PHARMAPAC PERSONAL LUBRICANT

K091554 · Pharmapac, LLC · NUC · Aug 7, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091554
• Device Name: PHARMAPAC PERSONAL LUBRICANT
• Applicant: Pharmapac, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Lubricating Liquid is a personal lubricant, for penile and/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 natural rubber latex, polyisoprene, and polyurethane condoms.

Device Story

PharmaPac Personal Lubricant is a water-based, non-greasy, clear gel-like liquid. Applied topically to penile and/or vaginal areas by the user to provide lubrication and moisture during sexual activity. Product supplements natural lubrication and is compatible with common condom materials (latex, polyisoprene, polyurethane). Intended for over-the-counter use.

Clinical Evidence

Bench testing only. Stability confirmed via accelerated stability study (90 days at 40°C / 75% R.H.) and parallel microbial testing in accordance with USP standards to support a 24-month shelf life.

Technological Characteristics

Water-based gel formulation. Ingredients consist of USP/NF grade components and Hydroxyethyl cellulose. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Non-greasy, non-sticky, non-staining, water-soluble.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during intimate sexual activity and supplement natural lubrication. Compatible with natural rubber latex, polyisoprene, and polyurethane 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 Personal Lubricant (K955648)

Submission Summary (Full Text)

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K091554

## 510(k) Summary

| Submitter | PharmaPac, LLC<br>110 Industrial Park Road<br>DeKalb, MS 39328 | AUG 07 2009 |
|---------------------|----------------------------------------------------------------|-------------|
| Contact Person | Tom Otto<br>[phone] phone<br>[phone] fax | |
| Date Prepared | 29 April 2009 | |
| Proprietary Name | PharmaPac Personal Lubricant | |
| Common Name | Personal Lubricant | |
| Classification Name | Patient Lubricant | |
| Predicate Device | K-Y® Brand Personal Lubricant (K955648) | |

## Description of Device

PharmaPac Personal Lubricant is a water-based personal lubricant formulated to be a non-greasy, non-sticky, non-staining clear gel-like liquid. The water-soluble formula allows this product to be rinsed off with water.

#### Intended Use

Lubricating Liquid is a personal lubricant, for penile and/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 natural rubber latex, polyisoprene, and polyurethane condoms.

# Technological Characteristics of Device Compared to Predicate

The technological characteristics of the PharmaPac Lubricating Jelly are identical to those of the predicate devices. This includes being formulated with only United States Pharmacopeia (USP) or National Formulary (NF) ingredients, all of which are listed as "Generally Recognized As Safe" (GRAS) with the exception of Hydroxyethyl Cellulose. As also noted in the predicate device, Hydroxyethyl cellulose is listed in the FDA's Inactive Ingredient Guide and has been historically been widely used in many drug products e.g. oral syrups and tablets, also otic and ophthalmic solutions.

### Performance Data

Stability of the PharmaPac Lubricating Jelly was confirmed throughout its labeled shelf life (24 Months) by an accelerated stability study for 90 days at 40°C / 75% R.H. and parallel microbial study in accordance with USP standards.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, representing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-9609 Silver Spring, MD 20993-0002

PharmaPac LLC c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG 0 7 2009

Re: K091554

Trade/Device Name: PharmaPac Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: NUC Regulatory Class: II Dated: July 22, 2009 Received: July 23, 2009

Dear Mr. Job:

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 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); medical device reporting (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Iadine M. Morris

Janine M. Morris Acting 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):

Device Name: . PharmaPac Personal Lubricant

Indications for Use:

Lubricating Liquid is a personal lubricant, for penile and/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 natural rubber latex, polyisoprene, and polyurethane condoms.

19155

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C (Part 21 CFR 801 Subpart E BELOW THIS LINE-CONTINUE ON ANOTHER (PLEASE DO NOT WR PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Heles Leurs

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