(208 days)
A non-sterile personal lubricant for OTC consumer use, as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide nor does it contain any such component.
The CVS Personal Lubricant & Moisturizer formula is non-sterile. clear, non- staining, non-greasy, aqueous gel intended for use as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms as demonstrated in condom compatibility testing. This device is not a contraceptive or spermicide, nor does it contain any such component. CVS Personal Lubricant & Moisturizer is packaged in PETE bottles with a foil seal and polypropylene cap.
This document describes the premarket notification for the CVS Personal Lubricant & Moisturizer, a device that is not an AI/ML product. Therefore, it does not include information on acceptance criteria or studies involving AI/ML performance.
The provided text details the device description, intended use, comparison of technological characteristics with a predicate device (Astroglide), and non-clinical studies conducted to demonstrate substantial equivalence. These non-clinical studies serve as the "performance data" for this type of medical device, ensuring its safety and effectiveness for its stated intended use.
Here's an analysis of the information provided, tailored to what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is not an AI/ML device, the concept of "acceptance criteria" is related to demonstrating substantial equivalence to a predicate device through physical, chemical, and functional characteristics, rather than diagnostic performance metrics.
| Feature / Test Category | Acceptance Criteria (Implied by Predicate Comparison and Standards) | Reported Device Performance (CVS Personal Lubricant & Moisturizer) |
|---|---|---|
| Composition | Substantially similar ingredients to predicate (Astroglide) | Contains: water, glycerin, propylene glycol, polyquaterium 15, methylparaben and propylparaben. Substantially similar to Astroglide in ingredient list. |
| Intended Use | Same intended use as predicate device | Personal lubricant for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. Compatible with latex condoms. Not a contraceptive or spermicide. (Identical to predicate's stated use). |
| Physical Characteristics | Non-sterile, clear, non-staining, non-greasy, aqueous gel (as described for the device). "Perceptual qualities" comparable to predicate. | Non-sterile, clear, non-staining, non-greasy, aqueous gel. "Test results rated CVS Personal Lubricant & Moisturizer (a 10 of 10 rating) as comparable to Astroglide" on the basis of perceptual qualities, physical and chemical properties. |
| Condom Compatibility | Must not adversely affect tensile strength, elongation, or burst pressure of latex condoms (standard for lubricants claiming compatibility). | When applied to latex condoms, it "does not adversely affect tensile strength, elongation or burst pressure, when compared to untreated condoms." |
| Shelf-Life Stability | Maintain product integrity and safety over time (typically a specified period under accelerated conditions). | Successfully passed 90-day accelerated stability. |
| Preservative Effectiveness | Must meet requirements of USP Antimicrobial Effectiveness Test. | Formulation with the preservative system has "successfully passed the requirements of the USP Antimicrobial Effectiveness Test." |
| Container Type | Similar to predicate for ease of use and safety. | Plastic (PETE bottles with a foil seal and polypropylene cap). Similar to predicate (Plastic). |
| Sterility | Non-sterile, as per device description and predicate. | Non-sterile. |
2. Sample size used for the test set and the data provenance:
- Non-Clinical Studies: The document does not specify exact sample sizes for the Stability, Preservative Effectiveness, or Condom Compatibility tests in terms of number of product units or condoms. These tests would typically follow established test protocols with defined sample sizes by relevant standards (e.g., ISO, ASTM, USP).
- Data Provenance: The studies were conducted by Lake Consumer Products, Inc., as part of their submission to the FDA. The data provenance is internal to the manufacturer. It is retrospective in the sense that the data was generated specifically for this 510(k) submission, not as part of a post-market surveillance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a personal lubricant, not a diagnostic AI/ML device requiring expert interpretation of medical images or data. Ground truth here refers to objective measurements against established physical, chemical, or biological standards.
4. Adjudication method for the test set:
- Not applicable for this type of device. Performance is determined by objective laboratory testing against established standards and comparison to a predicate device, not by expert adjudication of diagnostic outcomes.
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/ML device and therefore no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance evaluation comes from:
- Predicate Device Comparison: The chemical composition and intended use are compared directly to an existing legally marketed device (Astroglide, K935299).
- Established Standards:
- Preservative Effectiveness: USP Antimicrobial Effectiveness Test.
- Condom Compatibility: Industry-standard tests for tensile strength, elongation, and burst pressure of latex condoms (implied by the statement "does not adversely affect tensile strength, elongation or burst pressure"). These tests have predefined acceptance limits.
- Internal Laboratory Testing: Stability, perceptual qualities, physical, and chemical properties were assessed through internal testing, likely against predetermined specifications or direct comparison to the predicate.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
§ 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.