(60 days)
K-Y® Silicone is indicated for penile, vaginal and/or anal 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.
K-Y® Silicone is a non-sterile, odorless, and anhydrous personal lubricant that provides personal lubrication during intimate sexual activity and is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This product is composed of 100% Dimethicone. The product is packaged in a 50mL (1.69 FL oz.) HDPE bottle with a polypropylene pump. K-Y @ Silicone is identical in formulation and specifications to the predicate device (Durex Silicone, K143532).
The provided text describes the K-Y® Silicone personal lubricant, which claims to be substantially equivalent to the Durex Silicone (K143532) predicate device. The submission does not present a study proving the device meets acceptance criteria distinct from the predicate device; instead, it relies on the performance data of the predicate device due to their identical formulation and specifications.
Here's a breakdown of the requested information based on the provided text, recognizing that it primarily refers to the predicate device's data:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the specifications for the K-Y® Silicone, which are stated to be identical to the predicate device.
| Property | Acceptance Criteria | Reported Device Performance (based on predicate) |
|---|---|---|
| Color | Colorless | Colorless |
| Odor | Odorless | Odorless |
| Viscosity | 80-110 cps | Falls within 80-110 cps |
| TAMC (EP 2.6.12 harmonized to USP ) | ) | Absent |
| Absence of Pathogenic Organisms (Candida | Absent | Absent |
| albicans, Pseudomonas aeruginosa, | ||
| Staphylococcus aureus) (EP 2.6.13 harmonized | ||
| to USP ) | ||
| Biocompatibility: Cytotoxicity | Biocompatible | Biocompatible |
| Biocompatibility: Sensitization | Biocompatible | Biocompatible |
| Biocompatibility: Irritation | Biocompatible | Biocompatible |
| Biocompatibility: Systemic Toxicity | Biocompatible | Biocompatible |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible with natural rubber latex |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible with polyisoprene |
| Condom Compatibility (Polyurethane) | Compatible | Compatible with polyurethane |
| Shelf-Life | 24 months | 24 months |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the testing described for the predicate device. The data provenance is described as "performance testing provided in the predicate submission for the Durex Silicone personal lubricant (K143532)." This implies the data is retrospective for the K-Y® Silicone application, as it's leveraging previously generated data. The country of origin for the data is not specified in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a personal lubricant, and its performance (biocompatibility, condom compatibility, sterility, shelf-life) is evaluated through laboratory and material testing, not through expert review of diagnostic images or clinical assessments requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The testing described (biocompatibility, condom compatibility, analytical chemistry, microbiology, stability) are objective laboratory tests that do not involve subjective expert 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 product is a physical device (personal lubricant), not an AI-powered diagnostic or assistive technology for human readers.
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
For the predicate device's testing, the ground truth was established through:
- Laboratory test results: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), viscosity, color, odor, and microbiological assays (TAMC, TYMC, absence of pathogens).
- Standardized test methods: For condom compatibility (ASTM method D7661-10).
- Stability studies: For shelf-life (accelerated and real-time stability studies against device specifications).
8. The Sample Size for the Training Set
Not applicable. This is a physical product, not a machine learning model that requires a training set. The term "training set" doesn't apply in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a personal lubricant 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.