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510(k) Data Aggregation
(244 days)
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant
Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are non-sterile, water-based personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are sold as over-the-counter (OTC) products in tube packaging made of low-density polythethylene (outer layer), ethylene vinyl alcohol copolymer (middle layer) and low-density polyethylene (inner layer), ranging from 0.34 fl oz to 8 fl oz, depending on formulation.
These products are composed of purified water, propanediol, oat beta glucan, hyaluronic acid, gluconolactone, sodium benzoate, steviol glycosides, and Nelumbo Nucifera (Lotus) Root water. Depending on the formulation, the flavored formulations contain natural vanilla 1.5X flavor extract, organic coconut flavor concentrate, or organic mint flavor concentrate.
This FDA 510(k) summary provides information for a personal lubricant and as such, it does not involve an AI/ML device. Therefore, many of the requested sections regarding AI/ML device evaluation criteria, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "Multi reader multi case (MRMC) comparative effectiveness study," "Standalone (i.e. algorithm only without human-in-the loop performance)," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," are not applicable to this document.
However, I can provide the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
Acceptance Criteria and Device Performance for Sutil Luxe Personal Lubricants
The Sutil Luxe Personal Lubricant devices (Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant) were evaluated against several performance parameters to demonstrate their safety and effectiveness.
1. Table of Acceptance Criteria and the Reported Device Performance
| Parameter | Test Method | Acceptance Criteria (Specification) | Reported Device Performance (as implied by "met all device specifications") |
|---|---|---|---|
| Physical/Chemical Properties | |||
| Appearance | Visual | Viscous liquid | Viscous liquid (met) |
| Color | Visual | Clear (Sutil Luxe), Brownish (Vanilla), Off-white (Coconut, Mint) | Met specifications for each formulation. |
| Odor | Organoleptic | No scent (Sutil Luxe), Vanilla (Vanilla), Coconut (Coconut), Mint (Mint) | Met specifications for each formulation. |
| pH | USP | 4.0-5.0 (for all formulations) | Met specification (implied by "met all device specifications"). |
| Viscosity (cps) | USP | 900-5,000 (Sutil Luxe, Mint), 900-8,000 (Vanilla), 900-5,500 (Coconut) | Met specifications for each formulation. |
| Osmolality (mOsm/kg) | USP | 675-825 (Sutil Luxe, at 1:4 dilution), 750-900 (Vanilla, at 1:4 dilution), 725-875 (Coconut, Mint, at 1:4 dilution) | Met specifications for each formulation. |
| Microbiological Properties | |||
| Antimicrobial Effectiveness | USP | Meets USP criteria for category 2: Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days. | Met USP criteria (implied by "met all device specifications"). |
| Total Microbial Count (TAMC) | USP | ||
| Other Performance | |||
| Shelf-life | Real-time aging studies | Maintain all device specifications for 2 years. | Demonstrated a 2-year shelf-life, meeting all device specifications across this period. |
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | ||
| Human Repeat Insult Patch Test (HRIPT) (Skin Irritation and Sensitization) | |||
| ISO 10993-11:2017 (Acute Systemic Toxicity) | Non-cytotoxic, non-sensitizing, not systemically toxic. | The lubricants were found to be non-cytotoxic, non-sensitizing, and not systemically toxic. | |
| Condom Compatibility | ASTM D7661-18 | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms. | Determined to be compatible with natural rubber latex and polyisoprene condoms, and not compatible with polyurethane condoms, in accordance with ASTM D7661-18. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., how many units were tested for viscosity, pH, etc.). However, it refers to "testing on samples" for shelf-life, and general "testing" for other parameters. The data provenance (country of origin, retrospective/prospective) is not specified, but the testing would have been conducted as part of a prospective evaluation for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a physical/chemical product, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance is measured using standardized laboratory test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical/chemical product, and performance is determined by meeting objective industrial/pharmacopoeial standards, not by human adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical/chemical product, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical/chemical product, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by meeting predefined, objective specifications and standards set by pharmacopoeias (USP) and international standards organizations (ISO, ASTM). These are laboratory-derived measurements and tests, not human-interpreted ground truth.
8. The sample size for the training set
Not applicable. This is a physical/chemical product, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical/chemical product, not an AI/ML device.
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