(45 days)
Personal Warming Jelly is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.
Personal Warming Jelly is a non-sterile, clear, non-staining, I ersonal walling Jelly used as a personal lubricant. This non groups, inquily lubricous and may be used with or without a latex condom during intimate sexual activity.
The provided text describes a 510(k) premarket notification for "Personal Warming Jelly," a personal lubricant. The submission focuses on demonstrating substantial equivalence to a predicate device, K-Y Brand Warming Jelly Personal Lubricant, rather than establishing de novo performance criteria against a disease or condition. Therefore, many of the typical elements of acceptance criteria and study design for medical devices that involve clinical performance or diagnostic accuracy are not applicable here.
This submission is for a Class II medical device (Condom, Product Code: 85 NUC), which aligns with the general controls and special controls applied to such devices. The performance data presented is primarily non-clinical, focusing on stability and preservative effectiveness, as well as a direct comparison to the predicate device’s physical and chemical properties and warming loss.
Here's a breakdown based on the provided text, indicating where information is not applicable for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Stability | Successful completion of accelerated stability testing. | "Personal Warming Jelly has successfully passed 90 day accelerated stability." |
| Preservative Effectiveness | Demonstrated anti-microbial preservative challenge effectiveness. | "An anti-microbial preservative challenge has been completed on Qualis Personal Warming Jelly. The Preservative Effectiveness Study Report is in Attachment E." (Implied successful given the substantial equivalence determination) |
| Comparison to Predicate Device | Acceptable comparison to K-Y Brand Warming Jelly Personal Lubricant based on warming loss, physical/chemical properties, ingredients, label claims, and packaging. | "The result of this review was an acceptable comparison." |
| Intended Use | Designed to enhance the ease and comfort of intimate activity and compatible with latex condoms. | Verified as substantially equivalent to a device with the same intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. For non-clinical studies (stability, preservative challenge), the "sample size" would refer to the number of batches or units tested, which is not specified in this summary. For the comparative analysis, this was a review of characteristics rather than a test on a specific patient population.
- Data Provenance: Not applicable in the context of clinical data (e.g., country of origin, retrospective/prospective). The studies are non-clinical (laboratory-based).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This submission does not involve diagnostic accuracy or interpretation of medical images/data by experts. Ground truth, in this context, refers to objective laboratory measurements and comparisons.
4. Adjudication Method for the Test Set
- Not applicable. There is no expert adjudication process for this type of non-clinical product comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices interpreting medical images or data. This is a personal lubricant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-powered algorithm or diagnostic device.
7. The Type of Ground Truth Used
- For Stability: Laboratory measurements of physical, chemical, and functional properties over time.
- For Preservative Effectiveness: Laboratory challenge tests using specified microorganisms and methods.
- For Comparison with Predicate Device: Direct comparison of product specifications, physical and chemical properties, ingredients lists, label claims, and packaging characteristics against the established predicate device's information.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See #8)
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which are fundamentally criteria for demonstrating substantial equivalence to a legally marketed predicate device) consists of:
- Non-Clinical Stability Study: "Personal Warming Jelly has successfully passed 90 day accelerated stability." This demonstrates the product maintains its properties and safety over a simulated shelf life.
- Preservative Effectiveness Study: An "anti-microbial preservative challenge has been completed on Qualis Personal Warming Jelly." This study, detailed in Attachment E (not provided in the excerpt), ascertains the product's ability to resist microbial contamination during storage and use.
- Comparison Report (Shuster comparison Report in Attachment B): This report outlines a direct comparison of Personal Warming Jelly to the predicate device (K-Y Brand Warming Jelly Personal Lubricant). The comparison was based on:
- Warming loss characteristics.
- Physical and chemical properties.
- Ingredients list review.
- Label claims.
- Packaging.
The outcome of these studies, particularly the comparison report, led to the conclusion that "The result of this review was an acceptable comparison," which substantiated the claim of equivalence. The FDA, in its decision letter, concurred with this assessment, stating they "determined the device is substantially equivalent... for the indications for use stated above."
§ 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.