AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING

K130345 · Mayer Laboratories, Inc. · NUC · Aug 1, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K130345
• Device Name: AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
• Applicant: Mayer Laboratories, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Aqua Lube Natural 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Aqua Lube Natural Personal Lubricant is a non-sterile, water-based lubricant; available in Regular and Warming models. Regular model contains organic aloe, hydroxyethylcellulose, sorbitol, and tocopherols (vitamin E); Warming model adds organic peppermint oil. Packaged in low-density polyethylene tubes with polypropylene caps. Used by consumers during intimate sexual activity to supplement natural lubrication. Enhances ease and comfort of sexual activity. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity) per ISO 10993 and condom compatibility per ASTM D7661-10. All tests met acceptance criteria.

Technological Characteristics

Water-based lubricant. Ingredients: organic aloe, hydroxyethylcellulose, sorbitol, tocopherols (vitamin E); Warming model includes organic peppermint oil. Packaging: low-density polyethylene tube, polypropylene cap. Condom compatibility tested per ASTM D7661-10. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with 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

• Glycerin & Paraben Free Astroglide® (K072647)

Submission Summary (Full Text)

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### 510(k) SUMMARY

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| Submitter | Mayer Laboratories, Inc.<br>1950 Addison Street, Suite 101<br>Berkeley, CA 94704-1182 USA | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|
| Contact Person | David P. Mayer, President<br>[phone] (telephone)<br>[phone] (fax)<br>[e-mail] (email) | AUG 1 2013 | |
| Date Prepared | July 26, 2013 | | |
| Proprietary Name | Aqua Lube® Natural Lubricants | | |
| Common Name | Personal Lubricant | | |
| Classification Name | Condom<br>Class II (21 CFR § 884.5300)<br>Product Code: NUC | | |
| Predicate Device | Glycerin & Paraben Free Astroglide® (K072647) | | |
| Description of Device | Aqua Lube® Natural Personal Lubricant is a non-sterile, water-<br>based, personal lubricant designed to supplement the body's own<br>natural lubrication fluids. Aqua Lube® Natural Personal Lubricant<br>consists of two models: "Regular" and "Warming." This product is<br>a clear, non-greasy, high-viscosity, liquid. This product is composed<br>primarily of organic aloe, hydroxyethycellulose, sorbitol, and<br>tocopherols (vitamin E). The Warming model contains the same<br>ingredients as the Regular model plus the additional ingredient<br>organic peppermint oil. Aqua Lube® Natural Personal Lubricant<br>causes a warming response. | | |
| | This product may be used with or without a condom during intimate<br>sexual activity. | | |
| | This product is packaged in a tube made of low density polyethylene<br>with a polypropylene cap. Tube sizes included 1 oz., 2.5 oz, and 4.0<br>oz. Each tube is packaged in a paperboard carton, which constitutes<br>the device's individual carton. | | |

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#### Intended Use

Aqua Lube Natural 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

#### Technological Characteristics

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

#### Product Safety

Biocompatibility testing was conducted on Aqua Lube® Natural Personal Lubricant per 1SO 10993 series, in compliance with Good Laboratory Practices (GLPs). The proposed devices were evaluated for their potential to cause cytotoxicity, irritation, sensitization, and acute systemic toxicity. The results of testing showed that the device meets acceptance requirements for all tests, as summarized in the following table:

| Testing Performed | Results |
|---------------------------------------|------------------------|
| Cytotoxicity | Non-cytotoxic |
| Rabbit Vaginal Irritation | Non-Irritating |
| Acute Systemic Toxicity | Non-systemically toxic |
| Sensitization Guinea Pig Maximization | Non-sensitizing |

#### Condom Compatibility

Studies on condom compatibility were conducted according to the ASTM D7661-10. Both models of Aqua Lube® Natural Personal Lubricant demonstrated they do not affect the mechanical or physical integrity of natural rubber latex and polyisoprene condoms. The studies did show both models did affect polyurethane condoms. Therefore, Aqua Lube® Natural Personal Lubricant is compatible with natural rubber latex condoms and polyisoprene condoms. Aqua Lube Natural Personal Lubricant is not compatible with polyurethane condoms.

#### Shelf Life Data

Real time stability data confirms a minimum shelf life of 24 months for the Aqua Lube® Natural Lubricants - Warming Model and 14 month stability for Aqua Lube® Natural Personal Lubricant - Regular Model.

#### Substantial Equivalence

Aqua Lube Natural Personal Lubricant and the predicate device have the same intended use. Both are water-based personal lubricants and they have comparable physical parameters. The Aqua Lube Natural Personal Lubricant is substantially equivalent to predicate device regarding safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/15 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human figures standing below the eagle.

Public Health Service

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

August 1, 2013

Maver Laboratories, Inc. % David P. Mayer President and CEO 1950 Addison Street, Suite 101 Berkeley, CA 94704-1182

Re: K130345

Trade/Device Name: Aqua Lube® Natural Personal Lubricant

Aqua Lube Natural Personal Lubricant has two variants

- l) Regular
2) Warming

Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 18, 2013 Received: June 28, 2013

Dear David P. 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.

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Page 2 - David P. Mayer

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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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 STATEMENT

| 510(k) Number | K130345 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Aqua Lube® Natural Personal Lubricant |
| | Aqua Lube Natural Personal Lubricant has two variants<br>1) Regular<br>2) Warming |
| Indications for Use | Aqua Lube® Natural Personal Lubricant is a personal<br>lubricant, for penile and/or vaginal application,<br>intended to moisturize and lubricate, to enhance the<br>ease and comfort of intimate sexual activity and<br>supplement the body's natural lubrication. This product<br>is compatible with natural rubber latex and<br>polyisoprene condoms. This product is not compatible<br>with 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 CDRH, Office of Device Evaluation (ODE)

## Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130345 510(k) Number_