PERSONAL WARMING GEL

K050211 · Qualis, Inc. · NUC · Mar 17, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050211
• Device Name: PERSONAL WARMING GEL
• Applicant: Qualis, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.

Device Story

Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy liquid gel used as a personal lubricant. It is intended for over-the-counter use to enhance the ease and comfort of intimate sexual activity. The device is compatible with latex condoms. It is applied topically by the user. The gel provides lubrication during intimate activity.

Clinical Evidence

Bench testing only. Evidence includes 90-day accelerated stability testing and an anti-microbial preservative effectiveness challenge. No clinical data provided.

Technological Characteristics

Non-sterile, clear, non-staining, nongreasy liquid gel. Formulated for compatibility with latex condoms. No specific materials or software components described.

Indications for Use

Indicated for individuals engaging in intimate sexual activity to enhance ease and comfort; compatible with latex condoms. No specific age or gender contraindications noted.

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 Warming Ultra Gel Personal Lubricant (K040340)

Submission Summary (Full Text)

{0}------------------------------------------------

K050211

Oryelgf2

## 510 (k) Summary of Information Respecting Safety and 9. Effectiveness

- Legally Marketed Device. A.
Qualis claims substantial equivalence to K-Y Warming Ultra Gel Personal Lubricant (K040340), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc..

- Device Description. B.
Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy, liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.

- C. Intended Use.
Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.

- Comparison with Predicate Device. D.
A summary comparison of the features of Personal Warming Gel and the Predicate Device K-Y Brand Warming Ultra Gel Personal Lubricant is provided in Table 1.

- E. Performance Data
Non-Clinical Studies.

- Stability. 1.
Personal Warming Gel has successfully passed 90 day accelerated stability.

{1}------------------------------------------------

510(k) Premarket Notification Qualis, Inc. Personal Warming Gel

Kósozll

Jágé zafz

- Preservative Effectiveness. 2.
An anti-microbial preservative challenge has been completed for Personal Warming Gel. The Preservative Effectiveness Study Report is in Attachment E.

- Comparison with Predicate Device. 3.
Personal Warming Gel was compared to K-Y Brand Warming Ultra Gel Personal Lubricant on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was an acceptable comparison. See Attachment B for the Shuster comparison Report.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2005

Mr. Mike Peterson Quality Assurance Manager Qualis Inc. 4600 Park Ave DESMOINES IA 50321

Re: K050211 Trade/Device Name: Personal Warming Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 NUC Dated: January 18, 2005 Received: January 31, 2005

Dear Mr. Peterson:

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 the enolosate, to regally manthly of the Medical Device Amendments, or to devices that have been ready 20, 1770, 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 do not require upproval or wordsions of the Act. The general controls provisions of the Act device, subjor to the generation, listing of devices, good manufacturing practice, fabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket it your do roo to subject to such additional controls. Existing major regulations affecting your Apployally, it they of salyes to at Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of tound mouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Rase be advised that i Dr rion that your device complies with other requirements of the Act or any FDA has made a decemination and your would be other Federal agencies. You must comply with all the If coclar statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling ACT STEQuirements, medading, but not mixted is and (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) i mis letter will anow you to begin maneting of substantial equivalence of your device to a legally prematication. The PDA mailing of Cassification 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 If you desire spective auvice for your cerres on other 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 Also, please note the regulation emiliou, "Alsociation on your responsibilities under the Act from the 807.97). You may obtain other gelleral mional 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,

Nancy C. Hodgdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Personal Warming Gel

Indications For Use: Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms

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)

Nancy C. Brogdon
(Division Sign-Off)

ive, Abdominal, Division of Reproduct and Radiological Devices 510(k) Number

Page 1 of 1