(171 days)
Passion Natural Water Based Lubricant 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 polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.
The Passion Natural Water Based Lubricant is a non-sterile, water-based personal lubricant that is intended for penile and vaginal application 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 polyisoprene condoms, and is not compatible with natural rubber latex and polyurethane condoms. Its formulation consists of purified water, propanediol, xanthan gum, methocel, sodium benzoate, potassium sorbate, citric acid, and hydroxyethylcellulose. Passion Natural Water Based Lubricant is packaged in 4 oz polyethylene terephthalate bottles with a cap. Passion Natural Water Based Lubricant is a personal lubricant for over-the-counter (OTC) use.
Here's a breakdown of the acceptance criteria and the study information for the "Passion Natural Water Based Lubricant" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Clear, viscous liquid | Clear, viscous liquid |
| Color | Colorless | Colorless |
| Odor | Odorless | Odorless |
| Viscosity @ 25°C (Spindle LV#3hu @ 60rpm) | 700 cps – 900 cps | 700 cps – 900 cps |
| Specific Gravity @ 25°C | 1.00 – 1.20 | 1.00 – 1.20 |
| pH | 4.0 – 5.0 | 4.0 – 5.0 |
| Osmolality (1:10 dilution) | 92.5 - 192.5 mOsm/kg | 92.5 - 192.5 mOsm/kg |
| Total aerobic microbial count (TAMC) per USP and | and | |
| Presence of Pathogenic organisms ( S. aureus, P. aeruginosa, C. albicans) per USP | Absent | Absent |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization) | Non-sensitizing | Non-sensitizing |
| Biocompatibility (Vaginal Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Acute Systemic Toxicity) | Non-systemically toxic | Non-systemically toxic |
| Condom Compatibility | Compatible with polyisoprene condoms; not compatible with natural rubber latex and polyurethane condoms | Compatible with polyisoprene condoms; not compatible with natural rubber latex and polyurethane condoms |
| Shelf Life | Maintain all defined device specifications at all time points out to 8.5 months | Met all device specifications at all time points for 8.5 months. |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state a separate "test set" sample size in the context of an algorithm or AI model evaluation. The non-clinical performance testing described seems to refer to standard product testing rather than algorithm validation.
- Sample Size: Not specified for individual tests beyond general descriptions (e.g., "results showed that Passion Natural Water Based Lubricant...").
- Data Provenance: Not specified. It's implied to be internal testing conducted by or for the manufacturer (XR, LLC). The document does not indicate country of origin for the data or if it's retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The product is a personal lubricant, and the "ground truth" for its performance is established through laboratory and in-vivo (animal) biocompatibility testing, chemical/physical specification testing, and condom compatibility testing against established ASTM and USP standards, not through expert human review of data like in an imaging AI study.
4. Adjudication Method for Test Set
This information is not applicable for this type of device. The evaluation relies on standardized tests with objective pass/fail criteria, not on human adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. This device is a physical product, not an AI system.
6. Standalone Performance Study (Algorithm Only)
No standalone algorithm performance study was done. This document pertains to a physical medical device (personal lubricant), not an AI algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance was established through:
- Laboratory measurements and assays: For properties like appearance, color, odor, viscosity, specific gravity, pH, osmolality, and microbial counts.
- In-vivo (animal) testing: For biocompatibility (sensitization, vaginal irritation, acute systemic toxicity).
- Established
standard test methods: Such as ASTM D7661-10 for condom compatibility, USP , , , for microbial limits and effectiveness, and ISO 10993 series for biocompatibility. - Accelerated aging studies (ASTM F1980-16): For shelf-life determination.
8. Sample Size for Training Set
This information is not applicable. There is no AI model or algorithm being developed or "trained" for this device.
9. How Ground Truth for Training Set Was Established
This information is not applicable as there is no training set for an AI model.
§ 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.