(242 days)
Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are personal lubricants, 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 natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are non-sterile, aloe-based vaginal lubricants designed to supplement the body's own natural lubrication fluids, and to enhance the ease and comfort of intimate sexual activity. Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are specifically formulated with 95% organic aloe. The remaining five percent of ingredients are in all cases food grade and in many cases certified organic. This device is not a contraceptive or spermicide, nor does it contain any such component. All ingredients in Aloe Cadabra Flavored/Scented Lubricants are GRAS (Generally Recognized as Safe by FDA). The specifications for the Aloe Cadabra Lubricants include appearance, odor, pH, viscosity, osmolality, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms (straphylococcus aureus, pseudomonas aeruginosa, escheria coli, salmonella, bile tolerant gram negative bacteria, c. albicans and clostridia). The product is bottled in an HDPE opaque white plastic bottle with a white flip top cap. The bottle is packaged into a carton for sale to consumers. The product comes in five varieties of scents and flavors including Natural Aloe, Pina Colada, Tahitian Vanilla, French Lavender, and Peppermint.
The provided text describes a 510(k) summary for a personal lubricant, not an AI-powered medical device that requires a study to prove acceptance criteria. Therefore, most of the requested information (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this document.
However, I can extract the acceptance criteria and performance data related to the lubricant's safety and compatibility.
Acceptance Criteria and Reported Device Performance for Aloe Cadabra® Lubricants
The acceptance criteria for the Aloe Cadabra® Lubricants are established through various performance tests, primarily focusing on biocompatibility and condom compatibility, in comparison to the predicate device. The device aims to meet these criteria to demonstrate substantial equivalence to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Study Type/Standard Applied |
|---|---|---|---|---|
| Biocompatibility | Acute Systemic Toxicity | No systemic responses or biological reactivity in test animals. | All test group animals survived the test period and exhibited no biological reactivity at any tested time points. | ISO 10993-11: 2006 |
| Vaginal Irritation Testing | Non-irritating to vaginal mucosal tissue. | Considered non-irritating to the vaginal mucosa in female New Zealand White Rabbits. | ISO 10993-10: 2010 | |
| Cytotoxicity | No cytotoxic effect. | Not considered to have a cytotoxic effect based on qualitative evaluation. | ANSI/AAMI/ISO 10993-5: 2009 | |
| Skin Sensitization | No sensitization reactions. | Did not elicit sensitization reactions in the animals used. | ISO 10993-10: 2010 | |
| Product Stability | Shelf Life | Demonstrate a two-year shelf life. | Achieved a two-year shelf life based on real-time aging study results. | Real-time aging study |
| Condom Compatibility | Natural Rubber Latex Condoms | Compatible. | Compatible with natural rubber latex condoms. | ASTM D7661-10 |
| Polyisoprene Condoms | Compatible. | Compatible with polyisoprene condoms. | ASTM D7661-10 | |
| Polyurethane Condoms | Compatible (or specified as incompatible). | Not compatible with polyurethane condoms. | ASTM D7661-10 |
2. Sample Size Used for the Test Set and Data Provenance
- Acute Systemic Toxicity: Mice were used. Specific sample size not provided, but the standard implies a sufficient number for statistical relevance per ISO 10993-11.
- Vaginal Irritation Testing: Female New Zealand White Rabbits were used. Specific sample size not provided, but the standard implies a sufficient number per ISO 10993-10.
- Cytotoxicity: Not applicable to in vivo subjects; likely cell culture tests. Specific sample size (e.g., number of cell lines or replicates) not provided.
- Skin Sensitization: Guinea pigs were used. Specific sample size not provided, but the standard implies a sufficient number per ISO 10993-10.
- Shelf Life: Not applicable to biological samples; involves product samples over time. Specific number of product samples not provided.
- Condom Compatibility: Involved all 5 versions of the lubricants. Specific number of condoms tested per type not provided.
Data Provenance: The studies are described as performance tests performed by the submitter (Seven Oaks Ranch, Inc.) or contracted labs according to international ISO standards. The country of origin for the studies is not explicitly stated, but the submission is to the US FDA. The studies are prospective in nature, actively testing the device to gather performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for these tests refers to established biological responses (e.g., irritation, toxicity) as measured by standard laboratory methods outlined in the ISO documents. It does not involve expert consensus on image interpretation or similar qualitative assessments performed by medical professionals for diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth. For these objective, standardized biological and physical tests, the results are determined by laboratory observations and measurements against defined criteria, not by human expert interpretation that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Aloe Cadabra® Lubricants are personal care products, not diagnostic devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this question is not applicable. Standalone performance refers to the performance of an algorithm without human intervention, usually in the context of an AI/ML-powered device. The Aloe Cadabra® Lubricants are physical products, not software algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on objective, scientific measurements and observations performed according to established international standards (ISO, ASTM) for biological reactivity, irritation, toxicity, and material compatibility. For example:
- Biocompatibility: Absence of adverse biological reactions in animal models or cell cultures, as defined by the specific ISO standards.
- Shelf Life: The product maintaining its specifications (e.g., pH, viscosity, microbial count) over a defined period.
- Condom Compatibility: The condoms maintaining their physical integrity and performance after exposure to the lubricant, as defined by ASTM D7661-10.
8. The Sample Size for the Training Set
This information is not applicable. A "training set" refers to data used to train an AI/ML algorithm. The Aloe Cadabra® Lubricants are physical products and do not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for an AI/ML algorithm.
§ 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.