LIFESTYLES LIQUID PERSONAL LUBRICANT

K033076 · Ansell Healthcare, Inc. · HIS · Dec 19, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K033076
• Device Name: LIFESTYLES LIQUID PERSONAL LUBRICANT
• Applicant: Ansell Healthcare, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. If used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices. LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.

Device Story

LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based gel designed to supplement natural body lubrication and enhance comfort during intimate sexual activity. It is compatible with latex condoms. The device is available over-the-counter in three formulations: Long Lasting, Aloe & Vitamin E, and Strawberry. It is packaged in plastic tubes or foil/plastic laminate sachets. Users apply the lubricant topically as needed. The product benefits the patient by reducing friction and increasing comfort during sexual activity. It does not affect the in-vitro spermicidal activity of condoms lubricated with Nonoxynol-9.

Clinical Evidence

Bench testing only. Independent laboratory testing confirmed condom compatibility, biocompatibility, and preservative effectiveness. Testing also demonstrated no adverse effect on the in-vitro spermicidal activity of condoms lubricated with Nonoxynol-9.

Technological Characteristics

Water-based gel; ingredients include deionized water, glycerine, cellulose thickeners, methylparaben, and propylparaben. Formulations include variants with aloe, vitamin E, and strawberry fragrance. Non-sterile. Packaged in plastic tubes or foil/plastic film laminate sachets. Compatible with latex condoms.

Indications for Use

Indicated for individuals requiring personal lubrication to supplement natural fluids, moisturize, 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.

Predicate Devices

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

Submission Summary (Full Text)

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DEC 1 9 2003

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## 510(k) SUMMARY

033076

| Submitted by: | Ansell Healthcare Inc.<br>1635 Industrial Road<br>Dothan, AL 36303<br>USA | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------|
| Contact Person | Lon D. McIlvain<br>Quality Assurance/Regulatory Manager<br>Telephone: [phone] or 334-615-2562<br>Fax: [phone] | |
| Date Prepared: | September 25, 2003 | |
| Proprietary Name: | LifeStyles® Liquid Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom (21 CFR §884.5300) | Product Code 85HI |
| Predicate Device: | Astroglide® Personal Lubricant (K935299)<br>K-Y® Liquid Personal Lubricant (K955648) | |

## Description of the Device:

LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to supplement the body's natural lubrication fluids. The formula is a non-greasy, non-sticky, non-staining and non-irritating gel-like liquid that is compatible with latex condoms in laboratory testing. LifeStyles® Liquid Personal Lubricant is available over-the-counter in three formulas:

LifeStyles® Liquid Personal Lubricant Long Lasting LifeStyles® Liquid Personal Lubricant Aloe & Vitamin E LifeStyles® Liquid Personal Lubricant Strawberry

The product is packaged in a plastic tube with a flip-top cap or in an aluminum foil/plastic film laminate sachet.

## Intended Use of the Device:

Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. If used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices.

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LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.

Technological Characteristics:

The LifeStyles® Liquid Personal Lubricant formulations contain ingredients that are substantially the same as those used to manufacture the predicate devices. The strawberry fragrance used in the strawberry formulation contains standard ingredients commonly used in cosmetic applications as well as in drug flavors. The D&C and FD&C red colors are approved for use in drug and cosmetic applications. Aloe and Vitamin E are approved for use and commonly used in cosmetic applications.

The table below compares the technological characteristics of LifeStyles® Liquid Personal Lubricant to the predicate devices, K-Y® Liquid Personal Lubricant and Astroglide®.

| Feature | LifeStyles® Liquid<br>Personal Lubricant | K-Y® Liquid Personal<br>Lubricant | Astroglide® |
|---------------------------------------|------------------------------------------|-----------------------------------|--------------|
| Manufacturer | Ansell Healthcare Inc. | McNeil-PPC, Inc. | BioFilm Inc. |
| Contains dionized water | Yes | No | No |
| Contains purified water | No | Yes | Yes |
| Contains glycerine | Yes | Yes | Yes |
| Contains Cellulose<br>thickeners | Yes | Yes | No |
| Contains Methylparaben | Yes | Yes | Yes |
| Contains Propylparaben | Yes | No | Yes |
| Labeled water soluble | Yes | Yes | Yes |
| Labeled non-staining | Yes | Yes | Yes |
| Labeled condom<br>compatible | Yes | Yes | Yes |
| Labeled alcohol and<br>fragrance free | No | No | No |
| Container material | Plastic or Foil/Plastic<br>Film Laminate | Plastic | Plastic |
| Sterile | No | No | No |

LifeStyles® Liquid Personal Lubricant was tested by independent laboratories for condom compatibility, biocompatibility, and preservative effectiveness. Independent testing has also demonstrated that LifeStyles® Liquid Personal Lubricant does not affect the in-vitro spermicidal activity of condoms lubricated with spermicide (Nonoynol-9).

#### Conclusion

LifeStyles® Liquid Personal Lubricant is substantially equivalent to its predicate devices, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Ms. Cynthia A. Ingram Regulatory Affairs Administrator Ansell Healthcare, Inc. 1635 Industrial Road Dothan, Alabama 36303

Re: K033076

Trade/Device Name: LifeStyles® Liquid Personal Lubricant Long Lasting, Aloe & Vitamin E, and Strawberry Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 25, 2003 Received: September 29, 2003

Dear Ms. Ingram:

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 (PMA), 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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.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): K033076

# Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seghers

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

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