TRUST DAM

K091769 · Line One Laboratories, Inc. · MSC · Feb 5, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K091769
• Device Name: TRUST DAM
• Applicant: Line One Laboratories, Inc.
• Product Code: MSC · Obstetrics/Gynecology
• Decision Date: Feb 5, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.

Device Story

Oral dam; natural rubber latex sheet; covers pubic areas during oral-genital stimulation. Dimensions: 154 mm lay flat width, 250 mm length, 0.07 mm thickness. Non-lubricated; food-grade cornstarch dressing. Derived from male latex condoms conforming to ASTM D3492:2008. Used as physical barrier to reduce transmission of bodily fluids, germs, and STDs during sexual activity. Operated by user.

Clinical Evidence

Bench testing only. Device conforms to ASTM D3492:2008 standards for male latex condoms.

Technological Characteristics

Natural rubber latex; 154 mm width, 250 mm length, 0.07 mm thickness; non-lubricated with food-grade cornstarch. Conforms to ASTM D3492:2008. Standalone physical barrier.

Indications for Use

Indicated for individuals engaging in oral/vaginal or oral/anal sexual activity to reduce transmission of bodily fluids, germs, and sexually transmitted diseases.

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

• Sheer Glyde Dams (K990067)

Reference Devices

• Male Latex Condoms (K070830)

Submission Summary (Full Text)

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K09/769

## Abbreviated 510 (k) Notification for a Male Latex Condom

Page 5 of 13

### 510(k) SUMMARY

| Contact Person: | Eli J. Carter, Consultant<br>PO Box 12139<br>Durham, NC 27709<br>Tel: [phone]; Fax: [phone]<br>Email: [e-mail] | | | | FEB - 5 2010 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------|--|--------------|
| Date Prepared: | June 10, 2009 | | | | |
| Proprietary Name: | Trust Dams | | | | |
| Common Name: | Latex Dams | | | | |
| Classification Name: | Latex Dams | | | | |
| Predicate Devices: | Sheer Glyde Dams<br>K990067 | | | | |
| Description of Device: | This oral dam is made of natural rubber latex, which completely covers<br>a person's pubic areas during oral genital stimulation. This dam has a<br>smooth surface (both sides), nominal lay flat width 154 mm, nominal<br>length 250 mm, and nominal thickness 0.07mm. It is non- lubricated,<br>and food grade cornstarch is used as a dressing material.<br><br>The condoms from which the oral dams are made conform to current<br>established national and international voluntary standards which<br>include ASTM D3492:2008; and have been previously cleared by the<br>USFDA (ref: K070830).<br><br>The condoms will be offered in the following Colors and Flavors: | | | | |
| | | Color | Flavor | | |
| | 1. | Yellow | Banana | | |
| | 2. | Red | Strawberry | | |
| | 3. | Green | Mint | | |
| Indications for Use: | The Line One Trust Dam is used as a barrier when<br>engaging in oral/vaginal sex and oral/anal sex to help<br>reduce the transmission of bodily fluids, harmful germs,<br>and sexually transmitted diseases. | | | | |

## Technological Characteristics:

This oral dam has the same technological characteristics as the listed predicate device identified above. The latex condoms (sheaths) from which the dams are made conform with the ASTM D3492:2008 Male Latex Condom Standard.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

FEB - 5 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Line One Laboratories, Inc. c/o Mr. Eli Carter Consultant Eli Carter & Associates P.O. Box 12139 DURHAM NC 27709

Re: K091769

Trade Name: Trust Dam Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MSC Dated: January 25, 2010 Received: January 28, 2010

Dear Mr. Carter:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related

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adverse events) (21 CFR 803); 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.

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.goy/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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 STATEMENT

510(k) Number:

K_091769

Line One Trust Dam Device Name:

# Indications for Use

Indications for Use: The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.

(Sistsion Sign-Off)

Division of Reproductive. Abdominal, and Radidlogical Deviees 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)

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