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510(k) Data Aggregation
(269 days)
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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.
Exsens Personal Lubricants are non-sterile, water-based personal lubricants that provide personal lubrication during intimate sexual activity. They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor), Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The product is packaged in a 70ml polyethylene white tube with a flip-top cap and protective sleeve. It is for over-the-counter (OTC) use.
The document describes the acceptance criteria and performance data for Exsens Personal Lubricants. This information is presented in the context of a 510(k) premarket notification to the FDA, where the device is compared to a predicate device (K-Y Marilyn Pleasure Gel, K151884) to demonstrate substantial equivalence.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Exsens Personal Lubricant) |
|---|---|---|
| Appearance | Clear gel | Clear gel (Implicitly met as it's a characteristic, not a pass/fail test) |
| Odor | Neutral, mint, candy apple, raspberry | Neutral, mint, candy apple, raspberry (Implicitly met based on product description) |
| pH | 5.0 - 6.0 | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Viscosity | 7000 - 12,000 mPa | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Density | 1.14 | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Osmolality | 600 - 700 mOsmol/kg | Within specification (Implied by the statement "showed that the subject device specifications as listed in this 510(k) summary") |
| Antimicrobial Effectiveness | Meets acceptance criteria for Category 2 products | Met (Explicitly stated "Meets acceptance criteria for Category 2 products") |
| Total Microbial Count | <100 cfu/g | Met (Explicitly stated "<100 cfu/g") |
| Fungal/Yeast/Mold Limits | <10 cfu/g | Met (Explicitly stated "<10 cfu/g") |
| Absence of Pathogenic Organisms | Absent | Absent (Explicitly stated "Absent") |
| Biocompatibility: Cytotoxicity | Biocompatible | Demonstrated to be biocompatible |
| Biocompatibility: Sensitization | Biocompatible | Demonstrated to be biocompatible |
| Biocompatibility: Vaginal Irritation | Biocompatible | Demonstrated to be biocompatible |
| Biocompatibility: Acute Systemic Toxicity | Biocompatible | Demonstrated to be biocompatible |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene Male) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible |
| Shelf-life | 12 months | Showed 12 months shelf-life based on accelerated aging |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each test. For example, in biocompatibility testing, it mentions "Biocompatibility studies were conducted on the subject device," implying a sample was used, but the quantity is not given. Similarly, for condom compatibility, it states "The compatibility of the subject device... was evaluated," without specifying the number of lubricants or condoms tested.
- Data Provenance: The studies were conducted by the manufacturer, NEO COSMETIQUE, to support their 510(k) submission to the FDA. The document does not explicitly state the country of origin of the data beyond the manufacturer's address in France. The studies appear to be laboratory-based and conducted under specific standards (e.g., GLP, ISO, ASTM), suggesting controlled, prospective testing for the purpose of regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests described (biocompatibility, condom compatibility, stability, and chemical/physical properties) are objective laboratory tests with defined protocols and acceptance criteria based on established standards (ISO, ASTM). They do not involve expert interpretation or subjective ground truth establishment by medical professionals like radiologists.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The testing described involves objective laboratory measurements and adherence to specified standards, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and therefore not provided. This document pertains to the regulatory submission of a personal lubricant, not an AI or imaging device that would typically involve MRMC studies or human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and therefore not provided. The device is a personal lubricant, not an algorithm or software. Its performance is evaluated through material and biological compatibility tests, not algorithmic output.
7. The Type of Ground Truth Used
The ground truth for the performance claims are based on:
- Established laboratory standards and protocols: e.g., ISO 10993 for biocompatibility, ASTM D 7661-10 for condom compatibility, ASTM F1980-07 for shelf-life.
- Objective measurements: pH, viscosity, density, osmolality, microbial counts, and visual/olfactory characteristics.
- Pass/fail criteria: defined within these standards or as part of the product specification.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is a physical product (personal lubricant), not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As there is no training set, this question is not relevant.
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