(483 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical and chemical properties, with no mention of AI or ML technology.
Yes
The device is intended to moisturize and lubricate to enhance comfort, which is a therapeutic purpose.
No
Explanation: The device is a personal lubricant and moisturizer for vaginal application, intended to enhance comfort during intimate activity, not to diagnose any medical condition.
No
The device is a physical product (vaginal moisturizer) delivered by an applicator, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for vaginal application to moisturize and lubricate for comfort during sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details a physical product (gelatin ovule with silicone fill mass) and its components. There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on safety (irritation, sensitization, biocompatibility) and functional performance (moisturization, condom compatibility, stability). These are typical for a personal lubricant, not an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is applied in vivo (inside the body) and serves a physical purpose.
N/A
Intended Use / Indications for Use
K-Y® Brand Liquibeads® Vaginal Moisturizer is a personal lubricant for over-the-counter use, for 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, polyisoprene, and polyurethane condoms. The product is delivered by an applicator.
Product codes
NUC
Device Description
K-Y® Brand Liquibeads® Vaginal Moisturizer is a non-sterile, anhydrous silicone fill mass, encapsulated with a gelatin shell (ovule). The fill mass is composed of a proprietary blend of silicones. The gelatin shell is composed of gelatin NF, glycerin USP, and water USP. The K-Y® Brand Liquibeads® Vaginal Moisturizer is a transparent ovule with a yellowish fill mass. The product is packaged into single use blister packs with single use disposable applicators, which are then packed into a printed carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
- Biocompatibility Review & Testing: Studies of vaginal and penile irritation in rabbits were conducted using the fill mass of the subject device. The results showed that the fill mass is non-irritating to genital tissue. Four additional biocompatibility studies were conducted on the subject device. The test article evaluated in each study consisted of a mixture of the Liquibeads® ovule and 0.9% sodium chloride. The endpoints evaluated included in vitro cytotoxicity, systemic toxicity in mice, contact sensitization in guinea pigs, and vaginal irritation in rabbits. Each study was conducted in accordance with GLP requirements and the applicable ISO 10093 Standard. From the results obtained, it can be concluded that the subject device, K-Y® Brand Liquibeads® Vaginal Moisturizer, is not cytotoxic, does not elicit systemic toxicity, is not a contact sensitizer, and is not irritating to vaginal tissue.
- Performance Data - Clinical: A human repeat insult patch test was conducted to evaluate the safety of the fill mass of subject device. The study showed the product did not induce responses indicative of contact sensitization. Results from an in-home consumer use test show that K-Y® Brand Liquibeads® Vaginal Moisturizer provides vaginal moisturization.
- Performance Data - Non Clinical: Condom compatibility testing demonstrates that K-Y® Brand Liquibeads® Vaginal Moisturizer is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Routine testing demonstrated that the product will remain stable for the labeled shelf-life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-Y® Brand Intrigue® - K062796
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K - Y ® Brand Liquibeads® - 5 l0(k) K 122061: Response to Second AI Request - May 21, 2013
Johnson+Johnson
CONSUMER COMPANIES, Inc.
R COMPANIES, Inc
510(k) SUMMARY
2013
| Date Prepared | October 11, 2013 |
|---|---|
| Applicant | Johnson & Johnson Healthcare Products |
| Division of McNeil-PPC, Inc. | |
| 199 Grandview Road | |
| Skillman, NJ 08558 | |
| Contact Person | Joseph Chmielewski, R.A.C. |
| Associate Director, Regulatory Affairs | |
| Johnson & Johnson Consumer Companies, Inc | |
| 199 Grandview Road | |
| Skillman, NJ 08558 | |
| Phone: 908-874-1744 | |
| Fax: 908-904-3712 | |
| E-mail: jchmiele@its.jnj.com | |
| Proprietary Name | K-Y ® Brand Liquibeads ® |
| Common Name | Vaginal Moisturizer / Personal Lubricant |
| Classification Name | Condom |
| Classification | Class II |
| Product Code | NUC |
| Regulation | 21 CFR §884.5300 |
| Predicate Device | K-Y ® Brand Intrigue ® - K062796 |
| Description | K-Y ® Brand Liquibeads ® Vaginal Moisturizer is a non-sterile, anhydrous silicone fill mass, encapsulated with a gelatin shell (ovule). The fill mass is composed of a proprietary blend of silicones. The gelatin shell is composed of gelatin NF, glycerin USP, and water USP. The K-Y ® Brand Liquibeads ® Vaginal Moisturizer is a transparent ovule with a yellowish fill mass. The product is packaged into single. |
185 Tabor Road, Morris Plains, NJ 07950
1
:
K122061 pg 2 of 3
:
| | use blister packs with single use disposable applicators, which are then
packed into a printed carton. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | K-Y® Brand Liquibeads® Vaginal Moisturizer is a personal lubricant
for over-the-counter use. for 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. polyisoprene, and
polyurethane condoms. The product is delivered by an applicator. |
| Technological
Characteristics | The subject device. K-Y® Brand Liquibeads® Vaginal Moisturizer, and
the predicate device. K-Y® Brand Intrigue® have the same intended
use but have different technological characteristics as the subject
device encapsulates the personal lubricant in an ovule. |
| Biocompatibility
Review & Testing | The subject device varies from the cleared device only in the fact that
it is encapsulated in a gelatin shell and is inserted into the vagina by
means of a single-use, disposable applicator. At the concentrations
present in the formula, all ingredients are considered safe for human
use under the anticipated exposure conditions. In addition, all of the
ingredients have been used in legally marketed devices. The use of
these ingredients in the subject device raises no new questions of
safety or effectiveness. |
| | Studies of vaginal and penile irritation in rabbits were conducted using
the fill mass of the subject device. The results showed that the fill
mass is non-irritating to genital tissue. |
| | Four additional biocompatibility studies were conducted on the subject
device. The test article evaluated in each study consisted of a mixture
of the Liquibeads® ovule and 0.9% sodium chloride. The endpoints
evaluated included in vitro cytotoxicity. systemic toxicity in mice,
contact sensitization in guinea pigs, and vaginal irritation in rabbits.
Each study was conducted in accordance with GLP requirements and
the applicable ISO 10093 Standard. From the results obtained, it can
be concluded that the subject device, K-Y® Brand Liquibeads®
Vaginal Moisturizer, is not cytotoxic, does not elicit systemic toxicity.
is not a contact sensitizer, and is not irritating to vaginal tissue. |
| Performance Data
-Clinical | A human repeat insult patch test was conducted to evaluate the safety
of the fill mass of subject device. The study showed the product did
not induce responses indicative of contact sensitization. |
| | Results from an in-home consumer use test show that K-Y® Brand
Liquibeads® Vaginal Moisturizer provides vaginal moisturization. |
| Performance Data
-Non Clinical | Condom compatibility testing demonstrates that K-Y® Brand
Liquibeads® Vaginal Moisturizer is compatible with natural rubber
latex, polyisoprene, and polyurethane condoms. |
| | Routine testing demonstrated that the product will remain stable for
the labeled shelf-life. |
| Conclusion | The subject device, K-Y® Brand Liquibeads® Vaginal Moisturizer is
substantially equivalent to the predicate device, K-Y® Brand Intrigue®. |
.
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2
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K122061 pg 3 of 3
:
.
. .
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 8, 2013
Johnson & Johnson Healthcare Products Lorna-Jane Bremer, M.S., M.B.A., R.A.C. Director, Regulatory Affairs Johnson & Johnson Consumer Companies, Inc. 185 Tabor Road Morris Plains NJ 07950
Re: K122061
Trade/Device Name: K-Y Brand Liquibeads Vaginal Moisturizer Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Procode: NUC Dated: November 4, 2013 Received: November 5, 2013
Dear Lorna-Jane Bremer,
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
4
Page 2 - Lorna-Jane Bremer, M.S., M.B.A., R.A.C.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Benjamin R. Fisher -S
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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K122061
Device Name: K-Y® Brand Liquibeads® Vaginal Moisturizer
Indications for Use: K-Y® Brand Liquibeads® Vaginal Moisturizer is a personal lubricant for over-the-counter use, for 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, polyisoprene, and polyurethane condoms. The product is delivered by an applicator.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.11.08 16:20:48 -05'00'
X AND/OR Over-the-Counter Use Prescription Use (21 CFR §801 Subpart C) (Per 21 CFR §801 Subpart D)