Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.

Device Description

Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).

AI/ML Overview

This document describes the review of Durex® RealFeel™ Pleasure Gel Personal Lubricant for 510(k) premarket notification. The review focuses on establishing substantial equivalence to a legally marketed predicate device, ONE® Silicone Lubricant (K110690).

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance
Intended Use	Same as predicate device (moisturize and lubricate for intimate sexual activity, supplement natural lubrication). Condom compatibility is the key differentiating factor.	Durex® RealFeel™ Pleasure Gel is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication.
Material Composition	Similar to predicate device (silicone-based).	Comprised of cyclopentasiloxane and dimethiconol; a blend of silicone fluid ingredients similar to ingredients found in the predicate device.
Physical Specifications	Not explicitly stated, but assumed to be acceptable (e.g., appearance, odor, viscosity, specific gravity).	"The specifications... include appearance, odor, viscosity, specific gravity..." (Specific values not provided in this document but implied to meet internal standards).
Microbiological Purity	Absence of pathogenic organisms; acceptable total aerobic microbial count, total yeast and mold count.	"total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans)." (Specific limits not provided but implied to meet internal standards).
Biocompatibility	Pass relevant ISO 10993-1 standards for cytotoxicity, systemic toxicity, sensitization, and irritation.	"The results demonstrate that the subject device is biocompatible." (Based on four studies: cytotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits).
Condom Compatibility	Must be compatible with polyurethane condoms.	Compatible with polyurethane condoms. Not compatible with natural rubber latex and polyisoprene condoms (This is a differentiating factor from the predicate but is acceptable as it's clearly stated in the indications for use).
Stability/Shelf-Life	Maintains specifications over stated shelf life.	"The results of accelerated and real time studies demonstrate that the subject lubricant maintains its specifications over the duration of its shelf life."

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

This document does not specify the exact sample sizes for each of the performance tests (biocompatibility, condom compatibility, stability). However, it states that:

Biocompatibility Studies: Four studies were conducted. The specific number of animals/samples for each endpoint (cytotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits) is not detailed.
Condom Compatibility Testing: The sample size for this testing is not provided.
Stability Studies: The sample size for the accelerated and real-time studies is not provided.

The data provenance is not explicitly stated in terms of country of origin but is implied to be from studies conducted by or for Reckitt Benckiser, LLC. These studies are retrospective to the submission date of November 18, 2014.

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

This information is not applicable as the evaluation is for a personal lubricant, not a diagnostic device requiring expert interpretation of medical images or data for ground truth establishment. The ground truth (or reference standard) for this device's performance is based on standardized testing methods and laboratory measurements, not expert consensus on medical conditions.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic accuracy, which is not the case here.

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 information is not applicable. This is a submission for a personal lubricant and does not involve AI, human readers, or diagnostic interpretation.

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

This information is not applicable. This is not an algorithmic or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Standardized Laboratory Testing and Measurement:
- Biocompatibility: Adherence to GLP requirements and applicable ISO 10993-1 standards for endpoints like cytotoxicity, systemic toxicity, sensitization, and irritation.
- Condom Compatibility: Testing conducted in accordance with ASTM D7661-2010.
- Physical and Microbiological Specifications: Internal quality control standards and established methods for appearance, odor, viscosity, specific gravity, microbial counts, and absence of specific pathogens.
- Stability: Laboratory assessment of product specifications over time under accelerated and real-time conditions.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

December 17, 2014

Reckitt Benckiser, LLC Shahper Rahman Regulatory Strategic Lead Morris Corporate Center IV 399 Interpace Parkway Parsippany, NJ 07054

Re: K131643

Trade/Device Name: Durex® RealFeel™ Pleasure Gel Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 18, 2014 Received: November 19, 2014

Dear Shahper Rahman,

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 device

{1}------------------------------------------------

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 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): K131643

Device Name: Durex ® RealFeel™ Pleasure Gel Personal Lubricant

Indications For Use:

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Reckitt Benckiser. The logo consists of a pink triangle with the letters "rb" inside, followed by the words "Reckitt Benckiser" in a dark gray sans-serif font. The words are stacked on top of each other, with "Reckitt" on top and "Benckiser" on the bottom.

510(k) Summary K131643

Submitted by:

Submitted by:	Reckitt Benckiser, LLCMorris Corporate Center IV399 Interpace ParkwayParsippany, NJ 07054973-404-2781
Contact Person:	Shahper Rahman, Regulatory Strategic Lead, Reckitt Benckiser, LLC
Date Prepared:	November 18, 2014
Proprietary Name:	Durex® Personal Lubricant-Silicone
Trade Name:	Durex® RealFeel™ Pleasure Gel Personal Lubricant
Common Name:	Personal Lubricant
Classification Name:	Condom (21CFR 884.5300)
Product Code:	NUC (lubricant, personal)
Predicate Devices:	ONE® Silicone LubricantOne510(k) Control Number: K110690

Description of Device:

Intended Use of the Device:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Reckitt Benckiser. The logo consists of a pink triangle with the letters "rb" in white inside of it. To the right of the triangle are the words "Reckitt Benckiser" in a dark gray sans-serif font, with "Reckitt" on the top line and "Benckiser" on the bottom line.

Comparison of Technological Characteristics with the Predicate Device

Intended Use Comparison

The table below shows the indication statements for the Durex® RealFeel™ Pleasure Gel and the predicate devices:

	Durex® RealFeel™ Pleasure Gel	ONE Silicone Lubricant
510(k) Number	K131643	K110690
Indication for Use	Durex® RealFeel™ Pleasure GelPersonal Lubricant is intended for penileand/or vaginal application and tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with polyurethane condoms.It is not compatible with naturalrubber latex and polyisoprenecondoms.	ONE Silicone Lubricant is an over thecounter personal lubricant for penile and/orvaginal application, intended to moisturizeand lubricate, to enhance the ease of comfortof intimate sexual activity and supplement thebody's natural lubrication. This product iscompatible with natural rubber latex,polyisoprene, and polyurethane condoms

The only difference in the intended use Durex® RealFeel™ Pleasure Gel in comparison to predicate device is condom compatibility. This difference does not represent a new intended use. Therefore, to the Durex® RealFeel™ Pleasure Gel and the predicate device have the same intended use.

Technological Characteristics:

The Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.

The Durex® Embrace Pleasure Gels and the predicate device have technological characteristics.

Performance Data:

The performance data provided in the 510(k) submission are summarized below.

Biocompatibility:

Four biocompatibility studies were conducted on the subject device. The endpoints evaluated included cvtotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits. Each study was conducted in accordance with GLP requirements and the applicable ISO 10993-1 standard. The results demonstrate that the subject device is biocompatible.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Reckitt Benckiser. The logo consists of a pink triangle with the letters "rb" in white inside of it. To the right of the triangle is the company name, "Reckitt Benckiser", in a dark gray sans-serif font.

Condom Compatibility:

The condom compatibility testing was conducted in accordance with ASTM D7661-2010. The results demonstrate that the Durex® RealFeel™ Pleasure Gel is compatible with polyurethane condoms but in not compatible with natural rubber latex and polyisoprene condoms.

Stability:

The results of accelerated and real time studies demonstrate that the subject lubricant maintains its specifications over the duration of its shelf life.

Conclusion:

Based on the results of biocompatibility testing and nonclinical performance testing, Durex® RealFeel™ Pleasure Gel is substantially equivalent to the predicate device.

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.