(59 days)
JO Water Based Anal Thick 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 Water Based Anal Thick Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
JO Water Based Anal Thick Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./ 60 mL, 4 fl. oz./120 mL and 8 fl. oz./ 240 mL bottles. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle and capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethyl cellulose, Chlorphenesin, Vitamin E Acetate and Sodium Hydroxide.
The provided text describes the acceptance criteria and study for a medical device called "JO Water Based Anal Thick Lubricant." However, it is a 510(k) submission, which is for demonstrating substantial equivalence to a predicate device, not for a comparative effectiveness study with or without AI assistance, or for a standalone AI algorithm performance study.
Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, ground truth type and training set information) are not applicable to this type of regulatory submission and information is not present in the provided document. This document focuses on the physical, chemical, and biological properties of the lubricant and its compatibility with condoms, as well as its shelf-life.
Here's the information that can be extracted from the provided text, primarily focusing on the device's specifications and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The device specifications in Table 1 serve as the acceptance criteria for the JO Water Based Anal Thick Lubricant.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied by "meets specification") |
|---|---|---|
| Appearance | Semi-viscous liquid | Semi-viscous liquid |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity (cps) per USP | 6,500 - 9,000 | Within 6,500 - 9,000 |
| pH per USP | 6.50 to 7.50 | Within 6.50 to 7.50 |
| Specific Gravity per USP | 0.950 to 1.100 | Within 0.950 to 1.100 |
| Osmolality per USP | 550 - 850 mOsm/kg (1:1 dilution) | Within 550 - 850 mOsm/kg |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products | Meets USP acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Less than 10 cfu/g |
| **Presence of Pathogens per USP ** | ||
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella/Shigella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida albicans | Absent | Absent |
Performance Study Details:
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Biocompatibility Studies:
- Tests Conducted: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017).
- Results: The lubricant was demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not acutely systemically toxic.
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Shelf-Life Study:
- Methodology: Real-time and accelerated aging study.
- Results: Demonstrated the device maintains its specifications (from Table 1) for an 18-month shelf-life.
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Condom Compatibility Study:
- Methodology: Evaluated in accordance with ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Results: Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane condoms.
Regarding the requested information that is not applicable or not present:
- Sample size used for the test set and the data provenance: Not applicable. This is not a study involving human or image data for AI evaluation. The "test set" here refers to samples of the product for laboratory testing. The document does not specify the number of product samples used for each test (e.g., how many bottles were tested for viscosity). Data provenance is also not relevant in the context of these device characteristic tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests would be the chemical and physical properties measured by standard laboratory methods.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a diagnostic device or an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
- The type of ground truth used: For the physical/chemical tests, the ground truth is established by validated laboratory measurement methods and standard testing protocols (e.g., USP and ASTM standards). For biocompatibility, it's based on animal testing results and established biological endpoints (e.g., non-cytotoxic).
- The sample size for the training set: Not applicable. This involves product testing, not AI model training.
- 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.