(315 days)
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Not Found
No
The 510(k) summary describes a standard latex condom and makes no mention of AI or ML technology.
No
The device is described as being used for contraception and to help prevent the transmission of sexually transmitted diseases, which are preventative rather than therapeutic functions.
No
The device is a condom, used for contraception and prevention of STD transmission, not for diagnosing medical conditions.
No
The device description clearly states it is a physical condom made of natural rubber latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a condom used for contraception and preventing the transmission of sexually transmitted diseases. It is a physical barrier device applied externally to the penis.
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples to provide diagnostic information.
Therefore, based on the provided information, the Remed Preventor Coconut 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 Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.
Product codes
85 HIS
Device Description
The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut 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
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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 (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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 Re: K993409 Remed Pharma Male Banana Tutti Frutti Natural Rubber Latex Condom Dated: July 10, 2000 Received: July 11, 2000 Requiatory 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 and we have getermined the We have reviewed your Section 510(K) noticalions for use stated in the endos reditate devices and device is substantially equivalent (10 the nates in the endotal of orgalic of the Medical Perice Areners, or to devices that marketed in interstate commerce proc to May 26, 1976, the enders one model oneits Art (Act). You may, therefore,
have been reclassified in accordance with the provisions of have been reclassified in accordance with the provisions of the Act. The general convisions of the Act Includes of the Act Include market the device, subject to the general controls provisions of the general control of the end of the end of the mail of the and adulteration.
If your device is classified (see above) into either class III (Special Controls) in the Code of Federal Regulations. Title 2 lf your device is classified (see above) into elitection your device can be Code of Federal Regulation, Title 21,
such additional controls. Existing major regulations affec such additional controls. Extrang major regulations and Servit the Current Good Manufacturing Pracio.
Parts 800 to 895. A substantially equivalent delemination assumes neg Parts 800 to 895. A substantally equivalent delemination in assults overal resultsion (21 CFR Pat 820), and requirements, as set forth in the Qualif (QS) in Reden Brillen Bonnel (server stock socknown). Fallure to ormply will that, through periodic US inspections, the Fod and Drug Forminstation of the movements concerning your device in the GMP regulation may result in regulation in artistic notification submitssion does and after any obligation, you might the Federal Register. Please note: this response to your pennation backless of the Subscription of the Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematies in vour device and hus This letter will allow you to begily marketed predicate device in your over 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 Pat 801 and additionally for questions on the mombination lf you desire specific advice for your device of Our (21 v. 14). Additionally (econvestions on the promotions on the promotion and diagnostic devices), please contact the of Compliance at (301) 694-639. Also, please note the regulation entiled.
advertising of your device, please contact the of Compline advertising of your device, please contact the Off of Post and interprises wour resording under the mode the "Misbranding by releence to perflaked nources in Cor. ST/P - Cher goller (Mornal Mornet More on Pool (800) 63-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsma/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
510(K) Number (if known): K993409
Device Name: Remed Pharma Male Coconut Tutti Frutti Natural Rubber Latex Condom
Indications for Use:
The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut 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)
Prescription Use
Over-the-Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K993409