O.B. TAMPONS

{0}------------------------------------------------ K023789 Personal Products Company Division of McNeil – PPC, Inc. DEC 0 6 2002 Special 510(k), Device Modification Page 37 of 43 # 510(k) Summary of Safety and Effectiveness | Trade Name | o.b.® Tampons | | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common<br>Name | Menstrual tampons | | | Classification<br>Name | Unscented menstrual tampons<br>(21 CFR 884.5470) | | | Statement | This modification of the device is substantially equivalent to legally marketed<br>o.b.® tampons. | | | Device<br>description | The device is a cotton/rayon pledget with a removal string. It is available in<br>various absorbencies. | | | Intended use | This device is intended to be used to vaginally absorb menstrual fluid. | | | Performance<br>data | This device performs equivalently to the predicate device of the same<br>absorbency.<br>Syngyna values were the same. No untoward results were seen in the following tests on either the new<br>material or the finished proposed device: Cytotoxicity, Elution Method Cytotoxicity, Agarose Overlay Method Acute Systemic Toxicity in the Mouse Mucosal (Vaginal) Irritation in the Rabbit Dermal Irritation and Allergic Contact Sensitization: Human Repeat<br>Insult Patch Test (RIPT) Acute Intracutaneous Reactivity in the Rabbit TSST-1, Tampon Sac Method Continued on next page | | | Clinical<br>Equivalency | There was a randomized, double-blind, two-way crossover study in healthy<br>females comparing the proposed device with that of a commercially available<br>tampon over two menstrual cycles. | | | | The tampons were assessed by vaginal culture and speculum examinations<br>performed at screening and at pre-, mid-, and post menstrual visits, and by<br>vaginal and cervical colposcopy performed at screening and post-<br>menstruation. Subjects also completed a diary detailing tampon use. | | | | There were no clinically significant differences between the test and control<br>products. | | | Conclusion | The proposed device is substantially equivalent to the legally marketed<br>products in technology, intended use, and preclinical / clinical safety and<br>suitability characteristics. | | | Contact | Diana L.B. Uhl<br>Director, Regulatory Affairs, Engineered Products<br>Personal Products Company<br>Division of McNeil - PPC, Inc.<br>199 Grandview Road SF106<br>Skillman NJ 08558-9498 | | | Phone / Fax /<br>e-mail | Phone: 908 874 1402 Office<br>908 874 1700 Line reserved for the FDA | | | | Fax:<br>908 904 3748 | | | | e-Mail:duhl@cpcus.jnj.com | | | Date | November 4, 2002 | | [Information in Brackets is considered CONFIDENTIAL] els\Dule\WINWORD10(K)\Apollo 510(k)\Apollo 510(k)\S10k Apollo tampon: 110402.doc {1}------------------------------------------------ Special 510(k), Personal Products Company Device Modification Division of McNeil – PPC, Inc. # 510(k) Summary of Safety and Effectiveness, Continued ### Performance Data (continued) ICpcusskfpe0!VformelSDubliWTNWORDS10(K)Mpollo 510(k)Mpollo 510(k)10k Apollo lampon 110402.doc [Information in Brackets is considered CONFIDENTIAL] Page 38 of 43 {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 9200 Corporate Boulevard ockville MD 20850 McNeil-PPC, Inc. % Ms. Diana L.B. Uhl Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558 Re: K023789 Trade/Device Name: o.b. Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: November 12, 2002 Received: November 13, 2002 Dear Ms. Uhl: 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 Cosmetic 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 (PMA). it may be subject to 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. 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. {3}------------------------------------------------ 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Snogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Personal Products Company Division of McNeil - PPC, Inc. ## Special 510(k), Device Modification ## Indications for Use 510(k) Number; if known · KO23789 Device Name: o.b.® Tampons Indications for Use: o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use David A. Larson HAMILTON WORLDS 31(K), Apollo 51(K), Apollo 51(K), Apollo lampon 110402.doc Page 42 of 43 [Information in Brackets is considered CONFIDENTIAL|