LIFESTYLES XTRA PLEASURE
Device Facts
| Record ID | K983518 |
|---|---|
| Device Name | LIFESTYLES XTRA PLEASURE |
| Applicant | Ansell, Inc. |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Jul 6, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
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.
Device Story
Male contraceptive and prophylactic device; natural rubber latex sheath. Features straight shaft, reservoir tip, and flared closed end to enhance stimulation. Applied by user to cover penis during sexual intercourse. Acts as physical barrier to semen and body fluids. No electronic or software components.
Clinical Evidence
No clinical data provided. Substantial equivalence based on design, material, and adherence to established standards.
Technological Characteristics
Natural rubber latex sheath; length 170-180mm; shaft width 51-54mm; thickness 0.060-0.075mm; max flare width 81mm. Complies with ASTM D3492-96. Lubricated with polysiloxane fluid.
Indications for Use
Indicated for use by males as a contraceptive and prophylactic device to cover the penis during sexual intercourse to reduce the risk of pregnancy and the transmission of HIV and other sexually transmitted diseases.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- LifeStyles Lubricated
Submission Summary (Full Text)
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JUL - 6 1999
Appendix P
510(K) SUMMARY
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| Submitter: | Ansell Incorporated<br>1500 Industrial Road<br>Post Office Box 1252<br>Dothan, Alabama 36302<br>Phone: (334) 794 - 4231<br>Fax: (334) 792 - 8485 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Date summary was prepared: | June 26, 1998 |
| Name(s) of the device: | LifeStyles Xtra Pleasure |
| Identification of predicate device(s): | LifeStyles Lubricated |
# Description of the device:
The LifeStyles Xtra Pleasure condom is a male contraceptive and prophylactic device, which is 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. While the shaft of the condom is straight, the closed end is flared and terminates to a nipple at the tip. The "flare" is intended to enhance stimulation by the condom.
The acceptable lengths of this condom are established at between 170-180mm. as permissible by ASTM standard D3492-96. Likewise, acceptable widths of the shaft range from 51-54mm, and thicknesses range from 0.060-0.075mm. The maximum bulb (or flared) width is not to exceed 81mm, per internal specifications.
The LifeStyles Xtra Pleasure Condom shall be packaged with the same polysiloxane fluid lubricant, as is applied to the predicate device.
# Intended 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
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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.
# Comparison of device characteristics to predicate
The LifeStyles Xtra Pleasure condom is considered substantially equivalent to the LifeStyles Lubricated condom. The Xtra Pleasure condom has the same intended use, is fabricated of essentially the same materials and is produced in accordance with the same standards and procedures as the predicate device. The primary difference between these devices is in the width of the flare portion of the device flare width of the Xtra Pleasure condom is approximately 10mm wider than that of the Lubricated condom.
#### Conclusion
Because of the strong similarities between the subject device and its predicate, no new safety and effectiveness issues are expected to be raised.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized emblem that resembles three abstract human profiles or faces, stacked on top of each other, with flowing lines beneath them that could represent water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 1999
Mr. Lon D. McIlvain Ouality Assurance/Regulatory Manager Ansell Incorporated 1500 Industrial Road P.O. Box 1252 Dothan, Alabama 36302
Re: K983518
LifeStyles Xtra Pleasure Condom Dated: May 20, 1999 Received: May 21, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS
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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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## Page 2 - Mr. Lon D. McIlvain
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(i) 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,
Hind A. Legare
CAPT. David S. Settle, MD
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
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K983518 510(k) Number: None assigned as of this time.
## Device Name: LifeStyles Xtra Pleasure Condom
#### 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)
Prescription Use (per 21 CFR 801.109)
Over-the Counter Use
Daniel h. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
