(263 days)
Onetouch™ Non-paraben Lubricant Gel is a personal lubricant, for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Onetouch™ Non-paraben Lubricant Gel is a non-sterile, water-based, over-the-counter use personal lubricant that is intended for penile, vaginal and/or anal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Onetouch™ Nonparaben Lubricant Gel is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
Onetouch™ Non-paraben Lubricant Gel has the following eight flavor and color versions:
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- Natural Color, No Flavor
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- Natural Color, Cucumber Flavor
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- Natural Color, Mixfruit Flavor
- Pink Color, Strawberry Flavor 4.
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- Natural Color, Strawberry Flavor
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- Natural Color, Vanilla Flavor
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- Natural Color, Mentha Piperita (Peppermint) Flavor
- Natural Color, Aloe Vera Flavor 8.
The formulations of all versions consist of purified water, hydroxyethyl cellulose, refined glycerin, propane-1,3-diol, sodium benzoate, and PEG-40 hydrogenated castor oil. Specific versions of the device include flavors or a pink colorant, as shown in the list above.
Onetouch™ Non-paraben Lubricant Gel is packaged in 75ml LDPE plastic tubes or 5 ml PE layered aluminum foil sachets. Sachets and tubes are secondarily packaged in cartons.
The provided document describes the acceptance criteria and study for the Onetouch™ Non-paraben Lubricant Gel, which is a personal lubricant. It does not pertain to an AI/ML device. Therefore, many of the requested fields are not applicable.
Here's the information extracted from the document:
1. Table of acceptance criteria and the reported device performance
| Property | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Appearance | A clear medium viscous gel, free of foreign matter | Clear medium viscous gel, free of foreign matter, natural color or pink color depending on device version (consistent with predicate device) |
| Color | Colorless (all natural color versions) | |
| Pink (Pink Color, Strawberry Flavor version) | Consistent with specifications | |
| Odor | Odorless (Natural Color, No Flavor version) | |
| Cucumber (Natural Color, Cucumber Flavor version) | ||
| Mixfruit (Natural Color, Mixfruit Flavor version) | ||
| Strawberry (Pink Color, Strawberry Flavor version) | ||
| Strawberry (Natural Color, Strawberry Flavor version) | ||
| Vanilla (Natural Color, Vanilla Flavor version) | ||
| Mentha Piperita (Natural Color, Mentha Piperita (Peppermint) Flavor version) | ||
| Aloe Vera (Natural Color, Aloe Vera Flavor version) | Consistent with specifications | |
| Viscosity (USP) | 9,500 -16,000 cps | Within range of 9,500 -16,000 cps (similar to predicate device's 8,000 - 20,000cps) |
| pH at 25°C (USP) | 5.5 - 6.5 | 5.5 - 6.5 (same as predicate device) |
| Osmolality (USP) | 300-600 mOsm/kg (1:8 dilution) | Within range of 300-600 mOsm/kg (1:8 dilution) (different from predicate device's ≤1,200 mOsm/kg, but does not raise different S&E questions) |
| Antimicrobial Effectiveness (USP) | Bacteria: NLT 2.0 log reduction from the initial count at 14 days, and no increase from 14 days 'count at 28 days; | |
| Yeasts/Molds: No increase from the initial calculated count at 14 and 28 days. | Testing demonstrated effectiveness (same as predicate device) | |
| Total Aerobic Microbial Count (TAMC, per USP ) | )** | )** |
| Biocompatibility | Non-cytotoxic, non-irritating, not systemically toxic | Non-cytotoxic, non-irritating, and not systemically toxic |
| Shelf-Life | 12 months | 12 months (shorter than predicate device's three years, but confirmed through testing) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms. | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the specific tests, nor does it detail the data provenance (country of origin, retrospective/prospective). It refers to standard testing methods (e.g., USP, ISO, ASTM standards) which inherently include sample size considerations, but the exact numbers are not provided in this summary.
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)
Not applicable. This is a medical device (personal lubricant) requiring laboratory and biomechanical testing, not an AI/ML device relying on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device (personal lubricant) requiring laboratory and biomechanical testing, not an AI/ML device involving human reader adjudication.
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
Not applicable. This is a medical device (personal lubricant), not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (personal lubricant), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established through standardized laboratory testing and accepted industry methods (e.g., USP, ISO, ASTM standards). This includes:
- Chemical and Physical Properties: Direct measurements of appearance, color, odor, viscosity, pH, and osmolality.
- Microbiological Purity: Laboratory culture methods to count microbial load and detect specific pathogens.
- Biocompatibility: In vitro (cytotoxicity) and in vivo (sensitization, irritation, acute systemic toxicity) animal models.
- Shelf-Life: Real-time and accelerated aging studies to observe property changes over time.
- Condom Compatibility: Standardized mechanical testing of condom integrity after exposure to the lubricant.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a 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.