ONE PERSONAL LUBRICANT (SILICONE)

K110690 · One · NUC · Mar 28, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K110690
• Device Name: ONE PERSONAL LUBRICANT (SILICONE)
• Applicant: One
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 28, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

ONE® SILICONE 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

ONE® SILICONE Personal Lubricant is a non-sterile, clear, non-greasy, odorless liquid personal lubricant. Intended for OTC use to supplement natural lubrication and enhance comfort during sexual activity. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Packaged in plastic containers or foil wrappers. Device functions as a physical lubricant; no contraceptive or spermicidal properties. Benefits include reduced friction and increased comfort during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, and acute systemic toxicity; results showed no toxicity or sensitization. Vaginal irritation and systemic toxicity study in rabbits showed no macroscopic or microscopic evidence of toxicity. Condom compatibility tested per ASTM D7661-10 with natural rubber latex, polyisoprene, and polyurethane condoms; product confirmed compatible with all tested materials.

Technological Characteristics

Silicone fluid-based personal lubricant. Non-sterile. Packaged in plastic or foil. Biocompatibility per ISO 10993-1. Condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for penile and/or vaginal application to moisturize, lubricate, and enhance comfort during intimate sexual activity; supplements natural lubrication. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. No specific age or gender restrictions noted.

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 Brand Intrigue Personal Products Co. (K062796)

Submission Summary (Full Text)

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Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone)

#### II. 510(k) Summary

K110690

MAR 2 8 2012

| | 510(k) SUMMARY |
|--|----------------|
|--|----------------|

ONE® 12 Channel Street Boston, MA 02210

Contact Persons:

Submitted by:

Sharon Pietila Regulatory Affairs / Quality Assurance Manager Tel .: [phone] ext. 15 Fax: [phone] Email: [e-mail]

Davin Wedel President Tel .: [phone] ext. 14 Fax: [phone] Email: [e-mail]

ONE® SILICONE Personal Lubricant

Date Prepared:

March 19, 2012

Personal Lubricant

Propriety Name:

Proposed Trade Name:

Common Name:

Classification Name:

Predicate Device:

Device Description:

Condom Class II (21 CFR §884.5300) NUC

ONE® Personal Lubricant

K-Y Brand Intrigue Personal Products Co. 510(k) No. K062796

ONE® SILICONE Personal Lubricant is a non-sterile, personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless. liquid. This device is not a contraceptive nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.

Image /page/0/Picture/20 description: The image shows the word "ONE" in bold, white letters against a black rectangular background with rounded corners. The letters are large and fill most of the rectangle. The letter "E" is slightly stylized, with the horizontal bar in the middle being shorter than the top and bottom bars.

12 Channel Street Boston, MA 02210

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Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone) .

Intended Use:

Indications For Use:

ONE® SILICONE Personal Lubricant is an over-the-counter personal lubricant.

ONE® SILICONE 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.

## Technological Characteristics:

ONE® SILICONE Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device.

## Biocompatibility:

Biocompatibility testing was performed in accordance with ISO 10993-1.

| Testing Performed | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | Product is Non-toxic |
| ISO Guinea Pig Maximization Sensitization<br>Test | Product does not elicit a<br>sensitization response |
| Acute Systemic Toxicity | There is no evidence of system<br>toxicity |
| Vaginal Irritation and Systemic Toxicity Study<br>Following Repeated Exposure in Rabbits<br>(The study utilizes FDA recommended alternate<br>design that is a hybrid between ISO Vaginal<br>Irritation test and ISO Acute Systemic Toxicity) | Product produced no macroscopic or<br>microscopic evidence of systemic<br>toxicity and is considered a<br>nonirritant. |

## Condom Compatibility:

Compatibility Testing was performed in accordance with ASTM D7661-10, 'Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms' on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polyurethane condoms.

The results demonstrated that the condom compatibility testing of the silicone lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.

Image /page/1/Picture/13 description: The image shows the word "ONE" in bold, white letters against a black, rounded rectangle. The letters are large and fill most of the rectangle's space. The overall design is simple and modern, with a focus on readability and contrast.

12 Channel Street Boston, MA 02210

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# Abbreviated 510(k) Notification for ONE® Personal Lubricant (Silicone)

## Shelf-Life:

ONE® SILICONE Personal Lubricant has a one-year shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated both versions of packaging. The product met specifications.

A real-time aging study is being conducted to confirm results of the accelerated aging study.

Image /page/2/Picture/4 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif. The black background is a rounded rectangle, and there is a small black dot in the lower right corner of the image.

12 Channel Street Boston, MA 02210

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

### Public Health Service

MAR 2 8 2012

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

Ms. Sharon Pietila Regulatory Affairs / Quality Assurance Manager ONE 12 Channel Street BOSTON MA 02210

Re: K110690

Trade/Device Name: ONE® SILICONE Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 19, 2012 Received: March 20, 2012

Dear Ms. Pietila:

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

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Eicher

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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#### VII. Indications for Use Statement

## Indications for Use

| 510(k) Number: | |
|----------------|--|
|----------------|--|

K110690

Device Name:

ONE® SILICONE Personal Lubricant

Indications For Use:

ONE® SILICONE 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

## AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(Part 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)

2 Channel Street oston, MA 02210

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