(130 days)
Not Found
Not Found
No
The 510(k) summary describes a physical barrier device (condom) and contains no mention of AI, ML, or any software-based functionality that would typically incorporate these technologies.
No
The device is described as being used for contraception and preventing the transmission of sexually transmitted diseases, which are prophylactic measures, not therapeutic (treatment of an existing condition).
No
Explanation: The device is a condom, used for contraception and prevention of STDs. It does not diagnose any condition.
No
The device description clearly states it is a "natural rubber latex sheath," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the condom is a physical barrier applied to the penis. It does not involve the analysis of any biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
- The function is mechanical/barrier. The primary function is to prevent physical contact and the transmission of fluids, not to perform a diagnostic test on a sample.
The description aligns with a Class II medical device used for contraception and disease prevention through a physical barrier.
N/A
Intended Use / Indications for Use
The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
Product codes
85 HIS
Device Description
The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a series of interconnected human figures.
Public Health Service
FEB 1 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Remed Pharma c/o E. J. Smith Consultant Smith Associates P.O. Box 4341 Crofton, MD 21114 Re: K993404 Remed Pharma Male Natural Rubber Latex Condom Preventor, Lucky Boy, and Summit Dated: December 20, 1999 Received: December 21, 1999 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS
Dear Mr. Smith:
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.
Please note: this response to your premarket notification submission 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 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. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
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Page 2 - Mr. E. J. Smith
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,
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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
2
INDICATION FOR USE STATEMENT
K993404 510(K) Number (if known):
Device Name: Remed Pharma Male Natural Rubber Latex Condom
Indications for Use:
The Remed Preventor Classic Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Classic is a parallel sided, plain surfaced condom with no color additives, and is used for contraception and to help prevent the transmission of sexually transmitted diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
Radiological Devices
510(k) Number K993404