(248 days)
GLISSANT Intimate Lubricant Fragrance Free/Sea Salt & Caramel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and 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, polyisoprene, and polyurethane condoms.
GLISSANT Intimate Lubricant is a water-based, non-sterile, colorless, viscous personal lubricant It does not contain a contraceptive or spermicidal component. The device is packaged in a polyethylene bottle with a lockdown pump. The primary packaging is plastic placed inside of a display box (dimensions 1.375" width x 1.375" depth x 4.75" height).
This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, many of the requested elements for describing acceptance criteria and study proving device performance (especially those related to AI/ML and associated ground truth, expert readers, and human-in-the-loop studies) are not applicable.
However, I can extract the relevant information regarding the acceptance criteria for the GLISSANT Intimate Lubricant and the studies performed to demonstrate its performance, primarily non-clinical bench testing.
Device Name: GLISSANT Intimate Lubricant
Device Type: Personal lubricant (Class II medical device)
Regulatory Product Code: NUC (Condom)
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are presented as specifications for various parameters, and the reported device performance is that the device "met its specifications" for these parameters at baseline and after accelerated aging.
| Parameter | Specification Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Clear, viscous | Met specifications (Clear, viscous) |
| Color | Colorless | Met specifications (Colorless) |
| Odor | Odorless | Met specifications (Odorless) |
| pH | 3.9 – 4.1 | Met specifications (within 3.9 – 4.1) |
| Specific gravity | 1.003 g/mL | Met specifications (1.003 g/mL) |
| Viscosity | 250 – 500 cps | Met specifications (within 250 – 500 cps) |
| Osmolarity | 160 – 222 mOsm/kg | Met specifications (within 160 – 222 mOsm/kg) |
| Antimicrobial effectiveness | Per USP (Category 2) | Met specifications (Per USP ) |
| Total microbial count | Per USP (, (, (absent) | Met specifications (Per USP , absent for listed organisms) |
In addition, the following performance aspects were evaluated:
- Biocompatibility:
- Acceptance Criteria: Non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
- Reported Performance: The subject lubricants were found to be non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic based on ISO 10993 testing.
- Condom Compatibility:
- Acceptance Criteria: Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (as per claim).
- Reported Performance: Compatible with natural rubber latex, polyisoprene, and polyurethane condoms, based on ASTM D7661-10.
- Shelf Life (Stability):
- Acceptance Criteria: Maintain specifications for 12 months.
- Reported Performance: 12 months shelf life established based on accelerated aging study (ASTM F1980-16), with all aforementioned specifications met at baseline and post-aging.
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical, laboratory-based performance testing rather than a clinical trial or a machine learning study with a "test set" in the conventional sense. Therefore, "sample size" refers to the number of units or replications tested in the various benchtop studies. The document does not specify the exact number of samples tested for each parameter (e.g., how many bottles were tested for pH, or how many organisms for microbial counts).
- Data Provenance: The studies were performance-based, non-clinical tests conducted likely in a laboratory setting. The country of origin of the data is not specified, but the testing standards (USP, ISO, ASTM) are international. This was clearly retrospective data gathered for a premarket submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/ML device requiring expert annotation for ground truth. Ground truth for chemical and physical properties (pH, viscosity, etc.) is established by measurements against defined physical/chemical standards. Biocompatibility and microbial testing results are determined by laboratory assays following established protocols.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML device requiring expert adjudication of results. Laboratory tests have defined acceptance criteria and measurement methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is not an AI/ML device; therefore, no MRMC study was conducted or relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device. Performance is inherent to the product's physicochemical properties and biological interactions, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Industry Standards & Regulations: Defined by USP (United States Pharmacopeia) monographs for microbial limits and antimicrobial effectiveness, ISO (International Organization for Standardization) standards for biocompatibility (ISO 10993 series), and ASTM (American Society for Testing and Materials) standards for condom compatibility (ASTM D7661-10) and accelerated aging (ASTM F1980-16).
- Physicochemical Measurements: Direct measurements of properties like pH, specific gravity, viscosity, and osmolarity using standard laboratory equipment and methods.
- Biological Assays: In vitro and in vivo (for some biocompatibility tests) biological assays to assess cellular toxicity, irritation, sensitization, and presence/absence of specific microorganisms.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment process for it. Performance specifications are based on intended use, regulatory requirements, and comparison to predicate devices, verified through non-clinical testing.
§ 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.