ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT

K041432 · Biofilm, Inc. · HIS · Nov 30, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041432
• Device Name: ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
• Applicant: Biofilm, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Astroglide® Brand WARMING LIQUID is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. Astroglide® Brand WARMING LIQUID may be used with condoms.

Device Story

Astroglide® Brand WARMING LIQUID is a non-sterile, clear, non-greasy, high-viscosity personal lubricant. Applied topically by the user to enhance intimate activities and sexual intercourse; provides supplemental vaginal lubrication. Produces a slight warming sensation upon application. Compatible with latex condoms. Intended for over-the-counter use.

Clinical Evidence

No clinical data. Evidence consists of bench testing: Dermal Sensitization (guinea pigs), 5-day Rabbit Vaginal Irritation (minimal irritant), Mouse Systemic Toxicity (50mL/kg IV/IP, no mortality), USP Agar Diffusion (no cytotoxicity), and Human Repeat Insult Patch Test (n=53, no evidence of sensitization). Condom compatibility tested per ASTM D 3492.

Technological Characteristics

Water-soluble liquid personal lubricant. Proprietary formula. Compatible with latex condoms per ASTM D 3492. Non-sterile.

Indications for Use

Indicated for individuals requiring supplemental vaginal lubrication to enhance intimate activities and sexual intercourse. Compatible with 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.

Predicate Devices

• K-Y Brand WARMING LIQUID Personal Lubricant (K021492)

Submission Summary (Full Text)

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NOV 3 0 2004

510(k) SUMMARY

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K041432

| Date Prepared | May 21, 2004 |
|---------------------|------------------------------------------------------------------------------------------------------|
| Submitter | BioFilm, Inc.<br>3225 Executive Ridge<br>Vista, CA 92081 |
| Contact Person | Robert L. De Armond<br>V.P. Operations / Regulatory Affairs<br>[phone] Phone [phone] Fax |
| Proprietary Name | Astroglide® Brand<br>WARMING LIQUID Personal Lubricant |
| Common Name | Personal Lubricant |
| Classification Name | Patient lubricant |
| Predicate Device | K-Y Brand WARMING LIQUID Personal Lubricant<br>510(k) Number K021492 |

#### Device Classification

The General Hospital and Personal Use Device section of the General Medical Devices Panel has classified Patient Lubricants as Class . (21 CFR § 880.6375)

#### Description of Device

Astroglide® Brand WARMING LIQUID is a non-sterile clear non-greasy, high viscosity liquid used as a personal lubricant. The product is highly lubricous and may be used with or without a condom during sexual activity. Astroglide® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in condom compatibility testing conducted according to standards defined by ASTM D 3492.

#### Intended Use

Astroglide® Brand WARMING LIQUID is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.

Astroglide® Brand WARMING LIQUID may be used with condoms.

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#### Summary of Technological Characteristics

Astroglide® Brand WARMING LIQUID formula is proprietary. The product has no exceptional technological characteristics consisting mainly of water soluble ingredients similar to lubricants currently on the market.

#### Substantial Equivalence

This product is substantially equivalent to the currently marketed K-Y Brand WARMING LIQUID personal lubricant. Both devices have the same intended use and substantially similar formulas. Both devices produce a slight warming sensation upon application. Astroglide® Brand WARMING LIQUID is slightly more lubricious due to an additional ingredient also found in BioFilm's currently marketed Astroglide® Personal Lubricant.

### Product Testing

Biocompatibility testing of Astroglide® Brand WARMING LIQUID conducted by outside laboratories demonstrated:

- In a Dermal Sensitization Study that the product was considered not to be a . contact sensitizing agent in guinea pigs.
- In a 5 day Rabbit Vaginal Irritation Study, that the product did not cause any . pharmacotoxic effects when administered vaginally to rabbits for 5 consecutive days. Astroglide® Brand WARMING LIQUID received an irritation index score of 1, which is considered a minimal irritant.
- In a Mouse Systemic Toxicity Evaluation of Astroglide® Brand WARMING . LIQUID that at 50mL/kg IV the product did not cause mortality and was not associated with systemic toxicity when administered at 50mL/kg IP.
- In a USP Agar Diffusion Test Astroglide® Brand WARMING LIQUID did not . produce any evidence of cytotoxicity.
- In a Human Repeat Insult Patch Test involving 53 healthy adult males and . females the study showed no evidence of increased likelihood of sensitization to Astroglide® Brand WARMING LIOUID.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 3 0 2004

Mr. Robert L. De Armond Vice President Operations/ Regulatory Affairs BioFilm, Inc. 3225 Executive Ridge VISTA CA 92081

Re: K041432

Trade/Device Name: Astroglide® Brand WARMING LIQUID personal lubricant Regulation Number: 21 CFR 884,5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: October 8, 2004 Received: October 12, 2004

. Dear Mr. De Armond:

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 vou 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/cdrb/dsmaldsmamain.html

Sincerely yours,

Nancy C. Brogdon

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): K041432 Device Name: Astroglide® Brand Warming Liquid Indications For Use:

Recommended as a personal lubrication to enhance intimate activities.

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)

Torind A. Bergman

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

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