(86 days)
Premium Cooling 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, polyisoprene and polyurethane condoms.
Premium Anal Cooling 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, polyisoprene and polyurethane condoms.
Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and polyurethane condoms. These devices are non-sterile personal lubricants 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.
Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
These devices are composed of Dimethicone, Dimethiconol and Menthol.
The provided FDA 510(k) summary document for "Premium Cooling Personal Lubricant" and "Premium Anal Cooling Lubricant" is for a personal lubricant, not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) are not applicable to this document.
However, I can extract the acceptance criteria and study information for this non-AI/ML medical device from the document.
Acceptance Criteria and Reported Device Performance
| Property | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Appearance | Semi-viscous liquid | Not explicitly stated as "met", but implied by description |
| Color | Colorless | Not explicitly stated as "met", but implied by description |
| Odor | Odorless | Not explicitly stated as "met", but implied by description |
| Viscosity (cps) per USP | 800 to 1,075 | Met (implied by "The subject device met the device specifications at all time points" for shelf-life) |
| Specific Gravity per USP | 0.875 to 1.020 | Met (implied by "The subject device met the device specifications at all time points" for shelf-life) |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products. | Met (explicitly stated "Antimicrobial effectiveness per USP meets USP acceptance criteria for Category 2 products") |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g | Met (explicitly stated "Less than 100 cfu/g") |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Met (explicitly stated "Less than 10 cfu/g") |
| Presence of Pathogens per USP | Pseudomonas aeruginosa: Absent | |
| Staphylococcus aureus: Absent | ||
| Salmonella/Shigella: Absent | ||
| Escherichia coli: Absent | ||
| Candida albicans: Absent | Met (explicitly stated "Absent" for all listed pathogens) | |
| Biocompatibility - Cytotoxicity | Passing reactivity score (non-cytotoxic) | "only slightly cytotoxic with a passing reactivity score" |
| Biocompatibility - Sensitization | Non-sensitizing | "non-sensitizing" |
| Biocompatibility - Vaginal Irritation | Non-irritating | "non-irritating" |
| Biocompatibility - Acute Systemic Toxicity | Non-systemically toxic | "non-systemically toxic" |
| Shelf-Life | Maintain all device specifications for 3 years | "met the device specifications at all time points" (0, 1, 2, and 3 years) |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | "are compatible with natural rubber latex, polyisoprene and polyurethane condoms" |
Study Information (for non-AI/ML device):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility Studies: Not specified in terms of sample size for living organisms. The tests performed are standard in vitro and in vivo toxicology tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). Data provenance is not mentioned.
- Shelf-Life Study: Samples were tested at 0, 1, 2, and 3 years. The number of individual product units tested at each time point is not specified. Data provenance is not mentioned.
- Condom Compatibility Study: Evaluated in accordance with ASTM D7661-18. The number of condoms or lubricant samples tested is not specified. Data provenance is not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Performance is assessed against scientific/regulatory standards and specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML diagnostic device.
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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:
- Not applicable as this is not an AI/ML diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device. The device itself is the "standalone" product being evaluated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here refers to established scientific and regulatory standards/specifications (e.g., USP monographs for viscosity, microbial limits, and antimicrobial effectiveness; ISO standards for biocompatibility; ASTM standards for condom compatibility).
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The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires training data.
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How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device that requires training data.
§ 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.