(135 days)
BioNude 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 compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
The document describes the regulatory approval of the BioNude Lubricant (K180136), not a medical device in the context of an AI/ML study. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes for an AI/ML device is not available in the provided text.
The document discusses the substantial equivalence of the BioNude Lubricant to a predicate device based on its formulation, intended use, and performance tests (biocompatibility, condom compatibility, and shelf life).
Here's what can be extracted based on the provided text, modified to indicate absence where the requested information is not applicable or not provided for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a personal lubricant, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "device performance" relating to diagnostic accuracy, sensitivity, or specificity as would be relevant for an AI/ML device does not apply in the same way. The performance data presented are for the physical and chemical properties of the lubricant:
| Acceptance Criteria Category | Reported Device Performance (BioNude Lubricant) |
|---|---|
| Biocompatibility | Met per ISO 10993-5:2009 (cytotoxicity), human repeat insult patch testing (sensitization and irritation), and acute systemic toxicity testing per ISO 10993-11:2006. Found to be biocompatible. |
| Condom Compatibility | Met per ASTM D7661-10. Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. |
| Shelf Life | Results demonstrate that BioNude maintains its specifications over the duration of their proposed shelf life. |
| Formulation & Specifications | 100% isotonic water-based formula. Specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. (Specific numerical values for these specifications are not provided in the summary but were part of the submission.) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable to the BioNude Lubricant as it is not an AI/ML device undergoing diagnostic performance testing. The "test sets" would refer to samples tested for biocompatibility, condom compatibility, and shelf-life, but specific sample sizes and data provenance (country of origin, retrospective/prospective) for these tests are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation studies, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance for diagnostic tasks. This is a personal lubricant, not a diagnostic device.
6. If a Standalone Performance Study Was Done
The performance studies conducted (biocompatibility, condom compatibility, shelf life) can be considered "standalone" in the sense that they evaluated the device's intrinsic properties. However, this is not analogous to a "standalone algorithm performance" study for an AI/ML device.
7. The Type of Ground Truth Used
For the BioNude Lubricant, the "ground truth" for its performance claims is based on:
- Established scientific methods and standards: Biocompatibility standards (e.g., ISO 10993), condom compatibility standards (e.g., ASTM D7661-10), and internal quality control specifications for formulation and shelf life.
- Laboratory testing results: The outcomes of these tests directly demonstrated the product's compliance with the relevant properties.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device in the AI context.
§ 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.