(87 days)
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are personal lubricants 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. These products are compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Premium Warming 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 Warming Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
All-In-One Warming is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 4 fl. oz./120 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 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Dimethicone, Dimethiconol and Capsicum Frutescens Fruit Extract.
The provided text describes the 510(k) summary for the Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, and All-In-One Warming. This document is a regulatory submission to the FDA, and as such, it presents performance data to demonstrate substantial equivalence to a predicate device, rather than a "study that proves the device meets acceptance criteria" in the context of an AI/algorithm-driven device.
Given that this document is for a personal lubricant (a physical product, not an AI/algorithm), most of the requested information (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this type of device and submission.
However, I can extract the acceptance criteria and reported device performance from the provided "Device Specifications" table and the "Summary of Performance Data."
Here's the information that can be extracted, and where applicable, a note on why certain requested fields are not relevant for this device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Semi-viscous liquid | Semi-viscous liquid (implied, as it meets specification) |
| Color | Colorless | Colorless (implied, as it meets specification) |
| Odor | Odorless | Odorless (implied, as it meets specification) |
| Viscosity (cps) per USP \ | 800 to 1,075 | Meets specification (actual value not provided, but within range) |
| 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 (implied, as it meets specification) |
| Total yeast and mold count (TYMC) per USP \ and \ | Less than 10 cfu/g | Less than 10 cfu/g (implied, as it meets specification) |
| Presence of Pathogens per USP \ (Pseudomonas aeruginosa) | Absent | Absent (implied, as it meets specification) |
| Presence of Pathogens per USP \ (Staphylococcus aureus) | Absent | Absent (implied, as it meets specification) |
| Presence of Pathogens per USP \ (Salmonella/Shigella) | Absent | Absent (implied, as it meets specification) |
| Presence of Pathogens per USP \ (Escherichia coli) | Absent | Absent (implied, as it meets specification) |
| Presence of Pathogens per USP \ (Candida albicans) | Absent | Absent (implied, as it meets specification) |
| Biocompatibility | Pass (based on ISO standards) | The subject lubricant is biocompatible. |
| Shelf-Life | 3 years (maintaining all device specifications) | 3 years (met device specifications at 0, 1, 2, and 3 years) |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene and polyurethane condoms (per ASTM D7661-18) | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. |
Regarding the studies conducted, the following information is available:
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Biocompatibility Studies:
- Tests performed: Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity, and Sensitization Testing.
- Standards: ISO 10993-1:2016, ISO 10993-1:20019, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
- Outcome: "The results of this testing demonstrated that the subject lubricant is biocompatible."
-
Shelf-Life Study:
- Design: Real-time aging study.
- Duration: 3 years.
- Testing points: 0, 1, 2, and 3 years.
- Parameters tested: All device specifications listed in Table 1 (Appearance, Color, Odor, Viscosity, Antimicrobial effectiveness, Microbial counts, Pathogen presence).
- Outcome: "The subject device met the device specifications at all time points."
-
Condom Compatibility Study:
- Standard: ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Results: "Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are compatible with natural rubber latex, polyisoprene, and polyurethane condoms."
The following requested information is NOT APPLICABLE or NOT PROVIDED for this type of medical device (personal lubricant) in this regulatory submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical product; refers to software/AI. The "test set" here would refer to the physical samples of the lubricant subjected to the various chemical, microbiological, and physical tests. The document does not specify the number of units tested for each specific criterion but implies standard laboratory practices were followed.
- 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 to a physical product; refers to AI/algorithm performance evaluation. Ground truth for these tests comes from established scientific methods, not expert consensus in the diagnostic sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; refers to AI/algorithm. Laboratory tests have defined endpoints and pass/fail criteria.
- 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; refers to AI/algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; refers to AI/algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical product, "ground truth" is established through standardized laboratory testing methods (e.g., USP monographs for microbial testing, ISO standards for biocompatibility, ASTM for condom compatibility).
- The sample size for the training set: Not applicable; refers to AI/algorithm.
- How the ground truth for the training set was established: Not applicable; refers to AI/algorithm.
§ 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.