I-D GLIDE

K051295 · Westridge Laboratories, Inc. · NUC · Feb 15, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K051295
• Device Name: I-D GLIDE
• Applicant: Westridge Laboratories, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

I-D Glide lubricant is intended enhance the comfort and ease of intimate activity and is compatible with latex and polyurethane condoms.

Device Story

I-D Glide is a water-based, non-sterile personal lubricant; intended to enhance comfort and ease of intimate activity. Composition includes purified water, glycerin, propylene glycol, cellulose polymer, PEG 90m, Carbomer 981, antifungal preservatives, pH adjuster, and chelating agent. Device is compatible with latex and polyurethane condoms. Used by consumers in home settings for personal lubrication. Product provides physical lubrication to reduce friction during intimate activity, potentially increasing comfort for the user.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility and antimicrobial testing.

Technological Characteristics

Water-based, non-sterile gel. Ingredients: purified water, glycerin, propylene glycol, cellulose polymer, PEG 90m, Carbomer 981, antifungal preservatives, pH adjuster, chelating agent. Water-soluble. Compatible with latex and polyurethane condoms.

Indications for Use

Indicated for personal penile and vaginal lubrication. Compatible with latex and polyurethane condoms. For over-the-counter use.

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

• Instead Intimate Lubricant (K033776)
• Personal Lubricating Gel (K041129)

Submission Summary (Full Text)

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## FEB 1 5 2006

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

## The assigned 510(k) number is: KO5/295

- 1. Submitter's Identification:
Westridge Laboratories, Inc. 1671 Saint Andrew Place Santa Ana, CA 92705 Telephone: [phone] Fax: [phone]

Contact Person: Gregg Haskell, President

Date of Summary: May 12, 2005

- 2. Device Name: I-D Glide
- 3. Classification Name: Lubricant
- 4. Substantial Equivalence Statement: This product is similar in design, intended use and function to many other lubricants on the market. Section 5 contains a comparison of I-D Glide Personal Lubricant with Instead, Inc's Instead Intimate Lubricant and Qualis, Inc.'s Personal Lubricating Gel.

| Company | Product | 510(k) # |
|---------------|----------------------------|----------|
| Instead, Inc. | Instead Intimate Lubricant | K033776 |
| Qualis, Inc. | Personal Lubricating Gel | K041129 |

- 5. Intended Use: I-D Glide lubricant is intended enhance the comfort and ease of intimate activity and is compatible with latex and polyurethane condoms.
- 6. Device Description: I-D Glide Personal lubricant is a water-based non-sterile personal lubricant containing purified water, glycerin, propylene glycol, cellulose polymer, PEG 90m, Carbomer 981, various antifungal preservatives, pH adjuster, and chelating agent.

6

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- 7. Predicate Product Comparison:

| | Westridge<br>Laboratories, Inc.<br>I-D Glide | Instead, Inc<br>Instead Intimate<br>Lubricant | Qualis, Inc.<br>Personal<br>Lubricating Gel |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Lubricant | Lubricant | Lubricant |
| Product Code | 80 MMS | 80 MMS | 80 MMS |
| Intended Use | Personal<br>Lubricating Gel is<br>designed to enhance<br>the ease and<br>comfort of intimate<br>activity and is<br>compatible with<br>latex condoms. | Personal<br>Lubricating Gel is<br>designed to enhance<br>the ease and<br>comfort of intimate<br>activity and is<br>compatible with<br>latex condoms. | Personal<br>Lubricating Gel is<br>designed to enhance<br>the ease and<br>comfort of intimate<br>activity and is<br>compatible with<br>latex condoms. |
| Over the Counter Use | YES | YES | YES |
| Water-soluble | YES | YES | YES |
| Contains purified<br>water | YES | YES | YES |
| Contains<br>Preservatives | YES | YES | YES |
| Biocompatibility<br>Tested | YES | YES | YES |
| Antimicrobial Tested | YES | YES | NO |

Product comparison chart shows that the Westridge Laboratories, Inc.'s I -D Giide is Product comparison chart shows that the 1. Instead Intimate Lubricant and Qualis equivatent to the I rodicate Products (instituted use and design. Westridge Laboratories, Inc.
Inc., Personal Lubricating Gel) in intended use and designed of Sating associa Inc, Fersonal Eubricating Oor) in mendous as oncerns of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2006

Westridge Laboratories, Inc. % Albert Rego, Ph.D. Scientific Consultant 27001 La Paz Road, Suite 314 MISSION VIEJO CA 92691

Re: K051295

Trade/Device Name: I-D Glide I ubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 20, 2006 Received: January 20, 2006

Dear Dr. Rego:

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 the enerobate) to regary ment date of the Medical Device Amendments, or to devices that have been rear 20, 1978, ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require upproval on a 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 11 your ab, it may be subject to such additional controls. Existing major regulations affecting your Applorary, It also be rederal 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 docs 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 r odvards and regulirements, 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 his letter will anow you to ocgin hanceing your antial equivalence of your device to a legally premarket nothication: "The PDA mainly of backannal vour 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 desire spective advice for your device on our laboring - 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 promatics that from the Also, please note the regulation chitted, "Thisotananages on your responsibilities under the Act from the 190 807.97). You may obtain other general information on your copy and 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. Higdon

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

510(k) Number (if known): K051295

Device Name: I-D Glide Lubricant

Indications For Use: Personal lubricant for penile and vaginal use only. Compatible with latex and polyurethane condoms.

Prescription Use (Part 21 CFR 801 Subpart D) 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, Abdominal, and Radiological Device

510(k) Number K051295

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