(90 days)
The Trigg Laboratories WET ORIGINAL® Personal 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 ORIGINAL® Personal Lubricant is a non-sterile device. It is a water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, gel-like, liquid and odorless, aqueous-based. The proposed device contains a blend of ingredients similar to ingredients found in the predicate device.
The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing.
The device formula is neither a contraceptive nor a spermicide.
This document is a 510(k) summary for a personal lubricant and as such, it does not describe a study that uses AI or involves human readers as typically seen in image or data analysis medical devices. Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and MRMC studies is not applicable in the context of this document.
However, I can extract the relevant performance data and acceptance criteria for the physical and biological properties of the personal lubricant as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5:2009) | Meets acceptance requirements | Meets acceptance requirements |
| Guinea Pig Maximization Sensitization (ISO 10993-10:2010) | Meets acceptance requirements | Meets acceptance requirements |
| Vaginal Irritation (ISO 10993-10:2010) | Meets acceptance requirements | Meets acceptance requirements |
| Systemic Toxicity (ISO 10993-11:2006 (2010)) | Meets acceptance requirements | Meets acceptance requirements |
| Bench Testing (Specifications) | Comparable to predicate device | Meets specifications for pH, viscosity, specific gravity, osmolality, color, and odor |
| Microbial Quality | USP standards (total aerobic microbial count, total yeast and mold counts; absence of pathogenic organisms) | Meets USP standards; indicated antimicrobial effectiveness |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (ASTM D7661-10) | Compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials |
| Shelf Life | 2-year shelf life | 2-year shelf life achieved based on real-time aging study |
Study Proving Device Meets Acceptance Criteria:
The studies conducted for the personal lubricant are primarily laboratory-based evaluations of its physical, chemical, and biological properties, not a clinical study involving human patients in the usual sense for diagnostic or therapeutic devices.
2. Sample Sizes and Data Provenance:
- Test Set (Samples/Units): The document does not specify the exact number of lubricant samples or units used for each test. However, it indicates that biocompatibility studies and condom compatibility testing were performed on the "WET ORIGINAL®" device.
- Data Provenance: The tests were conducted by an "outside laboratory," in compliance with Good Laboratory Practices (GLPs), which would suggest prospective testing specifically for this submission. The country of origin of the data is not explicitly stated.
3. Number of Experts and Qualifications:
- Not applicable as this is not an interpretive diagnostic device requiring expert opinion for ground truth. The "experts" involved would be the laboratory personnel qualified to perform the ISO and ASTM standard tests mentioned.
4. Adjudication Method:
- Not applicable as this is not an interpretive diagnostic device. Test results are based on quantitative measurements and defined standard protocols (e.g., ISO, ASTM, USP).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not a device that involves human readers interpreting data or images.
6. Standalone Performance Study:
- Yes, the performance data presented (biocompatibility, bench testing, microbial quality, condom compatibility, shelf life) can be considered "standalone" performance for the lubricant itself, without human intervention in the usage/interpretation loop. The device's properties were tested objectively against established standards.
7. Type of Ground Truth Used:
- The ground truth is based on established international standards and regulations for medical device safety and performance criteria, specifically:
- ISO 10993 series for biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity).
- ASTM D7661-10 for condom compatibility.
- USP (United States Pharmacopeia) standards for microbial quality.
- Internal specifications for physical properties (pH, viscosity, specific gravity, osmolality, color, odor) designed to demonstrate substantial equivalence to the predicate.
8. Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable.
§ 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.