O.B. TAMPON

K990536 · Personal Products Co. · HEB · Aug 31, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990536
• Device Name: O.B. TAMPON
• Applicant: Personal Products Co.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Aug 31, 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. Non-applicator Tampons are vaginal inserts designed to absorb menstrual fluid and vaginal discharge. Device consists of commercial cotton and rayon fibers, a polyethylene/polyester cover, and a cotton or rayon string. Operation is manual; user inserts tampon into vagina. Device functions via physical absorption of fluid. Modified version features increased absorbency (15-18 gram range) achieved through slight increases in weight and dimensions compared to predicate. Used in home setting by patients. Output is fluid retention; benefits patient by providing menstrual hygiene management.

Clinical Evidence

Preclinical and clinical testing conducted. Testing included microbiological evaluation and clinical assessment. Results demonstrate that the safety of the modified tampon is comparable to current legally marketed commercial tampons.

Technological Characteristics

Materials: commercial cotton and rayon, polyethylene/polyester cover, cotton/rayon string. Absorbency: 15-18 grams per syngyna test method (21 CFR 801.430). Form factor: non-applicator tampon. No software or electronic components.

Indications for Use

Indicated for use by menstruating individuals to absorb menstrual fluid or other 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 Tampons (K990536)

Submission Summary (Full Text)

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## Appendices

K990536

## 510(k) Summary of Safety and Effectiveness (App. A)

| Device name | Trade name: o.b.® Tampons<br>Classification name: unscented menstrual tampons |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range.<br>o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. |
| Equivalence to a legally marketed device | The modified o.b.® Tampon is substantially equivalent to current commercial o.b.® Non-applicator Tampons. |
| Intended use | The modified o.b.® 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 ob® tampons and the predicate tampons is the absorbency has increased to 15-18 grams absorbency measured by the syngyna test method (21 CFR 801.430). This is accomplished by slight increases in the weight and dimensions of the tampons. |

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K990536

| Biocompat-<br>ability | Biocompatability and microbiological testing has been conducted on tampons<br>made with these commercial materials. The results of these tests demonstrate<br>that the modified ob® Tampon is equivalent to legally marketed tampons.<br>This testing included :<br>• Microbiological testing<br>• Clinical Testing |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Date | This Summary was prepared on February 1, 1999 |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

AUG 3 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K990536

> o.b. @Ultra Absorbency, non-applicator tampon (15-18 grams) Dated: June 3,1999 Received: June 4,1999 Regulatory Class: II 21 CFR 884.5435/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.

The agency is currently reviewing the comments that have been received in response to the proposed rule for labeling tampons with this absorbency (Labeling of Menstrual Tampons; Ranges of Absorbency; FR January 21, 1999). Please be advised that, depending on the term specified in the final rule, you may have to change your labeling.

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 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

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## Page 2 - Mr. Ralph Petrone

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 [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,

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

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## Appendix C- Indications for Use Statement

510(k) Number (if known) K9905 36

ﺔ ﺍﻟﻤ

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use

Over-The-Counter-

P

(per 21 CFR 801.109)

(Division Sign-Off) ( Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.