SENSUA!

K021125 · Aac Consulting Group, Inc. · HIS · Oct 25, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021125
• Device Name: SENSUA!
• Applicant: Aac Consulting Group, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.

Device Story

SENSUA! is a clear, colorless personal lubricating gel; composed of purified water, propylene glycol, L-arginine, hydroxyethyl cellulose, and methylparaben. Used as a moisturizer for vaginal dryness and personal lubricant to enhance comfort during intimate sexual activity and condom use. Intended for over-the-counter use by consumers. Device functions as a topical lubricant; no electronic or mechanical components.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing for condom compatibility and preservative effectiveness.

Technological Characteristics

Clear, colorless gel. Ingredients: purified water, propylene glycol, L-arginine, hydroxyethyl cellulose, methylparaben. Non-sterile, topical application. No electronic components, software, or energy sources.

Indications for Use

Indicated for individuals experiencing vaginal dryness requiring a moisturizer and personal lubricant to facilitate comfort during intimate sexual activity and enhance condom 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

• CVS Personal Lubricant (K983216)
• AstroGlide Personal Lubricant (K935299)
• LubriGel (K001077)

Submission Summary (Full Text)

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OCT 2 5 2002

# KOZIIZS

# 510(k) SUMMARY

## 1. General Information on Sponsor

| Name- | AAC Consulting Group Inc. |
|------------------|------------------------------------------------------|
| Address- | 7361 Calhoun Place, Suite 500<br>Rockville, MD 20855 |
| Telephone- | 301.838.3120 |
| Fax- | 301.838.3182 |
| Name of Contact- | Eduardo March |
| Date of Summary- | 3/ 8 / 02 |

# 2. General Information on Device

Name- SENSUA! Personal Lubricant

Classification Name: Patient Lubricant

### 3. Predicate Devices

CVS Personal Lubricant (K983216) by San Mar Labs Inc. AstroGlide Personal Lubricant (K935299) by Biofilm Inc. LubriGel (K001077) by Sheffield Labs

# 4. Description of the Device

SENSUA! is a clear, colorless personal lubricant composed of: purified water. Propylene glycol, L-arginine, Hydroxyethyl cellulose, Methylparaben and other ingredients.

# 5. Intended Use

Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.

#### 6. Substantial equivalence

SENSUA! is similar in function and intended use to the CVS Personal Lubricant and LubriGel. Sensua! has been tested for condom compatibility and preservative effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# CT 25 2002

Mr. Eduardo March Senior Consultant AAC Consulting Group 7361 Calhoun Place Suite 500 ROCKVILLE MD 20855-2765 Re: K021125

Trade/Device Name: Sensua! Personal Lubricating Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulation Number: 21 CFR 880.6375 Regulation Name: Patient lubricant Regulatory Class: II Product Code: 85 HIS and 80 KMJ Dated: July 30, 2002 Received: July 31, 2002

Dear Mr. March:

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 cnactment 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Grigdon

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

#### KO21125 510(K) NUMBER (If known):

Device Name:

# Indications for Use:

Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.

(Please do not write below this line -- Continue on other page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-the Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | X |

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number K021125