AQUA LUBE

K110325 · Mayer Laboratories, Inc. · NUC · Dec 8, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K110325
• Device Name: AQUA LUBE
• Applicant: Mayer Laboratories, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Aqua Lube 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, polyisoprene, and polyurethane condoms.

Device Story

Aqua Lube is a non-sterile, water-based, clear, high-viscosity personal lubricant. Designed for penile and/or vaginal application to supplement natural lubrication and enhance comfort during intimate sexual activity. Used by consumers in home settings; compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Product does not affect mechanical or physical integrity of condoms. Benefits include increased ease and comfort during sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility and toxicity studies conducted per GLP standards demonstrated no cytotoxicity, irritation, sensitization, or systemic toxicity. Compatibility studies confirmed no degradation of natural rubber latex, polyisoprene, or polyurethane condoms.

Technological Characteristics

Water-based, non-sterile, high-viscosity liquid lubricant. Proprietary formulation consisting of water and water-soluble ingredients. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

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, 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

• K-Y® Personal Lubricant (K955648)
• ForPlay Personal Lubricant (K051688)

Submission Summary (Full Text)

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DEC - 8 2011

K110325
Pg. 1 of 2

ATTACHMENT 10-Re 510(k) Pre-Market Notification Aqua Lube® Personal Lubricant

## 510(k) SUMMARY

Mayer Laboratories, Inc. 1950 Addison Street, Suite 101 Berkeley, CA 94704-1182 USA

Contact Person

Submitter

『

David P. Mayer, President [phone] telephone fax [phone] [e-mail] email

Date Prepared

February 1, 2011

Aqua Lube® (TX 407)

Personal Lubricant

Proprietary Name

Common Name

Classification Name

Predicate Device

Description of Device

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

K-Y® Personal Lubricant (K955648) ForPlay Personal Lubricant (K051688)

Aqua Lube® is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. This product is a clear, non-greasy, high-viscosity, liquid. This product may be used with or without a condom during intimate sexual activity.

#### Indications For Use

Aqua Lube 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, polyisoprene, and polyurethane condoms.

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ATTACHMENT 10-Rev.

510(k) Pre-Market Notification
Aqua Lube® Personal Lubricant

### Technological Characteristics

The Aqua Lube formula is proprietary. The product however, has no exceptional technological characteristics. Aqua Lube Personal Lubricant consists mainly of water and water-soluble ingredients similar to other lubricants currently on the U.S. market and substantially equivalent to the predicate devices.

### Substantial Equivalence

Aqua Lube is substantially equivalent to predicate devices currently marketed in the United States, including K-Y Personal Lubricant and ForPlay Personal Lubricant. Aqua Lube and the predicate devices have the same intended use and have similar formulations. The safety of the ingredients and of the finished products based on laboratory studies is substantially equivalent.

#### Safety Testing

Biocompatibility and Toxicity studies on Aqua Lube Personal Lubricant were conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs). The proposed devices were evaluated, for their potential to cause cytotoxicity, irritation, sensitization, and systemic toxicity and the results of testing showed that this formula meets acceptance requirements for all tests. Additionally, studies on latex condom compatibility were conducted. According to the data, Aqua Lube does not affect the mechanical or physical integrity of natural rubber latex, polyisoprene, and polyurethane condoms. Therefore, Aqua Lube is safe to use with latex condoms and non-latex condoms.

#### Conclusion

Laboratory and safety testing conducted on Aqua Lube personal lubricant has provided scientific evidence that this product is safe for its intended use, and that it is substantially equivalent to predicate devices.

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DEC - 8 2011

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

Mr. David P. Maver President Mayer Laboratories, Inc. 1950 Addison Street. Suite 101 BERKELEY CA 94704

Re: K110325

Trade/Device Name: Aqua Lube® (TX-407) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 21, 2011 Received: November 23, 2011

Dear Mr. Mayer:

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 of medical device-related

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adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.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,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 11-Rev.1 510(k) Pre-Market Notification Aqua Lube® Personal Lubricant CONFIDENTIAL

# INDICATIONS FOR USE STATEMENT

510(k) Number

# KI10325

Device Name

Aqua Lube®

Indications for Use

Aqua Lube 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, polyisoprene and polyurethane condoms.

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

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

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

Julius Kanne

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110325