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

Device Description

This condom is made of a natural rubber colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.

AI/ML Overview

This 510(k) submission for the Durex Flavored Latex Condom does not contain the detailed study information typically found for AI/ML-based diagnostic devices. This is a premarket approval for a physical medical device (condom) and therefore, the acceptance criteria and study design are related to manufacturing standards and physical performance tests, rather than algorithmic performance.

However, I can extract the relevant information based on the typical requirements for such devices, even if it's not presented in the same format as for an AI study.

Here's a breakdown of the information based on your request, applied to the context of a latex condom:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Standard)	Reported Device Performance (Conformance)
ISO 4074 (International voluntary standard for latex condoms)	Conforms to ISO 4074
EN 600 (European Standard for male condoms)	Conforms to EN 600
ASTM D3492 (Standard Specification for Rubber Contraceptives (Male Condoms))	Conforms to ASTM D3492
Physical Testing (e.g., burst pressure, freedom from holes, length, width, thickness)	All physical testing revealed results in conformance with required specifications.
Final Release Testing (e.g., visual inspection, integrity)	All final release testing revealed results in conformance with required specifications.
Shelf Life (Expiration Dating) for Latex Condoms (21 CFR 801.435)	Must comply with 21 CFR 801.435; expiration date supported by test data. Data maintained by manufacturer for FDA inspection.

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

This information is not provided in a typical AI/ML sense but rather refers to manufacturing quality control.

Sample Size: Not explicitly stated as a single "test set" sample size. Condoms are produced in large batches, and statistical sampling methods (e.g., AQL - Acceptable Quality Level) are used for quality control testing of physical attributes from each batch. The actual number of condoms tested would depend on the batch size and the specific testing protocol (e.g., for burst tests, freedom from holes).
Data Provenance: The testing is implied to be conducted by the manufacturer, SSL Americas, and its manufacturing partners (LS Rubber SDN and Thai Nippon Rubber Industry). It's a prospective internal quality control process during and after manufacturing.

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

In this context, "experts" are not human readers interpreting images, but rather the recognized standards bodies and material scientists/engineers who established the test methods and performance specifications for condoms.

Number of Experts: Not applicable in the sense of AI ground truth. The "ground truth" for condom quality is defined by the established national and international standards (ISO, EN, ASTM).
Qualifications of Experts: These standards are developed by committees of material scientists, engineers, medical professionals, and regulatory experts.

4. Adjudication Method for the Test Set

Not applicable in the sense of AI human reader adjudication. Product conformance to specifications is determined directly by objective physical and chemical tests against predefined limits set by the standards.

5. 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 as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. There are no "human readers" interpreting "cases" with or without "AI assistance."

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

Not applicable. There is no algorithm being tested. The device is a standalone physical product.

7. The Type of Ground Truth Used

The ground truth is based on established national and international voluntary standards for latex condoms (e.g., ISO 4074, EN 600, ASTM D3492) regarding physical properties, material composition, and performance. In addition, FDA regulation 21 CFR 801.435 defines the ground truth for expiration dating.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical manufacturing of condoms. The manufacturing process itself is akin to a "training" process, where continuous monitoring, process controls, and adjustments are made to ensure consistent product quality, but it's not a dataset in the AI sense.

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

Not applicable. As above, there's no "training set." The "ground truth" for manufacturing quality is established by adhering to Good Manufacturing Practices (GMP) and the quality control parameters derived from the aforementioned international standards and internal specifications.

Summary

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Durex Flavored Latex Condom Premarket approval [510(k)]

K032227

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

Kathleen Harris, Requlatory Affairs Manager, SSL Americas

C. Date Prepared July 11, 2003

D. Proprietary Name Durex Flavored Latex Condom

E. Common Name

Latex Condom

F. Classification Name

Condom (21 CFR 884.5300)

G. Predicated Device

Natural and Colored Condoms with Flavors [510(k) Number K020633] One Touch (or private label) Flavored Male Latex Condom [510(k) Number K011253]

Durex Lubragel Latex Rubber Condom [510(k) Number K983380]

H. Description of the Device

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Durex Flavored Latex Condom Premarket approval [510(k)]

I. 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 LS Rubber SDN and Thai Nippon Rubber Industry products are manufactured of natural rubber latex with flavor additives in lubricant . The Durex Lubragel product is the same condom and base lubricant as the product submitted in this 510(k). The condom design conforms to domestic and international regulations: ASTM D3492, ISO 4074 and EN 600. All physical testing and final release testing revealed results in conformance with required specifications.

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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized, curved lines that appear to be flowing or moving upwards. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2004

Ms. Kathleen Harris Regulatory Affairs Manager SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K032227

Trade Name/Device: Durex flavored Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: 85 HIS Dated: January 6, 2004 Received: January 8, 2004

Dear Ms. Harris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and §884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in §801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, §801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. 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

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Indications for Use

510(k) Number (if known): K032227

Device Name:___ Durex flavored natural rubber latex condom

Indications For Use: Durex latex condom is 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 X

(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. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033227

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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.