(483 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device called K-Y® Brand Liquibeads® Vaginal Moisturizer. This submission focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI algorithm.
Therefore, many of the requested points related to AI algorithm performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document. This document details the biocompatibility and safety testing of a physical product.
However, I can extract information related to the safety and performance studies that were conducted to support the device's substantial equivalence to the predicate device.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the safety and performance studies):
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Non-irritating to genital tissue (vaginal and penile) | The fill mass is non-irritating to genital tissue in rabbits. The subject device is not irritating to vaginal tissue in rabbits. |
| Non-cytotoxic | The subject device (mixture of ovule and 0.9% NaCl) is not cytotoxic in in vitro cytotoxicity evaluation. |
| Does not elicit systemic toxicity | The subject device (mixture of ovule and 0.9% NaCl) does not elicit systemic toxicity in mice. |
| Not a contact sensitizer / Does not induce contact sensitization | The subject device (mixture of ovule and 0.9% NaCl) is not a contact sensitizer in guinea pigs. A human repeat insult patch test of the fill mass showed the product did not induce responses indicative of contact sensitization. |
| Performance: | |
| Provides vaginal moisturization | Results from an in-home consumer use test show that K-Y® Brand Liquibeads® Vaginal Moisturizer provides vaginal moisturization. |
| Compatible with condoms (natural rubber latex, polyisoprene, polyurethane) | Condom compatibility testing demonstrates that K-Y® Brand Liquibeads® Vaginal Moisturizer is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. |
| Stable for labeled shelf-life | Routine testing demonstrated that the product will remain stable for the labeled shelf-life. |
2. Sample size used for the test set and the data provenance:
- Vaginal and Penile Irritation (Rabbits): Specific sample size not provided, but rabbits were used. Data provenance is likely laboratory animal studies.
- In Vitro Cytotoxicity, Systemic Toxicity (Mice), Contact Sensitization (Guinea Pigs), Vaginal Irritation (Rabbits): Specific sample sizes for each study not provided, but mice, guinea pigs, and rabbits were used for these "four additional biocompatibility studies." Data provenance is likely laboratory animal studies.
- Human Repeat Insult Patch Test: This implies human subjects were used, but the specific sample size is not provided. Data provenance is a human clinical study.
- In-Home Consumer Use Test: This implies human subjects were used for consumer feedback. The specific sample size is not provided. Data provenance is a human consumer study.
- Condom Compatibility Testing: Does not involve human or animal subjects, but rather testing with condom materials. Specific number of condoms/tests not provided.
- Stability Testing: Does not involve biological subjects. Specific number of samples/tests not provided.
All studies appear to be prospective, laboratory or consumer studies conducted to specifically evaluate the device. The country of origin of the data is not explicitly stated but is implied to be within the regulatory framework for FDA submission (likely US-based or internationally recognized labs).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies are primarily about the physical and biological effects of the device, not about algorithmic performance or diagnostic accuracy that would require expert-established ground truth. The 'ground truth' in these studies is the direct measurement of irritation, toxicity, sensitization, moisturization, compatibility, or stability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reasons as point 3. The studies involve direct measurements and observations, not interpretations requiring adjudication.
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 as this is not an AI device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This is not applicable as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the various tests was based on:
- Direct observation of biological responses: For irritation, systemic toxicity, and contact sensitization in animal models and human patch tests.
- In vitro assay results: For cytotoxicity.
- User feedback/reported experience: For vaginal moisturization in the in-home consumer test.
- Material compatibility tests: For condom compatibility.
- Analytical testing: For stability.
8. The sample size for the training set:
This information is not applicable as this is not a learning (AI) device.
9. How the ground truth for the training set was established:
This information is not applicable as this is not a learning (AI) device.
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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 ProductsDivision of McNeil-PPC, Inc.199 Grandview RoadSkillman, NJ 08558 |
| Contact Person | Joseph Chmielewski, R.A.C.Associate Director, Regulatory AffairsJohnson & Johnson Consumer Companies, Inc199 Grandview RoadSkillman, NJ 08558 |
| Phone: 908-874-1744Fax: 908-904-3712E-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
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K122061 pg 2 of 3
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| use blister packs with single use disposable applicators, which are thenpacked into a printed carton. | |
|---|---|
| Intended Use | K-Y® Brand Liquibeads® Vaginal Moisturizer is a personal lubricantfor over-the-counter use. for vaginal application, intended tomoisturize and lubricate, to enhance the ease and comfort of intimatesexual activity and supplement the body's natural lubrication. Thisproduct is compatible with natural rubber latex. polyisoprene, andpolyurethane condoms. The product is delivered by an applicator. |
| TechnologicalCharacteristics | The subject device. K-Y® Brand Liquibeads® Vaginal Moisturizer, andthe predicate device. K-Y® Brand Intrigue® have the same intendeduse but have different technological characteristics as the subjectdevice encapsulates the personal lubricant in an ovule. |
| BiocompatibilityReview & Testing | The subject device varies from the cleared device only in the fact thatit is encapsulated in a gelatin shell and is inserted into the vagina bymeans of a single-use, disposable applicator. At the concentrationspresent in the formula, all ingredients are considered safe for humanuse under the anticipated exposure conditions. In addition, all of theingredients have been used in legally marketed devices. The use ofthese ingredients in the subject device raises no new questions ofsafety or effectiveness. |
| Studies of vaginal and penile irritation in rabbits were conducted usingthe fill mass of the subject device. The results showed that the fillmass is non-irritating to genital tissue. | |
| Four additional biocompatibility studies were conducted on the subjectdevice. The test article evaluated in each study consisted of a mixtureof the Liquibeads® ovule and 0.9% sodium chloride. The endpointsevaluated 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 andthe applicable ISO 10093 Standard. From the results obtained, it canbe 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 safetyof the fill mass of subject device. The study showed the product didnot induce responses indicative of contact sensitization. |
| Results from an in-home consumer use test show that K-Y® BrandLiquibeads® Vaginal Moisturizer provides vaginal moisturization. | |
| Performance Data-Non Clinical | Condom compatibility testing demonstrates that K-Y® BrandLiquibeads® Vaginal Moisturizer is compatible with natural rubberlatex, polyisoprene, and polyurethane condoms. |
| Routine testing demonstrated that the product will remain stable forthe labeled shelf-life. | |
| Conclusion | The subject device, K-Y® Brand Liquibeads® Vaginal Moisturizer issubstantially equivalent to the predicate device, K-Y® Brand Intrigue®. |
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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
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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
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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)
§ 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.