(57 days)
Coconut Hybrid is a personal lubricant for penile 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.
Coconut Hybrid is a water-based personal lubricant that is non- sterile, contains coconut oil, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, fractionated coconut oil, tremella fuciformis extract, hyaluronic acid, propanediol, DL lactic acid, xanthan gum, sodium benzoate, potassium sorbate, and natural coconut flavor. Coconut Hybrid is packaged in a 50 mL polyethylene tubes and is a personal lubricant for over the counter (OTC) use.
This is a 510(k) premarket notification for the "Coconut Hybrid" personal lubricant. This document states that the device is substantially equivalent to the predicate device "Coconut Infused Hybrid Personal Lubricant" (K180712).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Specification | Observed Performance (from the document) |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Gel | Gel |
| Color | Opaque | Opaque |
| Odor | Characteristic (coconut) | Characteristic (coconut) |
| pH | 3.5 – 4.2 | "3.5 – 4.2" (Listed as a specification, implicit that it was met) |
| Viscosity | 8,000 - 59,000 cPs | "8,000 - 59,000 cps" (Listed as a specification, implicit that it was met) |
| Osmolality | 200 – 400 mOsm/kg | "200 – 400 mOsm/Kg" (Listed as a specification, implicit that it was met) |
| Microbiological Specifications | ||
| Antimicrobial Effectiveness | Category 2 product: Bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days. | "Yes" (Indicates testing was done and results met criteria, specifically in Table 2 "Antimicrobial Tested (USP , USP , USP)") |
| Total Aerobic Microbial Count | , USP , USP)") | |
| Total Yeast and Mold Count | , USP , USP)") | |
| Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, Clostridium Species) | Absent | "Yes" (Indicates testing was done and results met criteria, specifically in Table 2 "Antimicrobial Tested (USP , USP , USP)") |
| Biocompatibility | N/A (implied by "non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic") | "non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic" |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms. | "compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms." |
| Shelf Life | 1-year shelf life, maintaining specifications (as in Table 1) | "Coconut Hybrid has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device could maintain its specifications (as shown in Table 1) over the duration of its shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the biocompatibility, condom compatibility, or shelf-life test sets. It only mentions that testing was performed. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). This type of information is typically detailed in the full test reports that are summarized in the 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. For performance testing of a personal lubricant (biocompatibility, condom compatibility, microbial testing), "expert consensus" or "ground truth" in the way it might apply to an AI diagnostic device is not typically applicable. Instead, the ground truth is established by validated laboratory testing methods (e.g., ASTM standards, USP monographs). The qualifications of the laboratory personnel performing these tests would be relevant, but are not disclosed in this summary.
4. Adjudication Method for the Test Set
Not applicable for this type of device and performance testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human readers interpret results and a consensus among experts forms the ground truth. Here, the "truth" is determined by objective laboratory measurements adhering to established standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not relevant for this device. Such studies are typically conducted for diagnostic imaging devices or other AI-assisted diagnostic tools where the performance of human readers with and without AI assistance is being evaluated. This device is a personal lubricant, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The performance evaluations described (biocompatibility, condom compatibility, shelf life, microbiological testing) are "standalone" in the sense that they assess the device's inherent properties without a human-in-the-loop decision-making process. The device itself is not an algorithm, so "algorithm only" doesn't directly apply, but the tests were performed on the device itself.
7. The Type of Ground Truth Used
The ground truth for the performance testing is established by adherence to recognized national and international standards and validated laboratory methods.
- Biocompatibility: Based on alternate testing comparable to ISO 10993-5: 2009 (Cytotoxicity), Human Repeat Insult Patch Testing (sensitization and irritation), and Acute Systemic Toxicity Testing per ISO 10993: 2017. The "ground truth" is whether the results fall within acceptable toxicity/irritation parameters as defined by these standards.
- Condom Compatibility: Based on ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The "ground truth" is whether the lubricant causes unacceptable degradation to the condoms according to the standard.
- Microbiological Testing: Based on USP , USP , and USP monographs. The "ground truth" is whether the microbial counts and antimicrobial effectiveness meet the specified criteria.
- Physical/Chemical Specifications (pH, Viscosity, Osmolality): Based on USP , USP , and USP respectively. The "ground truth" is whether the measured values fall within the specified range.
- Shelf Life: Established through an accelerated aging stability study, where the "ground truth" is the device maintaining its specifications over time under accelerated conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (personal lubricant), not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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.