Durex Silicone is indicated for perile 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Description

Durex Silicone is a Personal Lubricant Device that is a non-sterile, odorless, anhydrous, silicone formulation that provides personal lubrication during intimate sexual activity. It is made up of 100% Dimethicone. The ingredient is clear (same as water) in appearance. The Viscosity at 25°C is 80-110 cps. The device will be made available in a 1.69 FL oz. (50mL) HDPE pump sealed bottle with an outer carton. The final dimensions of the carton are 138mmx74mmx28mm.

AI/ML Overview

This document is a 510(k) Premarket Notification for Durex Silicone, a personal lubricant. It does not describe a study involving an AI medical device or other complex diagnostic or therapeutic device. Therefore, many of the requested categories for acceptance criteria and study details are not applicable.

However, I can extract the relevant information regarding the performance data and the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from referenced standards)	Reported Device Performance (Durex Silicone)
Biocompatibility:
Non-cytotoxic (ISO 10993-5:2009)	Non-cytotoxic
Non-irritating to the vaginal area (ISO 10993-10:2010)	Non-irritating to the vaginal area
Not systemically toxic (ISO 10993-11:2010)	Not systemically toxic
Non-sensitizing (ISO 10993-10:2010)	Non-sensitizing
Condom Compatibility:
Compatible with natural rubber latex condoms (ASTM D7661-10)	Compatible with natural rubber latex condoms
Compatible with polyisoprene condoms (ASTM D7661-10)	Compatible with polyisoprene condoms
Compatible with polyurethane condoms (ASTM D7661-10)	Compatible with polyurethane condoms
Shelf Life:
24-month shelf life	Maintained specifications for 12 months in accelerated testing, supporting a 24-month shelf life.
Physical Appearance:
Clear, odorless, anhydrous, silicone formulation	Clear, odorless, silicone formulation (100% Dimethicone)
Viscosity at 25°C: 80-110 cps	Viscosity at 25°C: 80-110 cps

2. Sample size used for the test set and the data provenance

Biocompatibility (Cytotoxicity, Irritation, Systemic Toxicity, Sensitization): The document does not specify the sample sizes (e.g., number of cell cultures, animals) used for these tests. The provenance of the data is implicit as part of a regulatory submission to the FDA by the manufacturer, Reckitt Benckiser LLC. These are likely prospective laboratory and in-vivo animal studies conducted according to the cited ISO standards.
Condom Compatibility: The testing was done using ASTM method D7661-10 with "three marketed brands of Natural Rubber Latex condoms, one brand of polyisoprene condom, and one brand of polyurethane condoms." The specific number of condoms and lubricants tested per brand is not specified.

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

Not applicable. This device is a personal lubricant, and the 'ground truth' is established through standardized laboratory and animal testing for biocompatibility and material compatibility, not through expert clinical interpretation of medical images or patient data.

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

Not applicable. The tests performed are laboratory-based and follow standardized protocols, not human-read 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 is not an AI-enabled device.

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

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

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

The "ground truth" used for this device's performance evaluation is based on standardized testing protocols and methodologies defined by international (ISO) and national (ASTM) standards.
- For biocompatibility: Cellular response to extract, physiological reactions in animal models.
- For condom compatibility: Physical and chemical interaction with condom materials as measured by ASTM D7661-10.
- For shelf life: Stability of physical/chemical properties over time.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.

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

Not applicable. There is no "training set" for this device.

Summary

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

July 31, 2015

Reckitt Benckiser LLC Elizabeth Torre Regulatory Operations Lead 399 Interpace Parkway Parsippany, NJ 07054

Re: K143532 Trade/Device Name: Durex Silicone Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 9, 2015 Received: June 17, 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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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Indications for Use

510(k) Number (if known) K143532

Device Name Durex Silicone

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitted by:	Reckitt Benckiser, LLCMorris Corporate Center IV399 Interpace ParkwayParsippany, NJ 07054973-404-2715973-404-5702
Contact Person:	Elizabeth Torre, MPH, Regulatory Operations Lead, Reckitt Benckiser, LLC
Date Prepared:	December 8th, 2014
Proprietary Name:	Durex Silicone
Trade Name:	Durex Silicone
Common Name:	Personal Lubricant
Classification Name:	Lubricant (21 CFR §884.5300, Product Code NUC)
Predicate Device(s):	ONE® SILICONE Personal LubricantONE®510(k) Document Control Number: K110690

Description of the Device:

Intended Use of the Device: The intended use of this device is an OTC personal lubricant (for vaginal and penile application).

Indications of Use Statement: Durex Silicone is indicated 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Characteristics: Durex Silicone is a silicone based clear, odourless and colorless personal lubricant. The lubricant contains 100% Dimethicone. This ingredient is similar to the ingredients found in the predicate device.

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510(k)	DeviceName	Intended Use	Indications for Use	Manufacturer
K110690	ONE®SILICONEPersonalLubricant	ONE® SILICONEPersonal Lubricant isintended to moisturizeand lubricate, toenhance the ease andcomfort of intimatesexual activity andsupplement the body'snatural lubrication.	ONE® SILICONEPersonal Lubricant is apersonal lubricant, forpenile and/or vaginalapplication, intended tomoisturize andlubricate, to enhance theease and comfort ofintimate sexualactivity and supplementthe body's naturallubrication. This product iscompatible with naturalrubber latex, polyisoprene,andpolyurethane condoms.	ONE®

Table: Identification of Legally Marketed (Equivalence) Devices

Stability: Durex Silicone is shown to have a 24 month shelf life based on 12 month accelerated and real-time stability data. The device maintained its specifications during accelerated testing for up to 12 months.

Summary of Performance Data: The functional testing of Durex Silicone was conducted according to ISO 10993-1 for biocompatibility and ASTM D7661-10 for condom compatibility. Like the predicate device, this lubricant was tested per the above-mentioned standards, and was demonstrated to be biocompatible and compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Cytotoxicity: Durex Silicone was demonstrated to be non-cytotoxic per ISO 10993-5:2009.

ISO Vaginal Irritation and Systemic Toxicity: Durex Silicone was shown to be non-irritating to the vaginal area and not systemically toxic in a combined test based upon ISO 10993-10:2010 and ISO 10993-11:2010.

ISO Maximization Sensitization: Durex Silicone was shown to be non-sensitizing per ISO 10993-10:2010

Condom Compatibility: Durex Silicone has been demonstrated to be compatible with natural rubber latex, polyisoprene and polyurethane condoms. Testing was done using ASTM method D7661-10 using condoms on three marketed brands of Natural Rubber Latex condoms, one brand of polyisoprene condom, and one brand of polyurethane condoms.

Conclusion: The results of the testing discussed above demonstrate that the device is as safe, as effective, and performs as well the predicate device. Therefore, Durex Silicone 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.