Search Results

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.

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.

Ask a specific question about this device

Intended 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.

KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.

The subject device will be packaged as follows:

• 12 mL Polyethylene terephthalate (PET) bottle
• Polypropylene (PP) pump
• Polypropylene (PP) snap-on cap
• Outer carton

The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.

The provided document describes the K-Y® Marilyn Pleasure Gel (K151884), a personal lubricant. It presents performance data to demonstrate its substantial equivalence to predicate devices, particularly concerning biocompatibility and condom compatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device

Durex Silicone is indicated for perile 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.

Durex Silicone is a Personal Lubricant Device that is a non-sterile, odorless, anhydrous, silicone formulation that provides personal lubrication during intimate sexual activity. It is made up of 100% Dimethicone. The ingredient is clear (same as water) in appearance. The Viscosity at 25°C is 80-110 cps. The device will be made available in a 1.69 FL oz. (50mL) HDPE pump sealed bottle with an outer carton. The final dimensions of the carton are 138mmx74mmx28mm.

This document is a 510(k) Premarket Notification for Durex Silicone, a personal lubricant. It does not describe a study involving an AI medical device or other complex diagnostic or therapeutic device. Therefore, many of the requested categories for acceptance criteria and study details are not applicable.

However, I can extract the relevant information regarding the performance data and the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Biocompatibility (Cytotoxicity, Irritation, Systemic Toxicity, Sensitization): The document does not specify the sample sizes (e.g., number of cell cultures, animals) used for these tests. The provenance of the data is implicit as part of a regulatory submission to the FDA by the manufacturer, Reckitt Benckiser LLC. These are likely prospective laboratory and in-vivo animal studies conducted according to the cited ISO standards.
• Condom Compatibility: The testing was done using ASTM method D7661-10 with "three marketed brands of Natural Rubber Latex condoms, one brand of polyisoprene condom, and one brand of polyurethane condoms." The specific number of condoms and lubricants tested per brand is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is a personal lubricant, and the 'ground truth' is established through standardized laboratory and animal testing for biocompatibility and material compatibility, not through expert clinical interpretation of medical images or patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. The tests performed are laboratory-based and follow standardized protocols, not human-read 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 is not an AI-enabled device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" used for this device's performance evaluation is based on standardized testing protocols and methodologies defined by international (ISO) and national (ASTM) standards.
  • For biocompatibility: Cellular response to extract, physiological reactions in animal models.
  • For condom compatibility: Physical and chemical interaction with condom materials as measured by ASTM D7661-10.
  • For shelf life: Stability of physical/chemical properties over time.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set" for this device.

Ask a specific question about this device

Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.

Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).

This document describes the review of Durex® RealFeel™ Pleasure Gel Personal Lubricant for 510(k) premarket notification. The review focuses on establishing substantial equivalence to a legally marketed predicate device, ONE® Silicone Lubricant (K110690).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify the exact sample sizes for each of the performance tests (biocompatibility, condom compatibility, stability). However, it states that:

• Biocompatibility Studies: Four studies were conducted. The specific number of animals/samples for each endpoint (cytotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits) is not detailed.
• Condom Compatibility Testing: The sample size for this testing is not provided.
• Stability Studies: The sample size for the accelerated and real-time studies is not provided.

The data provenance is not explicitly stated in terms of country of origin but is implied to be from studies conducted by or for Reckitt Benckiser, LLC. These studies are retrospective to the submission date of November 18, 2014.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation is for a personal lubricant, not a diagnostic device requiring expert interpretation of medical images or data for ground truth establishment. The ground truth (or reference standard) for this device's performance is based on standardized testing methods and laboratory measurements, not expert consensus on medical conditions.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic accuracy, which is not the case here.

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

This information is not applicable. This is a submission for a personal lubricant and does not involve AI, human readers, or diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an algorithmic or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Standardized Laboratory Testing and Measurement:
  • Biocompatibility: Adherence to GLP requirements and applicable ISO 10993-1 standards for endpoints like cytotoxicity, systemic toxicity, sensitization, and irritation.
  • Condom Compatibility: Testing conducted in accordance with ASTM D7661-2010.
  • Physical and Microbiological Specifications: Internal quality control standards and established methods for appearance, odor, viscosity, specific gravity, microbial counts, and absence of specific pathogens.
  • Stability: Laboratory assessment of product specifications over time under accelerated and real-time conditions.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for a training set.

Ask a specific question about this device

Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended 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 lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Durex Embrace Pleasure Gels are clear odorless slightly viscous liquids that are packaged together and consist of two different formulation is water-based with multisensate (Tingling Experience Gel) and the female formulation (Warming Sensation Gel) is Vanillyl Butyl Ether in Glycerine base. The female lubricant (Pink Bottle) offers a warming experience, and one for the male partner (Purple bottle) offers a tingling experience. Devices are supplied in 60 ml PETG pump bottles. Both lubricant bottles are covered with a shrink sleeve including graphics that also provides tamper evident protection. Bottles are then placed in clear trays, which are then shrink-wrapped and placed in printed cartons.

The provided text describes the submission for a 510(k) premarket notification for Durex Embrace Pleasure Gels, seeking substantial equivalence to a predicate device (KY Yours + Mine). It outlines performance testing, but it is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

The document is for a personal lubricant, not an AI/ML device, and therefore does not have acceptance criteria or studies related to AI/ML performance metrics (like sensitivity, specificity, F1-score, AUC, etc.).

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its safety and performance based on the provided document.

Here's an interpretation of the request in the context of this non-AI medical device submission:

1. A table of acceptance criteria and the reported device performance

The document lists "Specifications" for which "acceptance specifications" have been developed, but it does not explicitly state the numerical acceptance criteria or the specific reported device performance values for each specification. It only states that "testing on samples collected up to 12 months of aging... showed that devices met their acceptance criteria" and that test results "demonstrated device materials to be biocompatible" and "non-irritating" or "did not elicit sensitization reactions."

Regarding AI/ML specific information, this document does not contain any of the following because it is not an AI/ML device:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Multi reader multi case (MRMC) comparative effectiveness study
• Standalone (i.e. algorithm only without human-in-the-loop performance) study
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set
• Sample size for the training set
• How the ground truth for the training set was established

Detailed information from the document (non-AI related):

2. Sample sizes used for the test set and data provenance:

• Acute Systemic Toxicity: "test group animals" (number not specified). Data provenance: Not specified, but likely conducted in a laboratory setting as per GLP requirements.
• Vaginal Irritation Testing: Not specified, but involved "rabbits" and assessed the Warming Sensation Gel.
• Penile Irritation Study: Not specified, but involved "rabbits" and assessed the Tingling Experience Gel.
• Cytotoxicity: Not specified, but tested using "tissue culture agar diffusion test."
• Sensitization: "study animals" (number not specified). Involved "Guinea Pig Maximization test."
• Condom Compatibility: Not specified for number of condoms or samples. Testing was "conducted in accordance with ASTM D7661-10."
• Stability: "samples collected up to 12 months of aging (real-time and accelerated at 40 C-75%RH)" (number of samples not specified).
• Data Provenance: Not explicitly stated, but all studies were conducted in accordance with GLP requirements and applicable ISO 10993 standards or ASTM D7661-10, implying controlled laboratory conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical/chemical/biological performance study, not an AI/ML ground truth establishment. The "ground truth" is determined by standardized test methods and observations/measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for this type of performance study. Results are based on direct observation, measurement, or established biological outcomes according to standard protocols.

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 as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable as this is not an AI/ML device. The performance tests are for the product itself (lubricant).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• The "ground truth" for these studies is based on observable biological reactions (e.g., irritation, sensitization, systemic toxicity), physical/chemical properties (e.g., pH, viscosity), and mechanical integrity (condom compatibility), as defined by established international standards (ISO 10993, ASTM D7661).

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable as this is not an AI/ML device.

Ask a specific question about this device