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K Number
K213671
Device Name
Astroglide Sensual Strawberry Personal Lubricant
Manufacturer
BioFilm Inc.
Date Cleared
2022-03-03

(101 days)

Product Code
NUC
Regulation Number
884.5300
Type
Traditional
Panel
OB
Reference & Predicate Devices
K072647
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Astroglide® Sensual Strawberry 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 or polyurethane condoms.

Device Description

Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.

AI/ML Overview

This document is a 510(k) Premarket Notification from BioFilm, Inc. to the FDA for their product, Astroglide® Sensual Strawberry Personal Lubricant. It aims to demonstrate substantial equivalence to a legally marketed predicate device (Glycerin & Paraben Free Astroglide, K072647).

Therefore, this document does not describe:

  • Acceptance criteria and device performance for an AI/ML medical device.
  • A study proving the performance of an AI/ML medical device.
  • Data provenance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to AI/ML model development or validation.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
  • Details about ground truth establishment for AI/ML models.

Instead, the document focuses on:

  • Device Description: A water-based personal lubricant, its physical characteristics, and specifications.
  • Predicate Device Comparison: Highlighting similarities (indications for use, over-the-counter status, base type, pH) and differences (ingredients, osmolality, viscosity, packaging, shelf-life). The document asserts that these differences do not raise new questions of safety and effectiveness.
  • Non-Clinical Performance Testing: This is the equivalent of "proof" in this context, demonstrating the device's safety and effectiveness through:
    • Biocompatibility Testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
    • Condom Compatibility Testing: Specifically with natural rubber latex condoms using ASTM D7661-10.
    • Shelf-Life Testing: Using accelerated aging (ASTM F1980-16) to determine an 8.5-month shelf-life.

To answer your specific questions based on the provided document, which is NOT about an AI/ML device:

  1. A table of acceptance criteria and the reported device performance:

    Physical Specification TestsAcceptance Criteria / Ranges/SpecificationsReported Device Performance (from text, implicitly met for approval)
    Particulate matterNo particlesMet (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
    ColorClear to slight goldenMet (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
    ClarityClearMet (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
    OdorStrawberry scentMet (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study.")
    pH (per USP )3.5-5.5Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
    Viscosity (per USP )200 - 450 cpsMet (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 cps is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
    Osmolality (per USP )200 - 450 mOsm/kg, dilution factor of 5Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." The value 200-450 mOsm/kg is the reported device performance for this specific product, which is different from the predicate, but deemed acceptable by the FDA.)
    Antimicrobial effectiveness (per USP )Category 2: bacteria show ≥2.0 log reduction at 14 days, no increase from 14-day count at 28-day count; yeast/molds show no increase from initial calculated count at 14 and 28 days.Met (implied by FDA clearance and statement: "All specifications for the subject lubricant... were met throughout the shelf-life study." Also stated in comparison table as "Same" to predicate.)
    Total yeast/mold count (per USP & USP )& USP )& USP )
    BiocompatibilityNon-cytotoxic, non-sensitizing, non-irritating, not systemically toxicDemonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic.
    Condom Compatibility (Natural Rubber Latex) (per ASTM D7661-10)CompatibleResults show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms.
    Shelf-Life (per ASTM F1980-16)All specifications from Section IV met throughout the study.8.5 months shelf-life achieved; all specifications in Section IV were met throughout the shelf-life study.

  2. Sample size used for the test set and the data provenance: This document describes non-clinical performance testing for a personal lubricant, not an AI/ML device using a "test set" in the machine learning sense. The tests are laboratory-based.

    • Sample Size: Not explicitly stated for each test (e.g., number of lubricant samples tested for pH, viscosity, microbial counts). For biocompatibility, it's not specified how many samples/subjects were used for the in-vitro and in-vivo tests. For condom compatibility, ASTM D7661-10 would specify the number of condoms and lubricant samples, but this detail is not provided in the summary. For shelf-life, a sufficient number of product units would have been put on accelerated aging.
    • Data Provenance: Not applicable in the geopolitical sense. The data comes from the results of laboratory testing conducted for the purpose of this 510(k) submission. These are not "retrospective or prospective" patient data sets.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lubricant is established by laboratory measurements (e.g., pH meter for pH, viscometer for viscosity, microbial culture for counts, established protocols for biocompatibility and condom compatibility). There are no human "experts" establishing a "ground truth" for classification or detection tasks as would be the case for an AI/ML device.

  4. Adjudication method: Not applicable. This is not a human-reader study where adjudication is needed.

  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: Not applicable. This document is not about an AI/ML device.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.

  7. The type of ground truth used:

    • Physical Specifications: Instrumental measurements (pH meters, viscometers, osmolality readers) and laboratory assays (microbial cultures, particulate inspection).
    • Biocompatibility: In-vitro (cytotoxicity) and in-vivo (sensitization, irritation, acute systemic toxicity) testing according to ISO standards.
    • Condom Compatibility: Standardized mechanical and material property testing (ASTM D7661-10).
    • Shelf-Life: Stability testing over time under accelerated conditions according to ASTM F1980-16, measuring the physical specifications listed in the table.

  8. The sample size for the training set: Not applicable. This is not an AI/ML device.

  9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.