INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

K992438 · Indus Medicare , Ltd. · LTZ · Aug 2, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K992438
• Device Name: INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
• Applicant: Indus Medicare , Ltd.
• Product Code: LTZ · Obstetrics/Gynecology
• Decision Date: Aug 2, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5310
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Invigra Plus condom is used for contraception and for prophytic purposes. Invigra Plus Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Device Story

Invigra Plus is a male natural rubber latex condom coated with a spermicidal lubricant. Designed for over-the-counter use, it serves as a physical barrier for contraception and reduction of STD/HIV transmission risk. The device functions by preventing direct contact between bodily fluids during intercourse. Users apply the device manually. Clinical benefit is derived from its barrier properties and the chemical action of the spermicidal lubricant. Labeling must comply with 21 CFR 801.435 regarding expiration dating, requiring shelf-life validation for both the condom and the spermicide.

Clinical Evidence

No clinical data provided; substantial equivalence is based on established regulatory standards for latex condoms and spermicidal lubricants.

Technological Characteristics

Natural rubber latex condom; spermicidal lubricant; physical barrier mechanism; over-the-counter form factor; compliant with 21 CFR 884.5310.

Indications for Use

Indicated for contraception and prophylaxis against pregnancy, HIV/AIDS, and other STDs (chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis) in individuals using male natural rubber latex condoms.

Regulatory Classification

Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 1999

Mr. P.K. Reddy Managing Director INDUS Medicare LTD. Suryodya 144. S.P. Road Hyderabad 500 016 INDIA

Re: K992438

INVIGRA Plus Brand Male Latex Condom with Spermicidal Lubricant Dated: July 19, 1999 Received: July 22, 1999 Regulatory Class: II 21 CFR §884.5310/Procode: 85 LTZ

Dear Mr. Reddy:

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.

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## Page 2 - Mr. P.K. Reddy

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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: [phone] or [phone], or at its Internet address: "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

David A. Sayre

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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## VII. INDICATIONS FOR USE STATEMENT

Applied For

510(K) Number:

Device Name:

Indications for use:

: 上一篇: 上一篇:

Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom

The Invigra Plus condom is used for contraception and for prophytic purposes. Invigra Plus Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

## (Please do not write below this line)

Concurrence of CDRH, Office of Device Evoluation (ODB)

Claind A. Symm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Over-the-Counter Use

INDUS MEDICARE LIMITED

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