(383 days)
ONE® SILICONE 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.
ONE® SILICONE Personal Lubricant is a non-sterile, personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless. liquid. This device is not a contraceptive nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.
This 510(k) notification describes ONE® SILICONE Personal Lubricant, a medical device. This product is a personal lubricant for penile and/or vaginal use to enhance comfort during sexual activity and supplement natural lubrication. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Performed | Reported Device Performance (Results) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Product is Non-toxic |
| ISO Guinea Pig Maximization Sensitization Test | Product does not elicit a sensitization response |
| Acute Systemic Toxicity | There is no evidence of systemic toxicity |
| Vaginal Irritation and Systemic Toxicity Study Following Repeated Exposure in Rabbits | Product produced no macroscopic or microscopic evidence of systemic toxicity and is considered a nonirritant. |
| Condom Compatibility: | |
| ASTM D7661-10: Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms (tested with NRL, Polyisoprene, and Polyurethane condoms) | Compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials. |
| Shelf-Life: | |
| Accelerated Aging Study (evaluating both versions of packaging) | Product met specifications for a one-year shelf life. |
| Real-time aging study | Being conducted to confirm results. |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility Studies: The specific sample sizes for each biological test (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Vaginal Irritation, and Systemic Toxicity in Rabbits) are not explicitly stated in the provided document. However, these are standard laboratory tests where sample sizes are dictated by the ISO 10993-1 standard and specific test methodologies.
- Data Provenance: The document does not specify the country of origin. These are laboratory studies. The document implicitly states these were prospective studies conducted for this device.
- Condom Compatibility Study: The document mentions testing was performed on "three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms." The specific number of individual condoms tested for each brand or material is not provided.
- Data Provenance: Not specified, but likely laboratory testing. These were prospective studies.
- Shelf-Life Study (Accelerated Aging): The document states that the study "evaluated both versions of packaging." The specific number of samples or batches tested is not provided.
- Data Provenance: Not specified, but likely laboratory testing. These were prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to the studies described. The tests performed are laboratory-based, objective assessments of material properties and biological responses, or compatibility with other materials. The "ground truth" is established by the standardized methods themselves (e.g., ISO 10993-1, ASTM D7661-10) and the interpretation of results by trained laboratory personnel, rather than expert consensus on subjective findings.
4. Adjudication Method for the Test Set:
- This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation of data, such as imaging studies where a consensus among experts is needed for a diagnosis. The studies for this device are laboratory-based, following predefined protocols where results are generally objective and interpreted against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used to evaluate the diagnostic accuracy of imaging or other interpretive medical devices with and without AI assistance, involving multiple human readers and a dataset of medical cases. The ONE® SILICONE Personal Lubricant is a consumer product (personal lubricant) and its evaluation involves chemical, physical, and biological compatibility testing, not diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a personal lubricant, not an algorithm or an AI-powered system. Therefore, the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used:
- The "ground truth" for the studies performed is based on:
- Standardized Test Methods and Criteria: For biocompatibility, the ground truth is defined by the established pass/fail criteria of ISO 10993-1 tests (e.g., absence of cytotoxicity, no sensitization response, no systemic toxicity, non-irritant).
- Material Compatibility Standards: For condom compatibility, the ground truth is defined by the requirements and outcomes of the ASTM D7661-10 standard.
- Product Specifications and Stability Data: For shelf-life, the ground truth is established by the product's defined specifications (e.g., chemical stability, physical properties) and the results of accelerated aging interpreted against these specifications.
8. The Sample Size for the Training Set:
- This is not applicable. The device is a physical product (personal lubricant), not an AI algorithm that requires a training set. The studies described are experimental validations of the product's properties.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable, as there is no training set for this type of medical device.
§ 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.