ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

K090071 · Rostam , Ltd. · HEB · May 28, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090071
• Device Name: ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
• Applicant: Rostam , Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: May 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Device Story

Rostam Compact Applicator Tampons are menstrual hygiene products designed to absorb menstrual or vaginal discharge. The device consists of an absorbent tampon body made of rayon and/or cotton with a polymeric overwrap and a cotton cord, housed within a plastic applicator. Available in light, regular, and super absorbencies. Intended for over-the-counter use; inserted into the vagina by the user. The device functions via physical absorption of fluids. Safety is established through biocompatibility testing and Syngyna absorbency testing.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, including standard Syngyna absorbency testing, and historical biocompatibility evaluations. 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: compact plastic applicator. Absorbency: light, regular, super. Principle: physical fluid absorption. No electronic components or software.

Indications for Use

Indicated for use by individuals requiring 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

• Tampax Compak Pearl Scented and unscented Tampons

Submission Summary (Full Text)

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K096671

# MAY 28 2009

# ATTCH 6, amended

# 510K SUMMARY

VII

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

Legally marketed device: These Tampons are substantially equivalent to legally marketed Tampax Compak Pearl 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, Light, regular and super.

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: The Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

### 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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with three curved lines representing its wings or feathers.

Public Health Service

MAY 28 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rostam Limited c/o Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates (RTA) 30 Neck Road OLD LYME CT 06371

Re: K090071

Trade/Device Name: Rostam Fragranced and Unfragranced Compact Applicator Tampons Regulation Number: 21 CFR §884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: May 2, 2009 Received: May 11, 2009

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.

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); medical device reporting (reporting of medical device-related adverse, events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### ATTCH 5, amended

Applicant: Rostam Ltd

510(k) Number K090071

Device Name: Rostam Ltd Fragranced and Unfragranced Compact Applicator Tampons.

# Indications For Use:

The Rostam Fragranced and Unfragranced Compact Applicator Tampons are 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)

louis R. Whay

(Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Over-the-Counter Use