(315 days)
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Not Found
No
The 510(k) summary describes a standard condom and makes no mention of AI or ML technology.
No
This device is intended for contraception and prevention of sexually transmitted diseases, which are preventative measures rather than therapeutic treatments for existing conditions.
No
Explanation: The device is a condom, intended for contraception and prevention of sexually transmitted diseases. It does not diagnose any condition or disease.
No
The device is a physical condom made of natural rubber latex, 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 of the Remed Preventor Strawberry Tutti Frutti Condom is for contraception and preventing the transmission of sexually transmitted diseases by covering the penis. It does not involve testing or analyzing biological samples.
- The description focuses on a physical barrier device. The device description clearly outlines a physical sheath made of latex.
- There is no mention of any diagnostic testing or analysis. The provided text does not describe any process of analyzing samples or providing diagnostic information.
Therefore, the Remed Preventor Strawberry Tutti Frutti Condom is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.
Product codes
HIS
Device Description
The Remed Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives.
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
penis
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The background is plain white.
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2000
Remed Pharma c/o E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114
Dear Mr. Smith:
Re: K993403 Remed Pharma Strawberry Male Tutti Frutti Natural Rubber Latex Condom Dated: July 10, 2000 Received: July 11, 2000 Requiatory Class: II. 21 CFR 884.5300/Procode: 85 HIS
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, 1975, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Oode 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 Recister. 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 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.
If 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 Compliance at (301) 594-4591. 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" (21CFR 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
INDICATION FOR USE STATEMENT
510(K) Number (if known): K993403
Device Name: Remed Pharma Male Strawberry Tutti Frutti Natural Rubber Latex Condom
Indications for Use:
The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives. It 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)
or
Prescription Use
Over-the-Counter Use X
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number