ONTEX TAMPON (UNSCENTED)

K090819 · Ontex International NV · HEB · Dec 23, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090819
• Device Name: ONTEX TAMPON (UNSCENTED)
• Applicant: Ontex International NV
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Ontex Tampon is a tampon that is inserted into the vagina and 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

Ontex Tampon is a conventional unscented menstrual tampon, available in digital and applicator versions. The device consists of an absorbent pledget made of 100% organic cotton, with a 100% organic cotton withdrawal cord and non-woven cover. Applicator versions utilize a cardboard applicator. The device is intended for over-the-counter use by females to absorb menstrual fluid. It functions by insertion into the vagina, where the absorbent material collects fluid. Safety and effectiveness are established through bench testing, including Syngina absorbency rate testing, expulsion force testing for applicators, fiber loss testing, and stability checks for digital tampons.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including Syngina absorbency rate, expulsion force for applicator tampons, fiber loss (ATS testing method), and stability checks for digital tampons.

Technological Characteristics

Materials: 100% organic cotton wadding, non-woven cover, and withdrawal cord. Applicator: Cardboard. Dimensions: Applicator tampons (45-50mm length, 14.2-15.7mm diameter); Digital tampons (42-26mm length, 11.8-12.2mm diameter). Absorbency: 9.0-12.0g (applicator) and 6.0-9.0g (digital) via Syngina test.

Indications for Use

Indicated for use by females for the absorption of menstrual fluid.

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

• Maxim Hygeine Organically Grown Cotton Tampon (K090098)

Submission Summary (Full Text)

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## DEC 2 3 2009

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 21 CFR §807.92.

510(k) number:

1. Submitter's Identification:

Ontex International NV Spinnerijstraat 12 9240 Zele Belgium Submitter Phone: 0032 / 52 454 651 Submitter Fax: [phone] Submitter Contact: Steven Smet Title:

2. Name of the Device: Digital and Applicator Menstrual Tampons Ontex Tampons (Unscented)

Device Class: II ·gulation: 884.5470 r roduct Code: HEB

#### 3. Predicate Device Information:

Maxim Hygeine Organically Grown Cotton Tampon 510(k) Number: K090098 Maxim Hygeine Products. 39 Maple Street Roslyn Heights, NY 11577-1941

### 4. Device Description:

The tampons to be marketed are conventional unscented menstrual tampons consisting of an absorbent pledget, with and without applicator.

#### 5.0 Device Comparison to Predicate Device(s):

The following tests were performed to support substantial equivalence (see Appendix 2 - Testing):

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

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# Applicator Tampon

| Parameters | Ontex International | Maxim Hygiene<br>Products |
|--------------------------------|---------------------|--------------------------------------|
| 510(k) Number | | K090098 |
| Dimensions | | |
| Total Weight | 5,0-5,9g | 5,0-5,9g |
| Weight without<br>applicator | 2,7-3,2g | 2,7-3,2g |
| Withdrawal Cord | 115-175 mm | 115-175 mm |
| Length with<br>Applicator | 120-125 mm | 120-125 mm |
| Length without Applicator | 45-50 mm | 45-50 mm |
| Diameter with Applicator | 15,9-16,1 mm | 15,9-16,1 mm |
| Diameter without Applicator | 14,2-15,7 mm | 14,2-15,7 mm |
| Syngina Absorption | 9,0-12,0g | 9,0-12,0g |
| Wadding | 100% organic cotton | 100% organic cotton |
| Non Woven | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord | 100% organic cotton | 100% organic cotton |
| Applicator | Cardboard | Cardboard |
| Parameters | Ontex International | Maxim Hygiene<br>Products<br>K090098 |
| Digital Tampon | | |
| Dimensions | | |
| Weight with Single Packaging | 2,1-2,5g | 2,1-2,5g |
| Weight Tampon | 2,0-2,4g | 2,0-2,4g |
| Length with Single Packaging | 42-26 mm | 42-26 mm |
| Diameter with Single Packaging | 11,8-12,2 mm | 11,8-12,2 mm |
| Withdrawal Cord | 130-160 mm | 130-160 mm |
| Syngina Absorption | 6,0-9,0g | 6,0-9,0g |
| Wadding | 100% organic cotton | 100% organic cotton |
| Withdrawal Cord | 100% organic cotton | 100% organic cotton |

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## Digital Tampon

#### Conclusions:

The subject device has the same intended use and technical characteristics as the predicate device. Similarly, there are no differences in materials used to fabricate the subject device and the predicate device. Therefore no new questions of safety or effectiveness are raised by this submission. Thus, the Ontex Tampon (Unscented) is substantially equivalent to the predicate device, the Maxim Hygeine Products Tampon (K090098).

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ontex International NV % Mr. Neal Kolber Project Manager Emergo Group 1705 S. Capital of Texas Highway, Suite 500 AUSTIN TX 78746

DEC 2 3 2009

Re: K090819

Trade/Device Name: Ontex Tampon (Unscented) Regulation Number: 21 CFR §884.5470 Regulation Name: Menstrual tampon Regulatory Class: II Product Code: HEB Dated: November 30, 2009 Received: December 1, 2009

Dear Mr. Kolber:

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); medical device reporting (reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janina M. Morris

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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## INDICATIONS FOR USE

090819

## 510(k) Number (if known):

Device Name: Ontex Tampon (Unscented)

## Indications for Use:

Ontex Tampon is a tampon that is inserted into the vagina and 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 X (21 CFR 801 Subpart C)

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

hopinothy
(Division Sign-Off)

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