(89 days)
JO Classic Hybrid Personal Lubricant is a personal lubricant for penile, anal 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.
JO Classic Hybrid Personal Lubricant is an off-white, semi-viscous, translucent gel type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
This document describes the premarket notification (510(k)) for the JO Classic Hybrid Personal Lubricant. Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance (all time points within shelf-life study) |
|---|---|---|
| Appearance | Opaque thick liquid | Met |
| Color | Off-white | Met |
| Odor | Odorless | Met |
| Viscosity (cps) | 15,000 cps to 34,000 cps | Met |
| pH | 6.20 to 7.20 | Met |
| Specific Gravity | 0.950 to 1.075 | Met |
| Osmolality (diluted 1:10) | 350 - 599 mOsm/kg | Met |
| Osmolality (undiluted) | 600 - 990 mOsm/kg | Met |
| Antimicrobial effectiveness per USP | Meets US acceptance criteria for Category 2 products | Met |
| Total aerobic microbial count (TAMC) per USP and | Less than 10 cfu/g | Met |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Met |
| Presence of Pseudomonas aeruginosa | Absent | Met |
| Presence of Staphylococcus aureus | Absent | Met |
| Presence of Salmonella/Shigella | Absent | Met |
| Presence of Escherichia coli | Absent | Met |
| Presence of Candida albicans | Absent | Met |
| Biocompatibility (Cytotoxicity) | Pass (ISO 10993-5:2009) | Met |
| Biocompatibility (Sensitization) | Pass (ISO 10993-10:2010) | Met |
| Biocompatibility (Vaginal Irritation) | Pass (ISO 10993-10:2010) | Met |
| Biocompatibility (Penile Irritation) | Pass (ISO 10993-10:2010) | Met |
| Biocompatibility (Acute Systemic Toxicity) | Pass (ISO 10993-11:2006) | Met |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not Compatible | Not Compatible |
| Shelf-Life | 3 years | 3 years |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a "test set" in the context of a typical AI/software study. This is a medical device (personal lubricant), and the performance is evaluated through material properties and biocompatibility testing.
- For Shelf-Life and Device Specifications: The "test set" would be samples of the lubricant tested at different time points (0, 1, 2, and 3 years). The specific number of samples tested at each time point is not provided. The data provenance is internal testing performed by the manufacturer (United Consortium).
- For Biocompatibility: The "test set" involves biological models (in vitro and in vivo studies). The specific sample sizes for each biocompatibility test (e.g., number of cells in cytotoxicity, number of animals in sensitization/irritation/toxicity studies) are not provided in this summary. The data provenance is from studies conforming to ISO 10993 standards.
- For Condom Compatibility: The "test set" would be lubricant samples tested with natural rubber latex, polyisoprene, and polyurethane condoms. The specific number of samples / tests is not provided. The data provenance is from studies conforming to ASTM D7661-10.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of medical device submission. "Ground truth" in this context is established by standardized material testing and biocompatibility protocols, not expert consensus on interpretations. Laboratories performing these tests would have qualified personnel, but they are not "experts establishing ground truth" in the same way radiologists might for an imaging AI.
4. Adjudication method for the test set
Not applicable as it's not an expert-based subjective assessment. The results are from objective laboratory tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a personal lubricant, not an AI-powered diagnostic or assistive device requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, chemical, and biological performance evaluation of a personal lubricant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on:
- Standardized Material/Chemical Specifications: Adherence to defined physical and chemical properties (e.g., pH range, viscosity range, osmolality range, microbial limits).
- International Standards: Compliance with recognized international standards for biocompatibility (ISO 10993 series) and condom compatibility (ASTM D7661-10). These standards define the test methods and acceptance criteria.
- Defined Acceptance Criteria: The device must meet the predefined specifications for each tested property.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of software development.
9. How the ground truth for the training set was established
Not applicable.
§ 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.