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    K Number
    K203541
    Device Name
    Okamoto 002 Lubricated Polyurethane Male Condom
    Manufacturer
    Okamoto U.S.A. Inc.
    Date Cleared
    2022-02-25

    (449 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K100767
    Why did this record match?
    Device Name :

    Okamoto 002 Lubricated Polyurethane Male Condom

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

    The Okamoto 002 Lubricated Polyurethane Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

    Device Description

    This condom is made of a polyurethane sheath, which completely covers the penis with a closely fitted membrane. This device is a smooth-surfaced, straight-walled, silicone-lubricated condom with nominal length 180 ± 10 mm, nominal width 57 ± 2 mm, and nominal thickness of 0.028 ± 0.008 mm with dimensions evaluated per ISO 23409-2011, Male condoms - Requirements and test methods for condoms made from synthetic materials. This condom also conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane. This product has a shelf life of 5 years.

    AI/ML Overview
    1. Table of Acceptance Criteria and Reported Device Performance:
    TestAcceptance CriteriaReported Device Performance
    BiocompatibilityNon-irritating, non-sensitizing, and not acutely, systemically toxic.The subject device was determined to be non-irritating, non-sensitizing, and not acutely, systemically toxic.
    Physical PerformanceCompliance with ASTM D6324-11 (2017) and ASTM D624-00 (2020) for various properties.The subject condom met the predefined acceptance criteria for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume, air burst pressure, and tear resistance.
    Package IntegritySatisfactory results according to ASTM D6324-11.An evaluation of seal integrity was performed on three lots of the subject device according to ASTM D6324-11 with satisfactory results.
    Barrier Properties/Viral PenetrationBarrier effectiveness comparable to predicate and natural rubber latex control condom per ISO 23409:2011.A viral penetration study demonstrated the barrier effectiveness of the subject device as compared to the predicate device and natural rubber latex control condom for viral penetration under conditions of the in vitro study.
    Shelf LifeAll samples meet predefined acceptance criteria in accelerated stability evaluations.The Okamoto 002 Lubricated Polyurethane Male Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435 and ASTM D6324-11. All samples met predefined acceptance criteria.
    Clinical In-Use Slip/BreakNo statistically significant difference in clinical breakage and slippage rate compared to a control latex condom.Clinical testing from the predicate device (Trojan Supra Lubricated Polyurethane Male Condom, K100767) was leveraged. This predicate device was statistically no different from the control latex condom in both clinical breakage and slippage rate. The subject device had comparable physical performance to the predicate device (tensile strength, force at break, tensile elongation, airburst volume, and tear resistance), thus supporting the use of the predicate's clinical data.

    1. Sample Size Used for the Test Set and Data Provenance:

      • Biocompatibility: The specific sample sizes for each test (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) are not explicitly stated in the provided text.
      • Physical Performance Testing: The sample sizes for these tests are not explicitly stated. The tests were performed to comply with ASTM D6324-11 (2017) and ASTM D624-00 (2020), which would dictate standard sample sizes.
      • Package Integrity: Three (3) lots of the subject device were used.
      • Barrier Properties/Permeability (Viral Penetration Study): Three (3) test lots of the subject polyurethane condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
      • Shelf Life: "All samples" in accelerated stability evaluations. The exact number of samples is not specified.
      • Clinical In-Use Slip/Break: The study was conducted using the predicate device with a standard natural rubber latex condom serving as control. The specific number of participants or condoms used in this clinical study (relying on predicate data) is not provided in this document.

      Data Provenance:

      • The studies were conducted by Okamoto U.S.A. Inc. or their commissioned laboratories.
      • The clinical in-use slip/break data was leveraged from testing done on the predicate device (Trojan Supra Lubricated Polyurethane Male Condom, K100767). The origin of this predicate data (e.g., country) is not specified.
      • The studies appear to be prospective as they were conducted to demonstrate compliance for the subject device or leveraged from a previous prospective study of the predicate device.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not applicable. These tests are primarily objective performance evaluations based on established standards, not expert consensus on interpretations of complex data like medical images.

    3. Adjudication Method for the Test Set: Not applicable, as there is no mention of expert review or consensus in the context of adjudication for these performance tests. The results are from direct measurement and laboratory analysis against predefined criteria.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for medical imaging or diagnostic devices where human interpretation is involved. The reported studies are for the physical and biological performance of a condom.

    5. Standalone Performance: Yes. All the non-clinical performance tests (Biocompatibility, Physical Performance Testing, Package Integrity, Barrier Properties/Permeability, Shelf Life) and the leveraged clinical in-use slip/break data represent the standalone performance of the device (or its predicate for clinical performance) against defined criteria. There is no mention of a human-in-the-loop component for these evaluations.

    6. Type of Ground Truth Used:

      • Biocompatibility: Established scientific standards and protocols (ISO 10993 series).
      • Physical Performance: Established industry standards (ASTM D6324-11, ASTM D624-00, ISO 23409-2011) and FDA guidance documents.
      • Package Integrity: Established industry standard (ASTM D6324-11).
      • Barrier Properties/Permeability: Established scientific protocols and industry standards (ISO 23409:2011).
      • Shelf Life: Regulatory requirements (21 CFR 801.435) and industry standard (ASTM D6324-11).
      • Clinical In-Use Slip/Break: Clinical outcome data (breakage and slippage rates) from a study following FDA guidance documents ("Clinical Testing Guidance for New Material Male Condoms").

    7. Sample Size for the Training Set: Not applicable. This refers to the training of machine learning algorithms. The device is a physical product (condom), not an AI/ML algorithm.

    8. How the Ground Truth for the Training Set Was Established: Not applicable (see point 8).

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