INTIMOL

K061466 · Dlc Laboratories, Inc. · NUC · Dec 4, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061466
• Device Name: INTIMOL
• Applicant: Dlc Laboratories, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

INTIMOLTM 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

INTIMOL™ is a non-sterile, aqueous-based personal lubricant; formulated as a clear, non-irritating, non-greasy, non-staining gel-like liquid. Intended for over-the-counter use to supplement natural body fluids and enhance comfort during intimate sexual activity. Compatible with latex condoms. Packaged in a plastic bottle with a flip-top cap. Device does not contain contraceptives or spermicides.

Clinical Evidence

Bench testing only. Independent laboratory testing confirmed condom compatibility, biocompatibility, and preservative effectiveness in accordance with established industry standards.

Technological Characteristics

Aqueous-based gel; ingredients include purified water, glycerin, cellulose thickeners, methylparaben, propylparaben, propylene glycol, and aloe vera. Ingredients meet USP/NF standards. Non-sterile. Packaged in plastic bottles. Water-soluble, non-staining, and condom-compatible.

Indications for Use

Indicated for individuals requiring supplemental lubrication during intimate sexual activity. Compatible with latex condoms. Not a contraceptive or spermicide.

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)
• Astroglide® Personal Lubricant (K935299)
• K-Y® Liquid Personal Lubricant (K955648)

Submission Summary (Full Text)

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1001466

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

OEC - 4 2006

### INTIMOL™ Liquid Personal Lubricant

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.87(h), this information serves as a Summary of Safety and Effectiveness for the INTIMOL™ Liquid Personal Lubricant

- Submitted By: DLC Laboratories, Inc. 7008 Marcelle Street Paramount, CA 90723
- Date: May 23, 2006
- Contact Person: Juan Manzur Operations Manager 562-602-2184 or 800-858-3889 Telephone: Fax: [phone]
- Proprietarv Name: INTIMOL TM
- Personal Lubricant Common Name:
- Classification Name: The General Hospital and Personal Use Device section of the General Medical Devices Panel within the FDA's Center for Medical Device & Radiological Health considers patient lubricants (21 CFR 8880.6375. Class I devices) to be Class II devices when promoted as being compatible for use with condoms (21 CFR 8884.5300)
- Predicate Device: Wet® Light Personal Moisturizer (K013086) Astroglide® Personal Lubricant (K935299) K-Y® Liquid Personal Lubricant (K955648)
- Intended Use: INTIMOLTM 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 Description

INTIMOLTM is a non-sterile, aqueous-based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, non-irritating, non-greasy, non-staining, gel-like liquid and is compatible

DLC Laboratories, Inc. 7008 Marcelle Street Paramount, CA 90723

Confidential Information

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for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility test results. This device is not a contraceptive or spermicide, nor does it contain any such component.

The product is packaged in a plastic bottle with a flip-top cap.

#### Summary of Technological Characteristics

INTIMOL™ Liquid Personal lubricant contains ingredients that are substantially the same as those used in the manufacture of the predicate devices. The ingredients meet specifications defined in the United State Pharmacopoeia (USP) or National Formulary (NF). and are "generally recognized as safe for their intended use" (21 CFR 172.515).

#### Summary of Substantial Equivalence Information:

The intended use, ingredients, and application of the proposed device are substantially equivalent to those of the predicate devices. In determining substantial equivalence, the INTIMOL™ has been compared with the following legally marketed device to which the Sponsor claims substantial equivalence.

The table below compares the technological characteristics of INTIMOL™ Liquid Personal Lubricant to the predicate devices, Wet® Light Personal Moisturizer, K-Y® Liquid Personal Lubricant and Astroglide®.

| Feature | Intimol™<br>Personal<br>Lubricant | Wet Light<br>Personal<br>Moisturizer | K-Y®<br>Personal<br>Lubricant | Astroglide® |
|--------------------------------|-----------------------------------|--------------------------------------|-------------------------------|--------------|
| Manufacturer | DLC<br>Laboratories,<br>Inc. | Trigg<br>Laboratories,<br>Inc. | McNeil-PPC,<br>Inc. | BioFilm Inc. |
| Contains purified water | Yes | Yes | Yes | Yes |
| Contains glycerin | Yes | Yes | Yes | Yes |
| Contains Cellulose thickeners | Yes | Yes | Yes | No |
| Contains Methylparaben | Yes | Yes | Yes | Yes |
| Contains Propylparaben | Yes | No | No | Yes |
| Contains Propylene glycol | Yes | Yes | Yes | Yes |
| Contains Aloe Vera | Yes | Yes | No | No |
| Over-the-Counter Use | Yes | Yes | Yes | Yes |
| Labeled water soluble | Yes | Yes | Yes | Yes |
| Labeled non-staining | Yes | Yes | Yes | Yes |
| Labeled condom compatible | Yes | Yes | Yes | Yes |
| Contains alcohol and fragrance | No | No | No | No |
| Container material | Plastic | Plastic | Plastic | Plastic |
| Sterile | No | No | No | No |

The product was tested by independent laboratories for condom compatibility, biocompatibility and preservative effectiveness. Final results from these tests demonstrate that the device meets established acceptance criteria in accordance with the identified industry standards.

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## Conclusion

INTIMOL™ Liquid Personal Lubricant is substantially equivalent to its predicate devices, Wet® Light Personal Moisturizer, K-Y® Liquid Personal Lubricant and Astroglide®. All of these products have the same intended use and similar technological characteristics. Therefore, no new safety and effectiveness issues are expected to be raised.

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

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Juan Manzur Operations Manager DLC Laboratories, Inc. 7008 Marcelle Street PARAMOUNT CA 90723

DEC - 4 2006

Re: K061466

Trade/Device Name: INTIMOL™ Liquid Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 16, 2006 Received: November 20, 2006

Dear Mr. Manzur:

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.

Image /page/3/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a smaller font. Three stars are printed below the word "Centennial". The logo is surrounded by a circular border.

Protecting and Promoting Public Health.

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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.

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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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.ida.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy Crogdon

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

Page 1_ of 1_

510(k) Number (if known): K061466

Device Name: INTIMOL™ Liquid Personal Lubricant

Indications for Use:

INTIMOL™ 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.

Prescription Use _ (Per 21 CFR 801.109) AND/OR

Over-The Counter Use __ X (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)

Nancy C. Brogdon

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

DLC Laboratories, Inc.
7008 Marcelle Street
Paramount, CA 90723

Confidential Information