(299 days)
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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
SILICONE Personal Lubricant is a non-sterile, clear and odorless siliconebased personal lubricant for use during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. Its formulation consists of dimethicone and dimethiconol. The product is packed into a 3.38 oz (100 mL) bottle.
This document describes the non-clinical performance testing for the "SILICONE Personal Lubricant" device (K191654) to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Viscosity (@ 25°C) per USP | 300-700 cps | 300-700 cps (met within the specified range) |
| Total aerobic microbial count (TAMC) per USP | ||
| Absence of Pseudomonas aeruginosa per USP | Absence | Absence |
| Absence of Staphylococcus aureus per USP | Absence | Absence |
| Absence of Salmonella Enterica subsp. per USP | Absence | Absence |
| Absence of Candida albicans per USP | Absence | Absence |
| Absence of Clostridium sporogenes per USP | Absence | Absence |
| Absence of Bile-tolerant Gram-negative Bacteria per USP | Absence | Absence |
| Shelf Life (Accelerated Aging Study) | Device met all specifications | Device met all specifications at baseline and throughout the proposed shelf life (18 months) |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible (with three different brands of natural rubber latex condoms) |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible (with one brand of polyisoprene condom) |
| Condom Compatibility (Polyurethane) | Not Compatible (This is a negative acceptance criterion for comparison to predicate) | Not Compatible (with one brand of polyurethane condom) |
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Non-cytotoxic |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing |
| Vaginal Irritation (ISO 10993-10:2010) | Non-irritating | Non-irritating |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Not systemically toxic | Not systemically toxic |
2. Sample size used for the test set and the data provenance
- Microbial Purity and Viscosity: The document does not specify a separate "test set" sample size for these chemical and microbiological tests. These are typically performed on representative batches of the final product. The data provenance is implied to be from the manufacturer's internal testing as part of their quality control and submission process.
- Shelf Life: The sample size for the accelerated aging study is not explicitly stated. The data provenance is from the manufacturer's testing.
- Condom Compatibility: The testing involved "three different brands of natural rubber latex," "one brand of polyisoprene," and "one brand of polyurethane condoms." The specific number of individual condoms tested for each brand is not provided. The data provenance is from testing performed to ASTM D7661-10.
- Biocompatibility: The specific sample sizes (e.g., number of animals for irritation/sensitization, cell cultures for cytotoxicity) are not provided in this summary. The data provenance is from testing performed according to ISO 10993 standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes non-clinical performance testing for a medical device (personal lubricant) rather than a diagnostic or AI-driven device. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the way it applies to image interpretation or clinical diagnosis is not directly applicable here. The "ground truth" for these tests is based on established scientific methods and standards (USP, ASTM, ISO) and laboratory measurements.
4. Adjudication method for the test set
Not applicable, as this is non-clinical performance testing following standardized protocols, not human-in-the-loop diagnostic assessment.
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 not an AI-driven or diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for the various tests is established by:
- Laboratory measurements and analytical chemistry: For properties like viscosity, appearance, color, and odor.
- Microbiological testing standards (USP , USP ): For microbial counts and absence of specific pathogens.
- Accelerated aging protocols: For shelf life, confirming product specifications remain within limits over time.
- ASTM D7661-10 standard: For condom compatibility, which involves physical testing of condom integrity after exposure to the lubricant.
- ISO 10993 series of standards: For biocompatibility, involving in vitro (cytotoxicity) and in vivo (sensitization, irritation, acute systemic toxicity) tests.
8. The sample size for the training set
Not applicable. This document does not describe an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this document.
§ 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.