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 straight walled , teat ended, coloured condom containing either red, yellow, orange or green pigment. The condoms are lubricated with a water based flavoured lubricant containing either lychee, guava, pineapple, mango or kiwi scent.

The device is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492-03.

AI/ML Overview

Here's an analysis of the provided information regarding the Durex Male Latex Colored Condom with Scented Lubricants, focusing on acceptance criteria and supporting studies:

It's important to note that this 510(k) application (K052959) is for a medical device that is a physical product (a condom), not a software-based AI/ML device. Therefore, many of the typical AI/ML-specific questions (like effect size of AI assistance, standalone algorithm-only performance, training set details, or complex ground truth establishment) are not applicable in this context. The "acceptance criteria" here refer to the device's conformance to established international and domestic standards for condoms, rather than performance metrics of an AI algorithm.

Acceptance Criteria and Device Performance for Durex Male Latex Colored Condom with Scented Lubricants

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Conformance)	Reported Device Performance
Material: Natural Rubber Latex	Conforms: Made of natural rubber latex sheath.
Design: Straight-walled, Teat-ended, Colored	Conforms: Straight walled, teat ended, colored (red, yellow, orange, green pigment).
Lubrication: Water-based, Scented	Conforms: Lubricated with water-based flavored lubricant (lychee, guava, pineapple, mango, kiwi scent).
Regulatory Conformance (General): Domestic and International Regulations	Conforms: Designed to conform to national and international voluntary standards.
Specific Standard 1: ISO 4074:2002 (Natural latex rubber condoms — Requirements and test methods)	Conforms: Device design conforms to ISO 4074:2002. Physical testing and release testing revealed results in conformance with required specifications.
Specific Standard 2: ASTM D3492-03 (Standard Specification for Rubber Contraceptives (Male Condoms))	Conforms: Device design conforms to ASTM D3492-03. Physical testing and release testing revealed results in conformance with required specifications.
Intended Use Equivalence: Contraception and Prophylaxis (STD prevention)	Conforms: Same intended use as predicate devices (K980174 & K900679). Used for contraception and for prophylactic purposes.
Technological Characteristics Equivalence: Material, Form, Lubricant Base, Pigments	Conforms: Same technological characteristics as predicate condoms. Same basic formulation as predicate devices (K980174 & K900679), same pigments, aqueous based lubricants.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a numerical sample size for the "test set" in the context of device testing. It states: "Physical testing and release testing of the finished product revealed results in conformance with required specifications."

Sample Size: Not explicitly stated. The testing would have been done on a manufacturing batch or sample of the produced condoms.
Data Provenance: Not explicitly stated, but it would be prospective testing conducted on manufacturing samples of the device itself. The country of origin of the data would likely be where the manufacturing and quality control testing took place (e.g., the manufacturer's facility or a contracted lab).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable to this type of device (physical condom). "Ground truth" in this context refers to the established standards (ISO 4074:2002 and ASTM D3492-03) and the objective measurements performed against these standards (e.g., burst pressure, dimensions, tensile strength, freedom from holes).
The "experts" involved would be a combination of engineers, quality control specialists, and regulatory affairs personnel who conduct and interpret the physical and chemical tests according to the established methodologies outlined in the referenced standards. Their qualifications would typically include expertise in materials science, mechanical engineering, and quality assurance relevant to rubber products.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations of data in diagnostic or AI studies. For a physical device like a condom, conformance to standards is determined through objective physical and chemical testing with pre-defined pass/fail criteria, not consensus among experts adjudicating subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (especially imaging) where human readers interpret patient cases, often with and without AI assistance, to assess the AI's impact on human performance. This is irrelevant for a physical contraceptive device like a condom.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The device is a physical product (condom), not an algorithm or software. There is no AI component to assess in a standalone mode.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on objective measurements against established engineering and material standards. Specifically, the ground truth is defined by the requirements and test methods outlined in ISO 4074:2002 and ASTM D3492-03. This includes parameters like:
- Dimensions (length, width, thickness)
- Burst volume and pressure (critical for tensile strength and hole prevention)
- Freedom from holes
- Package integrity
- Material composition properties
- Lubricant quantity and type

8. The Sample Size for the Training Set

This question is not applicable as there is no AI/ML model being "trained" for this physical device. The "training" for such a device involves developing and refining the manufacturing process, which is based on material science, engineering principles, and previous experience with similar products, rather than a data-driven training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. The establishment of "ground truth" (i.e., performance characteristics) for manufacturing and design would be based on:
- Extensive material science research and development for rubber latex.
- Adherence to internationally recognized standards (ISO, ASTM) which are developed through expert consensus, rigorous testing, and clinical experience over many years to define what constitutes a safe and effective condom.
- Feedback from previous product generations and market surveillance.

Summary

{0}------------------------------------------------

K052959

Durex Male Latex Colored Condom with Scented Lubricants Premarket Notification [510(k)] application

Section II: Summary

A. Submitter Information

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

September 2005

D. Proprietary Name

Durex male latex colored shaped condoms with scented lubricants Trade name: Durex Tropical

E. Common Name

Male latex condom

ட் Classification Name માર્ડ

G. Predicate Devices

Durex Colors and Scents - 510(k) Number K980174 Durex Mint Scented Condom - 510(k) Number K900679 (plus 'note to file' line extension dated 30.09.2003)

H. Description of the Device

The device is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492-03.

{1}------------------------------------------------

Durex Male Latex Colored Condom with Scented Lubricants

Premarket Notification [510(k)] application

Intended Use of the Device -

This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

J. Technological Characteristics

This condom has the same technological characteristics as the predicate condoms identified.

The condoms described in K980174 are natural rubber latex, straight walled, teat ended condoms containing pigments (red, yellow, orange) lubricated with scented lubricants (strawberry, banana, tangerine). This application is also concerned with straight walled, teat ended, colored natural rubber latex condoms of the same basic formulation containing the same pigments as used in the predicate devices, but with aqueous based lubricants with the alternative scents of lychee, guava, pineapple, mango.

The condoms described in K900679 are straight walled, teat ended, natural rubber latex condoms lubricated with a spearmint flavor. An 'Add to File' was prepared in September 2003 to cover a natural rubber latex condom containing green pigment and lubricated with spearmint flavour sourced from a new supplier. This application is also concerned with the same green pigmented natural rubber latex condom with an alternative scented (kiwi) lubricant.

The condom design conforms to domestic and international regulations: ASTM D3942-03 and ISO 4074:2002. Physical testing and release testing of the finished product revealed results in conformance with required specifications.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left.

Public Health Service

JAN 2 7 2006

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: K052959

Trade/Device Name: Durex Male Latex Colored Condom with Scented Lubricants Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 10, 2005 Received: November 7, 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 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 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:

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/industry/support/index.html.

Sincerely yours,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Durex Male Latex Colored Condom with Scented Lubricants

Premarket Notification [510(k)] application

Indications for Use

510(k) Number (if known):

K052959

Device Name:

Durex Tropical (male latex colored condom with scented lubricants)

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

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Nancy C. Brodon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052959

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.