(28 days)
K952415, K8220088
Not Found
No
The document describes a physical medical device (condom) with a drug-based lubricant, and there is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is primarily intended for contraception and prevention of STDs, not for treating or curing a medical condition. While the desensitizer helps prolong ejaculation, it is a temporary effect and not a treatment for premature ejaculation.
No
Explanation: This device is used for contraception and prophylaxis against STDs, not for diagnosing medical conditions. The desensitizer is for prolonging ejaculation, which is a functional effect, not a diagnostic one.
No
The device description clearly states it is a "natural rubber latex sheath with lubricant" and provides physical dimensions, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DUREX Latex Condom with Male Genital Desensitizer Lubricant is a barrier device used for contraception and disease prevention. It also contains a drug (Benzocaine) to temporarily prolong ejaculation.
- Lack of Specimen Analysis: The device does not analyze any specimens from the human body. Its function is physical (barrier) and pharmacological (drug delivery).
Therefore, based on the provided information, this device clearly falls outside the definition and function of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K952415, K8220088
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Drive
Norcross, Georgia 30092 |
|----------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Joyce Ning
Vice President, Regulatory Affairs
Phone: (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) and
Male 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.
2
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
3
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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