PERSONAL WARMING LUBRICANT

K040085 · Qualis, Inc. · HIS · Apr 20, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040085
• Device Name: PERSONAL WARMING LUBRICANT
• Applicant: Qualis, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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

Device Story

Personal Warming Lubricant is a non-sterile, clear, non-staining, non-greasy, high-viscosity liquid gel. It is applied topically by the user during intimate sexual activity to provide lubrication. The device is compatible with latex condoms. It functions as a physical lubricant to reduce friction and enhance comfort. It is intended for over-the-counter use by consumers.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including 90-day accelerated stability studies and antimicrobial preservative effectiveness testing.

Technological Characteristics

High-viscosity liquid gel; non-sterile; non-staining; non-greasy. Formulated for compatibility with latex condoms. No electronic or software components.

Indications for Use

Indicated for individuals engaging in intimate sexual activity to enhance ease and comfort; compatible with latex condoms. Over-the-counter use.

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 Warming Liquid Personal Lubricant (K021492)

Submission Summary (Full Text)

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K040085

## APR 2 0 2004

510(k) Premarket Notification Personal Warming Lubricant

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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 Brand Warming Liquid Personal Lubricant (K021492), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc..

- Device Description. B.
Personal Warming Lubricant is a non-sterile, clear, nonstaining, non-greasy, high viscosity 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 Lubricant is designed to enhance the case 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 Lubricant and the Predicate Device K-Y Brand Warming Liquid Personal Lubricant is provided in Table 1.

- Performance Data E.
Non-Clinical Studies.

- 1. Stability.
Personal Warming Lubricant has successfully passed 90 day accelcrated stability.

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

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- Preservative Effectiveness. 2.
Personal Warming Lubricant successfully passed the requirements of the Qualis, Inc., anti-microbial preservative challenge. See Attachment D for the Preservative Effectiveness Study Report

- Comparison with Predicate Device. 3.
Personal Warming Lubricant was compared to K-Y Brand Warming Liquid 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 ACTS comparison Report.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2004

Mr. Mike Peterson Quality Assurance Manager Qualis, Inc. 4600 Park Avenue DES MOINES IA 50321

Re: K040085

Trade/Device Name: Personal Warming Lubricant Regulation Number: 21 CFR §880.6375 Regulation Name: Patient Lubricant Product Code: 80 MMS Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: 85 HIS Regulatory Class: II Dated: January 15, 2004 Received: January 23, 2004

Dear Mr. Peterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) is the enactment date of the Medical Device Amendments, or to conimered provises that have been reclassified in accordance with the Federal Food, Drug, devices that have been receasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision 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 i Toast to advised that I Dr overan that your device complies with other requirements of the Act that I Dr Han made a and regulations administered by other Federal agencies. You must of any I edotal battatoo use as a requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), faceming (25) regulation (21 CFR Part 820); and if applicable, the electronic rorni in the quinty of trol 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 antini equivalence of your device to a legally premarket notification. The PDA miding of succemand equivalias on 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 last ling of your bers, based on the regulation number at the top of the letter.

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion on the regulation entitled, "Masbranding
Office of Compliance at [phone]. Internation one one Othce of Compliance at [phone]. Tably processor.97) you may obtain. Othics general by reference to premarket notification (210) It it it is a be obtained from the Division of Small information on your responsionalism uncer the reach its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-drively and consem Manufacturers, International and Collisamer institution in the market in the manain. html.

Sincerely yours,

Nancy C. Brogdon

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): K040085

Device Name: Personal Warming Lubricant

Indications For Use; Personal Warming Lubricant 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 X (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)

Daniel A. Denman

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

510(k) Number .

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