(225 days)
Not Found
Not Found
No
The summary describes a physical medical device (condoms) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The intended use of the device is for contraception and prophylactic purposes, not for treating or rehabilitating a disease or injury.
No
The device, a condom, is intended for contraception and prevention of disease transmission, not for diagnosing medical conditions.
No
The device description clearly states it is fabricated of natural rubber latex and is a physical sheath, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the condoms are for contraceptive and prophylactic purposes, specifically to reduce the risk of pregnancy and transmission of STDs. This is a direct physical barrier method used during sexual intercourse.
- Device Description: The description details the physical construction and materials of the condom.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (like blood, urine, or tissue) to diagnose a condition or disease. IVDs are designed for in vitro examination of specimens derived from the human body.
The device is a medical device, but it falls under the category of a barrier contraceptive and prophylactic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ansell condoms are male contraceptive devices, fabricated of latex, which are designed to completely cover the penis during sexual intercourse. These condoms are intended to be used for contraceptive and prophylactic purposes. 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 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.
The LifeStyles Xtra Pleasure condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. 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 (comma separated list FDA assigned to the subject device)
85 HIS, 85 LTZ
Device Description
Ansell condoms are male contraceptive and prophylactic devices, which are fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. Ansell condoms are designed to conform to established national and international voluntary standards including ASTM D 3492, ISO 4074 and EN 600.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
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.
Male Latex Condoms
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
JUL 2 1 1999
CONFIDENTIAL
ANSELL CONDOMS
Summary of Safety and Effectiveness
Submitter:
Ansell Incorporated 1500 Industrial Road Post Office Box 1252 Dothan, Alabama 36302 Phone: (334) 794 - 4231 Fax: (334) 792 - 8485
Date summary was prepared:
November 25, 1998
Name(s) of the device:
Ansell Condoms
Identification of predicate device(s):
Male Latex Condoms
Description of the device:
Ansell condoms are male contraceptive and prophylactic devices, which are fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. Ansell condoms are designed to conform to established national and international voluntary standards including ASTM D 3492, ISO 4074 and EN 600.
Intended Use:
Ansell condoms are male contraceptive devices, fabricated of latex, which are designed to completely cover the penis during sexual intercourse. These condoms are intended to be used for contraceptive and prophylactic purposes. 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 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,
December 4, 1998 Ansell Condoms
1
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.
Comparison of device characteristics to predicate:
The indications for use for the line of condoms covered by this 510(k) are the same as predicate male latex condoms. The design and manufacture of these condoms are the same as predicate male latex condoms. Therefore, this line of condoms is substantially equivalent.
Conclusion:
Because the condom materials and manufacturing processes conform to domestic and international regulations, no new safety and effectiveness issues are expected to be raised.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 1999
Mr. Lon D. McIlvain Quality Assurance/Regulatory Manager Ansell Incorporated 1500 Industrial Road P.O. Box 1252 Dothan, Alabama 36302
Re: K984392
Male Latex Condoms - Repackaging of Outsourced Condoms Dated: April 21, 1999 Received: April 22, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS 21 CFR §884.5310/Procode: 85 LTZ
Dear Mr. McIlvain:
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
3
Page 2 - Mr. Lon D. McIlvain
Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 products 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 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.
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number:
None assigned as of this time
Ansell Condoms Device Name:
Indications for Use:
The LifeStyles Xtra Pleasure condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. 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)
Image /page/4/Picture/9 description: The image contains a simple black rectangle. The rectangle is vertically oriented and appears to be a solid shape with no internal details. The background is plain and white, providing contrast to the dark rectangle.
Prescription Use (per 21 CFR 801.109)
Image /page/4/Picture/11 description: The image shows a simple line drawing of a square with a diagonal arrow pointing from the top right corner to the bottom left corner. The arrow is drawn with a single line and appears to be pointing downwards and to the left. The square is also drawn with a single line and appears to be a simple representation of a box or container.
Over-the Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 510(k) Number_
December 4, 1998 Ansell Condoms