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510(k) Data Aggregation
(307 days)
OneTouch Lubricant Gel
OneTouch™ Lubricant 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 rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of personal lubricants, 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. These lubricants are compatible with natural rubber latex and polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OneTouch™ Lubricant Gel:
This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a traditional sense. The "acceptance criteria" here largely refer to meeting recognized standards and demonstrating similar performance to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Findings |
|---|---|---|
| Material Safety | Biocompatibility Testing (Per ISO 10993-1, specifically -5, -10, -11) | OneTouch™ Lubricant Gel passed all biocompatibility testing. (This implies it met the criteria defined by ISO 10993-1 Parts 5, 10, and 11, assessing cytotoxicity, sensitization, and irritation). |
| Product Compatibility | Condom Compatibility Testing (Per ASTM D7661) | OneTouch™ Lubricant Gel passed all condom compatibility testing. (This means it did not compromise the integrity or performance of natural rubber latex and polyisoprene condoms, as assessed by ASTM D7661). |
| Microbial Purity | Total Aerobic Microbial Counts (Per USP 37 /) | OneTouch™ Lubricant Gel passed all testing. (Indicates microbial counts were within acceptable limits as per USP 37). |
| Total Combined Yeast and Mold Counts (Per USP 37 /) | OneTouch™ Lubricant Gel passed all testing. (Indicates yeast and mold counts were within acceptable limits as per USP 37). | |
| Product Stability | Package Shelf-Life (Per ASTM F1980) | OneTouch™ Lubricant Gel successfully completed testing. (Demonstrated a shelf-life of 3 years, indicating the product maintains its properties and safety over that period when packaged). This is comparable or better than the 1-year shelf life of one predicate and equal to the 3-year shelf life of the other predicate. |
| Risk Management | Device Risk Analysis (Per ISO 14971) | OneTouch™ Lubricant Gel successfully completed analysis. (Implies identified risks were managed and deemed acceptable according to ISO 14971 principles). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of lubricant samples for microbial testing, number of condoms for compatibility testing, or number of batches for shelf-life testing).
The data provenance is from Thailand, as the submission sponsor, Thai Nippon Rubber Industry Co., Ltd., is located in Thailand. The studies would be considered prospective in the sense that they were conducted specifically for this submission to evaluate the OneTouch™ Lubricant Gel.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are based on established national and international standards (ISO, ASTM, USP), which have predefined methodologies and acceptance limits. The "ground truth" is therefore derived from meeting these objective, quantitative standards, rather than expert consensus on specific cases.
4. Adjudication method for the test set
This is not applicable as the evaluations are based on adherence to quantitative standards and laboratory test results, not subjective expert review or consensus.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human interpretation (e.g., of images) is involved, potentially with AI assistance. The OneTouch™ Lubricant Gel is a personal lubricant, and its evaluation does not involve human readers interpreting cases or AI assistance in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study is not applicable as this device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the OneTouch™ Lubricant Gel is based on objective measurements and adherence to established international and national standards. This includes:
- Quantitative laboratory results for biocompatibility (e.g., cell viability, irritation scores), microbial counts (CFU/g), and physical properties for condom compatibility.
- Conformance to specifications and acceptance limits predefined by standards such as ISO 10993-1, ASTM D7661, USP 37 /, ASTM F1980, and ISO 14971.
8. The sample size for the training set
This is not applicable. The OneTouch™ Lubricant Gel is a physical medical device (personal lubricant), not an AI/ML algorithm or a diagnostic tool that requires a 'training set' in the computational sense. The product formulation development might involve iterative testing, but this is not typically referred to as a "training set" in this context.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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