CVS PERSONAL LUBRICANT

K983216 · San-Mar Laboratories, Inc. · HIS · May 17, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983216
• Device Name: CVS PERSONAL LUBRICANT
• Applicant: San-Mar Laboratories, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and and the ease of intimate activity.

Device Story

CVS Personal Lubricant is a clear, colorless, odorless topical lubricant. Composition includes purified water, glycerin, propylene glycol, polyquaternium #5, methylparaben, and propylparaben. Packaged in high-density polyethylene plastic bottle. Used by consumers for personal lubrication, vaginal dryness, and condom enhancement; also used by clinicians to facilitate entry of diagnostic or therapeutic devices into body orifices. Device functions as a physical lubricant to reduce friction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water and glycerin-based lubricant. Ingredients: purified water, glycerin, propylene glycol, polyquaternium #5, methylparaben, propylparaben. Packaging: high-density polyethylene plastic bottle.

Indications for Use

Indicated for personal lubrication, lubrication of body orifices to facilitate diagnostic or therapeutic device entry, vaginal dryness moisturization, and enhancement of condom use and intimate activity.

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 (K935291)

Submission Summary (Full Text)

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K9832

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## Laboratories Inc

MAY 17 1999

MANUFACTURING . PRODUCT DEVELOPMENT CONTRACT FILLING . CREATIVE PACKAGING

ELS . LOTIONS UCTS . SHAMPOOS

## ABBREVIATED 501(k)-SUMMARY

SUBMITTER'S NAME: San-Mar Laboratories, Inc.

ADDRESS: 4 Warehouse Lane Elmsford, New York 10523

TELEPHONE: [phone]

FAX: [phone]

CONTACT PERSON: Irwin Silverberg Vice President

DATE PREPARED: September 1, 1998

NAME OF DEVICE

PROPRIETARY NAME: CVS PERSONAL LUBRICANT

COMMON/USUAL NAME: Personal Lubricant

CLASSIFICATION NAME: Patient Lubricant-Class I

PREDICATE DEVICE: Astroglide Personal Lubricant, K935291

DESCRIPTION OF DEVICE: "CVS Personal Lubricant" is a clear , colorless and odorless personal lubricant, which is composed of the following ingredients; Purified Water, Glycerin, Propylene Glycol, Polyquaternium #5, Methyparaben and Propylparaben. The "CVS Personal Lubricant" bottle is composed of high density polyethylene plastic.

INTENDED USE: Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and and the ease of intimate activity.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Astroglide Personal Lubricant and "CVS Personal Lubricant" consist of a water and glycerin base, with the addition of thickening and preservative ingredients.

SUBSTANTIAL EQUIVALENCE: The ingredients used in the manufacture of "CVS Personal Lubricant" are substantially the same as those used to manufacture Astroglide Personal Lubricant.

While the actual percentage of each ingredient may vary slightly, it is likely, given the nature of the ingredients and the usual quantities found in such formulations, that such variation is not significant.

Therefore, "CVS Personal Lubricant" is substantially equivalent to Astroglide Personal Lubricant, manufactured by BioFilm, Inc., Vista, CA 92083.

- STATEMENT: San-Mar Laboratories, Inc. believes that all information submitted herewith is truthful and accurate and that no material facts have been omitted.
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fair. 3 of 3

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## DOCUMENTATION REFERENCES:

21 Code of Federal Regulations, April 1, 1997-Parts 800, 801, 803, 804, 807, 814, 820, 821, 860, 880.

21 CFR Part 820 Medical Devices: Qualiy System Regulation; Current Good Manufacturing Practice; Final Rule, October 7, 1996.

Federal Food, Drug, and Cosmetic Act, As Amended July 1993, Chapter V, Sec. 501, 502, 503, and 513.

Federal Medical Device Quality System Final Rule, October 7, 1996, 21 CFR Parts 808, 812, 820.

The New 501(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications-Final Guidance, March 20, 1998.

FDA Modernization Act of 1997-Guidance for the Device Industry on Implementation of Highest Priority Provisions, February 6, 1998.

Guidance Addendum: How to Submit a Premarket Notification [501(k)], March, 1995.

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MAY 1 7 1999

Mr. Irwin Silverberg Vice-President San-Mar Laboratories. Inc. 4 Warehouse Lane Elmsford, New York 10523 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983216 CVS Personal Lubricant Dated: March 26, 4 1999 Received: April 1, 1999 Requlatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Silverberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing maior requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Recister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

K983216 510 (k) Number (if known) :

Device Name: CVS PersonalLubricant Liquid

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Indications For Use:

Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use

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(Optional Format 1-2-96)

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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983216/5002