(90 days)
Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a medical device such as a condom, they are considered Class II Medical Devices.
K-Y® Brand WARMING LIQUID is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for purpose of lubrication, and moisturization. It is also compatible with latex condoms.
Personal Lubricant (compatible with latex condoms)
K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
The provided document describes the safety and performance testing of K-Y® Brand WARMING LIQUID™ Personal Lubricant, not an AI device. As such, many of the requested categories related to AI device evaluation (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.
However, I can extract the acceptance criteria and reported device performance from the provided text, focusing on the aspects that were evaluated.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Dermal Sensitization | Not to be a contact sensitizing agent. | The product was considered not to be a contact sensitizing agent. | Dermal Sensitization Study (in albino guinea pigs) |
| Penile Irritation | Not to cause any significant adverse effects or significant irritation. | The product did not cause any significant adverse effects and did not produce any significant irritation. | Rabbit Penile Irritation Study |
| Vaginal Irritation (Chronic) | Not to cause any pharmacotoxic effects; acceptable for use in humans. | The product did not cause any pharmacotoxic effects and was minimally irritating to the rabbit vaginal epithelium but considered acceptable for use in humans. | 10-Day Rabbit Vaginal Irritation Study |
| Systemic Toxicity | Not to cause mortality and not to be associated with systemic toxicity. | The product did not cause mortality and was not associated with systemic toxicity. | Mouse Systemic Injection Study (25% w/v at 50mg/kg i.p.) |
| Human Cumulative Irritation | To be mildly irritating and elicit no evidence of sensitization. | The product was considered to be only mildly irritating and elicited no evidence of sensitization on the skin of healthy humans. | Human 21-Day Cumulative Irritation Assay (occluded conditions) |
| Human Contact Sensitization | To be essentially non-irritating and not elicit evidence of sensitization. | The product was considered essentially non-irritating and did not elicit evidence of sensitization on healthy human skin. | Human Repeat Insult Patch Test (Modified Draize Procedure), compared to K-Y® Liquid |
| Consumer Perception of Warmth | Desired warming sensation perceived by consumers. | Greater than 85% of the participants perceived a warming sensation while using the product. | Two-Phase Consumer Use Study |
| Human Irritation (Post-Use) | No observed irritation upon gynecological examination after use. | After one week of home use, there was no observed irritation upon gynecological examination. | Two-Phase Consumer Use Study |
| Condom Compatibility | Compatible with latex condoms. | Compatible with latex condoms as demonstrated. | Condom Compatibility Testing (according to ASTM D 3492) |
| Lubricity | Comparable to predicate device (K-Y® Brand LIQUID Personal Lubricant). | Comparable lubricity was demonstrated. | Laboratory coefficient of friction testing |
Study Details (Non-AI Specific)
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Sample size used for the test set and the data provenance:
- Dermal Sensitization Study: Albino guinea pigs (specific number not provided).
- Rabbit Penile Irritation Study: Rabbits (specific number not provided).
- 10-Day Rabbit Vaginal Irritation Study: Rabbits (specific number not provided).
- Mouse Systemic Injection Study: Mice (specific number not provided).
- Human 21-Day Cumulative Irritation Assay: Healthy humans (specific number not provided).
- Human Repeat Insult Patch Test: Healthy human skin (specific number not provided).
- Two-Phase Consumer Use Study: Males and Females (initial perception and home use). Number of participants not explicitly stated, but implies a cohort.
- Data Provenance: Studies conducted by "outside laboratories" (preclinical) and within the US (implied by FDA submission context and "healthy humans" / "consumers" for clinical tests). These are prospective studies designed to evaluate the product.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of preclinical and clinical safety/performance studies. Ground truth is established by direct observation, laboratory measurements, and clinical assessments (e.g., macroscopic and microscopic findings for irritation, gynecological examinations).
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Adjudication method for the test set: Not applicable for these types of studies. Results are based on direct measurements and observations, not a consensus among reviewers of a complex output.
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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 device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
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The type of ground truth used:
- Preclinical: Histopathological examination (macroscopic and microscopic findings), physiological responses (mortality), and direct observation of skin reactions.
- Clinical: Direct observation of skin reactions, gynecological examinations, and subject self-reporting (perception of warmth).
- Compatability/Lubricity: ASTM standard testing and laboratory coefficient of friction measurements.
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The sample size for the training set: Not applicable. This is not an AI device.
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How the ground truth for the training set was established: Not applicable. This is not an AI 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.