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 Description

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

AI/ML Overview

This document describes comparative testing to demonstrate substantial equivalence between the Ontex Tampon (Unscented) and the predicate device, the Maxim Hygeine Organically Grown Cotton Tampon. It does not describe a study involving human readers or AI.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison of parameters between the applicant's device (Ontex International) and the predicate device (Maxim Hygiene Products). The "acceptance criteria" are implied to be that the Ontex Tampon's performance for each parameter should fall within the range or match the characteristic of the predicate device.

Parameters	Acceptance Criteria (Predicate Device K090098)	Reported Device Performance (Ontex International)
Applicator Tampon
Total Weight	5.0-5.9g	5.0-5.9g
Weight without applicator	2.7-3.2g	2.7-3.2g
Withdrawal Cord	115-175 mm	115-175 mm
Length with 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 Material	100% organic cotton	100% organic cotton
Applicator Material	Cardboard	Cardboard
Digital Tampon
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 (likely 26-42mm, discrepancy in text)	42-26 mm (likely 26-42mm, discrepancy in text)
Diameter with Single Packaging	11.8-12.2 mm	11.8-12.2 mm
Withdrawal Cord (Digital)	130-160 mm	130-160 mm
Syngina Absorption (Digital)	6.0-9.0g	6.0-9.0g
Wadding (Digital)	100% organic cotton	100% organic cotton
Withdrawal Cord Material	100% organic cotton	100% organic cotton

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the precise sample sizes for each test performed (e.g., number of tampons tested for Syngina absorption, expulsion force, fiber loss, or stability checks). It only lists the types of tests.
Data Provenance: The data is generated from laboratory testing performed by Ontex International NV in Zele, Belgium. This is prospective testing to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The study is a comparative laboratory performance study of a medical device (tampons) against a predicate device, focusing on physical and absorbent properties. It does not involve interpretation of data by human experts to establish ground truth in the way medical imaging or diagnostic studies do.

4. Adjudication method for the test set:

This is not applicable. There is no human adjudication process described, as the tests are objective measurements of physical properties.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This submission is for a menstrual tampon, not an AI-powered diagnostic or screening tool. There are no human readers or AI involved in this type of device comparison.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

The "ground truth" here is the established and measured performance characteristics of the legally marketed predicate device (Maxim Hygeine Organically Grown Cotton Tampon, K090098). The Ontex device's performance is compared directly against these values, and against standardized test methods (e.g., "Syngina Test," "ATS Testing Method").

8. The sample size for the training set:

This is not applicable. There is no "training set" in this context, as it is not a machine learning or AI algorithm.

9. How the ground truth for the training set was established:

This is not applicable. As stated above, there is no training set for this device submission.

Summary

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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:

Submitter's Identification:

Ontex International NV Spinnerijstraat 12 9240 Zele Belgium Submitter Phone: 0032 / 52 454 651 Submitter Fax: 0032 /52 454 610 Submitter Contact: Steven Smet Title:

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 HygieneProducts
510(k) Number		K090098
Dimensions
Total Weight	5,0-5,9g	5,0-5,9g
Weight withoutapplicator	2,7-3,2g	2,7-3,2g
Withdrawal Cord	115-175 mm	115-175 mm
Length withApplicator	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 HygieneProductsK090098
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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Page 2 -

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 884.5470 Unscented menstrual tampon.

(a)
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.(b)
Classification. Class II (performance standards).