K-Y® Silicone is indicated for penile, vaginal and/or anal 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.

Device Description

K-Y® Silicone is a non-sterile, odorless, and anhydrous personal lubricant that provides personal lubrication during intimate sexual activity and is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This product is composed of 100% Dimethicone. The product is packaged in a 50mL (1.69 FL oz.) HDPE bottle with a polypropylene pump. K-Y @ Silicone is identical in formulation and specifications to the predicate device (Durex Silicone, K143532).

AI/ML Overview

The provided text describes the K-Y® Silicone personal lubricant, which claims to be substantially equivalent to the Durex Silicone (K143532) predicate device. The submission does not present a study proving the device meets acceptance criteria distinct from the predicate device; instead, it relies on the performance data of the predicate device due to their identical formulation and specifications.

Here's a breakdown of the requested information based on the provided text, recognizing that it primarily refers to the predicate device's data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the specifications for the K-Y® Silicone, which are stated to be identical to the predicate device.

Property	Acceptance Criteria	Reported Device Performance (based on predicate)
Color	Colorless	Colorless
Odor	Odorless	Odorless
Viscosity	80-110 cps	Falls within 80-110 cps
TAMC (EP 2.6.12 harmonized to USP <61>)	<10 cfu/g	<10 cfu/g
TYMC (EP 2.6.12 harmonized to USP <61>)	Absent	Absent
Absence of Pathogenic Organisms (Candida	Absent	Absent
albicans, Pseudomonas aeruginosa,
Staphylococcus aureus) (EP 2.6.13 harmonized
to USP <62>)
Biocompatibility: Cytotoxicity	Biocompatible	Biocompatible
Biocompatibility: Sensitization	Biocompatible	Biocompatible
Biocompatibility: Irritation	Biocompatible	Biocompatible
Biocompatibility: Systemic Toxicity	Biocompatible	Biocompatible
Condom Compatibility (Natural Rubber Latex)	Compatible	Compatible with natural rubber latex
Condom Compatibility (Polyisoprene)	Compatible	Compatible with polyisoprene
Condom Compatibility (Polyurethane)	Compatible	Compatible with polyurethane
Shelf-Life	24 months	24 months

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the testing described for the predicate device. The data provenance is described as "performance testing provided in the predicate submission for the Durex Silicone personal lubricant (K143532)." This implies the data is retrospective for the K-Y® Silicone application, as it's leveraging previously generated data. The country of origin for the data is not specified in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This device is a personal lubricant, and its performance (biocompatibility, condom compatibility, sterility, shelf-life) is evaluated through laboratory and material testing, not through expert review of diagnostic images or clinical assessments requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The testing described (biocompatibility, condom compatibility, analytical chemistry, microbiology, stability) are objective laboratory tests that do not involve subjective expert 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

Not applicable. This product is a physical device (personal lubricant), not an AI-powered diagnostic or assistive technology for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the predicate device's testing, the ground truth was established through:

Laboratory test results: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), viscosity, color, odor, and microbiological assays (TAMC, TYMC, absence of pathogens).
Standardized test methods: For condom compatibility (ASTM method D7661-10).
Stability studies: For shelf-life (accelerated and real-time stability studies against device specifications).

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning model that requires a training set. The term "training set" doesn't apply in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a personal lubricant device.

Summary

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January 12, 2018

Reckitt Benckiser LLC Elizabeth Viguerie, MPH Sr. Regulatory Associate 399 Interpace Parkway Parsippany, NJ 07054

Re: K173504

Trade/Device Name: K-Y® Silicone Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 10, 2017 Received: November 13, 2017

Dear Elizabeth Viguerie:

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. Iisting 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.

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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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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510(k) Summary - K173504

Submitted by:	Reckitt Benckiser, LLCMorris Corporate Center IV399 Interpace ParkwayParsippany, NJ 07054-0224973-404-2715973-404-5702
Contact Person:	Elizabeth Viguerie, MPH, Senior Regulatory Associate, Reckitt Benckiser, LLC
Date Prepared:	January 11, 2018
Proprietary Name:	K-Y® Silicone
Trade Name:	K-Y® Silicone
Common Name:	Personal Lubricant
Classification Name:	Condom (21 CFR §884.5300)
Product Code:	NUC (lubricant, personal)
Regulatory Class:	II
Predicate Device(s):	Durex Silicone (K143532)

The predicate device has not been subject to a design-related recall.

Description of the Device:

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Property	Specification
Color	Colorless
Odor	Odorless
Viscosity	80-110 cps
TAMC (EP 2.6.12harmonized to USP <61>)	<10 cfu/g
TYMC (EP 2.6.12harmonized to USP <61>)	Absent
Absence of PathogenicOrganisms (Candidaalbicans, Pseudomonasaeruginosa, Staphylococcusaureus) (EP 2.6.13harmonized to USP <62>)	Absent

Specifications for the K-Y® Silicone personal lubricant are shown in the table below:

Indication for Use:

Predicate Device Comparison:

Intended Use:

The indications for use for the subject and predicate devices are shown in the table below:

K-Y® Silicone	Durex Silicone
K173504	K143532
K-Y® Silicone is indicated for penile,	Durex Silicone is indicated for penile and/or
vaginal and/or anal application, intended	vaginal application, intended to moisturize and
to moisturize and lubricate, to enhance the	lubricate, to enhance the ease and comfort of
ease and comfort of intimate sexual	intimate sexual activity and supplement the
activity and supplement the body's natural	body's natural lubrication. This product is
lubrication. This product is compatible	compatible with natural rubber latex,
with natural rubber latex, polyisoprene,	polyisoprene, and polyurethane condoms.
and polyurethane condoms.

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The subject and predicate device have similar indications for use. However, the indication for the subject device has been expanded from the current penile and vaginal use to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity.

Additionally, FDA has cleared otherpersonal lubricants with comparable indications including penile, vaginal, and anal use.

Technological Characteristics:

The technological characteristics of the K-Y@ Silicone personal lubricant are identical to the predicate device as both devices are made from the same material, have the same packaging, and have the same specifications.

Summary of Performance Data

This submission relies on the performance testing provided in the predicate submission for the Durex Silicone personal lubricant (K143532) as the subject device is identical to the predicate device. Data from the predicate submission used to support the subject device is summarized below:

Biocompatibility: Testing was conducted in accordance with ISO 10993-1:2009. The following endpoints were assessed in the testing conducted:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010) ●
. Irritation (ISO 10993-10:2010)
Systemic Toxicity (ISO 10993-11:2011 ●

The results of this testing demonstrated that the subject lubricant is biocompatible.

Condom Compatibility: Testing was done in accordance with ASTM method D7661-10 on condoms made of natural rubber latex. polyisoprene, and polyurethane. The results of testing showed compatibility of the lubricant with natural rubber latex, polyisoprene, and polyurethane condoms.

Shelf-Life: K-Y@ Silicone is a non-sterile personal lubricant with a 24 month shelf-life based on the results of accelerated a and real-time stability studies. Testing showed that devices were able to meet the device specifications shown in the Device Description section of this summary over the 24-month shelflife period.

Conclusion

As K-Y® Silicone is identical to the predicate Durex Silicone personal lubricant, the performance data described above demonstrates that the K-Y® Silicone personal lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.