THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT

K051668 · Goodmark USA, Inc. · NUC · Jul 8, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051668
• Device Name: THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT
• Applicant: Goodmark USA, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Art of Intimacy Response ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.

Device Story

The Art of Intimacy Response™ is a clear, viscous liquid gel personal lubricant. It is designed for over-the-counter use to supplement natural lubricating fluids and enhance comfort during intimate sexual activity. The device is compatible with latex condoms and does not contain contraceptives or spermicides. It is applied topically by the user as needed. The formulation utilizes ingredients recognized as safe and meeting USP/NF specifications, ensuring biocompatibility and condom compatibility.

Clinical Evidence

Bench testing only. Independent laboratory testing performed for biocompatibility, condom compatibility, and preservative effectiveness.

Technological Characteristics

Clear, viscous liquid gel. Ingredients meet USP/NF specifications and are recognized as safe (21 CFR 172.515). Compatible with latex condoms. Non-spermicidal. No electronic or software components.

Indications for Use

Indicated for individuals requiring personal lubrication to supplement natural fluids and enhance comfort during intimate sexual activity, with or without latex 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.

Submission Summary (Full Text)

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K05/668

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) [21 CFR 807.87(H)]

# The Art of Intimacy Response ™ Personal Lubricant

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Food and Drug Auministration new York, this information Medical Devices ACt of 1990 and in officitions with of Intimacy Response ™ Personal Lubricant

| Submitted By:<br>Date:<br>Contact Person: | Goodmark USA, Inc.<br>March 8, 2005<br>Boston Talbert<br>Project Manager |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | The Art of Intimacy Response ™ |
| Common Name: | Personal Lubricant |
| Classification Name: | The General Hospital and Personal Use Device section of<br>the General Medical Devices Panel within the FDA's<br>Center for Medical Device & Radiological Health considers<br>patient lubricants (21 CFR §880.6375, Class I) to be<br>Class II devices when promoted as being compatible for<br>use with condoms (21 CFR §884.5300) |
| Intended Use: | The Art of Intimacy Response ™ Liquid Personal lubricant<br>is principally intended as personal lubricant to supplement<br>the body's natural lubricating fluids, and to enhance the<br>ease and comfort of intimate sexual activity with or without<br>a latex condom. |

#### Device Description

Device Description The Art of millings of Rosponso - 16 a horners on fluids. It is specifically formulated to be a clear, supplement the body s own hatural lubriscosity liquid gel and is compatible for use with or non-intalling, non-starting, mgn-hectivity as evidenced by condom compatibility williout a latex condom daning intimate contraceptive or spermicide, nor does it contain any such component

### Summary of Technological Characteristics

The Art of Intimacy Response ™ Liquid Personal lubricant contains ingredients that are The Art of Intimaty Acoponos - used in the manufacture of the predicate devices. The ingredients meet specifications defined in the United State Pharmacopoeia (USP) or National ingrediction most openized as safe for their intended use" (21 CFR 172.515).

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Kosibos
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The product was tested by independent laboratories for condom compatibility, biocompatibility The product was tested by independent laboratorious for only the devices and preservative enectiveness. Thia results from the identified industry standards.

## Substantial Equivalence Information:

Substantial Equivalence Information:
The intended use, ingredients, and application of the proposed device are substantially The intended use, ingledients, and application of the proposatial equivalence, the Art of equivalent to those of the predicate device. "In acteming as ally marketed device to which the Sponsor claims substantial equivalence.

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its body and wings. The word "DEPARTMENT" is written vertically along the left side of the logo, following the curve of the bird's wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 8 2005

Goodmark USA, Inc. c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street, NW BUFFALO MN 55313

Re: K051668

Trade/Device Name: The Art of Intimacy Response™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 18, 2005 ري جي جي Received: June 22, 2005

Dear Mr. Job:

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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance 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 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/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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510(k) Premarket Notification The Art of Intimacy Response ™ Liquid Personal Lubricant

## Indications For Use

Page _________________________________________________________________________________________________________________________________________________________________________ of 1 510(k) Number (if known):

Device Name: The Art of Intimacy Response™ Personal Lubricant

Indications for Use:

"The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The Counter Use

(Optional Format 1-2-96)

David W. Lynn

(Division Sign-Off)
Division of Reproductive, Abdomi
and Radiological Devices
510(k) Number
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