O.B. APPLICATOR TAMPONS, O.B. TAMPONS

K991118 · Personal Products Co. · HEB · Jun 29, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991118
• Device Name: O.B. APPLICATOR TAMPONS, O.B. TAMPONS
• Applicant: Personal Products Co.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jun 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.

Device Story

o.b. Tampons (applicator and non-applicator versions) are menstrual hygiene products designed to absorb menstrual fluid or vaginal discharge. The device consists of a compressed absorbent core made of cotton and rayon, a polyethylene/polyester cover, and a removal string. The modified device incorporates an alternate fiber finish on the rayon and cotton components. The device is intended for over-the-counter use by individuals during menstruation. It functions via passive absorption of fluid upon vaginal insertion. Safety is established through biocompatibility, microbiological, and clinical testing, including vaginal irritation and microflora studies.

Clinical Evidence

Clinical evaluations included human sensitization, vaginal microflora studies, and human vaginal irritation studies. Preclinical testing included cytotoxicity, acute systemic toxicity, intracutaneous toxicity, vaginal irritation, Ames mutagenicity, chromosome aberration assay, and unscheduled DNA synthesis. Results indicate the modified tampon's safety is comparable to legally marketed commercial tampons.

Technological Characteristics

Materials: cotton, rayon, polyethylene/polyester cover, cotton/rayon string. Features: non-applicator and applicator versions; Regular, Super, and Super Plus absorbency ranges. Modification: alternate fiber finish on rayon and cotton components. No electronic or software components.

Indications for Use

Indicated for use by individuals requiring absorption of menstrual fluid or vaginal discharge.

Regulatory Classification

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.® non-applicator and applicator Tampons (K991118)

Submission Summary (Full Text)

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## 510(k) Summary

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| Device name | Trade name: o.b.® Tampons<br>Classification name: unscented menstrual tampons |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | o.b. ® non-applicator and applicator Tampons are used to absorb menstrual<br>fluid. The modified tampon will be available in Regular, Super, and Super<br>Plus syngyna absorbency ranges. |
| | o.b.® non-applicator and applicator Tampons are made of commercial cotton<br>and rayon, a polyethylene/polyester cover, and cotton or rayon string. |
| Equvalence to a<br>legally<br>marketed<br>device | The modified o.b.® Tampon is substantially equivalent to current commercial<br>o.b.® non-applicator and applicator Tampons. |
| Intended use | The modified o.b.® Tampons are inserted into the vagina to collect menstrual<br>fluid. This is the same intended use as current commercial tampons. |
| Technological<br>characteristics | The only difference between the modified o.b.® Tampons and the predicate<br>tampons is the substitution of an alternate fiber finish on the rayon and cotton<br>components of the tampon. |

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| Biocompat-<br>ability | Biocompatability and microbiological testing has been conducted on the<br>modified tampons and the fiber finish material. The results of these tests<br>demonstrate that the modified o.b.® Tampon is equivalent to legally<br>marketed tampons. This testing included : |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Preclinical Evaluations<br>• Cytotoxicity<br>• Microbiological Evaluation<br>• Acute Systemic Toxicity<br>• Intracutaneous Toxicity<br>• Vaginal Irritation<br>• Ames Mutagenicity<br>• Chromosome Aberation Assay<br>• Unscheduled DNA Synthesis |
| | Clinical Evaluations<br>• Human Sensitization<br>• Vaginal Microflora Study<br>• Human Vaginal Irritation Study |
| Conclusion | Results of preclinical and clinical testing indicate that the safety of the<br>modified tampon is comparable to current legally marketed, commercial<br>tampons. |
| Contact | Submitted by Personal Products Company<br>199 Grandview Road<br>Skillman NJ 08558-9418<br><br>Contact person: Ralph Petrone<br>Manager, Regulatory Affairs<br>Personal Products Worldwide<br>908 874 1214 (phone)<br>908 874 1118 (Fax) |
| Date | This Summary was prepared on March 3, 1999 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1999

Mr. Ralph Petrone Manager, Regulatory Affairs Personal Products Company 199 Grandview Road Skillman, NJ 08558-9418

Re: K991118 o.b.® Tampons, GML fiber finish, applicator and non-applicator versions, unscented Dated: March 31, 1999 Received: April 1, 1999 Regulatory Class: Il 21 CFR §884.5470/Procode: 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 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). 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html",

Sincerely yours,

CART. Daniel C. Stutts, M.P.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix C- Indications for Use Statement

510(k) Number (if known) K 99 111 8

Device Name: 0.b. 0 non applicator Tampons, Indications for Use:

o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (per 21 CFR 801.109)

OR ✓ Over-The-Counter-

David A. Eygenson

(Division Sig Ander inal, ENT, Division of Roper "הנייע and Rach Beckler 510(k) Number