TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS

{0}------------------------------------------------ ## p lofiz KOGZ638 ## Section 5: 510(k) Summary | Submitted by: | The Procter & Gamble Company<br>6110 Center Hill Avenue<br>Cincinnati, OH 45224 | NOV 22 2006 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------| | Contact Person: | Mark M. Anderson, Ph.D.<br>Regulatory Affairs Manager<br>(513) 634-5196 (voice)<br>(513) 634-7364 (FAX) | | | Date Summary Prepared: | September 1, 2006 | | | Trade Name: | TAMPAX® Compak Pearl Plastic Applicator Scented<br>Tampons and TAMPAX® Compak Pearl Plastic<br>Applicator Unscented Tampons | | | Common Name: | Scented Menstrual Tampon<br>Unscented Menstrual Tampon | | | Classification Name: | Scented or Scented Deodorized Menstrual Tampon<br>(21 CFR 884.5460) | | | | Unscented Menstrual Tampon (21 CFR 884.5470) | | | Predicate Devices: | TAMPAX® Compak Compact Plastic Applicator<br>Tampons - Scented and Unscented | | | | Tambrands, Inc., K880023 (Regular Absorbency);<br>K880022 (Super Absorbency) | | Device Description: The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. It is available in both scented and unscented versions. - The absorbent pledget consists of a scented or unscented pad of rayon ● fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped 彩 pledget. - The formed pledget is inserted into a plastic applicator consisting of an inner . pusher tube and an outer insertion tube with a closed, rounded tip. - Each tampon is wrapped in an individual plastic film wrapper and packaged . in sealed multi-unit containers for retail sale. Intended Uses: These devices are intended to be inserted into the vagina to absorb menstrual fluid. {1}------------------------------------------------ - Technological Characteristics: These devices are similar to the predicate devices in terms of component materials, overall design and labeling. These devices incorporate a change in the fragrance (scented version), changes in the colorants used in the plastic applicators, changes in the dimensions of the pad of absorbent fibers, and a change in the pledget overwrap configuration. - Safety Assessment: A battery of safety tests was conducted, including in vitro microbiological testing, biocompatibility testing and extraction testing, to evaluate the safety profile of the 510(k) devices. The results of these safety tests support the conclusion that these 510(k) devices are equally as safe as the predicate devices. - Effectiveness: TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons comply with the syngyna absorbency requirements of 21 CFR 801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate tampons in terms of effectiveness. - Conclusions: The results of evaluations of these devices support the conclusions that they are safe for their intended use and that they are substantially equivalent to the cited predicate devices with regard to safety and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is black and the background is white. ## NOV 2 2 2006 Mark M. Anderson, Ph.D. Regulatory Affairs Manager The Procter & Gamble Company, The Winton Hill Business Center Product Safety & Regulatory Affairs 6110 Center Hill Avenue CINCINNATI OH 45224 Re: K062638 Trade/Device Name: TAMPAX® Compak Pearl Plastic Applicator Scented/Unscented Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampons Regulatory Class: II Product Code: HIL and HEB Dated: November 6, 2006 Received: November 7, 2006 Dear Dr. Anderson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 Nostman Act (Act) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/2/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the logo in a stylized font. There are three stars below the word "Centennial". The logo is surrounded by a thin black border. Protecting and Promoting Public Health {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely vours. Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Section 4: Indications for Use Statement 510(k) Number (if known): K062438 Device Name: IAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons Indications for Use: TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons are menstrual trim 180 that are inserted into the vagina and used to absorb menstrual fluid. Prescription Use (Part 21 CFR 801 Supbart D) AND/OR Over-The-Counter Use _ X (21 CFR Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David h. Soyer --- (Division Sign Off) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Page 4.1 000013