(242 days)
Simply Slick™ Personal Lubricating Lotion is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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, polyurethane, and synthetic polyisoprene condoms.
Device specifications include pH, viscosity, preservation effectiveness, appearance, odor, and testing for bioburden, aerobes, fungi, spore, and obligate anaerobe. It is a biocompatible, water soluble, white, viscous liquid and is non-sterile. It is neither a contraceptive nor a spermicide and is sold over-the-counter in a 2 oz / 59 ml polyethylene squeeze bottle with a screw-on, disc press-flip up cap. A cap liner is placed over the opening of the bottle before the lid is screwed on the bottle. One bottle is placed into a plastic display carton which constitutes the device outer packaging. Simply Slick™ Personal Lubricating Lotion is a non-greasy and fragrance-free formulation and is to be stored at room temperature.
Here's a breakdown of the acceptance criteria and the study information for the Simply Slick™ Personal Lubricating Lotion, based on the provided text:
Important Note: The provided document is a 510(k) summary for a personal lubricant. It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing related to safety, biocompatibility, and compatibility with condoms. It does not involve AI algorithms, image analysis, or expert human readers interpreting data in the way medical diagnostic devices do. Therefore, many of the requested categories related to algorithm performance, expert review, and MRMC studies are not applicable to the information contained in this document.
Acceptance Criteria and Reported Device Performance
Since this is a personal lubricant, the "acceptance criteria" are based on meeting established standards for safety, biocompatibility, and intended use as defined by international and national standards organizations, and demonstrated through specific tests.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 (cytotoxicity, sensitization, irritation) | Demonstrated through specific testing conforming to the standard. |
| Antimicrobial Preservative Effectiveness | Meets USP 34, | Demonstrated through testing. |
| Packaging Integrity/Shipping Performance | Meets ISTA P2A (2011) and ASTM D4169-09 | Demonstrated through testing to ensure product stability during transport. |
| Compatibility with Natural Rubber Latex Condoms | Meets ASTM D7661-10 (Standard Test method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) | Critical for product compatibility claim and safety. |
| Water Solubility | Meets USP 35 | Demonstrated through testing. |
| pH | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Specific values not given, but confirmed to meet requirements. |
| Viscosity | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Specific values not given. |
| Color | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Specific values not given. |
| Feel | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Subjective, but confirmed to meet internal specifications. |
| Scent | Confirmed within acceptable range for 36 months shelf life | Part of shelf-life stability testing. Subjective, but confirmed to meet internal specifications. |
| Microbial quality (Aerobes, Fungi, Spores, Obligate Anaerobes) | Confirmed within acceptable limits for 36 months shelf life | Part of shelf-life stability testing (USP , , ). |
| Shelf Life | Confirmed to be 36 months | Demonstrated through real-time aged sample testing for various parameters. |
Study Details (Applicable to this type of device)
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Sample Size for the Test Set and Data Provenance:
- The document does not specify a "test set" in the context of diagnostic performance (e.g., patient data).
- For the performance testing mentioned (e.g., ISO, ASTM, USP standards), the sample sizes would be dictated by the specific test methodology outlined in each standard. These would involve quantities of the lubricant product itself, or materials (like condoms) interacting with the lubricant.
- The data provenance is not explicitly stated as retrospective or prospective data from human subjects, as this is a product performance study, not a clinical trial of a diagnostic device. The tests are performed on the product itself or in benchtop/in vitro setups.
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Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This device does not involve a "ground truth" established by human experts in the context of interpreting medical images or data. Performance is measured against physical, chemical, and biological standards.
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Adjudication Method for the Test Set:
- Not applicable. There is no ambiguous result requiring adjudication by multiple readers or experts. Test outcomes are quantitative or pass/fail based on established standards.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) with and without AI assistance. This is a personal lubricant, not a diagnostic device.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device does not involve an AI algorithm.
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Type of Ground Truth Used:
- The "ground truth" in this context is defined by established international and national standards (e.g., ISO 10993-1, USP 34, ASTM D7661-10) and internal specifications for physical/chemical properties (pH, viscosity, etc.). The device performance is measured against these objective criteria.
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Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that sense. The product's formulation and manufacturing processes are developed through R&D and tested against specification.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, for the same reason as above.
§ 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.