(354 days)
pjur® WOMAN Aloe is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® med Moisturising glide is a personal lubricant for penile, vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® BACK DOOR water-based is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® analyse me! water-based is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
pjur® med NATURAL glide is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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.
We-Vibe® Lube made by pjur® is a personal lubricant for penile, vaginal and/or anal application, intended to moisturize and lubricate, 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 polvisoprene condoms. This product is not compatible with polyurethane condoms.
The pjur® WOMAN Aloe, pjur® analyse me! water-based, pjur® BACK DOOR water-based, pjur® med Moisturising glide, pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are water-based personal lubricants provided non-sterile. These over-the-counter products have similar formulations and contain neither a contraceptive nor a spermicide. The pjur® analyse me! waterbased, pjur® BACK DOOR water-based, and pjur® med Moisturising glide are compatible with natural rubber latex condoms. They are not compatible with polyurethane and polyisoprene condoms. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
The pjur® WOMAN Aloe has a formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, citric acid, potassium sorbate, aloe barbadensis leaf juice powder. This lubricant is provided in 30 ml, 100 ml, and 250 ml polyethylene bottles. The pjur® med NATURAL glide, and We-Vibe® Lube made by pjur® have the same formulation that includes the same components as the lubricant above, without aloe barbadensis leaf juice powder. The pjur® med NATURAL glide device is provided in 10 ml and 100 ml polyethylene bottles. We-Vibe® Lube made by pjur® is provided in 30 ml polyethylene bottles, and 125 ml polyethylene/polypropylene pump bottles. The pjur® analyse me! water-based, pjur® BACK DOOR water-based, and pjur® med Moisturising glide have the same formulation that consists of water, glycerin, xanthan gum, benzyl alcohol, sodium benzoate, potassium sorbate, citric acid, sodium hyaluronate. The pjur® analyse me! water-based is provided in 10 ml, 100ml, and 250 ml polyethylene bottles. pjur® BACK DOOR water-based is provided in 10 ml, 100 ml, and 250 ml polyethylene bottles. pjur® med Moisturising qlide is provided in 10 ml and 100 ml polyethylene bottles.
The provided text describes a 510(k) premarket notification for a series of personal lubricants. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel safety or effectiveness through clinical trials, especially for common, low-risk devices like personal lubricants.
Therefore, the document does not describe a study with ground truth established by experts, multi-reader multi-case studies, or AI algorithm performance. Instead, it details non-clinical testing/performance data to demonstrate that the new devices meet established safety and performance criteria, primarily through comparison to a predicate device and adherence to recognized standards.
Here's an attempt to answer your questions based on the provided document, highlighting where the information is not applicable to an AI/medical imaging context:
Acceptance Criteria and Device Performance (based on Table 1: Device Specifications)
| Parameter | Acceptance Criteria (Specification) & Method Used | Reported Device Performance (Implied by "can maintain their specifications") |
|---|---|---|
| Appearance | Visual: Opaque fluid | Met |
| Odor | Olfactory: Characteristic (pjur® WOMAN Aloe) / Odorless (others) | Met |
| pH | USP: 4.0-4.5 | Met |
| Viscosity (mPa*s) | USP: 8500-9500 (pjur® WOMAN Aloe) / 9000-12000 (pjur® med Moisturising glide, BACK DOOR, analyse me!) / 8000-9500 (pjur® med NATURAL glide, We-Vibe® Lube) | Met |
| Osmolality (mOsmol/kg) | USP: 400-550 (1:9.5/9.8 dilution) / 400-600 (1:9.5 dilution) | Met |
| Total Aerobic Microbial Count (TAMC) | USP: : : Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans) | Met |
| Antimicrobial Preservation | USP: Category 2 - Topical (specific log reduction/no increase criteria) | Met |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be in an AI study. The "test set" here refers to samples of the manufactured lubricant products. For microbiological tests (TAMC, TYMC, pathogenic organisms, antimicrobial preservation), chemical tests (pH, viscosity, osmolality), and physical tests (appearance, odor), samples from production batches would be tested. The specific number of samples tested for each parameter is not detailed.
- Data Provenance: The data comes from in-vitro laboratory testing of the manufactured lubricant products. The country of origin of the data is not specified, but the applicant's address is in Luxembourg. The testing is prospective in the sense that it's performed on samples of the actual products being brought to market to verify they meet specifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this submission. This is not a study establishing "ground truth" for medical diagnosis via expert consensus. Instead, the "ground truth" for these performance criteria is defined by established scientific/technical standards and laboratory measurements (e.g., pH meter readings, culture results). The expertise lies in the certified laboratory personnel performing these tests according to the USP and ASTM standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images, to resolve discrepancies between expert readers. For the physical, chemical, and microbiological tests described here, the results are quantitative or qualitative assessments based on standardized procedures, not subjective interpretations requiring reader adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools and involves human readers interpreting cases. This submission is for personal lubricants, not diagnostic software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI algorithm. This question is not applicable to the device described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is based on established measurement standards and chemical/microbiological properties of the product, as defined by recognized pharmacopeial monographs (USP) and ASTM standards. For example, a pH meter provides the "ground truth" for pH, and specific culture methods provide the "ground truth" for microbial presence/count. Condom compatibility is verified through mechanical testing as per ASTM D7661. Biocompatibility relies on adherence to ISO 10993 standards.
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The sample size for the training set:
- Not applicable. This is not an AI model, so there is no training set in the machine learning sense. The "training" for such products involves formulation development and process optimization to consistently meet the specified product characteristics.
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How the ground truth for the training set was established:
- Not applicable. As there is no AI training set, this question does not apply.
§ 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.