K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.

Device Description

K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is a nonsterile, anhydrous, fragranced, glycol-in-silicone emulsion that provides a warming sensation upon contact with ambient moisture on the skin. It is composed of a combination of lubricants and emollients, an antioxidant, a gelling agent, a thickener, a film former, a stabilizer, a surfactant, and a fragrance. The emulsion is off-white to beige in color with a slight hint of vanilla and/or floral scent. It has a viscosity, specific gravity, and lubricity typical for emulsions of this type.

The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant. It's a regulatory approval, not a scientific study describing algorithm performance. Therefore, most of the requested information about acceptance criteria, study design, and ground truth for an AI/device performance study is not applicable.

However, I can extract information regarding the device's performance in the context of its regulatory approval.

Overview of the Device and its Changes:

The device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant, is a personal lubricant. It is a slightly modified version of a previously cleared device (K-Y® Brand Intrigue™ 2-in-1 Massage Creme™). The primary difference is the addition of a fragrance.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes compliance with established standards and satisfactory results from specific tests to demonstrate safety and effectiveness in the context of substantial equivalence to a predicate device.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Pass ISO 10993-5:2009 for Cytotoxicity	Results demonstrate that the device is biocompatible.
	Pass ISO 10993-10:2010 for Guinea Pig Maximization Sensitization	Results demonstrate that the device is biocompatible.
	Pass ISO 10993-10:2010 for Vaginal Irritation	Results demonstrate that the device is biocompatible.
	Pass ISO 10993-11:2006 for Acute Systemic Toxicity	Results demonstrate that the device is biocompatible.
Condom Compatibility	Meet ASTM D7661-10 integrity for condoms	Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms (mechanical and/or physical integrity affected).
Stability/Shelf-life	Support a two-year shelf-life	Satisfactory results to support a 2-year expiration date.
Substantial Equivalence	No new types of questions of safety or effectiveness compared to predicate; no change in intended use or fundamental scientific technology.	Concluded to be substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the biocompatibility, condom compatibility, or stability tests. These tests are typically conducted in a laboratory setting (prospective testing) but the document does not specify the country of origin for the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The evaluations (biocompatibility, condom compatibility, stability) are technical laboratory tests, not expert-driven assessments of a "ground truth" as might be found in diagnostic AI studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used for expert consensus in diagnostic studies, not for laboratory performance tests of a physical product.

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

No such study was conducted. This is a physical product (personal lubricant), not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is a physical product (personal lubricant), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on established scientific and regulatory standards for safety and performance:

Biocompatibility: Adherence to ISO 10993 series standards.
Condom Compatibility: Adherence to ASTM D7661-10.
Stability: Laboratory testing to demonstrate shelf-life.

8. The sample size for the training set

This information is not applicable. This is a physical product, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. This is a physical product, not an AI model that requires a training set and ground truth establishment for it.

Summary

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2015

Reckitt Benckiser Elizabeth Torre Regulatory Operations Lead Morris Corporate Center IV 399 Interpace Parkway Parsippany, NJ 07054

Re: K143511

Trade/Device Name: K-Y® Brand Touch® All-in-One Warming Caressing Crème and Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 21, 2015 Received: April 27, 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 mav 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

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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 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 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.

Joyce M. Whang -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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143511

Device Name

K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Submitted by:	Reckitt Benckiser LLCMorris Corporate Center IV399 Interpace ParkwayParsippany, NJ 07054Phone: (973) 404-2715
Contact Person:	Elizabeth Torre, MPHRegulatory Operations Lead,Reckitt Benckiser LLC
Date Prepared:	December 14, 2014
Proprietary Name(s):	K-Y® BRAND TOUCH® All-in-One WarmingCreme and Personal Lubricant
510(k) Number:	K143511
Classification Name:	Condom (21 CFR §884.5300); Class II
Product Code:	NUC (lubricant, personal)
Cleared Device/Predicate:	K081236K-Y® Brand Intrigue™ 2-in-1 Massage Creme™

Indication for Use:

Description of the Device:

The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.

Like the cleared device, the modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, will be marketed as a non-prescription medical device for over-the-counter (OTC) use.

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Technological Characteristics

The modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is substantially equivalent to the cleared device. The intended use is identical and the technical characteristics vary only slightly due to the addition of small amount of fragrance. Aside from the fragrance, all of the ingredients in the modified device are identical, and they are present at almost identical concentrations to those in the cleared device.

Performance Data:

Biocompatibility

K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant is varied slightly from the cleared predicate device; the only difference in the formula is the addition of a fragrance. All of the ingredients, except the fragrance, have been used in other 510k cleared marketed devices.

Biocompatibility evaluation of the K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant consisted of the following tests:

Cytotoxicity according to ISO 10993-5:2009
Guinea Pig Maximization Sensitization according to ISO 10993-10:2010
Vaginal Irritation according to ISO 10993-10:2010 ●
Acute Systemic Toxicity according to ISO 10993-11:2006

The results of these tests demonstrate that the K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant is biocompatible.

Condom Compatibility

Condom compatibility testing was conducted in accordance with ASTM D7661-10. Under current standards, the modified device may have an effect on the mechanical and/or physical integrity of natural rubber latex, synthetic polyisoprene and polyurethane condoms. Therefore, condom compatibility claims are not requested for this modified device.

Stability:

Shelf life testing was conducted on final devices to support the targeted two-year shelf-life. Based on satisfactory results of this testing, the product will be labeled with a 2 year expiration date.

Conclusion

Because the minor modifications (i.e., fragrance) to this cleared device do not raise new types of questions of safety or effectiveness, there is no change in intended use or fundamental scientific technology, and the results of additional technological characterization, biocompatibility testing, and performance testing are favorable, we conclude that the modified device, K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is substantially equivalent to our legally cleared predicate device, K-Y® Brand Intrigue™ 2-in-1 Massage Creme™.

Regulation Number and Section

§ 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.