(55 days)
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No
The provided text describes a condom and its intended use for contraception and STD prevention. There is no mention of any technology, let alone AI or ML.
No.
The device is indicated for contraception and prophylactic purposes, which are preventative rather than therapeutic.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the Invigra Condom is "used for contraception and for prophytic purposes" and helps "reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD)". It does not mention detection, diagnosis, monitoring, or treatment of any disease or condition; rather, it's a preventative measure.
No
The 510(k) summary describes a physical medical device (a condom) and provides no information about any software component.
Based on the provided information, the Invigra Condom is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for contraception and prophylactic purposes (reducing the risk of transmission of STDs). This is a physical barrier method used externally on the body.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or providing information about a person's internal health status.
Therefore, the Invigra Condom falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Invigra Condom is used for contraception and for prophytic 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 syphliss. contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
Product codes
HIS
Device Description
Invigra - Male Natural Rubber Latex Condom
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the top and left side of the design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 1999
Mr. P.K. Reddy Managing Director INDUS MEDICARE LTD. 144, S.P. Road Begumpet, HYDERABAD ANDHRA PRADESH - 500 016 INDIA
Re: K991374 INVIGRA Male Latex Condom Dated: April 19, 1999 Received: April 21, 1999 Regulatory Class: II 21 CFR 8884.5300/Procode: 85 HIS
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 (OS) 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 (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,
Elwood G. Begeman
$\mu$
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
K991374 Applied For 510(K) Number: Invigra - Male Natural Rubber Latex Condom Device Name: The Invigra Condom is used for contraception and for Indications for use: prophytic 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 syphliss. 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)
prescription __
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number
INDUS MEDICARE LIMITED
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No