(90 days)
Azul Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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.
The Azul Personal Lubricant is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using methylparaben. This medical device is designed to meet product specifications which include: Color/appearance, Odor, pH, Viscosity, Methylparaben assay, Osmolality, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms, Antimicrobial effectiveness. The Azul Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance and preservation.
The document describes the Azul Personal Lubricant and its supporting studies for 510(k) premarket notification. However, it does not provide specific acceptance criteria or a study with a table of reported device performance values compared to those criteria. The provided information focuses on the device's characteristics, intended use, and a summary of various studies conducted to demonstrate its safety and compatibility.
Here's an analysis of the requested information based on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document lists "product specifications" (Color/appearance, Odor, pH, Viscosity, Methylparaben assay, Osmolality, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms, Antimicrobial effectiveness) for which the device is "designed to meet." However, the specific acceptance criteria (e.g., pH range, maximum microbial count) and the actual reported performance values are not detailed in a table format.
The document also mentions "Condom compatibility" results but does not quantify them against acceptance criteria.
2. Sample Size for the Test Set and Data Provenance
The document does not specify a single "test set" in the context of validating a device's performance against detailed acceptance criteria using a specific sample size. Instead, it describes several types of studies performed:
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Biocompatibility studies:
- In vitro cytotoxicity study
- Rabbit vaginal irritation study
- Rabbit penile irritation study
- Acute systemic toxicity study
- Guinea pig maximization sensitization study
- Primary rabbit skin irritation study
- Sample Size: Not specified for any of these individual studies.
- Data Provenance: Not explicitly stated, but these are typically conducted in a laboratory setting. The country of origin is not mentioned. These would be considered prospective studies for the purpose of this submission.
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Shelf life - Stability and shelf life testing:
- Sample Size: Not specified.
- Data Provenance: In vitro study, typically laboratory-based. The country of origin is not mentioned. This would be a prospective study.
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Condom compatibility testing:
- Sample Size: Not specified (e.g., number of condoms tested, number of lubricant applications).
- Data Provenance: Laboratory testing using a modification of ASTM D7661. The country of origin is not mentioned. This would be a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable or not specified. The studies described are primarily
laboratory-based chemical, physical, and biological (animal) tests, not human-reader-based assessments requiring expert ground truth establishment in the way, for example, a diagnostic imaging AI would. Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications is not relevant to the types of studies reported for this personal lubricant.
4. Adjudication Method for the Test Set
Not applicable. Given the nature of the studies (laboratory tests, animal studies), there is no mention of an adjudication method involving multiple human assessors or an "adjudication method" in the context of clinical or diagnostic review.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study, which typically evaluates the performance of human readers with and without AI assistance, was not conducted as this device is a personal lubricant and not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No. This device is a personal lubricant, not an algorithm or AI system. Therefore, a standalone performance study in that context was not performed. The performance studies described (biocompatibility, stability, condom compatibility) assess the device's inherent properties.
7. Type of Ground Truth Used
The "ground truth" for the studies described is based on established scientific methodologies for assessing chemical properties, physical properties, biocompatibility (animal models), and material compatibility (e.g., ASTM standards).
- Biocompatibility: In vitro assay results (cytotoxicity) and observed biological responses in animal models (irritation, systemic toxicity, sensitization).
- Shelf life: Measured physical, chemical, and microbiological parameters over time under specified conditions (e.g., accelerated aging).
- Condom compatibility: Physical property changes or damage to condoms measured according to a modified ASTM standard.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The studies described are traditional device testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
§ 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.