(232 days)
The Trigg Laboratories Wet Platinum Premium Lubricant® is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, 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.
The Wet Platinum Premium Lubricant® is a non-sterile, silicone based personal lubricant, an over-the-counter personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. It is a Silicone soluble, gel-like liquid for use as a personal lubricant. The Wet Platinum Premium Lubricant® contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.
The specifications for Wet Platinum include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, and Clostrida), and antimicrobial effectiveness. Osmolality and pH are not applicable specifications because the subject lubricant is anhydrous.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Wet Platinum Premium Lubricant®, however, it's crucial to note that this 510(k) summary is for a personal lubricant, not a medical device involving AI or complex performance metrics typically found in device studies. Therefore, many of the requested points related to AI, medical imaging, human experts, and specific statistical analyses (like MRMC) are not applicable to this document.
I will fill in the relevant information and explicitly state when a requested point is not applicable or cannot be determined from the provided text.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Non-toxic (Cytotoxicity - MEM Elution Test) | Product is Non-toxic |
| Does not elicit a sensitization response (ISO Guinea | Product does not elicit a sensitization response |
| Pig Maximization Sensitization Test) | |
| Non-irritant & no acute systemic toxicity (Vaginal | Product produced no macroscopic or microscopic evidence of acute systemic toxicity and it is considered a non-irritant. |
| Irritation and Systemic Toxicity Following Once Daily | |
| Application for Ten Consecutive Days) | |
| Condom Compatibility (ASTM D7661-10): | |
| Compatible with Natural Rubber Latex condoms | The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex. |
| Compatible with Polyisoprene condoms | The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from... Polyisoprene materials. |
| Compatible with Polyurethane condoms | The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from... polyurethane materials. |
| Shelf Life: | |
| 1-year shelf life (accelerated aging study) | The Wet Platinum Premium Lubricant® has a one-year shelf life based on the results of an accelerated aging study. (Real-time aging studies continue to extend period to 3 years, but 1 year is the initial proven shelf life based on the accelerated study). |
| Product Specifications: | Not explicitly stated as acceptance criteria, but listed as specifications: Appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Escherichia coli, Salmonella, and Clostrida), and antimicrobial effectiveness. Osmolality and pH are not applicable as it is anhydrous. |
| Intended Use: | The device meets its intended use as a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, and is compatible with specified condoms. (Substantially equivalent to predicate devices). |
Study Details
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Sample size used for the test set and the data provenance:
- Biocompatibility Tests: The document does not specify the exact sample sizes (number of lubricant samples or animals used) for the cytotoxicity, sensitization, and vaginal irritation tests. The provenance is implied to be laboratory testing conducted to ISO 10993-1 and other standards. It is a prospective laboratory study.
- Condom Compatibility Tests: The tests were performed on "three marketed brands of Natural Rubber Latex condoms, two brands of Polyisoprene condoms, and one brand of Polyurethane condoms." The specific number of condoms tested per brand is not provided. The provenance is laboratory testing in accordance with ASTM Condom D7661-10. This is a prospective laboratory study.
- Shelf Life Testing: The sample size for the accelerated aging study is not specified. This is a prospective laboratory study.
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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. This device is a personal lubricant, not an diagnostic or imaging device requiring expert interpretation for "ground truth." The "ground truth" for this product is established through standardized laboratory testing protocols (e.g., ISO, ASTM standards) and direct measurement of physical and biological properties.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per the previous point, there are no human interpretations or judgments in the "test set" that would require adjudication in the way medical imaging or AI performance studies do. The results are objective measurements from laboratory tests.
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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. This is not an AI-assisted device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of this personal lubricant is established through objective measurements and observations from standardized laboratory tests (e.g., cytotoxicity assays, sensitization responses in animal models, visual and microscopic examination for irritation, mechanical properties of condoms after lubricant exposure, and stability readings from aging studies). It's essentially the direct experimental outcome based on established scientific protocols.
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The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 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.