(192 days)
K-Y® Jelly Personal Lubricant, ASTROGLIDE® Personal Lubricant
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No
The 510(k) summary describes a personal lubricant and its physical properties and performance in laboratory and clinical studies. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is described as an over-the-counter personal lubricant intended to enhance comfort during intimate activity, not to treat a disease or condition.
No
The device is described as a personal lubricant and its intended use is to enhance comfort and ease of intimate activity. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly states it is a "water soluble clear, high viscosity gel-like liquid" and is "packaged in a convenient to use squeeze bottle with a flip-top cap," indicating it is a physical product, not software.
Based on the provided text, the K-Y® Liquid Personal Lubricant is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "enhance the comfort and ease of intimate activity with or without a latex condom." This is a physical lubricant for use on the body and condoms, not for testing samples taken from the body.
- Device Description: The description details a "water soluble clear, high viscosity gel-like liquid" for lubrication. This aligns with a personal lubricant, not a diagnostic test.
- Performance Studies: The studies described focus on condom compatibility, lubrication properties, dermal irritation, vaginal irritation, and consumer preference. These are all relevant to a personal lubricant applied to the body, not to the performance of a diagnostic test on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
Therefore, the K-Y® Liquid Personal Lubricant is a medical device, but it falls under the category of a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use - The K-Y® Liquid Personal Lubricant is an over-the-counter personal lubricant.
Indications - This device is indicated to enhance the comfort and ease of intimate activity with or without a latex condom. K-Y ® Liquid Personal Lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourse.
Product codes
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Device Description
The K-Y® Liquid Personal Lubricant formula is non-sticky, nonstaining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble clear, high viscosity gel-like liquid. Because it is water-soluble, K-Y® Liquid Personal Lubricant is easily rinsed off with water. The product is packaged in a convenient to use squeeze bottle with a flip-top cap.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
genital body orifice
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A) Clinical Dermal Irritation Study - Human Repeat Insult Patch Test: A total of 105 subjects completed the entire study which was conducted comparing K-Y® Liquid Personal Lubricant and the predicate device. ASTROGLIDE®. Neither product showed significant evidence of primary irritation or allergic sensitization. There were no reactions during the induction series and only a single plus-minus reaction during the challenge phase.
B) 10 -Day Rabbit Vaginal Irritation Study with K-Y® Liquid Personal Lubricant: This study, which was conducted at an outside testing laboratory, showed that the proposed device does not exhibit the potential to produce significant irritation in rabbits when administered intravaginally for ten consecutive days.
Performance Data: Consumer home use testing of K-Y® Liquid Personal Lubricant compared to the predicate device, ASTROGLIDE®, demonstrated that on virtually all individual characteristic, the majority of women did not have a preference between K-Y® Liquid Personal Lubricant and ASTROGLIDE . Where preferences were indicated, they were split between K-Y® Liquid Personal Lubricant and ASTROGLIDE®, with each holding a few directional advantages over the other.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Lubricating study: K-Y® Liquid Personal Lubricant was more lubricating than both K-Y® Jelly and ASTROGLIDE®.
Non-staining study: K.- Y® Jelly showing the least amount of any staining (99% observation of no stain or very light staining) compared to the proposed device, K-Y® Liquid Personal Lubricant with 98%. ASTROGLIDE® was rated at 88%.
Predicate Device(s)
K-Y® Jelly Personal Lubricant, ASTROGLIDE® Personal Lubricant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/2 description: The image shows a handwritten number, "K955648", in black ink. The number is written in a bold, slightly irregular font, giving it a casual appearance. The digits are clearly legible, and the overall impression is that of a quickly jotted down note.
510 (k) SUMMARY of SAFETY AND EFFECTLIBNESS
Statement
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Information supporting claims of substantial equivalence, as defined under the Federal Food Drug and Cosmetic Act, with respect to safety and effectiveness is summanzed below. For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final rule ... "510(k) Summaries and 510(k) Statements"(21CFR807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
- New Device's Name: K-Y® Liquid Personal Lubricant
- Predicate Device(s)': . K-Y® Jelly Personal Lubricant, Johnson & Johnson ASTROGLIDE® Personal Lubricant, BioFilm Inc.
Intended Use - The K-Y® Liquid Personal Lubricant is an over-the-counter personal lubricant.
Indications - This device is indicated to enhance the comfort and ease of intimate activity with or without a latex condom. K-Y ® Liquid Personal Lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourse.
Device Description - The K-Y® Liquid Personal Lubricant formula is non-sticky, nonstaining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble clear, high viscosity gel-like liquid. Because it is water-soluble, K-Y® Liquid Personal Lubricant is easily rinsed off with water. The product is packaged in a convenient to use squeeze bottle with a flip-top cap.
Technological Characteristics - K-Y® Liquid Personal Lubricant is thoroughly tested and proven safe to use. It contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients all of which are listed as "generally recognized as safe" (GRAS), with the exception of Hydroxyethl Cellulose (Natrosol 250H).
[Hydroxycthl Cellulose is listed in the FDA's Inactive Ingredients Guide and has been safely used as an ingredient in the predicate device, K-Y Jelly for many years. It is also an ingrodiant in many drug products e.g.: oral syrups, oral tablets, ophthalmic, and otic solutions.]
1
Advanced Care Products Premarket Notification [510{k)] K-Y® Liquid Personal Lubricant
Laboratory testing demonstrated K-Y® Liquid Personal Lubricant to be compatible with latex condoms. The testing concluded that condoms treated with K-Y® Liquid Personal Lubricant and condoms that were not treated showed no substantial differences in mechanical properties.
K-Y® Liquid Personal Lubricant has been shown to be both non-staining and lubricating when compared to the predicate devices, K-Y® Jelly and ASTROGLIDE®. In 2 different studies conducted to evaluate these attributes, the K-Y Liquid Personal Lubricant formulation was tested against the two predicate devices. The lubricating study showed that K-Y® Liquid Personal Lubricant was more lubricating than both K-Y® Jelly and ASTROGLIDE®. In the non-staining study, all of the devices had similar results with the predicate device, K.- Y® Jelly showing the least amount of any staining (99% observation of no stain or very light staining) compared to the proposed device, K-Y® Liquid Personal Lubricant with 98%. ASTROGLIDE® was rated at 88%. Both predicate devices currently carry a claim of non-staining.
Safety Testing
Clinical Laboratory and Safety testing in humans and in animals demonstrated that K-Y® Liquid Personal Lubricant is safe and effective for its intended use.
A) Clinical Dermal Irritation Study - Human Repeat Insult Patch Test
A total of 105 subjects completed the entire study which was conducted comparing K-Y® Liquid Personal Lubricant and the predicate device. ASTROGLIDE®. Neither product showed significant evidence of primary irritation or allergic sensitization. There were no reactions during the induction series and only a single plus-minus reaction during the challenge phase.
B) 10 -Day Rabbit Vaginal Irritation Study with K-Y® Liquid Personal Lubricant
This study, which was conducted at an outside testing laboratory, showed that the proposed device does not exhibit the potential to produce significant irritation in rabbits when administered intravaginally for ten consecutive days.
Substantial Equivalence
K-Y® Liquid Personal Lubricant is substantially equivalent to other marketed predicate devices, namely ASTROGLIDE® and K-Y® Jelly. All of these products are sold overthe-counter and are indicated as personal lubricants. Laboratory tests comparing K-Y® Liquid Personal Lubricant to K-Y® Jelly and ASTROGLIDE® demonstrated these products to perform in a similar manner under similar conditions.
2
Advanced Care Products Premarket Notification [510(k)] K-Y® Liquid Personal Lubricant
Performance Data
Consumer home use testing of K-Y® Liquid Personal Lubricant compared to the predicate device, ASTROGLIDE®, demonstrated that on virtually all individual characteristic, the majority of women did not have a preference between K-Y® Liquid Personal Lubricant and ASTROGLIDE . Where preferences were indicated, they were split between K-Y® Liquid Personal Lubricant and ASTROGLIDE®, with each holding a few directional advantages over the other.
Based upon testing data and FDA's Own Substantial Equivalence Decision Process. K-Y® Liquid Personal Lubricant has been demonstrated to be a device which is safe and effective for its intended use.