O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT

K042915 · O'My Products Incorporated · NUC · Aug 31, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K042915
• Device Name: O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
• Applicant: O'My Products Incorporated
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Patient Lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices. O'My Lubricant and O'My Flavored Lubricants are principally intended as personal lubricants to supplement the body's own natural lubrication fluids. O'My Lubricants also reduce friction and enhance the comfort and ease of intimate sensual activity with or without a latex condom. O'My Lubricant and O'My Flavored Lubricants are also recommended for personal lubrication when dryness causes discomfort.

Device Story

O'My Lubricant and O'My Flavored Lubricants are water-based, non-sterile personal lubricants; designed to supplement natural body fluids; reduce friction; enhance comfort during intimate activity; compatible with latex condoms. Used by consumers in home settings; applied topically to body orifices. Device functions as a physical lubricant; no active electronic or mechanical components. Benefits include relief from dryness-related discomfort and facilitation of device entry or sexual activity.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Water-based, water-soluble personal lubricant. Non-sterile. No complex technological characteristics or active energy sources.

Indications for Use

Indicated for individuals experiencing vaginal dryness or requiring lubrication to facilitate intimate sensual activity, with or without latex condoms, or to facilitate the entry of diagnostic or therapeutic devices into a body orifice.

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 Ultra Gel (K020827)
• K-Y Brand Warming Liquid Personal Lubricant (K021492)

Submission Summary (Full Text)

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O'My Products Inc

K042915

AUG 3 1 2005

## 10. 510 (K) SUMMARY

| Submitted by: | O'My Products Inc.<br>188 Pemberton Avenue<br>North Vancouver, BC<br>V7P 2R5<br>Canada |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rob Logan<br>Vice President<br>[phone] |
| Proprietary Name: | O'My Lubricant<br>O'My Flavored Lubricants |
| Common Name: | Personal Lubricant |
| Classification Name: | Condom CFR 884.5300<br>Patient Lubricant CFR 880.6372 |
| Predicate Device: | Class: I<br>Regulation Number: 21 CFR 880.6375<br>Regulation Name: Patient Lubricant<br>K020827 – K-Y Brand Ultra Gel<br>K021492 – K-Y Brand Warming Liquid Personal Lubricant<br><br>Class: II<br>Regulation Number: Condom 21 CFR 884.5300<br>Regulation Name: Condom<br>K021492 – K-Y Brand Warming Liquid Personal Lubricant<br>K020827 - K-Y Brand Ultra Gel |

Description of the Device:

O'My Lubricant and O'My Flavored Lubricants are non-sterile, water-based personal lubricants designed to supplement the body's natural lubrication fluids. The formula is a clear, nonaccircu to supprement von-greasy natural liquid gel. O'My Lubricant and O'My Flavored I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Testing.

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#### O'My Products Inc

### Intended Use of the Device:

Patient Lubricants are devices intended to lubricate a body orifice to facilitate entry of a I anone Daorieans are do recessory to a condom, patient lubricants are deemed Class II Medical Devices.

O'My Lubricant and O'My Flavored Lubricants are principally intended as personal lubricants to o wy East the body's own natural lubrication fluids. O'My Lubricants also reduce friction Supprement and been of a se enhancing the comfort and ease of intimate sensual activity with or without a latex condom. O'My Lubricant and O'My Flavored Lubricants are also recommended for personal lubrication when dryness causes discomfort.

#### Technological Characteristics:

O'My Lubricant and O'My Flavored Lubricants contain a proprietary formula. However the products have no exceptional technological characteristics, consisting of water-soluble products nave no other lubricants currently on the US market. Tests have been performed to establish that the product does not compromise safety.

#### Conclusion:

O'My Lubricant and O'My Flavored Lubricants are substantially equivalent to the predicate o wi Laorean ducts have the same intended use and similar technological characteristics. No new safety or effectiveness issues have been raised through testing.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles a bird in flight, composed of three curved lines.

Public Health Service

AUG 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rob Logan Vice President O'My Products, Inc. 188 Pemberton Avenue North Vancouver BC V7P 2R5 CANADA

Re: K042915

Trade/Device Name: O'My Natural and O'My Natural Flavored Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 22, 2005 Received: August 24, 2005

Dear Mr. Logan:

.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anon-your of our and of substantial equivalence of your device to a legally prematication. " The PDF maning in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you deathe spoorne at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | () | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 601:57). I ou may overnmentanal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### K042915 510(k) Number (if known):

O'My Natural Lubricant & O'My Natural Flavored Lubricant

Device Name:

Indications For Use:

Patient Lubricants are devices intended to lubricate a body orifice to facilitate entry of a I attont bablicants are ac device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.

O'My Lubricant and O'My Flavored Lubricants are principally intended as personal lubricants to o My Lubricant and O My Pieres Jubrication fluids. O'My Lubricants also reduce friction suppliement the body of ovenhancing the comfort and ease of intimate sensual activity with or without a latex condom.

O'My Lubricant and O'My Flavored Lubricants are also recommended for personal lubrication when dryness causes discomfort.

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)

Daniel R. Layman
Mission Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number .

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