(257 days)
FLIP Lube is personal lubricant for penile, vaginal, and/or rectal 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 synthetic polyisoprene condoms. Not compatible with polyurethane condoms.
FLIP Lube is a water-based, personal lubricant used to provide lubrication during sexual intercourse. It is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
This document describes the premarket notification for FLIP Lube, a personal lubricant. It does not contain information about an AI/ML powered medical device. Therefore, it's not possible to describe acceptance criteria and associated studies in the context of AI/ML device performance or human reader improvement with AI assistance.
The provided text focuses on the substantial equivalence of FLIP Lube to a predicate device based on its intended use, classification, environment of use, and performance testing related to its physical and biological properties.
Here's a breakdown of the information that is present, in the closest possible interpretation of your request:
Acceptance Criteria and Device Performance (in the context of a personal lubricant)
While not "acceptance criteria" in the sense of an AI model's performance metrics (like sensitivity, specificity, AUC), the document outlines the tests conducted to demonstrate the lubricant's performance and safety.
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Shelf Life (accelerated aging equivalent to 12 months per ASTM F1980-16) | "The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life..." (implies 12 months in this context) |
| Condom Compatibility per ASTM D7661-10 | "...is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms..." |
| Biocompatibility: Cytotoxicity (ISO 10993-5:2009) | "biocompatible." (This is a summary statement covering all biocompatibility tests; specific results for each criterion are not detailed in this public summary.) |
| Biocompatibility: Sensitization (ISO 10993-10:2010) | "biocompatible." |
| Biocompatibility: Vaginal Irritation with Histopathology (ISO 10993-10:2010) | "biocompatible." |
| Biocompatibility: Acute Systemic Toxicity (ISO 10993-11:2006) | "biocompatible." |
| Specifications (Appearance, Color, Odor, pH, Viscosity, Osmolality, Antimicrobial effectiveness, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms) | "The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life..." (Specific values for each specification are not provided in this summary but are implied to have met internal acceptance criteria for substantial equivalence.) |
Information NOT present in the document (due to the nature of the device: a personal lubricant, not an AI/ML medical device):
- Sample size used for the test set and data provenance: Not applicable in the context of an AI/ML test set. The "test set" here refers to physical samples of the lubricant and materials for compatibility and biocompatibility.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lubricant involves laboratory testing according to established standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by standardized laboratory testing methods (e.g., ASTM, ISO standards) for chemical, physical, and biological properties.
- The sample size for the training set: Not applicable (no "training set" in the AI/ML sense).
- How the ground truth for the training set was established: Not applicable.
This document is a 510(k) clearance for a Class II medical device (a lubricant) based on substantial equivalence. Such clearances typically rely on a comparison to legally marketed predicate devices and specific performance testing demonstrating safety and effectiveness for its intended use, rather than AI/ML model validation studies.
§ 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.