INVIGRA

K993693 · Indus Medicare , Ltd. · HIS · Dec 29, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K993693
• Device Name: INVIGRA
• Applicant: Indus Medicare , Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Invigra is a male natural rubber latex condom; red-colored and strawberry-flavored. Used for contraception and prophylactic protection against pregnancy and STDs. Intended for over-the-counter use by individuals. Device acts as a physical barrier to prevent exchange of bodily fluids during sexual intercourse.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Natural rubber latex. Form factor: Male condom. Features: Red-colored, strawberry-flavored. Regulatory class: II (21 CFR 884.5300).

Indications for Use

Indicated for contraception and reduction of risk of pregnancy and transmission of HIV (AIDS) and other STDs (chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis) in individuals using male latex condoms.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Mr. P.K. Reddy Managing Director Indus Medicare Limited 144, S.P. Road Begumpet, Hyderabad Andhra Pradesh - 500 016 INDIA

Re: K993693 INVIGRA Male Latex Condom Red Colored & Strawberry Flavored Dated: October 28, 1999 Received: November 2, 1999 Requlatory Class: II 21 CFR §884.5300/Procode: HIS 85

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 reguirements 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 Requlation (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.

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.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiiance 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 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

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FROM

## ਜਿ ANNEA

TCI

## VI INDICATIONS FOR USE STATEMENT

Applied For K993693 510(K) Number: Device Name: Invigra - Male Natural Rubber Latex Condom Indications for use: The Invigra Condom is used for contraception and for prophylactic purposes. Invigra Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HTV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. 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)

/(Over the counter)

INDUS MEDICARE LIMITED

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number.

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