ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS

K062001 · Rostam , Ltd. · HEB · Dec 7, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K062001
• Device Name: ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
• Applicant: Rostam , Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

Menstrual tampon with plastic applicator; used to absorb menstrual fluid or vaginal discharge. Device consists of rayon and/or cotton absorbent core, polymeric overwrap, and cotton cord. Intended for over-the-counter use by females. Inserted vaginally to manage menstrual flow. Benefits include fluid absorption and hygiene management during menstruation.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including biocompatibility evaluations and standard Syngyna absorbency testing. A Repeated Insult Patch Test was conducted on 100 human subjects to assess safety.

Technological Characteristics

Materials: rayon, cotton, polymeric overwrap, cotton cord. Form factor: tampon with plastic applicator. Absorbency: slender regular and light. Sterilization: not specified. Connectivity: none. Software: none.

Indications for Use

Indicated for use by females for the absorption of menstrual 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

• Rostam Scented and Unscented Tampons (K062001)

Submission Summary (Full Text)

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## KOG 2001

VII

DEC - 7 2006

#### 510K SUMMARY

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 as two absorbencies, slender regular and light.

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.

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

***

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Rostam, Ltd. c/o Robert J. Staab, Ph.D. DABT, RAC RTA, Inc. 73 Franklin Tpk. ALLENDALE NJ 07401

#### DEC - 7 2006

Re: K062001

> Trade/Device Name: Rostam Ltd. Scented and Unscented Plastic Applicator Tampons Regulation Number: 21 CFR §884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Product Code: HIL Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Product Code: HEB Regulatory Class: II Dated: October 30, 2006 Received: October 31, 2006

#### Dear Dr. Staab:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/industry/support/index.html.

Sincerely yours,

Nancy C Hodgon

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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# . Food and Drug A

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## Indications for Use

510(k) Number (if known): K062001

Device Name: Trade Name: Rostam Ltd Scented and Unscented Plastic Applicator Tampons

Indications for Use:

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

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 801 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of

(Posted November 13, 2003)

Center for Devices and Radiological Health / CDRH

David A. Seymour
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K062000