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510(k) Data Aggregation

    K Number
    K221328
    Manufacturer
    Date Cleared
    2022-08-04

    (90 days)

    Product Code
    Regulation Number
    884.5300
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Bloomi Smooth Water Based Lubricant

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

    The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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

    The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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.

    Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract).

    The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.

    AI/ML Overview

    This document describes the acceptance criteria and the studies performed to demonstrate that the Bloomi Smooth Water Based Personal Lubricant meets these criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Specification)Reported Device Performance (Test Method)
    Absence of particulate matterClear viscous liquidClear viscous liquid
    ColorOff-whiteOff-white
    OdorNoneNone
    Viscosity1,800 - 4,500 cpsWithin specification (1,800 - 4,500 cps)
    Osmolality110 - 140 mOsm/kgWithin specification (110 - 140 mOsm/kg)
    pH4.0 - 5.0Within specification (4.0 - 5.0)
    Total yeast/mold count (TYMC)))
    Antimicrobial effectivenessMeets USP acceptance criteria for Category 2 products.Meets USP acceptance criteria for Category 2 products.
    Biocompatibility
    CytotoxicityNon-cytotoxic (ISO 10993-5:2009/(R)2014)Non-cytotoxic
    SensitizationNon-sensitizing (ISO 10993-10:2010/(R)2014)Non-sensitizing
    Vaginal IrritationNon-irritating (ISO 10993-10:2010/(R)2014)Non-irritating
    Acute Systemic ToxicityNot systemically toxic (ISO 10993-11:2017)Not systemically toxic
    Condom Compatibility
    Natural rubber latex condomsCompatible (ASTM D7661-18)Compatible
    Polyisoprene condomsCompatible (ASTM D7661-18)Compatible
    Polyurethane condomsNot compatible (ASTM D7661-18)Not compatible
    Shelf Life
    Maintenance of device specificationsMeets specifications across shelf-lifeMet specifications at all time points, supporting 8.5-month shelf-life

    2. Sample Size and Data Provenance

    The document does not explicitly state the sample sizes used for each specific test within the non-clinical performance evaluations (Biocompatibility, Shelf Life, Condom Compatibility). The data provenance is derived from these non-clinical performance studies conducted on the device itself. The studies appear to be prospective, as they were carried out to demonstrate the device's characteristics for regulatory submission. There is no indication of country of origin of the data beyond the standards used (ISO, USP, ASTM).

    3. Number of Experts and Qualifications for Ground Truth

    This information is not applicable. The device is a personal lubricant, and the evaluations performed are non-clinical (laboratory and in-vitro testing). Therefore, there is no "ground truth" established by human experts in the context of clinical interpretation, like radiologists or pathologists. The ground truth for these tests is based on established scientific and regulatory standards (e.g., ISO, USP, ASTM methods) and objective measurements.

    4. Adjudication Method for Test Set

    This information is not applicable. As explained above, the tests are non-clinical, objective measurements based on established protocols, not subjective human interpretations requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or other data, and the AI's assistance is evaluated. This is not relevant for a personal lubricant.

    6. Standalone Performance (Algorithm Only)

    This information is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI system. Therefore, the concept of "standalone performance" without human-in-the-loop is not relevant.

    7. Type of Ground Truth Used

    The ground truth for the non-clinical performance testing (biocompatibility, shelf life, condom compatibility) is based on:

    • Established scientific and regulatory standards: ISO 10993 series for biocompatibility, USP , , for microbial limits and antimicrobial effectiveness, and ASTM D7661-18 for condom compatibility.
    • Objective laboratory measurements: Viscosity, Osmolality, pH, microbial counts, etc.
    • Defined acceptance criteria: These criteria are based on scientific understanding and regulatory expectations for the safety and performance of personal lubricants.

    8. Sample Size for the Training Set

    This information is not applicable. As the device is a personal lubricant and not an AI/ML algorithm, there is no "training set." The product's formulation and manufacturing processes are developed and refined based on general scientific principles and quality control measures, not machine learning training.

    9. How the Ground Truth for the Training Set Was Established

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

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