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A personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

The Trojan™ Riviera™ Personal Lubricant is an anhydrous, clear silicone-based personal lubricant with fragrance that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.

The Riviera™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packaged in a carton.

This document describes the premarket notification for the Trojan™ Riviera™ Personal Lubricant (K150886). It focuses on demonstrating substantial equivalence to a predicate device, Trojan™ Tingly Warmth Personal Lubricant (K120706), rather than presenting a study to prove device performance against specific acceptance criteria in the context of an AI/algorithm-based diagnostic device.

Therefore, the following information, typically found in submissions for AI/algorithm-based devices, is not available or applicable in this document:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

However, I can provide information regarding the performed tests and their results for the Trojan™ Riviera™ Personal Lubricant to support its substantial equivalence.

Acceptance Criteria and Device Performance (Biocompatibility & Condom Compatibility)

The "acceptance criteria" here are implied by the "results" of the biocompatibility and condom compatibility tests. The device demonstrates satisfactory performance against these established tests for personal lubricants.

Study Details:

The document describes non-clinical performance data, biocompatibility review and testing, and safety data to establish substantial equivalence.

• Biocompatibility Testing: Performed on the final device in accordance with ISO 10993, "Biological Evaluation of Medical Devices, 2009."

  • Sample Size: Not explicitly stated, but typically involves a small number of animals for each test (e.g., rabbits for skin/vaginal/penile irritation, guinea pigs for sensitization).
  • Data Provenance: In vivo (animal testing).
  • Ground Truth: Established by standard biological evaluation methods and expert interpretation of results according to ISO 10993.

• Condom Compatibility Testing: Performed according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms," with a modification to include pre-lubricated and un-lubricated dry condoms.

  • Sample Size: Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. The number of individual condoms tested per brand is not specified but would follow ASTM D7761-10 protocols.
  • Data Provenance: In vitro (laboratory testing of condoms with the lubricant).
  • Ground Truth: Established by the ASTM D7761-10 standard test method, which defines criteria for compatibility.

• Shelf-Life Testing: An accelerated stability study was conducted, and a real-time stability study is being performed. Evaluation included viscosity, odor, color, appearance, and microbial evaluation via USP testing.

  • Sample Size: Not explicitly stated, but stability studies typically involve multiple samples tested at different time points.
  • Data Provenance: In vitro (laboratory testing of the lubricant product over time).
  • Ground Truth: Established by industry standards for stability testing (e.g., USP for microbial evaluation) and pre-defined acceptance criteria for physical and chemical properties.

Summary of Unavailable Information (for AI/Algorithm context):

Since this is not an AI/algorithm-based device, the following aspects are irrelevant and therefore not provided in the document:

• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Training set size or ground truth establishment for a training set.
• Expert involvement for establishing ground truth for test sets (beyond general expert interpretation in standard lab tests).

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