ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS

K042773 · Rostam , Ltd. · HIL · Nov 23, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K042773
• Device Name: ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
• Applicant: Rostam , Ltd.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

These tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Device Story

Rostam plastic applicator tampons consist of a plug made from rayon and/or cotton with a polymeric overwrap and cotton cord. The device is used by consumers for the absorption of menstrual fluid or vaginal discharge. It is inserted into the vagina via a plastic applicator. The device is provided in three absorbency levels: regular, super, and super plus. It is available in both scented and unscented versions. The device functions as a passive absorbent material.

Clinical Evidence

No clinical trials were conducted. Evidence consists of historical biocompatibility testing, safety evaluations of components, and standard Syngyna absorbency testing. A repeated insult patch test was performed on 100 human subjects to assess safety.

Technological Characteristics

Materials: rayon, cotton, polymeric overwrap, cotton cord. Form factor: tampon with plastic applicator. Absorbency levels: regular, super, super plus. Scented and unscented options. No electronic components or software.

Indications for Use

Indicated for use by females for the absorption of menstrual or other vaginal discharge.

Regulatory Classification

Identification

A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

Predicate Devices

• Rostam Scented and unscented Tampons with plastic applicators

Submission Summary (Full Text)

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# K042773

## NOV 2 3 2004

### 510K SUMMARY VII

Device Name: Rostam Scented and unscented plastic applicator Tampons (Various Trade Tampons Sold Under Private Labels As Plastic Applicators)

Legally marketed device: These Tampons are substantially equivalent to legally marketed Rostam Scented and unscented Tampons with plastic applicators.

Device description: Rostam plastic applicator tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 3 absorbencies, regular, super and super plus.

These Tampons are made from rayon and/or cotton polymeric overwrap and cotton cord.

The materials used in these tampons are similar to those used in other legally marketed tampons.

Intended Use: These tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

### Assessment of Performance Standards: Not Applicable

Non-Clinical Testing: Biocompatibility testing and safety evaluations of tampon components were historically carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted and are relevant to the safety of Rostam plastic applicator tampons.

#### � Repeated Insult Patch Test, 100 human subjects

***

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2004

Rostam Ltd. % Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates, Inc. 73 Franklin TPK. ALLENDALE NJ 07401

Re: K042773

Trade/Device Name: Rostam Ltd. Fragranced or Unfragranced New Plastic Applicator Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulation Number: 21 CFR 892.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HIL and HEB Dated: September 20, 2004 Received: October 5, 2004

Dear Dr. Staab:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your betthe beace is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosale) to regarly mant ont of the Medical Device Amendments, or to devices that have been May 20, 1770, the chance 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 do not require approval or a premiums provisions of the Act. The general controls provisions of the Act de nee, subjoct to the general 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 it your de rio is ensorities (to such additional controls. Existing major regulations affecting your / Ipploval), It they be babyer 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 I odelife states and roganing, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, modaling practice requirements as set forth in the quality systems (QS) (2) Cric Late Corp. Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This Ictter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you'ts ought inding of substantial equivalence of your device to a legally prematice notification: - river 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 If you desire specific at nev of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Atso, prease note and regulation on your responsibilities under the Act from the 807.77). Tou may obtain barees, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Applied for

Device Name: Rostam Ltd. Fragranced or Unfragranced New Plastic Applicator Tampons

Indications For Use:

As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).

Rostam Ltd. Fragranced plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Prescription Use (Part 21 CFR 801 Subpart D)

...

AND/OR

Over-The-Counter Use __ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
Division Sign-Off

(Division Sign-Off) 0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042773

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