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510(k) Data Aggregation
(358 days)
Vagisan MoistCream Cremolum is a personal lubricant, a suppository for 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 not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
The Vagisan MoistCream Cremolum is a ready-to-use, non-sterile, glycerin-based personal lubricant suppository for intravaginal application that melts after digital insertion to form a smooth cream. The device is intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Vagisan MoistCream Cremolum consists of hydrogenated coco-glycerides, ceteary1 alcohol, lactic acid, calcium lactate, PEG-20 glyceryl stearate, and sodium carbomer. Each vaginal suppository is individually packaged in a foil blister pack, which are sold in boxes of eight or 16 vaginal suppositories.
This document is a 510(k) Summary for a medical device called "Vagisan MoistCream Cremolum." It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. The information provided does not describe a study involving an AI/Machine Learning device. Instead, it describes non-clinical performance testing for a personal lubricant.
Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Device Specifications" table and summarize the non-clinical performance tests that were conducted.
Acceptance Criteria and Device Performance for Vagisan MoistCream Cremolum
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Smooth surface, no cracks, torpedo shaped suppository | The device is described as having a smooth surface, no cracks, and being torpedo-shaped. |
| Color | White | The device is described as white. |
| pH | 4.0-5.0 | Meets (Explicitly stated in comparative table) |
| Osmolality | 600 - 1200 mOsm/kg (1:1 Dilution) | The product's osmolality is stated to be within this range. |
| Average Mass per Ph. Eur. 2.9.5 | 1960-2040 mg | The product's average mass is stated to be within this range. |
| Uniformity of Mass per Ph. Eur. 2.9.5 | ≥18/20 inside ø ± 5 %; 20/20 inside ø ± 10 % | The product's uniformity of mass is stated to meet these criteria. |
| Disintegration Time per Ph. Eur. 2.9.2 | ≤30 minutes | The product's disintegration time is stated to be within this limit. |
| Particle Size | 100% ≤150 µm | The product's particle size meets this criteria. |
| Total aerobic microbial count (TAMC) | ≤ 100 CFU/g | The product's TAMC is stated to be within this limit. |
| Total yeast and mold count (TYMC) | ≤ 10 CFU/g | The product's TYMC is stated to be within this limit. |
| Presence of Pathogens (Pseudomonas aeruginosa) | Absent | Meets (Stated as absent) |
| Presence of Pathogens (Staphylococcus aureus) | Absent | Meets (Stated as absent) |
| Presence of Pathogens (Candida albicans) | Absent | Meets (Stated as absent) |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic | The results of testing demonstrated that Vagisan MoistCream Cremolum meets these criteria. |
| Shelf-Life | Maintain original specifications for 36 months | Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of a 36-month shelf-life. |
| Condom Compatibility | Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms (explicitly stated) | Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. (No testing was conducted, leading to this stated incompatibility.) |
Study Details:
This document describes non-clinical performance testing for a personal lubricant, not a study evaluating an AI/Machine Learning device. Therefore, the following AI/ML specific information is largely not applicable.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This document details non-clinical laboratory testing of a physical product, not a data-driven AI/ML model. The "test set" would refer to the batches of product samples used in each specific test (e.g., a certain number of suppositories for mass uniformity, a certain number of samples for microbial count), but specific sample sizes for each test are not provided in this summary.
- Data Provenance: Not specified for individual tests. The manufacturer is based in Germany (Dr. August Wolff GmbH & Co. KG Arzneimittel, address D-33611 Bielefeld, Germany). The testing standards cited are international (ISO, Ph. Eur., USP) suggesting internationally recognized lab practices. The submission is to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The "ground truth" for the physical and chemical properties (like pH, osmolality, mass, microbial limits) are established by standard analytical and microbiological testing methods, not by expert consensus as would be for clinical image interpretation. Biocompatibility testing results are also based on standardized assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 are used for expert consensus in fields like clinical image interpretation, not for objective measurements of physical or chemical properties.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the device's performance relies on objective laboratory measurements and standardized test procedures as defined by pharmacopeial monographs (Ph. Eur., USP) and ISO standards for biocompatibility.
8. The sample size for the training set
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
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(261 days)
Vagisan® Moisturizing Cream is a personal lubricant for 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 not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Vagisan Moisturizing Cream is a non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream delivered in a tube with a reusable applicator or sachet (sample size) as a long-lasting moisturizer for vaginal dryness.
The provided text details the 510(k) premarket notification for Vagisan® Moisturizing Cream, a personal lubricant. It does not describe an AI/ML device or its performance criteria, but rather a medical device (a cream) and its studies to prove substantial equivalence to a predicate device.
Therefore, most of the requested information (like AI/ML specific acceptance criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth for AI) is not applicable to the provided document.
However, I can extract information related to the performance studies conducted for the Vagisan® Moisturizing Cream as a medical device.
Acceptance Criteria and Device Performance (Based on provided studies for device safety and tolerability, not AI/ML performance):
| Acceptance Criteria (Study Endpoint) | Reported Device Performance (Vagisan® Moisturizing Cream) |
|---|---|
| Human Repeat Insult Patch Test (HRIPT): | |
| Non-irritating and non-sensitizing on skin | 104 out of 106 subjects (98%) showed no signs or symptoms of cutaneous irritation, demonstrating non-irritating and non-sensitizing properties. |
| Prospective, Multicenter, Controlled, Randomized Study: | |
| Tolerability assessed as "very good" or "good" by subjects and physicians. | 93% of study subjects assessed tolerability as "very good" or "good." |
| 100% of physicians assessed tolerability as "very good" or "good." | |
| Non-irritating and non-sensitizing on vaginal mucosa (implied by tolerability) | Demonstrated non-irritating and non-sensitizing properties in the vaginal area. |
| Prospective, Non-randomized, Non-controlled Study (Breast Cancer Patients): | |
| Tolerability assessed as "very good" or "good" by subjects and physicians. | 90% of study subjects assessed tolerability as "very good" or "good." |
| 91% of physicians assessed tolerability as "very good" or "good." | |
| Cytotoxicity Testing (ISO 10993-5:2009): | |
| Acceptable cytotoxicity profile given intended use | Showed a concentration-dependent cytotoxic effect (not uncommon for neat lubricants), but considered acceptable given better performance than some cleared lubricants and clinical study results. |
| Toxicological Risk Assessment: | |
| Ingredients within tolerable exposure values | Total amount of each ingredient less than tolerable exposure values obtained from literature review. |
| Stability Testing: | |
| Maintains specifications over stated shelf-life | Maintains specifications over 24 months. |
Since this is not an AI/ML device, the following points are not applicable and cannot be answered based on the provided text:
- Sample size used for the test set and the data provenance: Not an AI/ML test set. Clinical study sample sizes are given in the table above (106, 117, 117 subjects). Data provenance is human subjects from studies, implied to be prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Clinical observations by physicians and self-assessments by subjects served as data points.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the medical device's safety and tolerability was established through clinical observations by physicians, self-reported symptoms by subjects, and laboratory testing (e.g., cytotoxicity, analytical chemistry).
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable (no AI/ML training set).
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