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510(k) Data Aggregation

    K Number
    K961119
    Device Name
    CAREFREE PANTYLINERS
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    1996-04-17

    (27 days)

    Product Code
    HHL
    Regulation Number
    884.5425
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The modified device and the pre-amendments device are both used to absorb small amounts of menstrual or other vaginal discharge.

    Device Description

    The modified device and the Pre-amendments device are both ultrathin, beltless, absorbent feminine napkins made of absorbent material. A fragrance is added for aesthetic purposes.

    AI/ML Overview

    This 510(k) summary describes the safety testing for a Carefree Scented Pantyliner with modified perfumes. The document focuses on demonstrating that the revised perfumes do not introduce new safety or effectiveness concerns, rather than on the performance of the pantyliner itself against specific acceptance criteria for absorption or fit, which would typically be assessed for the device's primary function.

    Therefore, the requested information elements cannot be fully populated as they are generally related to the performance of a diagnostic device or a device with measurable clinical outcomes. However, I will extract and present the available information in the spirit of your request, focusing on the safety evaluations.

    Here's the breakdown:

    Acceptance Criteria and Reported Device Performance (Safety Focus)

    Acceptance Criteria (Safety)Reported Device Performance (Safety of Perfumes)
    Acute Oral Toxicity: LD50 > 5 mL/kg (of 1.1% solution)Acute Oral Toxicity Ruts: LD50 for both perfumes was found to be greater than 5 mL/kg of a 1.1% solution.
    CHO Mammalian Cell Cytotoxicity Assay: Results showed a reduction in viability of the hamster ovary cells for both perfumes. (Note: While a reduction in viability was observed, the summary does not explicitly state an acceptance threshold for this test, making it difficult to definitively state if it "met" an unstated criterion. It's reported as an observation.)
    Guinea Pig Sensitization: No sensitization at actual use concentrations.Guinea Pig Sensitization Maximization Test (Magnusson-Kligman): In an initial exaggerated study, both perfumes caused weak to moderate sensitization. In a second study with concentrations close to actual levels, neither perfume caused sensitization in guinea pigs.
    Primary Dermal Irritation (Rabbits): Class IV - Mild or Slight Irritation at 72 Hours.Primary Dermal Irritation Study Rabbits: The Dermal Irritation Toxicity Category for both perfumes was considered to be Class IV - Mild or Slight Irritation at 72 Hours. The Primary Dermal Irritation Index for both fragrances was considered "slight."
    Primary Eye Irritation (Rabbits): Non-irritating at tested concentrations.Primary Eye Irritation Study Rabbits: Both perfumes were found to be non-irritating at the concentrations tested.
    Repeated Insult Patch Test (Humans): No potential for dermal irritation and/or sensitization.Repeated Insult Patch Test (RIPT) Humans: Under the conditions of this study, neither perfume indicated a potential for dermal irritation and/or sensitization.

    Study Details (Safety Focus)

    Here's a breakdown of the available information regarding the safety studies conducted:

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

      • Acute Oral Toxicity Ruts: "Ruts" (likely a typo for rats) - Number of animals not specified.
      • CHO Mammalian Cell Cytotoxicity Assay: "CHO-K1-BH4 mammalian cell line" - In vitro study, not a human or animal test set.
      • Guinea Pig Sensitization Maximization Test: "Guinea pigs" - Number of animals not specified.
      • Primary Dermal Irritation Study Rabbits: "Rabbits" - Number of animals not specified.
      • Primary Eye Irritation Study Rabbits: "Rabbits" - Number of animals not specified.
      • Repeated Insult Patch Test (RIPT) Humans: "Humans" - Number of participants not specified.
      • Data Provenance: Not explicitly stated, but these are pre-clinical (animal and in vitro) and clinical (human patch test) studies conducted by "Johnson & Johnson Worldwide Absorbent Products and Materials Research." The country of origin is not specified. All studies appear to be prospective for the purpose of this submission.

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

      • This question is not applicable to these types of pre-clinical and basic clinical safety studies. Ground truth is established by standardized laboratory methods and observations, not by expert consensus on interpretations like in diagnostic imaging. The results are based on objective measures (e.g., LD50, cell viability, irritation scores, sensitization responses).

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not applicable. These are laboratory studies with objective endpoints or standardized scoring by trained personnel, not multi-reader adjudication of clinical cases.

    4. 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 device is a consumer product (panty liner) and the studies are safety assessments of its components (perfumes), not a diagnostic device involving human readers or AI assistance.

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

      • Not applicable. This device does not involve an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • Acute Oral Toxicity: Measured lethality (LD50) in animals.
      • CHO Mammalian Cell Cytotoxicity: Measured reduction in cell viability (in vitro).
      • Guinea Pig Sensitization: Observed dermal reactions (sensitization) in animals.
      • Primary Dermal Irritation: Observed dermal irritation scores in animals.
      • Primary Eye Irritation: Observed eye irritation scores in animals.
      • Repeated Insult Patch Test: Observed dermal reactions (irritation/sensitization) in human subjects.
      • The "ground truth" for these tests is the direct empirical outcome of the standardized assays and observations.

    7. The sample size for the training set:

      • Not applicable. These are safety studies, not machine learning studies requiring training data. The "training" for such studies would involve standardizing laboratory procedures and personnel expertise.

    8. How the ground truth for the training set was established:

      • Not applicable. (See #7)
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