CVS PERSONAL LUBRICANT AND MOISTURIZER

K062682 · Lake Consumer Products, Inc. · NUC · Apr 4, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K062682
• Device Name: CVS PERSONAL LUBRICANT AND MOISTURIZER
• Applicant: Lake Consumer Products, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

CVS Personal Lubricant & Moisturizer is intended as a personal lubricant for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. The lubricous nature of the product helps supplement the body's natural lubricating fluids, thereby reducing friction. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide, nor does it contain any such component.

Device Story

CVS Personal Lubricant & Moisturizer is a non-sterile, aqueous, water-soluble gel. Intended for OTC use by consumers to alleviate vaginal dryness and facilitate sexual activity. Applied topically to the vaginal area; compatible with latex condoms. Formula consists of water, glycerin, propylene glycol, polyquaternium 15, methylparaben, and propylparaben. Packaged in PETE bottles with foil seals and polypropylene caps. Benefits include friction reduction and enhanced comfort during intimacy. No contraceptive or spermicidal properties.

Clinical Evidence

Bench testing only. Stability testing (90-day accelerated) and USP <1227> Antimicrobial Effectiveness Test passed. Condom compatibility testing confirmed no adverse effects on tensile strength, elongation, or burst pressure of latex condoms. Perceptual quality comparison against predicate rated 10/10.

Technological Characteristics

Aqueous gel formulation containing water, glycerin, propylene glycol, polyquaternium 15, methylparaben, and propylparaben. Non-sterile. Packaged in PETE plastic bottles. Water-soluble. Compatible with latex condoms.

Indications for Use

Indicated for OTC consumer use as a vaginal moisturizer and personal lubricant to reduce friction and enhance comfort 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

• Astroglide (K935299)

Submission Summary (Full Text)

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# APR 4 - 2007

## 510(k) SUMMARY

| <b>Submitter:</b> | Lake Consumer Products, Inc. |
|-------------------|------------------------------|
| | 1 Pharmacal Way |
| | Jackson, WI 53037 |

- Contact Person: Mary L. Wundrock Vice President- Laboratory Services [e-mail] Phone: [phone] Ex 7110 Fax: [phone]
September 6, 2006 Date Submitted:

Proprietary Name: CVS Personal Lubricant & Moisturizer

- Personal Lubricant Common Name:
- Predicate Name: Astroglide 510(k) Number: K935299

### Classification Name:

21 CFR 880.6375 Patient Vaginal Lubricant Product Code MMS Class I

21 CFR880.5300 Lubricant, Patient, Vaginal, Latex Compatible Product Code NUC Class II

### Description of Device:

The CVS Personal Lubricant & Moisturizer formula is non-sterile. clear, non- staining, non-greasy, aqueous gel intended for use as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms as demonstrated in condom compatibility testing. This device is not a contraceptive or spermicide, nor does it contain any such component. CVS Personal Lubricant & Moisturizer is packaged in PETE bottles with a foil seal and polypropylene cap.

న-I

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## Intended Use:

CVS Personal Lubricant & Moisturizer is intended as a personal lubricant for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. The lubricous nature of the product helps supplement the body's natural lubricating fluids, thereby reducing friction. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide, nor does it contain any such component.

### Comparison of Technological Characteristics:

CVS Personal lubricant & Moisturizer contains water, glycerin, propylene glycol, polyquaterium 15, methylparaben and propylparaben. CVS Personal Lubricant & Moisturizer is substantially similar to the predicate device.

A summary comparison of the features of CVS Personal Lubricant & Moisturizer and the predicate device Astroglide is provided in Table 1.

| Features | CVS Personal<br>Lubricant &<br>Moisturizer | Predicate Device-<br>Astroglide |
|-------------------------------|--------------------------------------------|---------------------------------|
| Labeled Condom<br>Compatible | Yes | Yes |
| Personal Lubricant | Yes | Yes |
| Contains Water | Yes | Yes |
| Contains Glycerin | Yes | Yes |
| Contains<br>Propylene Glycol | Yes | Yes |
| Contains<br>Polyquaternium 15 | Yes | Yes |
| Contains<br>Methylparaben | Yes | Yes |
| Contains<br>Propylparaben | Yes | Yes |
| Sterile | No | No |
| Container type | Plastic | Plastic |

# TABLE 1

CVS Personal Lubricant & Moisturizer is substantially equivalent to the following device that is currently in commercial distribution:

Astroglide, BioFilm Inc., K935299

ર-2

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#### Substantial Equivalence:

CVS Personal Lubricant & Moisturizer is substantially similar to the predicate device, Astroglide. The products have the same intended use and technological characteristics. No new safety or effectiveness issues have been raised through testing. Both products are intended for use as personal lubricants, safe to use with condoms, water-soluble and for over-the-counter (OTC) use.

### Summary of Performance Data:

### Non-Clinical Studies

Stability- CVS Personal Lubricant & Moisturizer has successfully passed 90 day accelerated stability.

Preservative Effectiveness-CVS Personal Lubricant & Moisturizer formulation with the preservative system has successfully passed the requirements of the USP <1227> Antimicrobial Effectiveness Test.

Comparison with Predicate Device- CVS Personal Lubricant & Moisturizer was compared to Astroglide on the basis of perceptual qualities, physical and chemical properties, ingredient list review, label claims and packaging. Test results rated CVS Personal Lubricant & Moisturizer (a 10 of 10 rating) as comparable to Astroglide.

Condom Compatibility Testing- CVS Personal Lubricant & Moisturizer, when applied to latex condoms does not adverselv affect tensile strength, elongation or burst pressure, when compared to untreated condoms.

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Image /page/3/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 its wings spread, and three human figures in profile facing the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Mary L. Wundrock Vice President - Laboratory Services Lake Consumer Products, Inc. 1 Pharmacal Way, P.O. Box 198 JACKSON WI 53037

FEB 2 4 2014

Re: . K062682 Trade/Device Name: CVS Personal Lubricant & Moisturizer Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): March 21, 2007 Received (Date on orig SE ltr): March 22, 2007

Dear Ms. Wundrock:

This letter corrects our substantially equivalent letter of April 4, 2007.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Benjamin R. Fisher -S**

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement:

KC62682 510(k) Number:

Device Name: CVS Personal Lubricant & Moisturizer

Indications for Use:

A non-sterile personal lubricant for OTC consumer use, as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide nor does it contain any such component.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

David A. Bergman

Division Sien-Division of Reproductive, and Radiological Dev 510(k) Number

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