricant) undergoing non-clinical performance testing, not a machine learning model.

    9. How the ground truth for the training set was established

    This section is not applicable, as there is no training set for this type of device.

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