(185 days)
The Love Liquid® Personal Lubricant, 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. This product is compatible with natural rubber latex and Polyisoprene condoms. It is not compatible with polyurethane condoms.
The Love Liquid® Personal Lubricant is a non-sterile; water based personal lubricant, an over-the-counter personal lubricant, formulated to be a clear, non-irritating, non-greasy, liquid and odorless, aqueousbased. The proposed device contains a blend of ingredients found in the predicate device. The device is designed to supplement the body's own natural lubrication fluids and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The device formula is neither a contraceptive nor a spermicide.
The provided text describes the 510(k) summary for the "Love Liquid® Personal Lubricant," and includes information about its performance testing. However, it does not contain specific "acceptance criteria" as clear numerical thresholds that the device must meet for approval. Instead, it presents the results of various tests and concludes that the device is safe and substantially equivalent to predicate devices.
Therefore, the response below will present the reported device performance and infer the implied "acceptance criteria" from the successful outcome of those tests.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Implied Acceptance Criteria (Based on successful results) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (Direct Contact) | Non-toxic | Product is Non-toxic |
| ISO GUINEA PIG MAXIMIZATION SENSITIZATION TEST (Method for Liquid Test Articles) | Does not elicit a sensitization response | Product does not elicit a sensitization response |
| Vaginal Mucosa Irritation with Histopathology | Non-irritant to vaginal tissue | Product is considered a non-irritant to vaginal tissue |
| Acute Systemic Toxicity | No evidence of systemic toxicity | There is no evidence of system toxicity |
| Condom Compatibility | ||
| Natural Rubber Latex Condoms (ASTM D7661-10) | Compatible | Product is compatible with natural rubber latex condoms |
| Polyisoprene Condoms (ASTM D7661-10) | Compatible | Product is compatible with Polyisoprene condoms |
| Polyurethane Condoms (ASTM D7661-10) | Not compatible (stated as a known limitation) | Product is not compatible with polyurethane condoms |
| Microbiology | ||
| Antimicrobial Effectiveness (USP ) | Passed tests | Passed the tests for Antimicrobial Effectiveness |
| Total Microbial Count (USP ) | Passed tests | Passed the tests for Total Microbial Count |
| Total Yeast and Mold Count (USP ) | Passed tests | Passed the tests for Total Yeast and Mold Count |
| Absence of Pathogenic organism (USP ) | Passed tests | Passed the tests for Absence of Pathogenic organism |
| Shelf-life | ||
| Maintained appearance, color, odor, pH, osmolality, viscosity, and microbiology for 9 months | Maintained specifications for the tested duration | Maintained its appearance, color, odor, pH, osmolality, viscosity and microbiology specifications over a period of nine (9) months (On-going testing for 3 years) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the individual biocompatibility tests (e.g., number of animals for sensitization, irritation, or toxicity tests), nor for the microbiology tests or shelf-life samples.
For Condom Compatibility, the testing was performed on "three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms." The number of individual condoms tested per brand is not specified.
The data provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided text, but these types of tests are typically conducted in a laboratory setting per specific standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The tests described are laboratory-based assays (biocompatibility, microbiology, physical performance) that rely on standardized protocols and measurements, rather than subjective expert interpretation for "ground truth" in the way a medical image analysis might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests described are primarily objective laboratory measurements following standardized protocols, not subjective assessments requiring expert adjudication like in certain clinical trials or image interpretation studies.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading medical images with AI assistance), which is not the nature of this personal lubricant product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a personal lubricant, not an algorithm or AI system. Its performance is assessed directly through laboratory tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is established by the results of standardized laboratory assays and protocols. For example:
- Biocompatibility: Based on established biological endpoints (e.g., cell viability for cytotoxicity, lack of specific tissue changes for irritation, absence of systemic effects for toxicity, absence of immune response for sensitization).
- Condom Compatibility: Based on physical integrity measurements (Air Burst and Tensile) according to ASTM D7661-10.
- Microbiology: Based on quantitative microbial counts and detection of specific microorganisms according to USP , , and standards.
- Shelf-life: Based on maintaining pre-defined chemical and physical specifications (appearance, color, odor, pH, osmolality, viscosity) over time.
8. The sample size for the training set
Not Applicable. This product is a physical medical device (personal lubricant), not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As stated above, this device does not involve a training set.
§ 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.