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 Description

This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.

The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).

The condoms will be offered in the following Colors and Flavors:

Yellow Banana
Red Strawberry
Green Mint

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a male latex condom (Trust Dams). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with detailed acceptance criteria and expert-read studies.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving it meets those criteria. Specifically:

No acceptance criteria table or reported device performance is present because this is a physical medical device (condom), not an AI algorithm. The performance is assessed against established standards for latex condoms.
No sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details are provided, as these are concepts relevant to AI/algorithm validation, not to the pre-market notification for a physical medical device like a condom.
No training set details are relevant here.

The document indicates that the device (Trust Dams) is made from natural rubber latex condoms that conform to established national and international voluntary standards, specifically ASTM D3492:2008 Male Latex Condom Standard. The predicate device is "Sheer Glyde Dams (K990067)", and the condoms from which the oral dams are made were previously cleared by the USFDA (K070830).

The "technological characteristics" section states: "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." This conformity to an established industry standard is the primary basis for demonstrating substantial equivalence for this type of device.

In summary, the provided text does not contain information about an AI or algorithmic device study. It details the 510(k) submission for a physical medical device (latex dam) and bases its substantial equivalence on adherence to existing condom standards.

Summary

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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, ConsultantPO Box 12139Durham, NC 27709Tel: 919 544 4098; Fax: 919 544 5849Email: carterej@aol.com
Date Prepared:	June 10, 2009
Proprietary Name:	Trust Dams
Common Name:	Latex Dams
Classification Name:	Latex Dams
Predicate Devices:	Sheer Glyde DamsK990067
Description of Device:	This oral dam is made of natural rubber latex, which completely coversa person's pubic areas during oral genital stimulation. This dam has asmooth surface (both sides), nominal lay flat width 154 mm, nominallength 250 mm, and nominal thickness 0.07mm. It is non- lubricated,and food grade cornstarch is used as a dressing material.The condoms from which the oral dams are made conform to currentestablished national and international voluntary standards whichinclude ASTM D3492:2008; and have been previously cleared by theUSFDA (ref: K070830).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 whenengaging in oral/vaginal sex and oral/anal sex to helpreduce the transmission of bodily fluids, harmful germs,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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 884.5300 Condom.

(a)
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.(b)
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.