(268 days)
LubriZenzs is a personal lubricant for vaginal and/or penile application, intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
LubriZenzs is a non-sterile, water-based, over-the-counter personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. Its formulation consists of water, propanediol, cellulose gum, algin, 1,2-hexanediol, sodium hyaluronate, lactic acid, gluconolactone, Tremella fuciformis (mushroom) extract, caprylhydroxamic acid, sodium benzoate, calcium gluconate, sodium hydroxide, xylitylglucoside, anhydroxylitol, glycogen, xylitol, and glucose.
The Lubricant comes in a 100 mL white polypropylene plastic airless pump bottle, with a clear overcap. The lubricant has a shelf-life of 2 years.
Specifications:
- Appearance: Clear, flowable
- Color: Colorless
- Odor: Odorless
- pH: 4.5-5.0
- Viscosity: 10,000 – 25,000 cps
- Osmolality: 135 - 380 mOsm/kg (1:10 dilution)
- Total Microbial Count (TAMC): 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.
The FDA 510(k) clearance letter for LubriZenzs (K242712) pertains to a personal lubricant, not an AI-powered medical device. Therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 (related to AI study design, experts, ground truth, and training sets) is not applicable to this submission.
However, I can extract the acceptance criteria and the summary of performance testing for the LubriZenzs device as described in the provided text.
Acceptance Criteria and Device Performance for LubriZenzs
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Clear, flowable | Meets specification |
| Color | Colorless | Meets specification |
| Odor | Odorless | Meets specification |
| pH | 4.5 – 5.0 | Meets specification (USP ) |
| Viscosity | 10,000 – 25,000 cps | Meets specification (USP ) |
| Osmolality | 135 - 380 mOsm/kg (1:10 dilution) | Meets specification (USP ) |
| Total Microbial Count (TAMC) | ) | |
| Fungal/Yeast/Mold Limits (TYMC) | ) | |
| Absence of Pathogenic Organisms | Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Candida albicans) | Meets specification (USP ) |
| Antimicrobial Effectiveness | 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.) | Meets USP criteria |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, not acutely systemically toxic | Demonstrated to be non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms | Compatible with natural rubber latex condoms and synthetic polyisoprene condoms; not compatible with polyurethane condoms |
| Shelf Life | 2 years | Demonstrated 2-year shelf-life, meeting specifications at endpoint |
2. Sample size used for the test set and the data provenance:
- Biocompatibility: The document does not specify the exact sample sizes for each biological test (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.
- Condom Compatibility: The document does not specify the sample size of condoms or lubricant used for testing. The provenance of the data is not mentioned.
- Shelf-Life Testing: The document does not specify the number of samples or batches tested for real-time stability. The provenance of the data is not mentioned.
- Other Device Specifications (Appearance, Color, Odor, pH, Viscosity, Osmolality, Microbial Counts): The document does not specify sample sizes for these tests or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a lubricant, and its performance is assessed via standardized chemical, physical, and biological tests, not expert interpretation of diagnostic images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Performance is based on objective measurements against predefined specifications using established test methods.
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 personal lubricant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a personal lubricant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on compliance with predefined physical, chemical, and biological specifications established by relevant industry standards (e.g., USP, ASTM, ISO) and regulatory guidance. For example:
- Chemical/Physical properties (pH, viscosity, osmolality): Measured against numerical ranges.
- Microbiological purity: Measured against limits for colony-forming units and absence of specific pathogens.
- Biocompatibility: Assessed through in-vitro and in-vivo tests designed to detect cytotoxic, sensitizing, irritating, or toxic effects.
- Condom compatibility: Tested according to a specific ASTM standard (ASTM D7661-18) which defines compatibility criteria.
8. The sample size for the training set:
Not applicable. This is a physical product (lubricant), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is involved.
§ 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.