MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON

K090098 · Maxim Hygiene Products, Inc. · HEB · Jan 30, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090098
• Device Name: MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
• Applicant: Maxim Hygiene Products, Inc.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

Device Story

Maxim Hygiene Organically Grown Cotton Tampon is an unscented, internally worn menstrual tampon. It consists of 100% organic cotton wadding, non-woven fabric, and a withdrawal cord, available with or without a cardboard applicator. The device is designed for over-the-counter use by women to absorb menstrual flow. It functions via physical absorption of fluid. The device is available in various absorbency levels to accommodate different menstrual flow volumes. It is used by the patient during their menstrual period and disposed of after use. The device is substantially equivalent to existing organic cotton tampons, sharing identical materials, dimensions, and performance characteristics.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included Syngina absorption rates, expulsion force, fiber loss (ATS method), and stability checks.

Technological Characteristics

Materials: 100% organic cotton (wadding, non-woven, withdrawal cord), cardboard applicator. Form factor: Digital or applicator-style tampons. Dimensions: 42-125 mm length, 11.8-16.1 mm diameter depending on model. Performance: Syngina absorption 6.0-12.0g. Non-powered, passive absorption device.

Indications for Use

Indicated for use by women to absorb menstrual fluid during a menstrual period.

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

• Organic Essentials Organic Cotton Tampon (K983478)
• Natracare Tampon (K914430)

Submission Summary (Full Text)

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K090098

# 510(k) SUMMARY

JAN 30 2009

November 24, 2008

Company

Contact:

Maxim Hygiene Products 39 Maple Street Roslyn Heights, NY 11577-1941

Tampon, Menstrual, Unscented

Kenneth Alvandi CEO Phone: [phone] Fax: [phone]

Device Classification Name:

Proprietary Name:

Maxim Hygiene Organically Grown Cotton Tampon

21 CFR 884.5470

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Predicate Device(s):

Regulation Number:

Product Code:

K983478 Organic Essentials Organic Cotton Tampon K914430 Natracare Tampon

#### 11.0 Intended Use:

Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid.

The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

#### Product Description 11.1

A tampon is used for internally absorbing menstrual flow during a period. A range of absorbencies are available designed to cope with various menstrual flows which differ not only from woman to woman, but also during a woman's menstrual life and during each period. Typically 80% of fluid is lost in the first two days and some 60 mls. (an egg cup full) to 90 mls. in a full period. This underlines the need for users to change products throughout their period and for manufacturers to offer a wide range of products for their users.

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Biocompatibility requirements were addressed in K983478 and K914430 based on the fact that Maxim Hygiene's tampons are identical to the cleared devices found in K983478 and K914430.

### 12.2 Summary of Safety and Effectiveness

The Maxim Hygiene Organically Grown Cotton Tampon based on the following comparisons demonstrate substantial equivalent. The device subject to this review is manufactured by the same manufacturer and is identical to the predicate devices does not raise any new issues as to safety and effectiveness.

The following tests were also performed to support substantial equivalence:

- Determination of Absorbency Rate of Tampons = Syngina Test .
- . Expulsion Force Applicator Tampons
- 8 Fiber Loss ATS Testing Method
- Stability Check on Digital Tampons �

| Parameters | Maxim Hygiene<br>Products | Organic Essentials | Bodywise |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K983478 | K914430 |
| Intended Use<br>Statement | Maxim Hygiene<br>Organically Grown<br>Cotton Tampon is a<br>tampon that is<br>inserted into the<br>vagina and used to<br>absorb menstrual<br>fluid.<br>The intended use of<br>the organic cotton<br>tampon is the same as<br>all other products that<br>are legally marketed. | Organic Essentials<br>Organically Grown<br>Cotton Tampon is a<br>tampon that is<br>inserted into the<br>vagina and used to<br>absorb menstrual<br>fluid.<br>The intended use of<br>the organic cotton<br>tampon is the same as<br>all other products that<br>are legally marketed. | Natracare<br>Tampon is a<br>tampon that is<br>inserted into the<br>vagina and used<br>to absorb<br>menstrual fluid.<br>The intended use<br>of the organic<br>cotton tampon is<br>the same as all<br>other products<br>that are legally<br>marketed. |
| Applicator Tampon<br>Super with Crown<br>End | | | |
| Dimensions | | | |
| Total Weight | 5,0-5,9g | 5,0-5,9g | 5,0-5,9g |
| Weight without<br>applicator | 2,7-3,2g | 2,7-3,2g | 2,7-3,2g |
| Withdrawal Cord | 115-175 mm | 115-175 mm | 115-175 mm |
| Length with<br>Applicator | 120-125 mm | 120-125 mm | 120-125 mm |

### Applicator Tampon Super with Crown End

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| Length without<br>Applicator | 45-50 mm | 45-50 mm | 45-50 mm |
|--------------------------------|---------------------|---------------------|------------------------|
| Diameter with<br>Applicator | 15,9-16,1g | 15,9-16,1g | 15,9-16,1g |
| Diameter without<br>Applicator | 14,2-15,7g | 14,2-15,7g | 14,2-15,7g |
| Syngina Absorption | 9,0-12,0g | 9,0-12,0g | 9,0-12,0g |
| Wadding | 100% organic cotton | 100% organic cotton | 100% organic<br>cotton |
| Non Woven | 100% organic cotton | 100% organic cotton | 100% organic<br>cotton |
| Withdrawal Cord | 100% organic cotton | 100% organic cotton | 100% organic<br>cotton |
| Applicator | Cardboard | Cardboard | Cardboard |

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| Parameters | Maxim Hygiene<br>Products | Organic Essentials | Bodywise |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K983478 | K914430 |
| Intended Use<br>Statement | Maxim Hygiene<br>Organically Grown<br>Cotton Tampon is a<br>tampon that is<br>inserted into the<br>vagina and used to<br>absorb menstrual<br>fluid.<br>The intended use of<br>the organic cotton<br>tampon is the same as<br>all other products that<br>are legally marketed. | Organic Essentials<br>Organically Grown<br>Cotton Tampon is a<br>tampon that is<br>inserted into the<br>vagina and used to<br>absorb menstrual<br>fluid.<br>The intended use of<br>the organic cotton<br>tampon is the same as<br>all other products that<br>are legally marketed. | Natracare<br>Tampon is a<br>tampon that is<br>inserted into the<br>vagina and used<br>to absorb<br>menstrual fluid.<br>The intended use<br>of the organic<br>cotton tampon is<br>the same as all<br>other products<br>that are legally<br>marketed. |
| Digital Tampon<br>Regular<br>Dimensions | | | |
| Weight with Single<br>Packaging | 2,1-2,5g | 2,1-2,5g | 2,1-2,5g |
| Weight Tampon | 2,0-2,4g | 2,0-2,4g | 2,0-2,4g |
| Length with Single<br>Packaging | 42-26 mm | 42-26 mm | 42-26 mm |
| Diameter with Single<br>Packaging | 11,8-12,2 mm | 11,8-12,2 mm | 11,8-12,2 mm |

# Digital Tampons Regular

.

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| Withdrawal Cord | 130-160 mm | 130-160 mm | 130-160 mm |
|--------------------|---------------------|---------------------|------------------------|
| Syngina Absorption | 6,0-9,0g | 6,0-9,0g | 6,0-9,0g |
| Wadding | 100% organic cotton | 100% organic cotton | 100% organic<br>cotton |
| Withdrawal Cord | 100% organic cotton | 100% organic cotton | 100% organic<br>cotton |

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the bird-like figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maxim Hygiene Products, Inc. c/o Mr. Neil E. Devine, Jr. Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

## JAN 3 0 2009

Re: K090098

> Trade/Device Name: Maxim Hygiene Organically Grown Cotton Tampon Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: January 12, 2009 Received: January 15, 2009

Dear Mr. Devine:

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 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 os 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) | [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" (21 CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppor/index.html.

Sincerely yours,

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

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# Indications for Use

Kog 009 8 510(k) Number (if known):

Device Name: Maxim Hygiene Organically Grown Cotton Tampon

Indications for Use:

Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid.

The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Hulda Gunn

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