Tampons included in this submission are conventional unscented menstrual tampons consisting of an absorbent pledget (viscose material in a W-shape wadding form), polyester/cotton withdrawal cord, and a polymeric overwrap. The tampon component of this submission is identical to that cleared in the predicate submission (K122603).

Tampons included in this submission are placed in the vagina using a polyethylene applicator. The applicator is available in two sizes: full size (long) or compact size. The full size applicator is ready for use. The compact size consists of an inner and outer tube that requires the inner tube to be retracted prior to use. Applicators included in this submission are provided in different colors including green, yellow, lilac, orange and pink.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (tampons). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain the kind of detailed study information (like acceptance criteria, sample sizes for test/training sets, expert ground truth qualifications, or MRMC studies) that would be present for a diagnostic AI/ML device.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them, as this document does not contain that level of detail for this type of medical device submission.

Here's why the requested information isn't available in the provided text:

Type of Device: The device is a physical product (tampon) and not a diagnostic AI system or software. The "performance" being discussed relates to physical properties and material safety, not diagnostic accuracy.
Regulatory Pathway: A 510(k) submission for a Class II device like a tampon focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance tests for physical characteristics and biocompatibility, rather than clinical efficacy studies with expert ground truth validation in the way an AI diagnostic tool would require.
Lack of AI/ML Component: The request specifically asks about "device performance" in a context usually applied to AI/ML or diagnostic devices, which this tampon is not.

If you have a document describing an AI/ML diagnostic device, I would be able to extract the requested details.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design element below them.

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

June 23, 2015

ONTEX BVBA % Rachel Paul Senior Consultant QA/RA Emergo Europe Consulting Prinsessegracht 20 The Hague 2514 AP The Netherlands

Re: K142786

Trade/Device Name: Ontex Unscented Tampons with Colored Plastic Applicators Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: April 30, 2015 Received: May 18, 2015

Dear Rachel Paul.

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142786

Device Name

Ontex Unscented Tampons with Colored Plastic Applicators

Indications for Use (Describe)

The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary For Ontex Unscented Tampons with Colored Plastic Applicators

510(k) Number: K142786

1. Submission Sponsor

ONTEX BVBA Genthof 5 9255 Buggenhout Belgium Phone: + 32 9376 77 06 Fax: + 32 9 378 13 33 Contact: HENRI LESAGE, R&D Manager Strategic Projects

2. Submission Correspondent

Emergo Europe Consulting Prinsessegracht 20 2514 AP The Hague The Netherlands Cell Phone: + 33 (0)6 89 83 16 09 Office Phone: + 31 (0) 70 345 8570 Direct: + 31 (0) 70 850 8249 Fax: + 31 (0) 70 346 7299 Contact: Rachel PAUL, Senior Consultant, QA/RA Email: project.management@emergogroup.com

3. Date Prepared

30/04/2015

4. Device Identification

	Trade/Proprietary Name:	Ontex Unscented Tampons with Colored Plastic Applicators
	Common/Usual Name:	Unscented Menstrual Tampon
	Classification Name:	Unscented Menstrual Tampon
	Classification Regulation:	21 CFR 884.5470
	Product Code:	HEB
	Device Class:	Class II
	Classification Panel:	OBGYN, Obstetrics/Gynecology

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5. Legally Marketed Predicate Device(s)

Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons K122603

6. Device Description

7. Indication for Use Statement

The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.

8. Substantial Equivalence Discussion

The following table compares the Unscented Tampons with Colored Plastic Applicators to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	ONTEX	ONTEX	SIGNIFICANT DIFFERENCES
Trade Name	Ontex Unscented Tampons with Colored Plastic Applicators (K142786)	Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons (K122603)	Colored applicators tubes
510(k) Number	K142786	K122603	NA.
Product Code	HEB	HEB	Same.
Regulation Number	21 CFR PART 884.5470	21 CFR PART 884.5470	Same.
Regulation Name	Unscented menstrual tampons.	Unscented menstrual tampons.	Same.
Indications for Use	The Ontex Unscented Tampons with Colored Plastic Applicators are	The Ontex Unscented Digital and Plastic and Cardboard Applicator	Only menstrual discharge for K142786.

Table 5A -General Comparison of Characteristics

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Manufacturer	ONTEX	ONTEX	SIGNIFICANTDIFFERENCES
Trade Name	Ontex Unscented Tamponswith Colored PlasticApplicators(K142786)	Ontex Unscented Digitaland Plastic andCardboard ApplicatorTampons(K122603)	Colored applicatorstubes
	inserted into the vagina toabsorb menstrualdischarge.	Tampons, available inlight, regular, super andsuper plus absorbencyare inserted into thevagina and used toabsorb menstrual orother vaginal discharge.
Overall Design	W wadding tampon withplastic applicators of fullsize (long) and compactsize	Roll wadding tampondigital (withoutapplicator)W wadding tampon typewith a plastic/cardboardapplicator in full size(long) and in compact size	No digital tampon, orcardboard applicator.
Unscented/Scented	Unscented	Unscented	Same
DimensionsSpecifications (mm)	Total length (in ready topush position): 110 - 135Outside diameter (outertube): 13.5 - 18.2	Total length (in ready topush position): 110 - 135Outside diameter (outertube): 13.5 - 18.2	Same
WeightSpecifications (g)	3.6 – 8.1	3.6 - 8.1	Same
Absorbent Pledget	Viscose	Viscose	Same
Withdrawal Cord	Cotton polyester	Cotton polyester	Same
Applicator	Plastic -polyethyleneincluding pigments	Compact size: Plastic -polyethyleneFull size (long): plastic -polyethylene with whitepigment	Different withpigments of colorgreen, lilac, orange,yellow or pink
	NA	Cardboard - Paper	Different, nocardboard applicator
Absorbencies	<6g, 6-9g, 9-12g, 12-15g	<6g, 6-9g, 9-12g, 12-15g	Same
Expulsion Force	< 6N	< 6N	Same
Fibre Shedding	< 1mg	< 1mg	Same
Cord Strength	> 60N	> 60N	Same
Packaging	Primary packaging:	Primary packaging:	Same

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Manufacturer	ONTEX	ONTEX	SIGNIFICANTDIFFERENCES
Trade Name	Ontex Unscented Tamponswith Colored PlasticApplicators(K142786)	Ontex Unscented Digitaland Plastic andCardboard ApplicatorTampons(K122603)	Colored applicatorstubes
	individual polymericwrapperSecondary packaging:cardboard box	individual polymericwrapperSecondary packaging:cardboard box
Sterile	no	no	Same
Single-Use	yes	yes	Same

9. Non-Clinical Performance Data

The predicate and the subject device are exactly the same at the exception of the presence of different colored pigments in the plastic applicator tubes.

The following tests were performed to support substantial equivalence:

Extraction 24h at 37°C in water
Visual inspection and spectrophotometric analysis
· Gravimetric analysis
· Gas chromatography and mass spectrophotometry (GC-MS)

After extraction of each colored applicator and additional testing for determination of possible leachates, the test results showed there is no potential for leachables to migrate from the colored plastic tampon applicators in water.

A toxicological risk assessment explains that the color variants of the tampon applicator would not be expected to cause any adverse effects under normal and reasonably foreseeable conditions of use and also supports the safety of each of the color variants.

10. Performance Testing - Bench

The predicate and the subject device are exactly the same at the exception of the presence of different colored pigments in the plastic applicator tubes.

The following test was performed to support substantial equivalence:

. Expulsion force applicator
Expulsion force met the specifications as defined for the predicate.

The modification has no impact on the absorptive capacity (Syngena), fiber loss and cord strength of the device. The predicate testing specifications are still applicable to the subject device for these tests.

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11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The proposed device and the predicate have the same intended use. The technological characteristics are identical or similar.

Ontex has completed a number of tests in order to demonstrate that the Ontex Unscented Tampons with Colored Plastic Applicators meet the applicable requirements for bench testing and that there is no potential for leachables to migrate. The toxicological risk assessment supports the safety of each of the color variants under normal and reasonably foreseeable conditions of use.

It has been shown in this 510(k) submission that the difference between the Ontex Unscented Tampons with Colored Plastic Applicators and the predicate devices do not raise any different questions regarding its safety and effectiveness. The Ontex Unscented Tampons with Colored Plastic Applicators, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices.

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).