PERSONAL WARMING JELLY

K050212 · Qualis, Inc. · NUC · Mar 17, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050212
• Device Name: PERSONAL WARMING JELLY
• 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 Jelly is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms.

Device Story

Personal Warming Jelly is a non-sterile, clear, non-staining personal lubricant. It is applied topically to enhance ease and comfort during intimate sexual activity. The device is compatible with latex condoms and is intended for over-the-counter use. It functions as a physical lubricant to reduce friction.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including 90-day accelerated stability testing and an anti-microbial preservative challenge study.

Technological Characteristics

Non-sterile, clear, non-staining personal lubricant. Formulated for compatibility with latex condoms. No electronic or mechanical components.

Indications for Use

Indicated for individuals engaging in intimate sexual activity to enhance ease and comfort; compatible with 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

• K-Y Warming Jelly (K040164)

Submission Summary (Full Text)

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K050212 MAR 17 2005

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

- Legally Marketed Device. A.
Qualis claims substantial equivalence to K-Y Warming Jelly Qualis claims cant (K040164), currently in commercial I Crsonal Lucrican on Products Company Division of McNeil-PPC inc ..

- Device Description. B.
Personal Warming Jelly is a non-sterile, clear, non-staining, I ersonal walling Jelly used as a personal lubricant. This non groups, inquily lubricous and may be used with or without a latex condom during intimate sexual activity.

- Intended Use. C.
Personal Warming Jelly 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 Jelly and the Predicate Device K-Y Brand Warming Jelly Personal Lubricant is provided in Table 1.

- Performance Data E.
Non-Clinical Studies.

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

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

Kogawa 212
Page 242

## Preservative Effectiveness. 2.

An anti-microbial preservative challenge has been An and International Warming Jelly. The Preservative Effectiveness Study Report is in Attachment E.

- Comparison with Predicate Device. 3.
Personal Warming Jelly was compared to K-Y Brand Warming Jelly Personal Lubricant on the basis of warming loss, 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2005

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

Re: K050212 Trade/Device Name: Personal Warming Jelly 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 we have levice your becared your becally equivalent (for the indications for use stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the enclosure) to regary marketed predical Device Amendments, or to devices that have been May 26, 1770, the charantenedato of the Federal Food, Drug, and Cosmetic Act (Act) that recrassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premanel approvisions of the Act. The general controls provisions of the Act device, subject to the general controls prove, 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 (Premarket 11 your device is classified (600 above) and controls. Existing major regulations affecting your Apploval), It ifay of subject to such aceral Regulations, Title 21, Parts 800 to 898. In addition, FDA ucvice can be round in the coments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Flease oc advised mar 1 27 i in that your device complies with other requirements of the Act or any FDA has made a decemination and your rederal agencies. You must comply with all the I cuean statues and regulations as a limited to registration and listing (21 CFR Part 807); labeling ACL S requirements, morading, but not a more a cause as set forth in the quality systems (QS) (21 CFR Part 801); 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) This letter will allow you to begin marketing your artice of your device of your device of your device to a legally
premarket notification. The FDA finding of substantial eq premarket notification. The FDA Inting of substantial of 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 specific advice for your device on our labering regarances.
contact the Office of Compliance at one 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 entitled, "Misoranians" of tressnonibilities under the Act from the 807.97). You may obtain other general information on your respections of its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at DIVISion of [phone] or at its Internet address 058-2041 or (901) v/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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): Ko50212

Device Name: Personal Warming Jelly

Indications For Use: Personal Warming Jelly is designed to enhance the ease and comfort mulcations For SSC. Forechants of Scottan Processor of intimate activity and imm

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)

Division of Revenductive, Abde and Radiological Devices minal, 510(k) Number.

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