(81 days)
LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to supplement the body's natural lubrication fluids. The formula is a non-greasy, non-sticky, non-staining and non-irritating gel-like liquid that is compatible with latex condoms in laboratory testing. LifeStyles® Liquid Personal Lubricant is available over-the-counter in three formulas: LifeStyles® Liquid Personal Lubricant Long Lasting LifeStyles® Liquid Personal Lubricant Aloe & Vitamin E LifeStyles® Liquid Personal Lubricant Strawberry. The product is packaged in a plastic tube with a flip-top cap or in an aluminum foil/plastic film laminate sachet.
Acceptance Criteria and Device Performance for LifeStyles® Liquid Personal Lubricant
This report details the acceptance criteria and the results of the study demonstrating the performance of LifeStyles® Liquid Personal Lubricant, as presented in the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily demonstrates substantial equivalence to predicate devices. The acceptance criteria are implicitly derived from the characteristics of these predicate devices and the intended use. The performance of LifeStyles® Liquid Personal Lubricant is then compared against these established characteristics through various tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance for LifeStyles® Liquid Personal Lubricant |
|---|---|---|
| Composition/Properties | Contains deionized water | Yes |
| Contains glycerine | Yes | |
| Contains Cellulose thickeners | Yes | |
| Contains Methylparaben | Yes | |
| Contains Propylparaben | Yes | |
| Labeled water soluble | Yes | |
| Labeled non-staining | Yes | |
| Non-greasy, non-sticky | Yes (described in general description) | |
| Non-irritating | Yes (described in general description) | |
| Safety | Condom compatibility with latex condoms | Yes (tested in laboratory testing) |
| Biocompatibility | Yes (tested by independent laboratories) | |
| Preservative effectiveness | Yes (tested by independent laboratories) | |
| Does not affect in-vitro spermicidal activity of condoms lubricated with spermicide (Nonoxynol-9) | Yes (demonstrated by independent testing) | |
| Intended Use | Supplement body's natural lubrication fluids | Yes (stated in intended use) |
| Moisturize | Yes (stated in intended use) | |
| Enhance comfort and ease of intimate sexual activity with or without a latex condom | Yes (stated in intended use) | |
| Classification | Non-sterile | Yes |
2. Sample Size and Data Provenance
The 510(k) summary does not explicitly state specific sample sizes for the tests conducted. It mentions that LifeStyles® Liquid Personal Lubricant was "tested by independent laboratories" for condom compatibility, biocompatibility, and preservative effectiveness. It also states that "Independent testing has also demonstrated that LifeStyles® Liquid Personal Lubricant does not affect the in-vitro spermicidal activity of condoms lubricated with spermicide (Nonoynol-9)."
- Test set sample size: Not explicitly specified for any of the tests.
- Data provenance: The data was generated through "independent laboratories" and "independent testing." The country of origin is not specified, but the applicant (Ansell Healthcare Inc.) is based in the USA. The studies would be considered prospective as they were conducted to test the performance of the specific device for this submission.
3. Number of Experts and Qualifications for Ground Truth
The 510(k) summary does not provide information regarding the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of the device (personal lubricant) and the types of tests described (e.g., condom compatibility, biocompatibility), the ground truth would likely be established through standardized laboratory test procedures and validated analytical methods rather than expert consensus on diagnostic interpretations.
4. Adjudication Method
The 510(k) summary does not mention any adjudication method. This is expected as the performance evaluation involves objective laboratory tests rather than subjective interpretations requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically relevant for interpretative diagnostic devices where human reader performance is a key metric. LifeStyles® Liquid Personal Lubricant is not a diagnostic device.
6. Standalone Performance Study
Yes, standalone performance studies were done. The description of tests for "condom compatibility, biocompatibility, and preservative effectiveness," and the demonstration that the product "does not affect the in-vitro spermicidal activity of condoms lubricated with spermicide" are all examples of standalone performance testing of the algorithm (in this case, the product formulation) in isolation, without human-in-the-loop directly influencing the outcome of the specific measurement.
7. Type of Ground Truth Used
The ground truth used for the performance evaluation appears to be based on:
- Standardized laboratory test results: For condom compatibility (e.g., burst strength, freedom from pinholes), biocompatibility, and preservative effectiveness.
- In-vitro experimental data: For the effect on spermicidal activity.
- Material composition and formulation analysis: For confirming ingredients and properties.
It is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on objective measurements from these laboratory tests.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. LifeStyles® Liquid Personal Lubricant is a medical device (personal lubricant), not an artificial intelligence or machine learning algorithm that requires a training set for model development. The product's formulation and manufacturing processes are developed based on scientific principles and validated through testing, not through iterative learning from data.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a training set is not applicable to this device, and therefore, the establishment of ground truth for a training set is not relevant.
§ 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.