INVIGRA

K020223 · Indus Medicare , Ltd. · HIS · Mar 4, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020223
• Device Name: INVIGRA
• Applicant: Indus Medicare , Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

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 HIV 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 Male Natural Rubber Latex Condom; intended for contraception and prophylactic protection against STDs/HIV. Device functions as physical barrier; prevents exchange of bodily fluids during sexual intercourse. Used by consumers in home/private settings; over-the-counter availability. Effectiveness dependent on proper use; no contraceptive guarantees 100% efficacy. Device provides patient benefit through pregnancy prevention and risk reduction of sexually transmitted infections.

Clinical Evidence

No clinical data provided; substantial equivalence based on compliance with established regulatory standards for latex condoms, including expiration dating requirements per 21 CFR 801.435.

Technological Characteristics

Natural rubber latex; physical barrier device; dimensions/form factor standard for male condoms; non-sterile or sterile as per standard manufacturing; no software or electronic components.

Indications for Use

Indicated for use by individuals for contraception and the reduction of risk of transmission of HIV and other STDs.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure, emphasizing the organization's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2002 MAR

Mr. P.K. Reddy Managing Director INDUS MEDICARE LIMITED 144, S.P. Road Begumpet, HYDERABAD ANDHRA PRADESH-500 016 INDIA

Re: K020223

Trade Name/Device: INVIGRA Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: January 16, 2002 Received: January 22, 2002

Dear Mr. Reddy:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your becally in the device is substantially equivalent (for the indications for use above and we nave dolorimined and articled predicate devices marketed in interstate commerce stated in the encrosale) to logally manate of the Medical Device Amendments, or to devices that provision 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 Costlede Act (Act). " Fouritaly and controls provisions of the Act include requirements for provisions of the Act. "The general vestably of the 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 (1 Childrice Approval), it the J of Saysee of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good 893. A substainmally oquirements, 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 mspections, the Food and Diam may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please note: this response to your premarket notification submission does not affect any I teluse note. " uns response to your prions 531 through 542 of the Act for devices under the obligation you might have ancor 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 nonication. The I Dry imating of bassification 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 I Rase be advisod that, as of Mass Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the 21 Cl Ic 801.435. "History as (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 axpiration be compared with the areng 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, 100 ures that you mamani and uneal-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. mounds in 9001:199(4), and 1 outh 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 If you desire specific at [phone]. Additionally, for questions on the connotion and advertising of your device, please contact the Office of Compliance at (301) 594promotion and the regulation entitled, "Misbranding by reference to premarket 4057. Also, production of the general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer may oc obtained from the DPT12000 638-2041 or [phone],or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

David G. Segnon

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

## VII. INDICATIONS FOR USE STATEMENT

510(K) Number:

## Applied For KO20223

Device Name:

Indications for use:

Invigra - Male Natural Rubber Latex Condom

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 HIV 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)

**Over-the-Counter Use**

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Bergman

(Division

## INDUS MEDICARE LIMITED

Page 18