ONE PERSONAL LUBRICANT (WATER BASED)

K110691 · One · NUC · Feb 1, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K110691
• Device Name: ONE PERSONAL LUBRICANT (WATER BASED)
• Applicant: One
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 1, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

ONE® Oasis 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® Oasis is a non-sterile, aqueous-based personal lubricant. It is a clear, non-irritating, non-greasy, odorless gel-like liquid. It is not a contraceptive and contains no spermicide. The device is intended for over-the-counter use by individuals to enhance the ease and comfort of intimate sexual activity. It is applied topically to the penis and/or vagina. The lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. It is supplied in plastic packaging or foil wrappers. The product benefits the user by reducing friction and supplementing natural lubrication during sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 included cytotoxicity, ISO Guinea Pig Maximization sensitization, vaginal and penile irritation with histopathology, acute systemic toxicity, and primary skin irritation; all results were favorable. Condom compatibility testing performed per ASTM D11.40.01 on natural rubber latex, polyisoprene, and polyurethane condoms confirmed compatibility. Shelf-life established via accelerated aging study.

Technological Characteristics

Aqueous-based personal lubricant containing water and water-soluble ingredients. Formulated as a clear, non-greasy, odorless gel. Biocompatibility testing conducted per ISO 10993-1. Condom compatibility testing conducted per ASTM D11.40.01. Packaged in plastic or foil.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate, enhancing comfort during sexual activity and supplementing 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

• Wet Light Personal Moisturizer (K013086)

Submission Summary (Full Text)

{0}------------------------------------------------

K11069 Page

#### II. 510(k) Summary

FEB - 1 2012

| 510(k) SUMMARY<br>Submitted by: | ONE®<br>12 Channel Street<br>Boston, MA 02210 | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Persons: | Sharon Pietila<br>Regulatory Affairs / Quality Assurance Manager<br>Tel.: [phone] ext. 15<br>Fax: [phone]<br>Email: [e-mail] | |
| | Davin Wedel<br>President<br>Tel.: [phone] ext. 14<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared: | January 19, 2012 | |
| Propriety Name: | ONE® Personal Lubricant (Water-Based) | |
| Proposed Trade Name: | ONE® Oasis | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom<br>Class II (21 CFR §884.5300)<br>NUC | |
| Predicate Device: | Wet Light Personal Moisturizer<br>Trigg Laboratories<br>510(k) No. K013086 | |
| Device Description: | ONE® Personal Lubricant (water-based formulation) is a non-<br>sterile, aqueous-based personal lubricant for use with or without a<br>condom. It is specifically formulated to be a clear, non-irritating,<br>non-greasy, odorless, gel-like liquid. This device is not a<br>contraceptive nor does it contain any spermicidal component. Two<br>forms of packaging are intended. The first primary packaging<br>(having direct contact with product) consists of a plastic<br>packaging. The second primary packaging is foil wrappers. | |
| Intended Use: | ONE® Personal Lubricant (water-based formulation) is an over-<br>the-counter personal lubricant. | |

{1}------------------------------------------------

ONE® Oasis is a personal lubricant, for penile and/or vaginal Indications For Use: 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, polvisoprene, and polyurethane condoms.

#### Technological Characteristics:

ONE® Personal Lubricant water-based formulation contains water and water-soluble ingredients similar to ingredients found in the predicate device.

# Biocompatibility:

| Testing Performed | Results |
|---------------------------------------------------|-----------------------------------------------------|
| Cytotoxicity | Product is Non-toxic |
| ISO Guinea Pig Maximization<br>Sensitization Test | Product does not elicit a sensitization<br>response |
| Vaginal Irritation with Histopathology | Product is non-irritating to vaginal tissue |
| Penile Irritation with Histopathology | Product does not cause penile mucosal<br>irritation |
| Acute Systemic Toxicity | There is no evidence of system toxicity |
| Primary Skin Irritation | Dermal irritation response is negligible |

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

# Condom Compatibility:

Compatibility Testing was performed in accordance with Lubricant Compatibility DRAFT #2010-1 ASTM D11.40.01 04/30/2010 on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polvurethane condoms.

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

Image /page/1/Picture/10 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif, and they are enclosed in a rounded rectangle. The letter "E" is stylized, with the middle stroke slightly shorter than the top and bottom strokes. There is a small star symbol in the bottom right corner of the rectangle.

{2}------------------------------------------------

### Shelf-Life:

ONE® Oasis Personal Lubricant (water-based formulation) 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 contirm results of the accelerated aging studv.

Image /page/2/Picture/5 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif, and they are contained within a rounded rectangle. The overall design is simple and eye-catching, with a clear contrast between the text and the background.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

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

FEB - 1 2012

Re: K110691

Trade/Device Name: ONE® Oasis Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 19, 2012 Received: January 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 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 0011917 While and 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

Page 2 -

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/ReportalProblem/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,

Sincerely yours,

Benjamin K. Evans

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

{5}------------------------------------------------

Abbreviated 510(k) Notification for ONE® Personal Lubricant (Water-Based)

#### Indications for Use Statement VII.

# Indications for Use

510(k) Number:

K110691

Device Name:

5

ONE® Oasis Personal Lubricant

Indications For Use:

ONE® Oasis 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 | X |
|-----------------------------|--------|-----------------------------|---|
| (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)

| (Division Sign-Off) |
|----------------------------------------------------------------|
| Division of Reproductive, Gastro-Renal, and Urological Devices |

| 510(k) Number | K110691 |
|---------------|---------|
|---------------|---------|

| | 12 Channel Street<br>Boston, MA 02210 | | Page 20 of 234 |
|--|---------------------------------------|--|----------------|
|--|---------------------------------------|--|----------------|