(265 days)
Natureplex Warm Touch Warming Jelly 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms
Warm Touch Warming Jelly is a non-sterile, clear, colorless, viscous jelly for use as a personal lubricant. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with natural rubber latex condoms during intimate sexual activity. The device is not compatible with polyurethane or polyisoprene condoms. The primary packaging for the product is a low-density polyethylene (LDPE) tube with a cap, and peel seal for safety. Each tube is secondarily packaged in a cardboard carton.
This document is a 510(k) Pre-Market Notification from the FDA regarding the "Natureplex Warm Touch Warming Jelly." It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence.
Based on the provided text, here is an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Natureplex Warm Touch Warming Jelly) |
|---|---|---|
| Appearance | Smooth clear gel | Smooth clear gel |
| Odor | None to slight wax scent | None to slight wax scent |
| pH | 4.0-6.0 | 4.0-6.0 |
| Viscosity | 60,000-155,000 cP | 60,000-155,000 cP |
| Total Aerobic Microbial Count (TAMC) per USP | ||
| Absence of Pathogenic Organisms (S. aureus, P. aeruginosa, C. albicans) | Absent | Absent |
| Biocompatibility (Cytotoxicity) | Biocompatible | Biocompatible |
| Biocompatibility (Sensitization) | Biocompatible | Biocompatible |
| Biocompatibility (Vaginal Irritation) | Biocompatible | Biocompatible |
| Biocompatibility (Acute Systemic Toxicity) | Biocompatible | Biocompatible |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible |
| Shelf-Life | 2 years | 2 years |
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 sample sizes used for the various tests (biocompatibility, condom compatibility, shelf-life).
The data provenance (country of origin, retrospective/prospective) is not mentioned for any of the studies.
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 information is not applicable as the device is a personal lubricant, not an AI or diagnostic device that requires expert ground truth for interpretation. The ground truth for performance criteria is based on established laboratory testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for this type of device and testing. Test results are typically objective measurements against defined specifications.
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 information is not applicable as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is not an AI/algorithm-based device. The device itself (the lubricant) is the standalone entity being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria is derived from:
- Laboratory testing standards: For pH, viscosity, microbial counts, water activity, and absence of pathogenic organisms, the "ground truth" is measured values compared against established specifications (e.g., USP , USP ).
- International Standards: Biocompatibility testing was performed in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. Condom compatibility testing was performed in accordance with ASTM D7661-10. These standards define the methods and acceptance criteria for establishing compatibility and safety.
- Real-time stability studies: For shelf-life, the "ground truth" is the observed maintenance of specifications over the duration of the shelf-life.
8. The sample size for the training set
This information is not applicable as there is no training set for an AI/machine learning model. The device is a physical product subject to physical and chemical testing.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
§ 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.