Durex Silicone

K143532 · Reckitt Benckiser, LLC · NUC · Jul 31, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143532
• Device Name: Durex Silicone
• Applicant: Reckitt Benckiser, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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 Story

Durex Silicone is a non-sterile, anhydrous, 100% dimethicone personal lubricant; intended for OTC use to moisturize and lubricate during intimate sexual activity; enhances comfort; supplements natural lubrication; compatible with natural rubber latex, polyisoprene, and polyurethane condoms; packaged in 50mL HDPE pump bottle; applied topically by user; provides physical lubrication; benefits patient by reducing friction during sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (vaginal irritation/sensitization), and ISO 10993-11 (systemic toxicity) confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-toxic. Condom compatibility testing per ASTM D7661-10 confirmed compatibility with natural rubber latex, polyisoprene, and polyurethane condoms.

Technological Characteristics

Silicone-based lubricant; 100% Dimethicone; viscosity 80-110 cps at 25°C; non-sterile; HDPE pump bottle packaging; biocompatibility per ISO 10993; condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity; compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ONE® SILICONE Personal Lubricant (K110690)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| 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)

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#### 510(k) Summary

| Submitted by: | Reckitt Benckiser, LLC<br>Morris Corporate Center IV<br>399 Interpace Parkway<br>Parsippany, NJ 07054<br>973-404-2715<br>973-404-5702 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 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 Lubricant<br>ONE®<br>510(k) Document Control Number: K110690 |

#### Description of the Device:

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.

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) | Device<br>Name | Intended Use | Indications for Use | Manufacturer |
|---------|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| K110690 | ONE®<br>SILICONE<br>Personal<br>Lubricant | ONE® SILICONE<br>Personal Lubricant is<br>intended to moisturize<br>and lubricate, to<br>enhance the ease and<br>comfort of intimate<br>sexual activity and<br>supplement the body's<br>natural lubrication. | ONE® SILICONE<br>Personal Lubricant is a<br>personal lubricant, for<br>penile and/or vaginal<br>application, intended to<br>moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual<br>activity and supplement<br>the body's natural<br>lubrication. This product is<br>compatible with natural<br>rubber latex, polyisoprene,<br>and<br>polyurethane 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.