(304 days)
O Glide Personal Lubricant is a 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 not compatible with condoms.
The O Glide Personal Lubricant is a non-sterile, oil-based personal lubricant designed to supplement the body's own natural lubrication fluids and to enhance the ease and comfort of intimate sexual activity.
The O Glide Personal Lubricant is specifically formulated with naturally occurring plant derived oils. The specifications for the subject lubricant include appearance, odor, viscosity, total microbial count (TAMC), total combined yeast and molds count, and absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Coliforms, and Clostridia). Osmolality, pH, and antimicrobial effectiveness are not applicable to the subject device because it is an oil-based lubricant.
The product is bottled in an LDPE white plastic tube with a white flip top cap. The tube is packaged in a carton for sale to consumers.
This document is a 510(k) Pre-market Notification for the "O Glide Personal Lubricant," which is a Class II medical device (condom product code NUC). It describes the technical characteristics and performance data to demonstrate substantial equivalence to a predicate device, Aloe Cadabra Personal Lubricant (K124044).
Here's an analysis of the provided information, focusing on the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a typical quantitative format alongside performance. Instead, it describes performance across various tests, implying successful completion as the acceptance. Here's a table summarizing the tests and their reported outcomes:
| Test Category | Specific Test | Purpose/Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO Elution Method) | No cytotoxic effects | "The test article extract showed no evidence of causing cell lysis or toxicity." |
| Acute Systemic Toxicity (Mice) | No mortality or evidence of systemic toxicity | "There was no mortality or evidence of systemic toxicity from the extracts injected into mice." | |
| Maximization Sensitization (Guinea Pig) | No dermal contact sensitization | "The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig." | |
| Vaginal Irritation (Rabbit with Histopathology) | Non-irritant to vaginal tissue | "The test article extracts were considered to be a non-irritant to vaginal tissue of the rabbit." | |
| Shelf Life | Accelerated Aging Study | Maintain specifications over the proposed shelf life (1 year) | "The subject device met its specifications over the duration of the proposed shelf life." |
| Condom Compatibility | N/A | Not compatible with condoms (based on labeling and stated characteristic) | "The subject device is labeled not for use with condoms." |
Beyond these specific tests, the "specifications for the subject lubricant" include appearance, odor, viscosity, total microbial count (TAMC), total combined yeast and molds count, and absence of pathogenic organisms. While no specific numerical criteria are given in this document, it's implied that the device met these specifications, as it passed the shelf-life testing. Osmolality, pH, and antimicrobial effectiveness were deemed "not applicable" due to the oil-based nature of the lubricant.
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- Cytotoxicity: Not specified (in vitro cell culture).
- Acute Systemic Toxicity: "Mice" - specific number not provided.
- Maximization Sensitization: "Guinea pig" - specific number not provided.
- Vaginal Irritation: "Rabbits" - specific number not provided.
- Shelf Life: Not specified; likely involves multiple product samples tested over time intervals.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It implies prospective testing conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this document. The studies conducted are laboratory-based experimental tests on animals (mice, guinea pigs, rabbits) and in vitro cell cultures, as well as product stability testing. There is no "ground truth" derived from human experts in the context of diagnostic interpretation for this type of device (personal lubricant). The "ground truth" for these tests is the objective measurement of biological reactions or physical/chemical properties.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert review processes where there's a possibility of disagreement in interpretation (e.g., image reading). The tests performed for this lubricant are laboratory experiments with objective endpoints.
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
This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation, and would assess the performance of human readers, potentially with or without AI assistance. This document pertains to a personal lubricant, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document does not concern an AI algorithm or software. It is about a physical chemical product (personal lubricant).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data presented is based on objective laboratory measurements and accepted biological responses in standardized animal models and cell cultures. For example:
- Cytotoxicity: Observed cell lysis/toxicity.
- Acute Systemic Toxicity: Mortality or observable systemic effects in mice.
- Sensitization: Observable dermal contact sensitization in guinea pigs.
- Vaginal Irritation: Histopathological findings in rabbit vaginal tissue.
- Shelf Life: Adherence to defined physical, chemical, and microbiological specifications of the product.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a personal lubricant device. Training sets are used for machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of 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.