(315 days)
The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.
The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana flavor and no color additives.
The provided documents are regulatory approval letters and indication for use statements for "Remed Pharma Male Coconut Tutti Frutti Natural Rubber Latex Condom" and "Remed Pharma Male Banana Tutti Frutti Natural Rubber Latex Condom." They do not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details to prove the device meets them from the provided text. The documents indicate the devices are substantially equivalent to previously marketed predicate devices and thus permitted to proceed to market under general controls. There is no mention of specific performance studies or their associated metrics.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.
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: K993389 Remed Pharma Male Coconut Tutti Frutti Natural Rubber Latex Condom Dated: July 10, 2000 Received: July 11, 2000 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 around prodicely devices We have reviewed your Section 5 firent of then of the enclosied to teetily marketed predicate devices device is substantially equivalent (tor the endoment of our cendone) or velice (en memoriments, or to devices that marketed in interstate commerce prol to way 20, 1910, the Federal Food, Dog, and Cosmelin Act (Act). You may, therefore,
have been reclassified in accordance with the provi have been recassmed in accordance will the provisions of the Act. The penerge contriols provisions of the Act include market the device, subject to the general controls of the roc. "The golled online of the more of the more of the mail of the and adulteration.
If your device is classified (see above) into either class III (Fremarke Approval), it may be subject to If your device is classified (see above) into eller cass it (opedar Over in the Code of Federal Regulations, Title 21,
such additional controls. Existing major regulations a such additional controls. Extism frajo Tegulations and one with be Current Good Manufacturing Pradice
Parts 800 to 895. A substantially equivalent delemination (SOL (Conc Paris 800 (0 895. A substantally equivalent decembradion (AS) for Mediation (21 CFR Pat 820) and requirements, as set form in the Quality System Negulation (FDA) will verify such assumptions. Fallyre to comply with that, through periodic us inspections, the Pool and Drag runing publish further announcements concerning your device in the GMP regulation may result in regulation in addition submission does not affect any obligation you might the Federal Register. Please fore this response to your premaint neatler 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) premates in order device and thus This letter will allow you to begally 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 and any of the may in If you desire specific advice for you device of Online at (301) 594 4591. Additionally for quesions on the promotion and diagnostic devices), please contact the Office of Complianos at (311) 594-639. Also, please note the regulation entilled, under hand advertising of your device, please colliation" (21CFR 807.97). Other general information on your responsibilities under the may be "Misoranding by lelefited to prehiance nouleation (210-11-6. of its older gold-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel C. 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)
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INDICATION FOR USE STATEMENT
510(K) Number (if known):
Device Name: Remed Pharma Male Banana Tutti Frutti Natural Rubber Latex Condom
Indications for Use:
The Remed Preventor Banana Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Banana Tutti Frutti condom is a parallel sided, plain surfaced condom with banana 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 X
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
§ 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.