(28 days)
The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.
DUREX Latex Condom with Male Genital Lubricant is made of a natural rubber latex sheath with lubricant Desensitizer containing Benzocaine, an over-the-counter drug recognized as safe and effective by US FDA under 21 CFR 5300 for condom and 21 CFR Part 348 for external analgesic drug products for over-the-counter human use. The condom is a straightwalled, nipple-end condom with the nominal length of 180 mm and width of 52 mm as required by ASTM D-3492-97.
The provided text is a 510(k) Pre-market Notification for a latex condom, and as such, it does not contain the detailed information typically associated with clinical studies for device performance or AI/ML model evaluations. The document focuses on demonstrating substantial equivalence to a predicate device, which primarily relies on technological characteristics, safety, and intended use, rather than a rigorous performance study with acceptance criteria in the manner requested.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to compliance with ASTM D-3492-97 for "Rubber Contraceptives (Male Condoms)" as the primary standard for the device's technical specifications. While the exact acceptance criteria from this ASTM standard are not explicitly listed in the document, meeting this standard would imply passing its specified tests for dimensions, burst volume/pressure, and freedom from holes. The document states that both the proposed and predicate devices "are of the similar design meeting ASTM Standard (D3492) specification."
| Acceptance Criteria (Implied by ASTM D-3492-97 compliance) | Reported Device Performance (Implied by substantial equivalence and ASTM compliance) |
|---|---|
| Nominal length of 180 mm | Meets nominal length of 180 mm |
| Nominal width of 52 mm | Meets nominal width of 52 mm |
| Burst volume/pressure (specific values not stated) | Meets ASTM D-3492-97 requirements |
| Freedom from holes (specific values not stated) | Meets ASTM D-3492-97 requirements |
| Benzocaine concentration for desensitizer (effective and safe) | Benzocaine recognized as safe and effective by US FDA under 21 CFR 5300 and 21 CFR Part 348 |
| Shelf life for latex condom and lubricant | Must comply with 21 CFR 801.435, with expiration date supported by test data (data not included in 510(k), but required to be maintained) |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. The document focuses on substantial equivalence based on design and material rather than a specific clinical performance test set. Data provenance is not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable and not provided. This is a device submission for a condom, not an AI/ML diagnostic device requiring expert ground truth for image or diagnostic interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This information is not applicable and not provided. This is not an AI-assisted device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
For the physical characteristics of the condom, the "ground truth" would be established by physical measurements and standardized tests as outlined in ASTM D-3492-97. For the desensitizer lubricant, the ground truth for safety and effectiveness is based on the FDA's existing recognition of Benzocaine as safe and effective under 21 CFR 5300 and 21 CFR Part 348.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This is not an AI/ML device relying on a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided.
Summary of what is present in the document regarding "proof of meeting acceptance criteria":
The primary "proof" relies on the device meeting the ASTM D-3492-97 standard for male condoms and the fact that Benzocaine is a recognized over-the-counter drug for desensitizing purposes by the FDA. The submission states that the proposed device, with "variation merely in the lubricant application," is technologically similar to the predicate device and meets the same ASTM standard. The FDA's letter of clearance indicates that the agency determined the device is "substantially equivalent" to legally marketed predicate devices, implying that it meets the necessary safety and effectiveness requirements, including those indirectly referenced by the ASTM standard and Benzocaine's existing regulatory status. The FDA also specifically mentions the requirement to comply with 21 CFR 801.435 for expiration dating, supported by test data, which must be maintained by the manufacturer.
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MAR 2 9 2002
510(k) Pre-market Notification DUREX Latex Condom with Male Genital Desensitizer Lubricant SSL-Americas, Inc.
February 28, 2002
PART VIII. 510(K) SUMMARY
| Submitter by: | SSL Americas, Inc.3585 Engineering DriveNorcross, Georgia 30092 |
|---|---|
| Contact Person: | Joyce NingVice President, Regulatory AffairsPhone: (770) 582-2152 |
| Date Prepared: | February 15, 2002 |
| Proprietary Name: | Durex® latex condom with male desensitizer lubricant |
| Common Name: | Latex Condom |
| Classification Name: | Condom (21 CFR § 884.5300) |
| Predicate Device: | DUREX® Hispano Ico Latex Condom (K952415) andMale Condom with Desensitizer (K8220088) |
Description of the Device: DUREX Latex Condom with Male Genital Lubricant is made of a natural rubber latex sheath with lubricant Desensitizer containing Benzocaine, an over-the-counter drug recognized as safe and effective by US FDA under 21 CFR 5300 for condom and 21 CFR Part 348 for external analgesic drug products for over-the-counter human use. The condom is a straightwalled, nipple-end condom with the nominal length of 180 mm and width of 52 mm as required by ASTM D-3492-97.
Intended Use of the Device: DUREX Latex Condom with Male Genital Desensitizer Lubricant has the same intended use as the predicate condom. It is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases (STDs). In addition, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time till ejaculation.
Technological Characteristics: Both the proposed device and the predicate device are of the similar design meeting ASTM Standard (D3492) specification for Rubber Contraceptives (Male Condoms). Both are straight-walled, nipple-end, lubricated made with the similar formulation of natural rubber latex. The proposed condom is a modification of the predicate device with variation merely in the lubricant application.
Image /page/0/Picture/10 description: The image shows the logo for SSL Americas, Inc. The logo consists of the text "SSL Americas, Inc." with a curved line above and below the text. The text is in a bold, sans-serif font. The logo is in black and white.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Joyce Ning Vice President Regulatory Affairs SSL Americas, Inc. 3585 Engineering Drive, Suite 200 P.O. Box 926090 NORCROSS GA 30092-9214
MAR 2 9 2002
Re: K020659
Trade Name/Device: DUREX® Latex Condom with Male Genital Desensitizer Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: February 28, 2002 Received: March 1, 2002
Dear Ms. Ning:
We have reviewed your Section 510(k) notification of intent to market the device referenced above w durve 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 (QS) 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.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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 8801.435(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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR §807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
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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510(k) Pre-market Notification
DUREX Latex Condom with Male Genital Desensitizer Lubricant
SSL-Americas, Inc. February 28, 2002
PART V. INDICATIONS FOR USE STATEMENT
3.0
Indications for Use Statement
| Applicant: | SSL-Americas, Inc. |
|---|---|
| 510(k) Number (if known): * | K020659 |
| Device Name: | DUREX ® Latex Condom with Male Genital Desensitizer Lubricant |
Indications for Use:
The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | or | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
|--|--|
SSL Americas, Inc.
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K020659 |
|---|---|
| --------------- | --------- |
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§ 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.