GLYCERIN & PARABEN FREE ASTROGLIDE

K072647 · Biofilm, Inc. · NUC · Jan 25, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072647
• Device Name: GLYCERIN & PARABEN FREE ASTROGLIDE
• Applicant: Biofilm, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jan 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with latex condoms.

Device Story

Glycerin & Paraben Free Astroglide® is a non-sterile, clear, high-viscosity liquid personal lubricant. It is applied topically by the user to penile, anal, or vaginal areas to moisturize and facilitate intimate sexual activity. The device is intended for over-the-counter use. It functions by providing physical lubrication to reduce friction. It is compatible with latex condoms. The device provides a benefit by enhancing comfort and supplementing natural lubrication.

Clinical Evidence

Bench testing only. Biocompatibility studies conducted per ISO 10993: Dermal sensitization (Grade I weak sensitizer in guinea pigs); 5-day rabbit penile irritation (minimal irritant); 5-day rabbit vaginal irritation (nonirritant); mouse systemic injection (no toxicity); 50-human subject repeat insult patch test (non-primary irritant/sensitizer); ISO MEM elution cytotoxicity test (passed at 1:4 dilution).

Technological Characteristics

Water-soluble liquid lubricant. Proprietary formulation. Compatible with latex condoms per ASTM D 3492. Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-11.

Indications for Use

Indicated for individuals requiring personal lubrication for penile, anal, or vaginal application to enhance comfort during intimate sexual activity and supplement natural lubrication. 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

• Good Lubrications Personal Lubricant (K020586)
• Astroglide Personal Lubricant (K935299)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K072647

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| Applicant | 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<br>[phone] Fax |
| Date Prepared | September 11, 2007 |
| Proprietary Name | Glycerin & Paraben Free Astroglide® |
| Common Name | Personal Lubricant |
| Classification Name | HIS - Condom, (21 CFR 884.5300)<br>MMS - Patient Lubricant (21 CFR 880.6375) |
| Predicate Device | Good Lubrications Personal Lubricant (K020586) |

#### Description of Device

Glycerin & Paraben Free Astroglide® is a non-sterile, clear, non-greasy, high viscosity liquid used as a personal lubricant. Glycerin & Paraben Free Astroglide® is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

#### Indications for Use

Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is compatible with latex condoms.

#### Technological Characteristics

Glycerin & Paraben Free Astroglide® formula is proprietary. The product however has no exceptional technological characteristics consisting mainly of water soluble ingredients similar to other lubricants currently on the market.

#### Substantial Equivalence

This product has been shown in laboratory testing to be substantially equivalent to the currently marketed Good Lubrications Personal Lubricant (K020586) and Astroglide Personal Lubricant (K935299). Both devices have the same intended use and similar formulation.

> Rev. 1 January 25, 2008

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## 510(k) SUMMARY

### Product Testing per ISO 10993

Biocompatibility studies on Glycerin & Paraben Free Astroglide® conducted by outside laboratories, in compliance with Good Laboratory Practices (GLP's) demonstrated:

- . in a Dermal Sensitization Study that the product was considered to be a Grade I (weak) sensitizer in guinea pigs. (ISO 10993-10)
- . in a 5-Day Rabbit Penile Irritation Study that the product was considered to be a minimal irritant as compared to the control article, 0.9% NaCL. (ISO 10993-10)
- . in a 5-Day Rabbit Vaginal Irritation Study that the product was considered to be a nonirritant as compared to the control article, 0.9% NaCL. (ISO 10993-10)
- in a Mouse Systemic Injection Study that the product did not cause mortality and was not . associated with systemic toxicity. (ISO 10993-11)
- . in a 50 human subject Repeat Insult Patch Test that the product may be considered as a Non-Primary Irritant and Non-Primary Sensitizer.
- in a test for Cytotoxicity at a dilution of 1:4 or greater that the product satisfied the . requirements of a ISO MEM Elution Test and passed the test. (ISO 10993-5)

Rev. 1 January 25, 2008

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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 graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

2 5 2008 JAN

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

Re: K072647

Trade/Device Name: Glycerin & Paraben Free Astroglide Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 4, 2007 Received: December 10, 2007

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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in a stylized font. The word "Centennial" is written in cursive below the acronym. There are three stars at the bottom of the logo. The logo is surrounded by a dotted circle.

Protesting 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.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

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# Indications for Use

510(k) Number (if known): K072647

Device Name: Glycerin & Paraben Free Astroglide®

Indications For Use:

Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, or vaginal application, intended to moisturize and fubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is compatible with latex 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)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K072647 |

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