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510(k) Data Aggregation
(307 days)
pjur® AQUA Baseline for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® AQUA Guarana for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® BACK DOOR anal Provitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® AQUA ProVitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
The piur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 are water-based personal lubricants provided non-sterile. These personal lubricants are for over-the-counter use. They are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The products are provided in 30 mL and 100 mL polyethylene bottles.
The pjur® AQUA Baseline consists of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, and citric acid. The pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 have the same formulation and consist of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyltrimonium chloride, propylene glycol, hydroxyethylcellulose, panthenol, polysorbate 20, citric acid, chamomilla recrutita (matricaria) flower extract, paullinia cupana seed extract, cananga odorata flower oil, alcohol, 1,2hexanediol, decylene glycol, lactic acid, sodium benzoate, and potassium sorbate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are presented as "Specifications" in "Table 1: Device Specifications" on page 4. The reported device performance is implicitly stated as meeting these specifications.
| Parameter | Acceptance Criteria (pjur® AQUA Baseline) | Reported Device Performance (pjur® AQUA Baseline) | Acceptance Criteria (pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5) | Reported Device Performance (pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5) |
|---|---|---|---|---|
| Appearance | Clear fluid | Clear fluid (Implied from meeting specifications) | Clear fluid | Clear fluid (Implied from meeting specifications) |
| Odor | Product typical | Product typical (Implied from meeting specifications) | Product typical | Product typical (Implied from meeting specifications) |
| pH | 4.1-4.7 | Meets 4.1-4.7 (Implied) | 4.1-4.7 | Meets 4.1-4.7 (Implied) |
| Viscosity (mPa*s) | 750 - 1250 | Meets 750 - 1250 (Implied) | 690 - 1100 | Meets 690 - 1100 (Implied) |
| Osmolality (mOsmol/kg) | 500-625 (diluted 1:3.9) | Meets 500-625 (diluted 1:3.9) (Implied) | 500-625 (diluted 1:4.1) | Meets 500-625 (diluted 1:4.1) (Implied) |
| Total Yeast and Mold Count (TYMC) | <10 cfu/g | <10 cfu/g (Implied) | <10 cfu/g | <10 cfu/g (Implied) |
| Total Aerobic Microbial Count (TAMC) | <100 cfu/g | <100 cfu/g (Implied) | <100 cfu/g | <100 cfu/g (Implied) |
| Presence of Pathogenic Organisms | Pseudomonas aeruginosa Absent, Staphylococcus aureus Absent, Candida albicans Absent | Absent (Implied) | Pseudomonas aeruginosa Absent, Staphylococcus aureus Absent, Candida albicans Absent | Absent (Implied) |
| Antimicrobial Preservation (Category 2 Topical) | Bacteria: ≥ 2.0 log reduction at 14 days, no increase at 28 days. Yeast/Molds: no increase at 14 and 28 days. | Meets criteria (Implied) | Bacteria: ≥ 2.0 log reduction at 14 days, no increase at 28 days. Yeast/Molds: no increase at 14 and 28 days. | Meets criteria (Implied) |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the non-clinical tests (condom compatibility, biocompatibility, shelf-life) or the precise data provenance for these tests. It only states that testing was "performed."
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter is based in Luxembourg. The testing standards (ASTM, ISO, USP) are international/US standards.
- Retrospective or Prospective: Not explicitly stated, but typically these types of performance and stability studies are conducted prospectively on manufactured batches.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing for personal lubricants involves objective, laboratory-based measurements against established standards (e.g., USP monographs, ISO 10993, ASTM D7661) rather than expert interpretation of a test set for diagnostic accuracy (which is common for AI/ML devices in imaging, for example).
4. Adjudication method for the test set
Not applicable. As noted above, these are objective laboratory tests, not subjective assessments requiring adjudication.
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 device is a personal lubricant, not an AI/ML-enabled diagnostic or assistance device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI/ML device performance validation, which is not relevant for a personal lubricant.
7. The type of ground truth used
The "ground truth" for the acceptance criteria and performance data is based on:
- Established physical and chemical properties: pH, viscosity, osmolality, appearance, odor. These are measured according to standardized methods (USP<791>, USP<912>, USP<785>).
- Microbiological standards: Total microbial counts and absence of specific pathogens, measured according to USP<61> and USP<62>.
- Antimicrobial effectiveness: Standardized challenge tests per USP<51>.
- Safety standards: Biocompatibility testing conforms to ISO 10993 series for cytotoxicity, sensitization, irritation, and systemic toxicity.
- Functionality standards: Condom compatibility testing follows ASTM D7661-10.
- Stability standards: Real-time and accelerated aging studies for shelf-life determination.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a personal lubricant's physical, chemical, and biological testing. These are direct measurements of manufactured product characteristics.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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