(186 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a personal lubricant. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
Explanation: This device is explicitly described as a "personal lubricant" intended to "moisturize and lubricate" and "enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." It does not claim to treat, prevent, or cure any disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The "Intended Use/Indications for Use" states that the device is "intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This description indicates a therapeutic or supportive function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly states it is a "personal lubricant that is a non-sterile, water-based formulation" and lists chemical ingredients. It also describes physical packaging components (bottle, pump, cap). This indicates a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 describes a product applied to the body for physical lubrication and comfort during sexual activity.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description: The description details a personal lubricant with a specific formulation and physical properties. It does not mention any components or functions related to analyzing biological specimens.
- Performance Studies: The performance studies focus on biocompatibility (irritation, sensitization, cytotoxicity) and compatibility with condoms. These are relevant to a personal lubricant applied to the body, not to an IVD.
The information provided clearly indicates that this device is a personal lubricant intended for direct application to the body, not for the in vitro analysis of biological specimens.
N/A
Intended Use / Indications for Use
Intended 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. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.
The subject device will be packaged as follows:
- 12 mL Polyethylene terephthalate (PET) bottle ●
- Polypropylene (PP) pump ●
- Polypropylene (PP) snap-on cap ●
- . Outer carton
The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Stability Study: KY Marilyn is shown to have a 9 month shelf life based on 9 month accelerated stability data provided for the formulation. The formulation has met the specification criteria at all temperature conditions.
- Biocompatibility Testing (ISO 10993-10:2009):
- The test article was considered a non-irritant to vaginal tissue of the rabbit. Conclusion: Device shown to be non-irritating.
- The test article solution showed no evidence of causing delayed dermal contact sensitization in the guinea pig. Conclusion: Device shown to be non-sensitizing in guinea pig maximization study.
- Biocompatibility Testing (ISO 10993-11:2009):
- The test article was not considered a sensitizer in the guinea pig maximization test. Conclusion: Device did not cause any mortality or systemic toxicity.
- Biological Reactivity Tests, in vitro (USP :2015):
- There was evidence of slight cytotoxicity to the cells exposed to the test item of the subject device. Conclusion: Device shown to be non-cytotoxic.
- Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber latex Condoms (ASTM D7661-10:2010):
- The test results indicate that KY Marilyn (TDS8125708), have passed the condom compatibility test for 510(k) condom for 3NRL and PI condoms- with no tests having % difference values > 20% and the majority of results
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2016
Reckitt Benckiser LLC Elizabeth Torre Regulatory Operations Lead 399 Interpace Parkway Parsippany, NJ 07054
Re: K151884 Trade/Device Name: K-Y® Marilyn Pleasure Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: December 2, 2015 Received: December 3, 2015
Dear Elizabeth Torre,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151884
Device Name K-Y® Marilyn Pleasure Gel
Indications for Use (Describe)
Intended 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. This product is not compatible with polyurethane condoms.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 【X】Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for RB, a company focused on health, hygiene, and home products. The logo features a pink triangle pointing upwards with the letters "rb" in white inside. Below the triangle, the words "HEALTH HYGIENE HOME" are written in a simple, sans-serif font, with small triangles separating each word.
510(k) Summary
| Submitted by: | Reckitt Benckiser, LLC |
|---|---|
| 399 Interpace Parkway | |
| Parsippany, NJ 07054-0224 | |
| 973-404-2715 | |
| 973-404-5702 | |
| Contact Person: | Elizabeth Torre, Regulatory Operations Lead, Reckitt Benckiser, LLC. |
| Date Prepared: | January 4, 2016 |
| Proprietary Name: | K-Y ® Marilyn Pleasure Gel |
| Trade Name: | K-Y ® Marilyn Pleasure Gel |
| Common Name: | Personal Lubricant |
| Classification Name: | Lubricant (21 CFR §884.5300, Product Code NUC) |
| Predicate Device(s): | KY® Brand Liquid Reckitt Benckiser LLC |
| Product Code: NUC | |
| 510(k) No.: K955648 | |
| Durex® Embrace Warming Sensation Gel | |
| Reckitt Benckiser LLC | |
| Product Code: NUC | |
| 510(k) No.: K140193 | |
| Durex® Embrace Tingling Experience Gel | |
| Reckitt Benckiser LLC |
Product Code: NUC 510(k) No.: K140193
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Image /page/4/Picture/0 description: The image shows the logo for RB, which stands for Reckitt Benckiser. The logo features a pink abstract shape resembling a stylized letter 'r' and 'b' stacked on top of each other. Below the logo, the words "HEALTH HYGIENE HOME" are written in a simple, sans-serif font, with heart symbols separating the words.
Description of the Device:
KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.
The subject device will be packaged as follows:
- 12 mL Polyethylene terephthalate (PET) bottle ●
- Polypropylene (PP) pump ●
- Polypropylene (PP) snap-on cap ●
- . Outer carton
The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.
Indications for Use Statement: KY Marilyn is indicated 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. This product is not compatible with polyurethane condoms.
Summary of Technological Characteristics of New Device in Comparison to Predicate:
Predicate comparison can be seen in Table 1 below.
| 510(k) | Device Name | Intended Use | Indications for Use | Physical | Manufacturer |
|---|---|---|---|---|---|
| Features | |||||
| K151884 | KY Marilyn | The intended use of this | |||
| device is 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 device is compatible | |||||
| with natural rubber latex | |||||
| and synthetic | |||||
| Polyisoprene condoms. | |||||
| This device is not | |||||
| compatible with | |||||
| polyurethane condoms. | Intended 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. This | |||||
| product is not compatible | |||||
| with polyurethane condoms. | Homogeneous | ||||
| Clear | |||||
| Gel/Odorless | Reckitt | ||||
| Benckiser | |||||
| LLC |
Table 1: Technological Characteristics of Subject Device Compared to Predicate
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Image /page/5/Picture/0 description: The image shows a logo with the letters 'rb' in lowercase, stylized in a modern, sans-serif font. The letters are a vibrant pink color and are positioned above a pink, triangular shape that resembles an arrowhead pointing downwards. The overall design is simple, clean, and eye-catching, suggesting a brand identity that is contemporary and dynamic.
| K955648 | KY Liquid | The intended use of this
device is a personal
lubricant (for vaginal and
penile application)
compatible with latex
condoms ONLY. | Intended as a personal
lubricant for penile and
vaginal application. It is
compatible with latex
condoms ONLY. | Homogeneous
Clear
Gel/Odorless | Reckitt
Benckiser
LLC |
|---------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------|
| K140193 | Durex
Embrace
Warming
Sensation Gel | The intended use of this
device is 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 device is compatible
with natural rubber latex,
synthetic Polyisoprene
and polyurethane
condoms. | Intended 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.
Lubricant is compatible with
natural rubber latex.
synthetic polyisoprene and
polyurethane condoms. | Homogeneous
Clear
Gel/Odorless | Reckitt
Benckiser
LLC |
| K140193 | Durex
Embrace
Tingling
Experience
Gel | The intended use of this
device is 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 device is compatible
with natural rubber latex,
synthetic polyisoprene
and polyurethane
condoms. | Intended 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.
Lubricant is compatible
with natural rubber latex,
synthetic polyisoprene and
polyurethane condoms. | Homogeneous
Clear Gel/Odorless | Reckitt
Benckiser
LLC |
Stability: KY Marilyn is shown to have a 9 month shelf life based on 9 month accelerated stability data provided for the formulation. The formulation has met the specification criteria at all temperature conditions.
Summary of Performance Data:
| Standard Used | Name of Standard | Result | Conclusion |
|---|---|---|---|
| ISO 10993-10:2009 | Biological Evaluation and | ||
| Biocompatibility Testing | |||
| of Medical Devices | The test article was considered a non- | ||
| irritant to vaginal tissue of the rabbit. | Device shown to | ||
| be non-irritating | |||
| ISO 10993-10:2009 | Biological Evaluation and | ||
| Biocompatibility Testing | |||
| of Medical Devices | The test article solution showed no | ||
| evidence of causing delayed dermal | |||
| contact sensitization in the guinea | Device shown to | ||
| be non-sensitizing | |||
| in guinea pig | |||
| maximization | |||
| study. |
Table 2: Summary of Performance Data
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Image /page/6/Picture/0 description: The image shows the logo for RB, a health, hygiene, and home company. The logo features a pink triangle with the letters "rb" in white inside. Below the triangle are the words "HEALTH, HYGIENE, HOME" in black with pink triangle bullet points separating the words.
| ISO 10993-11:2009 | Biological Evaluation and
Biocompatibility Testing
of Medical Devices | The test article was not considered a
sensitizer in the guinea pig
maximization test. | Device did not
cause any
mortality or
systemic toxicity |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| USP :2015 | Biological Reactivity
Tests, in vitro | There was evidence of slight
cytotoxicity to the cells exposed to
the test item of the subject device. | Device shown to
be non-cytotoxic |
| ASTM D7661-10:
2010 | Standard Test Method for
Determining Compatibility
of Personal Lubricants
with Natural Rubber latex
Condoms | The test results indicate that KY
Marilyn (TDS8125708), have passed
the condom compatibility test for
510(k) condom for 3NRL and PI
condoms- with no tests having %
difference values > 20%
and the
majority of results