(351 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 single use pouches 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, 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).
This document is a 510(k) premarket notification for a medical device called LUBRIGYN CREAM, a personal lubricant. It details the device's indications for use, description, and technological characteristics, and aims to prove substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (according to ISO 10993-5) | Test performed. Results demonstrated the device can be considered biocompatible. |
| Sensitization (according to ISO 10993-10) | Test performed. Results demonstrated the device can be considered biocompatible. |
| Vaginal Irritation (according to ISO 10993-10) | Test performed. Results demonstrated the device can be considered biocompatible. |
| Acute Systemic Toxicity (according to ISO 10993-11) | Test performed. Results demonstrated the device can be considered biocompatible. |
| Stability: | |
| Shelf life | 36 months (confirmed by stability tests on expired product). |
| Microbiological Effectiveness: | |
| Anti-microbial effectiveness (according to USP 51) | Microbiological challenge test performed on expired product. Confirmed anti-microbial effectiveness. |
| Condom Compatibility: | |
| Compatibility with Natural Rubber Latex condoms (per ASTM D7661-10) | Not compatible (testing showed LUBRIGYN CREAM is not compatible). |
| Compatibility with Polyisoprene condoms (per ASTM D7661-10) | Not compatible (testing showed LUBRIGYN CREAM is not compatible). |
| Compatibility with Polyurethane condoms (per ASTM D7661-10) | Not compatible (testing showed LUBRIGYN CREAM is not compatible). |
| Device Specifications (Intrinsic to product): | |
| Appearance | Specifications for appearance established. |
| Color | Specifications for color established. |
| Viscosity | Specifications for viscosity established. |
| Density | Specifications for density established. |
| Emulsion stability | Specifications for emulsion stability established. |
| Osmolality | Specifications for osmolality established. |
| Total microbial count | Specifications for total microbial count established. |
| Total yeast and mold count | Specifications for total yeast and mold count established. |
| Absence of pathogen organisms (Escherichia Coli, Pseudomonas Aeruginosa, Staphylococcus Aureus, Enterococcus Species, Candida Albicans) | Specifications for absence of pathogen organisms established (implicitly met through testing / QC). |
Note: The document states that the "no-clinical performance testing conducted demonstrates that LUBRIGYN CREAM is substantially equivalent to the proposed predicate device." The acceptance criteria for the comparative effectiveness of the device itself are related to demonstrating similarity in performance to a predicate device, as this is a 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing (biocompatibility, stability, microbiological challenge, condom compatibility). It does not mention a clinical "test set" in the context of human subjects or a dataset for an AI algorithm.
- Sample size for non-clinical testing: The specific sample sizes for each of the non-clinical tests (e.g., number of animals for toxicity, number of condoms for compatibility) are not provided in this summary.
- Data provenance: The standard tests cited (ISO 10993 series, USP 51, ASTM D7661-10) are international standards for laboratory testing. The country of origin of the data is not explicitly stated beyond the submitter and consultant being based in Italy. This is prospective data generated specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The LUBRIGYN CREAM product is a personal lubricant, and the testing described is non-clinical laboratory testing, not a diagnostic device analyzed by human experts.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no "test set" in the context of human expert review or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a personal lubricant, not a diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this question is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" is established by adherence to recognized international and national standards/test methods (ISO, USP, ASTM) that define acceptable performance characteristics for medical devices of this type. For example, for biocompatibility, the ground truth is "non-toxic," "non-sensitizing," etc., as determined by the specific criteria within the ISO standards. For condom compatibility, the ground truth is "compatible" or "not compatible" based on the measurements and criteria outlined in ASTM D7661-10.
8. The Sample Size for the Training Set
This information is not applicable. There is no AI or machine learning component to this device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is 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.