Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Device Description

The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a shaped, teat ended, lubricated condom which is lubricated with a water based warming lubricant.

AI/ML Overview

This document is a 510(k) premarket notification for a Durex Male Latex Condom with Warming Lubricant. It does not describe a study that proves the device meets acceptance criteria in the way a medical device AI/algorithm submission would. Instead, it demonstrates substantial equivalence to predicate devices based on conformity to existing standards and physical testing.

Here's an analysis of the provided text in the context of your request, highlighting what is and isn't present:

This submission is for a physical medical device (condom with lubricant), not an AI/algorithm. Therefore, many of the requested criteria regarding AI performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable or described in the provided text.

However, I can extract the relevant information regarding the device's conformance to standards and the basis for its safety and effectiveness.

Acceptance Criteria and Reported Device Performance (as much as can be inferred):

Acceptance Criteria (Inferred)	Reported Device Performance
Conformance to ISO 4074	Conformance stated
Conformance to ASTM D3492	Conformance stated
Physical testing	Conformance to required specifications
Lubricant compatibility	Water-based, condom compatible

Explanation of the Study and Device Conformance (where applicable):

A table of acceptance criteria and the reported device performance
See table above. The document states, "The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted." And for the finished product, "Physical testing and release testing of the finished product revealed results in conformance with required specifications."
Sample size used for the test set and the data provenance
Not explicitly stated in the provided text. For a physical device, testing involves material properties and functional tests, often using batches or statistical samples, which are not detailed here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is not an AI/algorithm submission requiring expert-established ground truth. Conformance to standards is the primary "ground truth" for this type of device.
Adjudication method for the test set
Not applicable as this is not an AI/algorithm submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical device, not an AI/algorithm.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an AI/algorithm.
The type of ground truth used
The "ground truth" for this device's acceptance is its conformance to established national and international voluntary standards (ISO 4074 and ASTM D3942) and its physical/release testing specifications.
The sample size for the training set
Not applicable. There is no AI/algorithm training set for this physical device.
How the ground truth for the training set was established
Not applicable. There is no AI/algorithm training set. The "ground truth" for the device's safety and effectiveness is established through its design, materials, manufacturing processes, and testing that demonstrate conformance to recognized engineering and product standards for condoms and lubricants. The substantial equivalence argument relies on comparing these characteristics to legally marketed predicate devices.

Summary

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Premarket Notification [510(k)] application

K 0512957

FEB 1 7 2005

Section II Summary

Submitter Information A. _

SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233

B. Contact Person

Chris Robinson, Controller Head of Global Regulatory Affairs, SSL Americas

C. Date Prepared

October 8, 2004

D. Proprietary Name

Durex Male Latex Condom with warming lubricant. Trade name: Durex Warming Pleasure.

E. Common Name

Male Latex Condom

F. Classification Name

મારિ

G. Predicate Device

Durex Latex Rubber Condom - 510(k) Number K980319 Trojan Shared Pleasure condom - 510(K) Number unknown. KY Warming liquid personal lubricant - 510(k) Number K021492

H. Description of the Device

The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted.

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I. Intended Use of the Device

This latex condom has the same intended use as the predicate condoms. This lates condom nas the camo mon and for prophylactic purposes (to help The condom is aoou for contrassmission of sexually transmitted diseases). prevent pregnancy and the transmit the same intended use as the predicate rne warming condowhen used as an accessory to a condom. It relieves portonial labrisant and comfort of intimate sexual activity.

J. Technological Characteristics

This condom has the same technological characteristics as the predicate rmle Sondom nus the condoms described in K980319 are manufactured of ootuothe latex with the same shape as the condoms in this application. The competitor Trojan Shared Pleasure condoms are Natural Rubber Latex male condoms with 'Warm Sensations' lubricant to help enhance sexual pleasure.

The K-Y Warming liquid (K021492) is a water based, condom compatible personal lubricant which provides a warming sensation. It is of similar composition as the warming lubricant on the Durex condom in this submission.

The condom design conforms to domestic and international regulations: ASTM D3942 and ISO 4074. Physical testing and release testing of the finished product revealed results in conformance with required specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris Robinson Controller Head of Global Regulatory Affairs SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K042957

FEB 1 7 2005

Trade/Device Name: Durex Male Latex Condom with Warming Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: January 31, 2005 Received: February 9, 2005

Dear Mr. Robinson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 FI)A 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 clectronic 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 and my was finding of substantial equivalence of your device to a legally prematicated notified by one of 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 11 you don't 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 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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Durex Male Latex Condom with Warming Lubricant

Premarket Notification [510(k)] application

Indications for Use K042957 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use: Durex latex condom used for contraception and for manoutic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use

01 Subpart D)

(21 CFR 807

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ernst M. Seyrum

Division Sion-Off Division of Reproductive, Abdomina and Radiological Device 510(k) Number

Page 1 of 1.

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.