(90 days)
No
The device description and intended use focus on the physical properties of a latex condom and the chemical properties of a desensitizing lubricant. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The primary intended uses are contraceptive and prophylactic (reducing risk of STIs and pregnancy), not for treating a disease or condition. While the desensitizing lubricant may address premature ejaculation, this is a secondary function and does not classify the overall device as primarily therapeutic.
No
This device is a male latex condom designed for contraception and prevention of sexually transmitted diseases. It is not used to diagnose any condition or disease.
No
The device description clearly states it is a physical product made of natural rubber latex with lubricant, designed to cover the penis. It is a tangible medical device, 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 perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The provided description clearly states that this device is a male latex condom used for contraception and prophylaxis during sexual intercourse. It is a physical barrier device applied to the body, not a device used to test samples from the body.
- Intended Use: The intended use is to prevent pregnancy and reduce the risk of transmitting sexually transmitted diseases through physical contact. This is a preventative and barrier function, not a diagnostic testing function.
The presence of a desensitizing lubricant containing Benzocaine is a drug component, but the overall device's primary function is not diagnostic.
N/A
Intended Use / Indications for Use
The LifeStyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
Product codes
85 HIS
Device Description
These condoms are male contraceptive and prophylactic devices fabricated of natural rubber latex with lubricant containing Benzocaine, an over-the-counter drug generally recognized as safe and effective by the U.S. FDA as a male genital desensitizer (21 CFR Part 348 - External Analgesic Drug Products for Over-the-Counter Human Use). The condoms are designed as fitted sheaths with an integral ring at the open end and a reservoir at the closed end to contain semen. These condoms are designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K030176
II. 510(k) SUMMARY
| Submitted by: | Ansell Healthcare Inc.
1500 Industrial Road
Dothan, AL 36303
USA | | APR 1 7 2003 | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------|--|--|
| Contact Person | Lon D. McIlvain
Quality Assurance/Regulatory Manager | Telephone: 334-794-4231 or 334-615-2562
Fax: 334-615-2568 | | | |
| Date Prepared: | January 15, 2003 | | | | |
| Proprietary Name: | LifeStyles, Contempo or private label –
Latex Condom with Male Genital Desensitizer Lubricant | | | | |
| Common Name: | Latex condom | | | | |
| Classification Name: | Condom (21 CFR §884.5300) | | | | |
| Predicate Device: | Suretex Prophylactics (India) Limited, Royale Brand Latex
Condoms (Silicone) Natural or Assorted Colors
510(k) Document Control Number K983320
Suretex Ltd., Latex Condoms with Spermicidal Lubricant
(Natural or Assorted Colors)
510(k) Document Control Number K942858 | | | | |
Description of the Device:
These condoms are male contraceptive and prophylactic devices fabricated of natural rubber latex with lubricant containing Benzocaine, an over-the-counter drug generally recognized as safe and effective by the U.S. FDA as a male genital desensitizer (21 CFR Part 348 - External Analgesic Drug Products for Over-the-Counter Human Use). The condoms are designed as fitted sheaths with an integral ring at the open end and a reservoir at the closed end to contain semen. These condoms are designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600.
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Intended Use of the Device:
These condoms have the same intended use as the predicate condoms. The condoms are used for contraception and for prophylactic purposes. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. If used properly, these condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B. and syphilis. In addition, these condoms will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condoms should be applied before any such contact.
Technological Characteristics:
The basic design, composition (natural rubber latex) and manufacture of these condoms are the same as the predicate male latex condoms. The condom design conforms to national and international regulations: ASTM D3492, ISO 4074 and EN 600. Accordingly, when compared to the predicate male latex condoms, the condoms intended to be introduced do not incorporate any significant changes in intended use, method of operations, materials, or design that could affect safety and effectiveness. The proposed condom is a modification of the predicate device in that the condoms differ only in the lubricant applied.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cynthia A. Ingram Regulatory Affairs Administrator Ansell Healthcare, Inc. 1500 Industrial Road P.O. Box 1252 DOTHAN AL 36302
APR 1 7 2003
Re: K030176
Trade/Device Name: Male Latex Condom with Desensitizing Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: January 15, 2003 Received: January 17, 2003
Dear Ms. Ingram:
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 (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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Page 2 - Ms. Cynthia Ingram
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 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. 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 yours,
David A. Syverson
Image /page/3/Picture/6 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is likely from a document or other official paper.
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 STATEMENT
| 510(k) Number: | None assigned as of this time
K030176 |
|----------------|-------------------------------------------------------------------------------------------|
| Device Name: | LifeStyles, Contempo or private label -
Male Latex Condom with Desensitizing Lubricant |
Indications for Use:
The LifeStyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109) OR Over-The-Counter Use
✓
David G. Ingram
510/k) Nimi