ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS

K032080 · Rostam , Ltd. · HIL · Aug 14, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032080
• Device Name: ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
• Applicant: Rostam , Ltd.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Aug 14, 2003
• 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

Menstrual tampon with plastic applicator; used to absorb menstrual fluid or vaginal discharge. Device consists of rayon, cotton, and cotton cord. Available in five absorbencies: junior (mini), regular, slender regular, super, and super plus. Intended for over-the-counter use by patients. Device functions via physical absorption of fluid. Substantially equivalent to existing Rostam Ltd. tampons with paper applicators.

Clinical Evidence

Clinical evidence includes a Repeated Insult Patch Test conducted on 100 human subjects. Non-clinical evidence includes historical biocompatibility testing and safety evaluations of tampon components, and standard Syngyna testing to confirm absorbency.

Technological Characteristics

Materials: rayon, cotton, cotton cord. Form factor: menstrual tampon with plastic applicator. Absorbency levels: junior (mini), regular, slender regular, super, super plus. Principle: physical absorption of fluid. No electronic or software components.

Indications for Use

Indicated for use by individuals requiring absorption of menstrual or other vaginal discharge. Device is a plug made of cellulosic or synthetic material inserted into the vagina.

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 Ltd. tampons with paper applicators (K032080)

Submission Summary (Full Text)

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#### KO32080 VII 510K SUMMARY

### Device Name: ROSTAM Ltd Plastic Applicator Fragranced Tampons

Legally marketed device: These Tampons are substantially equivalent to legally marketed Rostam Ltd. tampons with paper applicators.

Device description: Rostam plastic applicators are menstrual tampons used to absorb menstrual fluid. These Tampons will be provided with 5 absorbencies, junior (MINI), regular, slender regular, super and super plus.

These Tampons are made from rayon and cotton and cotton cord.

The material 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 was 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 Ltd. plastic applicator fragranced tampons.

### Clinical testing

o Repeated Insult Patch Test, 100 human subjects

***

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Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains an abstract image of a bird in the center. The bird is made up of three curved lines that resemble feathers. The text "TRUST OF HEALTH & HUMAN SERVICES" is written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

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

## Re: K032080

Trade/Device Name: ROSTAM Ltd. Fragranced Plastic Applicator Tampon Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: 85 HIL

Dated: July 2, 2003 Received: July 7, 2003

Dear Dr. Stabb:

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.

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This letter will allow you to begin marketing your device as described in your Section 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. 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 [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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Verl 3 - 4/24/96

Applicant: Rostam Ltd

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

KU32080

KO 32080

Device Name: ROSTAM Ltd Fragranced 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 made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual 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)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel G. Benson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032080

L Over-the-Counter Use.