(41 days)
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.
Invigra - Male Natural Rubber Latex Condom
The provided document is an FDA 510(k) clearance letter for the INVIGRA Male Latex Condom and does not contain information on acceptance criteria for a device performance study nor a description of such a study. Instead, it confirms the device is substantially equivalent to legally marketed predicate devices.
The document refers to labeling requirements for latex condoms (21 CFR §884.5300 and 21 CFR §801.435) which include an expiration date supported by test data. However, the specific acceptance criteria for these tests, the study design, or the results are not detailed in this document.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence and post-market labeling requirements rather than a detailed performance study with acceptance criteria.
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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.
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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 (301) 594-4616. 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 (301) 443-6597,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
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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
§ 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.