LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT

K122477 · Ansell Healthcare Products, LLC · NUC · Feb 19, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K122477
• Device Name: LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
• Applicant: Ansell Healthcare Products, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

LifeStyles® Luxe™ Premium Personal Lubricant is a personal lubricant, 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, polyurethane, and polyisoprene condoms.

Device Story

LifeStyles® Luxe™ Premium Personal Lubricant is a silicone-based, non-sterile gel-like liquid. It is applied topically to the penis or vagina to provide lubrication and moisture during intimate sexual activity. The device is intended for over-the-counter use by consumers. It is packaged in a plastic pump dispenser. The lubricant is formulated to be compatible with natural rubber latex, polyurethane, and polyisoprene condoms. By supplementing natural lubrication, the device enhances ease and comfort during sexual activity. It is designed to last longer than hydrous lubricants without drying out or becoming sticky.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, vaginal irritation, sensitization, systemic toxicity per ISO 10993), condom compatibility (ASTM D7661), microbial quality (USP <61>, <62>), and physical property characterization (viscosity, specific gravity, appearance, odor). Real-time and accelerated aging tests support a 3-year shelf life.

Technological Characteristics

Silicone-based gel lubricant. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7661. Microbial quality per USP <61> and USP <62>. Packaged in plastic pump dispenser. No electronic or software components.

Indications for Use

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

• Vielle™ Lubricant (K051288)

Submission Summary (Full Text)

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Traditional 510(k) Summary

# 510(k) SUMMARY

Applicant:

Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, AL 36303 USA Phone: [phone] Fax: [phone]

Contact Person:

January 19, 2013

Date Prepared:

510K:

K122477

LifeStyles® Luxe™ Premium Personal Lubricant Proprietary Name:

Personal Lubricant Common Name:

Classification Name: Lubricant, patient, vaginal, latex compatible (Class II, 21 CFR 884.5300, Product Code NUC)

Robert Mahler, Regulatory Affairs Director, Americas

Predicate Device: Vielle™ Lubricant (K051288)

#### Device Description:

LifeStyles® Luxe™ Premium Personal Lubricant is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a biocompatible gel-like liquid that lasts longer than hydrous lubricants, without drying out or becoming sticky, and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.

#### Indications for Use:

LifeStyles® Luxe™ Premium Personal Lubricant is a personal lubricant. 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, polyurethane, and polyisoprene condoms.

#### Technological Characteristics:

LifeStyles® Luxe™ Premium Personal Lubricant contains a similar blend of silicone oils as the predicate device. Testing per ASTM D7661 indicated that the lubricant formulation is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. As with the predicate, testing for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity in accordance with ISO 10993 indicated device biocompatibility. Bench testing indicated that the lubricant lasts longer than hydrous lubricants, without drying out or becoming sticky, and that it has an appropriate viscosity, specific gravity, appearance, color and odor for substantial equivalence to the predicate. Microbial limits testing was conducted per USP <61> and USP <62> indicated microbial quality. Realtime and accelerated aging tests indicate a 3 year shelf-life for the lubricant.

### Summary:

LifeStyles® Luxe™ Premium Personal Lubricant has the same intended use and basic technological characteristics as the predicate device. This lubricant is substantially equivalent to its proposed predicate device.

J

Rg.1c

FEB 1 9 2013

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

February 19, 2013

Ansell Healthcare Products, LLC % Ms. Donna Di Gangi Principal Consultant DiGangi Consulting 4 Los Verdes Drive SAN LUIS OBISPO CA 93401

Re: K122477

Trade/Device Name: LifeStyles® Luxe™ Premium Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 29, 2013 Received: February 4, 2013

Dear Ms. Di Gangi:

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.

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Page 2 -- Ms. Donna Di Gangi

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R Fisher -S

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): K122477

Device Name: LifeStyles® Luxe™ Premium Personal Lubricant

Indications for Use: LifeStyles® Luxe™ Premium Personal Lubricant is a personal lubricant, 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, polyurethane, and polyisoprene condoms.

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

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

# Benjamin R. Fisher -S 2013.02.19 18:17:55 -05'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122477 510(k) Number

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