(169 days)
Bucked Stride Silicone Lubricant is a silicone-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
#LubeLife Thin Silicone Lubricant is a silicone-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal 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 Bucked Stride Silicone Lubricant product is to be sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity.
#LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
The provided text is a 510(k) Summary for personal lubricants and does not contain information about a medical device that utilizes artificial intelligence or requires extensive clinical studies with human readers or image interpretation. Therefore, a direct answer to the prompt's request for acceptance criteria and studies proving the device meets them, especially those pertaining to AI model performance (like MRMC studies, ground truth establishment for training/test sets, expert adjudication, etc.), cannot be extracted from this document.
The document focuses on the physical and chemical properties, biocompatibility, shelf-life, and condom compatibility of the personal lubricants. The "acceptance criteria" discussed are essentially the device specifications and the results of non-clinical performance testing.
However, I can provide the available information in a structured way that addresses the spirit of the request as much as possible, mapping the given content to the closest relevant sections of your prompt.
Acceptance Criteria and Study for Personal Lubricants (K190858)
1. Table of Acceptance Criteria and the Reported Device Performance:
The device's performance is demonstrated through non-clinical testing against established specifications.
| Property / Acceptance Criteria | Reported Device Performance |
|---|---|
| Appearance | Clear, thin liquid |
| Color | Clear, colorless |
| Odor | Odorless |
| Viscosity (cps) | 200 to 325 cps |
| Specific Gravity | 0.850 to 1.025 |
| **Antimicrobial effectiveness per USP ** | Meets US acceptance criteria for Category 2 products |
| **Total aerobic microbial count (TAMC) per USP and ** | Less than 100 cfu/g |
| **Total yeast and mold count (TYMC) per USP and ** | Less than 10 cfu/g |
| Presence of Pathogens per USP : | |
| - Pseudomonas aeruginosa | Absent |
| - Staphylococcus aureus | Absent |
| - Salmonella/Shigella | Absent |
| - Escherichia coli | Absent |
| - Candida albicans | Absent |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, non-systemically toxic. |
| Shelf-Life | 2 years (met specifications at all time points) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of distinct "samples" in microbiological or physical testing terms, but testing was performed on "various packaging types" and "largest volumes associated with each packaging type" for shelf-life, considered "worst case." Biocompatibility tests would involve animal models or cell cultures, but specific numbers are not provided.
- Data Provenance: The studies were non-clinical performance testing (laboratory-based). The country of origin for the data is not specified, but the submission is to the U.S. FDA. The studies are by nature prospective as they are designed to test the product's compliance with specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable as the device is a personal lubricant, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" here is the adherence to physicochemical and biological specifications, determined by standard laboratory methods and validated against USP and ISO standards.
4. Adjudication Method for the Test Set:
- Not applicable. Performance is assessed against predetermined quantitative and qualitative specifications using laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where AI assists human readers (e.g., radiologists) in interpreting medical images. The device in this submission is a personal lubricant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this concept is not applicable. The device is a physical product, not an algorithm. Its "standalone performance" refers to its intrinsic properties and safety/effectiveness without human applied intervention beyond its intended use.
7. The Type of Ground Truth Used:
- For this device, the "ground truth" is based on:
- Validated laboratory methods and specifications: Adherence to physical properties (viscosity, specific gravity, appearance, color, odor).
- Industry and regulatory standards: Compliance with USP (, , , ) for antimicrobial effectiveness and microbial counts.
- International standards (ISO 10993-series) and FDA guidance: For biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity).
- ASTM standards (ASTM D7661-10): For condom compatibility.
8. The Sample Size for the Training Set:
- Not applicable. This device is a manufactured product, not an AI model that undergoes "training."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As the "training set" concept does not apply to this product, neither does the establishment of its ground truth.
§ 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.