VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS

{0}------------------------------------------------ VII ## 510K SUMMARY ## Device Name: Paragon Trade Brand Digital Tampons Legally marketed device: These Tampons are substantially equivalent to legally marketed Tampax tampons with applicators. Device description: Paragon Trade Brands Digital Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus. These Paragon Trade Brands Tampons are made from rayon and cotton and cotton cord. The material used in Paragon Trade Brand tampons are similar to those used in other legally marketed tampons. Intended Use: Paragon Trade Brands Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid. ## Assessment of Performance Standards: Not Applicable Non-Clinical Testing: biocompatibility testing of the Paragon Trade Brands Tampons components was carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of Paragon Trade Brand Digital tampons. Relevant Studies form the literature include: - � irritation testing - 0 sensitization testing - 0 acute oral toxicity - 0 eye irritation testing - 0 gene toxicology studies - 0 chronic studies - 0 reproductive studies Studies carried out specific to Paragon Trade Brands Components include: - 0 cytotoxicity testing - 0 dioxins and furans analysis {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 1998 Paragon Trade Brands c/o Robert J. Staab, Ph.D. Regulatory and Technical Associates 73 Franklin Tpk. Allendale, NJ 07401 Re: K983381 Paragon Trade Brands Tampons Dated: September 23, 1998 Received: September 25, 1998 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB Dear Dr. Staab: We have reviewed vour 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 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 probibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral 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. 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmaldsmamain.html". Sincerely yours Lillian Yin, Ph.D. Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/15 description: The image is a black and white abstract design. It features a triangular shape on the left side, with a jagged edge. The right side of the image is filled with a cluster of irregular shapes, creating a sense of visual texture and contrast. ATTACHMENT XI Page of ## 510(k) NUMBER (IF KNOWN): K98336) DEVICE NAME: Various Trade-Tampons-sold under private Label INDICATIONS FOR USE: Intended Use As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470) Paragon Trade Brands Digital Tampons are made of a plug of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 4 1 - 1 IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use ( (Optional Format 1-2-96) Yurid h. Seaymon (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number