(425 days)
X-Y Lubricating Jelly 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 product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
X-Y Lubricating Jelly is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The lubricant formulation consists of water, glycerin, hydroxyethylcellulose, and methylparaben. X-Y Lubricating Jelly is packaged in 35 g and 100 g polyethylene tubes with a flip-top closure. The tube is then packaged in a carton. X-Y Lubricating Jelly is a personal lubricant for over-the-counter (OTC) use.
Here's a summary of the acceptance criteria and study information for the X-Y Lubricating Jelly, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Throughout Shelf-Life) |
|---|---|---|
| Appearance, color | Clear colorless | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Odor | Odorless | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| pH per USP | 6.0-7.0 | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Osmolality per USP | 200-900 mOsm/Kg | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Viscosity per USP | 600-900 cPs | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Antimicrobial effectiveness per USP | Bacteria: NLT 2.0 log reduction from the initial count at 14 days, and no increase from 14 days 'count at 28 days; Yeasts/Molds: No increase from the initial calculated count at 14 and 28 days. | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Total aerobic microbial count (TAMC) per USP | ** | |
| Bile-tolerant gram-negative bacteria | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Pseudomonas aeruginosa | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Staphylococcus aureus | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Salmonella | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Escherichia coli | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Clostridia | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Candida albicans | Absent/g | Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.") |
| Biocompatibility | Demonstrated biocompatibility according to ISO 10993-1, 10993-5:2009, 10993-10:2010 (Sensitization & Vaginal Irritation), and 10993-11:2017. | The results of the testing demonstrated that the subject lubricant is biocompatible. |
| Shelf-Life | 3 years (based on real-time testing with all specifications in Table 1 met) | The subject device has a shelf-life of 3 years. All specifications listed in Table 1 were met throughout the shelf-life duration. |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (in accordance with ASTM D7661-18). | X-Y Lubricating Jelly was determined to be compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides details of specific tests, but does not explicitly state the sample sizes for each test or the data provenance (e.g., country of origin, retrospective/prospective). The study refers to:
- Real-time testing for shelf-life.
- Biocompatibility studies following ISO standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
- Condom compatibility testing following ASTM D7661-18.
Without further information, the exact sample sizes and provenance for these specific tests cannot be determined from this document. However, all these are typically prospective laboratory-based studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a medical lubricant is established through objective laboratory testing against material and biological specifications, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., radiologists reviewing medical images). The studies for this lubricant are laboratory-based, not interpretative.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This information is not applicable. MRMC studies are used for evaluating diagnostic imaging devices and the impact of AI on human readers. This document describes a lubricant, which is not a diagnostic device.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable. This device is a physical product (lubricating jelly), not an algorithm or AI. The performance studies are for the physical properties and biological interactions of the lubricant.
7. Type of Ground Truth Used
The ground truth used for this device's performance studies is based on:
- Established laboratory standards and specifications: From USP (United States Pharmacopeia) for pH, osmolality, viscosity, antimicrobial effectiveness, and microbial counts.
- International standards: ISO 10993 series for biocompatibility.
- Industry standards: ASTM D7661-18 for condom compatibility.
- Real-time product testing: For assessing shelf-life performance against all established specifications.
8. Sample Size for the Training Set
This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.