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510(k) Data Aggregation
(90 days)
Agape Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
Agape Cooling Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
The device is provided in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in clear polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Mentha Piperita (Peppermint) Leaf Extract.
The document describes the regulatory approval for "Agape Cooling Personal Lubricant" and includes details about its acceptance criteria and the studies performed to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Semi-viscous liquid | Meets specification (implied, as part of overall compliance) |
| Color | Colorless | Meets specification (implied, as part of overall compliance) |
| Odor | Peppermint | Meets specification (implied, as part of overall compliance) |
| Viscosity (cps) per USP \ | 2150 to 4000 | Meets specification (implied, as part of overall compliance) |
| pH per USP \ | 3.50 to 4.50 | Meets specification (implied, as part of overall compliance) |
| Specific Gravity per USP \ | 1.010 to 1.030 | Meets specification (implied, as part of overall compliance) |
| Osmolality per USP \ (1:2 dilution) | 500 to 750 mOsm/kg | Meets specification (implied, as part of overall compliance) |
| Microbiological Specifications | ||
| Antimicrobial effectiveness per USP \ | Meets USP \ acceptance criteria for Category 2 products | Meets specification |
| Total aerobic microbial count (TAMC) per USP \ and \ | Less than 100 cfu/g | Meets specification |
| Total yeast and mold count (TYMC) per USP \ and \ | Less than 10 cfu/g | Meets specification |
| *Presence of Pathogens per USP * | Absent | Absent |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella/Shigella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida albicans | Absent | Absent |
| Biocompatibility | ||
| 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 10993-11:2006) | Non-systemically toxic | Non-systemically toxic |
| Shelf-Life | Maintain all device specifications for 3 years | All device specifications met at Time 0 and end of 3-year shelf-life |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., biocompatibility, condom compatibility, microbiological tests, or shelf-life). The data provenance is not specified in terms of country of origin, but the studies were conducted to comply with US FDA guidance and international ISO standards. All studies appear to be prospective as they are testing the product prior to its market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. The acceptance criteria and testing methods refer to internationally recognized standards (e.g., USP, ISO, ASTM), implying that expert consensus is embedded within these standards, but individuals involved in performing or interpreting these tests are not detailed.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method (e.g., 2+1, 3+1). The testing process relies on standardized laboratory methods (USP, ISO, ASTM) and the results are reported as meeting or not meeting these standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically associated with imaging algorithms or diagnostic devices where human readers interpret cases. The device in question is a personal lubricant, and its performance evaluation does not involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a personal lubricant, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance tests conducted are "standalone" in the sense that they evaluate the lubricant itself against physical, chemical, and biological criteria, without human interaction as part of the primary performance metric.
7. The Type of Ground Truth Used
The ground truth for the performance tests is based on:
- Established industry standards and regulatory guidelines: USP (United States Pharmacopeia), ISO (International Organization for Standardization), and ASTM (American Society for Testing and Materials) standards define the acceptable limits and methodologies for testing.
- Scientific measurement and observation: Laboratory tests measure properties like viscosity, pH, osmolality, microbial counts, and observe biological responses (cytotoxicity, irritation, sensitization).
- Predicate device comparison: The device's safety and effectiveness are also framed in comparison to a legally marketed predicate device (Premium Cooling Personal Lubricant K200602), showing substantial equivalence despite some formulation differences.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product (personal lubricant), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
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