← Product Code [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB) · K970954 # O.B. APPLICATOR TAMPONS (K970954) _Personal Products Co. · HEB · Jun 10, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K970954 ## Device Facts - **Applicant:** Personal Products Co. - **Product Code:** [HEB](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB.md) - **Decision Date:** Jun 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.5470 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use o.b. Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. ## Device Story o.b. Applicator Tampon is a menstrual hygiene device designed for vaginal insertion to absorb menstrual fluid or vaginal discharge. The device consists of a tampon body made of cotton and rayon, a polyethylene/polyester cover, and a cotton or rayon string. The applicator is constructed from a cardboard laminate with a coating. The device is intended for over-the-counter use by individuals during menstruation. The modification involves a change in the composition of the applicator coating compared to the predicate device. The device functions mechanically to absorb fluid; it does not involve electronic, software, or algorithmic components. ## Clinical Evidence Clinical evidence includes a Repeat Insult Patch Test conducted to assess the potential for human dermal irritation and sensitization. Non-clinical testing included biocompatibility (cytotoxicity, vaginal irritation in rabbits) and microbiological testing on extracts of the coated applicator. Results indicate safety is comparable to legally marketed tampons. ## Technological Characteristics Materials: cotton, rayon, polyethylene/polyester cover, cotton/rayon string. Applicator: cardboard laminate with coating. The device is a non-powered, mechanical absorbent product. No software or electronic components. ## Regulatory Identification An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs. ## Predicate Devices - o.b.® Applicator Tampon ([K970954](/device/K970954.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970954 Page 1 of 2 JUN 10 1997 # Appendices ## Appendix A - 510(k) Summary | Device Name | Trade name :o.b.® Applicator Tampon Classification name: unscented menstrual tampon | | --- | --- | | Equivalence to legally marketed device | The modified o.b.® Applicator Tampon is substantially equivalent to the current commercial o.b.® Applicator Tampon. | | Device description | o.b.® Applicator Tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies. o.b.® Applicator Tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating. | | Intended use | o.b.® Applicator Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. | | Technological characteristics | The only difference between the modified applicator tampon and the predicate device is the composition of the coating on the applicator. All other technological characteristics are the same for the modified and the predicate device. There is no impact on the function of the device because of the change in applicator coating. | 35 {1} page 2 y 2 K910954 Performance data Non-clinical testing Biocompatibility and microbiological testing were conducted on extracts of the coated applicator. The results of these tests demonstrate that the modified o.b.® Applicator Tampon is equivalent to legally marketed tampons. The following tests were conducted: - Cytotoxicity - Vaginal Irritation in Rabbits - Microbiological testing Performance data Clinical testing A Repeat Insult Patch Test was conducted to confirm the lack of the potential for human dermal irritation and sensitization. Conclusion Results of non-clinical and clinical testing indicate that the safety of modified applicator is comparable to current legally marketed, commercial applicator tampons. Contact Submitted by Personal Products Company 199 Grandview Road Skillman, NJ, 08558-9418 Contact person: Ralph A. Petrone Manager, Regulatory Affairs J&J Consumer Franchises Worldwide 908 874 1214 Date This Summary was prepared on February 21,1997 36 {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 10 1997 Mr. Ralph Petrone Manager, Regulatory Affairs Johnson & Johnson Consumer Franchises Worldwide 199 Grandview Road Skillman, New Jersey 08558-9418 Re: K970954 o.b. Applicator Tampon Dated: April 17, 1997 Received: April 21, 1997 Regulatory class: II 21 CFR §884.5470/Product code: 85 HEB Dear Mr. Petrone: We have reviewed your 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 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} 39 # INDICATION FOR USE 510(k) Number (if known): K970954 Device Name: o.b. applicator tampon Indications for Use: * o.b. applicator tampons are used to absorb mentrual fluid or other vaginal discharge. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use ☑ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K970954 (fortune Format 1-2-96) h:\winword\rap97\inforuse.doc --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K970954](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HEB/K970954) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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