(28 days)
LUBRIGYN CREAM 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 not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
LUBRIGYN CREAM is a non-sterile, non-oily, water based personal lubricant for the intimate vaginal area. LUBRIGYN CREAM is supplied in a 50 mail airless container and can be used daily to supplement the body's natural lubrication when vaginal dryness causes discomfort. The specifications for the LUBRIGYN CREAM include appearance, color, odor, pH, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count and absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans).
The provided text describes the 510(k) premarket notification for "LUBRIGYN CREAM" in an airless container. The submission aims to demonstrate substantial equivalence to a predicate device, which is an earlier version of LUBRIGYN CREAM in single-use sachets (K132772).
Here's an analysis based on the request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a typical statistical sense (e.g., minimum sensitivity, specificity) for a diagnostic or AI device. Instead, it focuses on demonstrating equivalence to a predicate device by comparing technological characteristics and conducting stability testing.
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance (LUBRIGYN CREAM - Airless Container) |
|---|---|
| Identical Formulation | Identical formulation |
| Identical Bulk Manufacturing Process | Identical bulk manufacturing process |
| Identical Product Release Specification | Identical product release specification (including appearance, color, odor, pH, viscosity, density, emulsion stability, osmolality, total microbial count, total yeast and mold count, and absence of pathogen organisms) |
| Shelf-life | 36 months (confirmed by stability testing on not opened and opened containers) |
| Packaging Functionality | Airless container prevents air ingress when product is dispensed. Tamper evident seal in primary packaging and warning in secondary packaging. |
| Intended Use | Same intended use as predicate: 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. |
| Compatibility | Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (same as predicate). |
2. Sample Size for Test Set and Data Provenance:
The document describes stability testing and comparison of characteristics, not a clinical "test set" in the context of evaluating a diagnostic or AI device.
- Sample Size: Not explicitly stated as a number of subjects or cases. The "sample" for stability testing would refer to units of the LUBRIGYN CREAM product. It mentions "stability tests performed on already expired product," implying multiple units were tested over time.
- Data Provenance: The study is focused on the product itself and its characteristics. The manufacturer is "UNIDERM FARMACEUTICI srl" located in Italy. The testing was conducted internally or by a contracted lab. This is product performance data, not patient-derived data from a specific country.
- Retrospective/Prospective: Stability testing is inherently prospective, as it involves monitoring product characteristics over time.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This is a product performance study, not a study requiring expert clinical review to establish ground truth for a diagnostic or AI device. The "ground truth" here is the established specifications and verified shelf-life of the product.
4. Adjudication Method for Test Set:
Not applicable. There is no "test set" requiring adjudication in the context of diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This submission is for a personal lubricant, not a diagnostic or AI device requiring an MRMC study. There's no AI component.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- Identical Formulation & Manufacturing Process: Verification of consistency with the predicate device.
- Product Release Specifications: Defined by the manufacturer for parameters like pH, viscosity, microbial counts, etc. These are established laboratory standards.
- Stability Test Results: Objective measurements over time showing the product maintains its specifications.
8. Sample Size for Training Set:
Not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no training set.
§ 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.