(114 days)
The Wet Organics 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. The product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
The Wet Organics Personal Lubricant is a non-sterile, water-based, over-the-counter personal lubricant. The proposed device contains a blend of organic aloe and other ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The device is also compatible for use with natural rubber latex and polyisoprene condoms. The device is neither a contraceptive nor a spermicide.
The Wet Organics Personal Lubricant is packaged in 3 oz. polyethylene terephthalate bottle with a dispensing bottle cap with a disc top.
This document describes the 510(k) summary for the Wet Organics Personal Lubricant and contains information about its acceptance criteria and the studies performed.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear to slightly cloudy, semi-viscous, particle-free liquid | Clear to slightly cloudy, semi-viscous, particle-free liquid (Implied by meeting spec.) |
| Color | brown | brown (Implied by meeting spec.) |
| Odor | Odorless (Characteristic) | Odorless (Implied by meeting spec.) |
| Viscosity@25°C Spindle LV#3hu@10rpm (cps) | 1,000 cps – 2,300 cps | Within 1,000-2,300 cps range (Implied by meeting spec.) |
| Specific Gravity@25°C | 0.95 - 1.05 | Within 0.95-1.05 range (Implied by meeting spec.) |
| pH | 4.0 to 5.0 | Within 4.0-5.0 range (Implied by meeting spec.) |
| Osmolality | Meets USP acceptance criteria for Category 2 products | |
| Total aerobic microbial count (TAMC) per USP and | and | |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| E. Coli | Absent | Absent |
| Salmonella | Absent | Absent |
| Candida albicans | Absent | Absent |
| Biocompatibility (Cytotoxicity) | Not cytotoxic | Not cytotoxic |
| Biocompatibility (Sensitization) | Not sensitizing | Not sensitizing |
| Biocompatibility (Vaginal Irritation) | Not irritating | Not irritating |
| Biocompatibility (Acute Systemic Toxicity) | Not acutely systemically toxic | Not acutely systemically toxic |
| Condom compatibility (Natural rubber latex) | Compatible | Compatible |
| Condom compatibility (Polyisoprene) | Compatible | Compatible |
| Condom compatibility (Polyurethane) | Not compatible (Stated in Indications for Use) | Not compatible |
| Shelf Life | 12 months | 12 months (Met device specifications after this period) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test (biocompatibility, condom compatibility, shelf-life). It states "three marketed brands of natural rubber latex condoms, one brand of polyisoprene condoms, and one brand of polyurethane condoms" for condom compatibility. The provenance of the data (country of origin, retrospective/prospective) is not explicitly mentioned. However, given that these are standard laboratory tests for medical device submission to the FDA, they are generally conducted in a controlled, prospective manner following established protocols and standards (e.g., ISO, ASTM).
3. 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)
This is not applicable to the submitted document. The document describes laboratory performance tests for a personal lubricant, not a diagnostic device requiring expert interpretation of results to establish a "ground truth." The ground truth for these tests is based on the results of the standardized assays and measurements themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers provide interpretations (e.g., medical imaging) and disagreements need to be resolved. The tests described are laboratory-based with objective measurements.
5. 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
This is not applicable as the document is for a personal lubricant and doesn't involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a personal lubricant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests in this document is based on:
- Quantitative measurements and chemical analyses: For properties like viscosity, pH, specific gravity, osmolality, and microbial counts.
- Established biological assays: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
- Standardized physical test methods: For condom compatibility (ASTM D7661-10).
- Real-time stability testing: For shelf-life, where samples are tested against specifications over time.
These are objective, laboratory-derived results against predefined specifications and standards.
8. The sample size for the training set
This is not applicable. The device is a manufacturing product (personal lubricant), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
§ 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.