Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Device Description

Durex Embrace Pleasure Gels are clear odorless slightly viscous liquids that are packaged together and consist of two different formulation is water-based with multisensate (Tingling Experience Gel) and the female formulation (Warming Sensation Gel) is Vanillyl Butyl Ether in Glycerine base. The female lubricant (Pink Bottle) offers a warming experience, and one for the male partner (Purple bottle) offers a tingling experience. Devices are supplied in 60 ml PETG pump bottles. Both lubricant bottles are covered with a shrink sleeve including graphics that also provides tamper evident protection. Bottles are then placed in clear trays, which are then shrink-wrapped and placed in printed cartons.

AI/ML Overview

The provided text describes the submission for a 510(k) premarket notification for Durex Embrace Pleasure Gels, seeking substantial equivalence to a predicate device (KY Yours + Mine). It outlines performance testing, but it is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

The document is for a personal lubricant, not an AI/ML device, and therefore does not have acceptance criteria or studies related to AI/ML performance metrics (like sensitivity, specificity, F1-score, AUC, etc.).

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its safety and performance based on the provided document.

Here's an interpretation of the request in the context of this non-AI medical device submission:

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

The document lists "Specifications" for which "acceptance specifications" have been developed, but it does not explicitly state the numerical acceptance criteria or the specific reported device performance values for each specification. It only states that "testing on samples collected up to 12 months of aging... showed that devices met their acceptance criteria" and that test results "demonstrated device materials to be biocompatible" and "non-irritating" or "did not elicit sensitization reactions."

Specification	Acceptance Criteria (Not explicitly stated numerically in this document)	Reported Device Performance (Summary)
Appearance	(Implied: clear, odorless, slightly viscous liquids)	"clear odorless slightly viscous liquids" (Description of Device section)
Odor	(Implied: odorless)	"clear odorless slightly viscous liquids" (Description of Device section)
pH @ 25 degree C	(Implied: within a specified range)	Not detailed, but document states Durex Embrace Pleasure Gels are "substantially equivalent to the predicate device KY Yours + Mine in terms of technological characteristics such as... pH" and "met their acceptance criteria" during stability testing.
Total Aerobic Microbial Count	(Implied: Below a specified threshold)	Not detailed, but implied to have met acceptance criteria during stability testing.
Total Yeast and Mold Count	(Implied: Below a specified threshold)	Not detailed, but implied to have met acceptance criteria during stability testing.
Lack of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans)	(Implied: Absence of these organisms)	Not detailed, but implied to have met acceptance criteria during stability testing.
Preservative Effectiveness	(Implied: Meets specified criteria, e.g., USP <51>)	Not detailed, but implied to have met acceptance criteria during stability testing.
Viscosity-RV4, 10rpm at 25 degree C	(Implied: Within a specified range)	Not detailed, but implied to have met acceptance criteria during stability testing.
Osmolality	(Implied: Within a specified range, e.g., WHO guidelines for lubricants)	Not detailed, but implied to have met acceptance criteria during stability testing.
Biocompatibility (Acute Systemic Toxicity)	No biological reactivity at tested time points for test group animals.	All test group animals survived the test period and none exhibited any biological reactivity (for Tingling Experience Gel, Warming Sensation Gel, and 1:1 mixture) at any tested time points.
Biocompatibility (Vaginal Irritation)	Considered non-irritating.	Durex Embrace Pleasure Gel, Warming Sensation Gel, is considered non-irritating.
Biocompatibility (Penile Irritation)	Considered non-irritating.	Durex Embrace Pleasure Gel, Tingling Experience Gel, is considered non-irritating.
Biocompatibility (Cytotoxicity)	Non-cytotoxic, or if cytotoxic, mitigated by other in vivo biocompatibility results.	Cytotoxicity results for Warming Sensation Gel (alone and in combination) may have the potential to produce a biological response. However, other in vivo biocompatibility results were non-irritant, and the overall profile does not indicate a significant risk.
Biocompatibility (Sensitization)	Did not elicit sensitization reactions.	Durex Embrace Pleasure Gels did not elicit sensitization reactions in study animals (for Tingling Experience Gel, Warming Sensation Gel, and 1:1 mixture).
Condom Compatibility (Natural Rubber Latex, Synthetic Polyisoprene, and Polyurethane Condoms)	Does not affect the mechanical and physical integrity of the condoms as per ASTM D7661-10.	Both formulations demonstrated they do not affect the mechanical and physical integrity of natural rubber latex, synthetic polyisoprene and polyurethane condoms.
Stability/Shelf Life (up to 12 months)	Maintain all specifications/acceptance criteria (Appearance, Odor, pH, Microbial Counts, Pathogens, Preservative Effectiveness, Viscosity, Osmolality) for the target shelf life.	Testing on samples collected up to 12 months of aging (real-time and accelerated) showed that devices met their acceptance criteria.

Regarding AI/ML specific information, this document does not contain any of the following because it is not an AI/ML device:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
Multi reader multi case (MRMC) comparative effectiveness study
Standalone (i.e. algorithm only without human-in-the-loop performance) study
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for test set
Sample size for the training set
How the ground truth for the training set was established

Detailed information from the document (non-AI related):

2. Sample sizes used for the test set and data provenance:

Acute Systemic Toxicity: "test group animals" (number not specified). Data provenance: Not specified, but likely conducted in a laboratory setting as per GLP requirements.
Vaginal Irritation Testing: Not specified, but involved "rabbits" and assessed the Warming Sensation Gel.
Penile Irritation Study: Not specified, but involved "rabbits" and assessed the Tingling Experience Gel.
Cytotoxicity: Not specified, but tested using "tissue culture agar diffusion test."
Sensitization: "study animals" (number not specified). Involved "Guinea Pig Maximization test."
Condom Compatibility: Not specified for number of condoms or samples. Testing was "conducted in accordance with ASTM D7661-10."
Stability: "samples collected up to 12 months of aging (real-time and accelerated at 40 C-75%RH)" (number of samples not specified).
Data Provenance: Not explicitly stated, but all studies were conducted in accordance with GLP requirements and applicable ISO 10993 standards or ASTM D7661-10, implying controlled laboratory conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a physical/chemical/biological performance study, not an AI/ML ground truth establishment. The "ground truth" is determined by standardized test methods and observations/measurements.

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

Not applicable for this type of performance study. Results are based on direct observation, measurement, or established biological outcomes according to standard protocols.

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 as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device. The performance tests are for the product itself (lubricant).

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

The "ground truth" for these studies is based on observable biological reactions (e.g., irritation, sensitization, systemic toxicity), physical/chemical properties (e.g., pH, viscosity), and mechanical integrity (condom compatibility), as defined by established international standards (ISO 10993, ASTM D7661).

8. The sample size for the training set:

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary

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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

November 4, 2014

Reckitt Benckiser, LLC Sapana Amin Regulatory Operations Lead 399 Interpace Parkway Parsippany, NJ 07030

Re: K140193

Trade/Device Name: Durex Embrace Pleasure Gels (Warming Sensation Gel and Tingling Experience Gel) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: October 3. 2014 Received: October 8, 2014

Dear Sapana Amin,

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

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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,

Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in black text. The text is arranged in two lines, with "Herbert P." on the first line and "Lerner -S" on the second line. To the left of the name is a faded gray logo that appears to be the FDA logo.

for

Benjamin 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

510(k) Number (if known) K140193

Device Name

Durex Embrace Pleasure Gels (Warming Sensation Gel and Tingling Experience Gel)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Residential Use (Call 877-931-9212 to Select)	Owner-Tier Construction (Call 877-931-9212 to Select)
--------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------

| | 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.

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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" in white inside of it. To the right of the triangle is the company name, "Reckitt Benckiser", in a dark gray sans-serif font.

510(k) Summary K140193

Submitted by:	Reckitt Benckiser LLCMorris Corporate Center IV399 Interpace ParkwayParsippany, NJ 07054Phone: 973-404-2687Fax: 973-404-5702
Contact Person:	Sapana Amin, Regulatory Affairs Operations Lead, Reckitt Benckiser LLC
Date Prepared:	October 23rd, 2014
Proprietary Name:	Durex Personal Lubricant
Trade Name:	Durex Embrace Pleasure Gels:Warming Sensation GelTingling Experience Gel
Common Name:	Personal Lubricant
Classification Name:	Condom (21 CFR §884.5300)
Product Code:	NUC (lubricant, personal)
Predicate Device(s):	KY Yours + MineJ&J Healthcare Products, Division of McNeil-PPC Inc.510(k) Document Control Number: K072421

Indication for Use:

Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Both lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

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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, followed by the words "Reckitt Benckiser" in gray. The words are stacked on top of each other, with "Reckitt" on top and "Benckiser" on the bottom.

Description of the Device:

Devices are supplied in 60 ml PETG pump bottles. Both lubricant bottles are covered with a shrink sleeve including graphics that also provides tamper evident protection. Bottles are then placed in clear trays, which are then shrink-wrapped and placed in printed cartons.

The table below lists parameters for which acceptance specifications for the devices have been developed:

Specifications
Appearance
Odor
pH@ 25 degree C
Total Aerobic Microbial
Count
Total Yeast and Mold Count
Lack of Pathogenic
Organisms (Pseudomonas
aeruginosa, Staphylococcus
aureus, Candida albicans)
Preservative Effectiveness
Viscosity-RV4, 10rpm at 25
degree C
Osmolality

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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" inside it on the left side. To the right of the triangle is the text "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 Embrace Pleasure Gels and the KY Yours + Mine (K072421) predicate device:

	Durex Embrace Pleasure Gels	KY Yours + Mine
510(k) Number	K140193	K072421
Indication for Use	Durex Embrace Lubricantswhich are packaged together areintended for penile and/orvaginal application, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. Both lubricants arecompatible with natural rubberlatex, synthetic polyisoprene andpolyurethane condoms.	KY Yours + Mine is intended asa personal lubricant for penileand vaginal applicationcompatible with latex condoms

The indications of use statement for the KY Yours + Mine is cleared for use for application to the vaginal or penile area or a condom in order to enhance comfort ease and pleasure of intimate activity. The only difference in the intended use of KY Yours + Mine in comparison to Durex Embrace Pleasure Gels is condom compatibility. KY Yours + Mine is compatible only with natural rubber latex condoms, while the Durex Embrace Pleasure Gels are compatibile with natural rubber latex, synthetic polyisoprene and polyurethane condoms. This difference does not represent a new intended use. Therefore, both devices can be considered to have the same Intended Use.

Technological Characteristics:

Durex Embrace Pleasure Gels are substantially equivalent to the predicate device KY Yours + Mine in terms of technological characteristics such as being non-sterile, color/appearance/odor, pH and for over the counter use. Durex Embrace Pleasure Gels contain similar formulation components.

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Image /page/6/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 gray text.

The subject device Durex Embrace Pleasure Gels are substantially equivalent to the predicate device. The concept of using two lubricants together or separately is similar to the predicate KY Yours + Mine. The predicate device and Durex Embrace Pleasure Gels are couples lubricants including two different intimate lubricants; the first lubricant designed to offer a tingling experience, and the second lubricant is designed to offer a warming sensation. In addition, when the two lubricants are mixed together, they are designed to create extra sensation. Provided below is a table of similiarities of Durex Embrace Pleasure Gels and KY Yours & Mine:

	Durex Embrace Pleasure Gels	KY Yours + Mine
Number of Lubricants	Two- (Tingling Experience Gel &Warming Sensation Gel)	Two- (Tingling sensation for her &Warming sensation for him)
Formulation of lubricants	Tingling/cooling sensation fromMultisensate (water-based)Warming sensation from glycerinebased lubricant (glycerin-based)	Tingling/cooling sensation fromMethyl salicylate and Menthyllactate (water-based)Warming sensation from glycerinebased lubricant (glycerine-based)
Condom Compatibility	Condom Compatible with naturalrubber latex, synthetic polyisopreneand polyurethane condoms	Condom compatible with Latexcondoms
Over the Counter Use	Yes	Yes
Biocompatible	Yes	Yes
Provided Sterile	No	No

There is no difference in the fundamental technological characteristics of Durex Embrace Pleasure Gels and the predicate KY Yours + Mine. The proposed lubricants are substantially equivalent to the predicate KY Yours + Mine cleared under 510(k) K072421.

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Image /page/7/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 gray text.

Performance Data:

Biocompatibility:

Studies of vaginal and penile irritation in rabbits were conducted and the results showed that the product is non-irritating to genital tissue. Three additional biocompatibility studies were conducted on the subject device. The endpoints evaluated included cytotoxicity, systemic toxicity in mice, and maximization sensitization in guinea pigs. Each study was conducted in accordance with GLP requirements and the applicable ISO 10993 Standard. The results of testing demonstrated device materials to be biocompatible.

The following tests were conducted to evaluate the safety of Durex Embrace Pleasure Gels:

Acute Systemic Toxicity: The test evaluated the systemic response in mice after injection of the subject lubricants, Tingling Experience Gel and Warming Sensation Gel at a dose rate equivalent to 100 ml in a 70 kg human. The test was conducted in accordance with ISO 10993-11:2010. Testing was conducted separately for each of the lubricants as well as in a 1:1 mixture. All test group animals survived the test period and none of the test group animals exhibited any biological reactivity at any of the tested time points.

Vaginal Irritation Testing: The potential of the subject lubricant, Warming Sensation Gel, to produce irritation of the vaginal mucosal tissue was assessed. The testing was conducted on neat (undiluted lubricant and in accordance with ISO 10993-10:2010. The vaginal irritation test was only conducted on the Warming Sensation Gel based on its intended use. Results of the testing indicate that Durex Embrace Pleasure Gel, Warming Sensation Gel, is considered non-irritating.

Penile Irritation Study: The potential of the subject lubricant, Tingling Experience Gel, to produce irritation of the penile mucosal tissue was assessed. The testing was conducted on rabbits in which the test material was applied neat and in accordance with ISO 10993-10:2010. The Penile Irritation test was only conducted on the Tingling Experience Gel based on its intended use. Results of the testing indicate that Durex Embrace Pleasure Gel, Tingling Experience Gel, is considered non-irritating.

Cytotoxicity: The cytotoxicity potential of the Durex Embrace Pleasure Gels was tested using a tissue culture agar diffusion test in accordance with ISO 10993-5:2009. The cytotoxicity results for Warming Sensation Gel both alone and in combination with Tingling Experience Gel may have the potential to produce a biological response. The results of other in vivo biocompatibility tesults were shown to be non-irritant and the overall profile of the lubricant does not indicate a significant risk to the safety of consumers.

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Image /page/8/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.

Sensitization: The ISO Guinea Pig Maximization test was performed on neat (undiluted) Tingling Experience Gel and Warming Sensation Gel to determine to what extent the subject lubricant has the potential to act as a contact sensitizer. Testing was conducted separately for each of the lubricants as well as in a 1:1 mixture. The test was conducted in accordance with ISO 10993-10: 2010. The results of this study indicate that the Durex Embrace Pleasure Gels did not elicit sensitization reactions in study animals.

Condom Compatibility:

Condom compatibility testing was conducted in accordance with ASTM D7661-10. Both formulations of Durex Embrace Pleasure Gels demonstrated they do not affect the mechanical and physical integrity of natural rubber latex, synthetic polyisoprene and polyurethane condoms. Therefore, Durex Embrace Pleasure Gels are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Stability:

Shelf life testing was conducted on final devices to support the targeted two-year shelf-life. Testing assessed the parameters outlined in the table included in the Device Description section of this summary. Testing on samples collected up to 12 months of aging (real-time and accelerated at 40 C-75%RH) showed that devices met their acceptance criteria.

Conclusion

Durex Embrace Pleasure Gels have the same intended use and basic technological characteristics as the predicate device. In addition, results from performance testing shows that Durex Embrace Pleasure Gels performance 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.