INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS

K020535 · Rostam , Ltd. · HEB · May 9, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020535
• Device Name: INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
• Applicant: Rostam , Ltd.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: May 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• 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 Interlude and private label tampons are menstrual hygiene products consisting of an absorbent core made of rayon and cotton with a cotton cord, housed in a plastic applicator. The device is intended for over-the-counter use by females to absorb menstrual fluid. The user inserts the tampon into the vagina using the plastic applicator. The device functions through the physical absorption of fluid by the cellulosic/synthetic materials. It is marketed in three absorbency levels: regular, super, and super plus.

Clinical Evidence

No clinical data. Safety established via non-clinical bench testing, including biocompatibility (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity) and standard Syngyna absorbency testing.

Technological Characteristics

Materials: Rayon, cotton, cotton cord. Form factor: Tampon with plastic applicator. Absorbency: Regular, super, super plus. Principle: Passive fluid absorption. Sterilization: Not specified.

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.

Submission Summary (Full Text)

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#### 510K SUMMARY

### Device Name: ROSTAM Interlude and Other Private Label Plastic Applicator Tampons

Legally marketed device: These Tampons are substantially equivalent to legally marketed predicate tampons with applicators.

Device description: Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: 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 in the US.

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.

- irritation testing 0
VII

- sensitization testing 0
- 0 acute oral toxicity
- 0 eye irritation testing
- cytotoxicity testing �

***

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 0 9 2002

Received: February 19, 2002

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

Trade/Device Name: Interlude Tampons and Other Under Private Label Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: February 15, 2002

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 ror answer 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.

Re: K020535

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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. The I Dr I missification 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 of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Addisons of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other of Comphanes at ( notification" (21 CFR Part 807.97). Other general information on of recreation to premiered the Act may be obtained from the Division of Small Manufacturers, Jour robjonal 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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## K020535

Page_ __ ol

510(k) Number (if known):

K020535
applied for

Device Name: Interlude and other private label plastic applicator tampons Indications For Uso:

As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470)

Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use /

(Optional Format 1-2-96)

Nancy C Hodgson

Reproductive, Abdomin and Radiological Devices 510(k) Number