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510(k) Data Aggregation

    K Number
    K232279
    Device Name
    LifeStyles NRL Textured Condom
    Manufacturer
    Suretex Limited
    Date Cleared
    2023-10-05

    (66 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K220576
    Why did this record match?
    Device Name :

    LifeStyles NRL Textured Condom

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

    The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

    Device Description

    The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for a medical device, specifically a condom. It details the device's characteristics, comparison to a predicate device, and non-clinical performance testing. However, the request asks for information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device, including details like sample sizes, expert ground truth establishment, MRMC studies, and training set information.

    The provided document does not contain any information about an AI/algorithm-based medical device study. The "LifeStyles® NRL Textured Condom" is a physical medical device, not an AI or algorithm-driven one. Therefore, I cannot extract the requested information from the given text as it is not present.

    The document discusses:

    • Device Name: LifeStyles® NRL Textured Condom
    • Regulation: 21 CFR § 884.5300 Condom, Class II
    • Performance Testing: Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), Physical Property Testing (conformance to ASTM D3492-16 and ISO 4074:2015 for parameters like lubricant quantity, length, width, thickness, burst volume, burst pressure), and Shelf-Life (5 years based on accelerated stability).

    These are all standard tests for a physical condom and do not relate to the evaluation of an AI or algorithm.

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