(139 days)
The Sex Gel 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 latex, polyisoprene, and polyurethane condoms.
The Sex Gel is a non-sterile, water-based, over-the-counter personal lubricant, formulated to be a clear liquid. The 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 natural rubber latex, polyisoprene, or polyurethane condoms during intimate sexual activity. The device formula is neither a contraceptive nor a spermicide.
The product is packaged in (50 ml / 1.7 oz) bottles made from high density polypropylene (POLY WHITE P 8555). The bottle is fitted with a pump for dispensing lubricant made of polypropylene, butyl, and steel. Each bottle is packaged in a paperboard carton, which constitutes the device's individual carton.
The provided document is a 510(k) premarket notification for "The Sex Gel," a personal lubricant. It describes various performance tests and acceptance criteria to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Properties | ||
| Appearance | Clear to slightly hazy | Met |
| Color | Colorless | Met |
| Odor | Characteristic | Met |
| Viscosity (cps) | 3,000 cps - 5,000 cps | Met |
| Specific Gravity | 1.01 to 1.06 | Met |
| pH | 4.0 to 5.0 | Met |
| Osmolality | 435 to 535 mOsm/kg | Met |
| Microbiological Properties | ||
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products | Met |
| Total aerobic microbial count (TAMC) per USP and | and | ** |
| Pseudomonas aeruginosa | Absent | Met (Absent) |
| Staphylococcus aureus | Absent | Met (Absent) |
| Salmonella | Absent | Met (Absent) |
| E. Coli | Absent | Met (Absent) |
| Candida albicans | Absent | Met (Absent) |
| Biocompatibility | ||
| Cytotoxicity | Not cytotoxic (per ISO 10993-5:2009) | Met |
| Sensitization | Not sensitizing (per ISO 10993-10:2010) | Met |
| Vaginal Irritation | Not irritating (per ISO 10993-10:2010) | Met |
| Penile Irritation | Not irritating (per ISO 10993-10:2010) | Met |
| Acute Systemic Toxicity | Not acutely systemically toxic (per ISO 10993-11:2006) | Met |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (per ASTM D7661-10) | Met |
| Shelf Life | 6 months shelf life (per ASTM F1980-15 for Accelerated Aging) | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of animals for irritation studies, number of batches for physical/chemical tests, number of condoms tested). It refers to tests being conducted "in accordance with" specific ISO and ASTM standards, which would typically define appropriate sample sizes.
Data Provenance: The studies were conducted by "Independent third-party laboratories." The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though biocompatibility and condom compatibility testing are inherently prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The studies described are laboratory tests of a physical/chemical product, not a diagnostic device requiring expert interpretation of results. Therefore, there were no "experts" in the sense of radiologists or clinicians establishing ground truth for a diagnostic test set. The "ground truth" for these tests is defined by the objective criteria and methodologies outlined in the referenced ISO and ASTM standards. The "experts" involved would be the qualified laboratory personnel performing the tests according to the standards. Their qualifications are implicitly that they are trained and competent in conducting these specific standardized tests.
4. Adjudication Method for the Test Set
Not applicable. As described above, these were objective laboratory tests against pre-defined specifications rather than subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess diagnostic performance. This document concerns a personal lubricant, which does not involve human interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. "The Sex Gel" is a personal lubricant, not an algorithm or AI-powered device. Therefore, a standalone algorithm performance study is not relevant. The performance studies described are for the physical device itself.
7. The Type of Ground Truth Used
The ground truth used for "The Sex Gel" studies is based on:
- Standardized objective measurements: For physical and chemical properties (e.g., viscosity, pH, osmolality).
- Defined microbiological limits: For microbial counts and absence of specific pathogens.
- Biological response criteria: For biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity), where observed biological reactions are compared against established acceptance criteria from ISO standards.
- Material compatibility tests: For condom compatibility, where the integrity and performance of condoms after lubricant exposure are evaluated against ASTM standards.
Essentially, the ground truth is established by universally recognized and validated laboratory testing standards and their associated acceptance criteria.
8. The Sample Size for the Training Set
Not applicable. "The Sex Gel" is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a physical product, there is no ground truth to be established for it.
§ 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.