The Roll wadding plastic Applicator Compact size Unscented Tampon is a menstrual tampon. These tampons are unscented tampons it means without any perfume. These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is made from polyester and cotton. These tampons have an applicator. The applicator is made from plastic (polyethylene). . The applicator is in a compact size meaning that the inner tube and the outer tube are slided into each other telescopically so the inner tube needs to be retracted before usage. These tampons have a Roll wadding form. In a roll tampon, the fleece band is folded and then rolled (like a Swiss roll) before being radially pressed. The Roll wadding plastic Applicator Compact size Unscented Tampon is available in 3 absorbencies: regular, super plus absorbency (regular (6-9g), super (9-12g), and super plus (12-15g)).

AI/ML Overview

This document describes a 510(k) summary for the "ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS." The submission aims to demonstrate substantial equivalence to a previously cleared predicate device rather than presenting a novel device requiring extensive clinical trials for effectiveness. Therefore, the provided text focuses on conformance to existing standards and comparison with the predicate, not a study evaluating human reader improvement with AI or standalone algorithm performance.

Here's the breakdown of the acceptance criteria and the "study" (bench testing and comparison) that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Predicate Device Specification (Implicitly the Acceptance Criteria for New Device)	Reported Device Performance (New Device)
Biocompatibility	Non-cytotoxic, non-irritant, no acute systemic toxicity, no dermal irritation, no allergic contact sensitization (based on predicate)	Non-cytotoxic, non-irritant, no terminal or gross observations in reproductive tracts, no toxic signs, negligible dermal response. No potential for dermal irritation or allergic contact sensitization.
Microbiology	Doesn't enhance Staphylococcus aureus growth, doesn't increase TSST-1 production, no effect on culture pH, doesn't alter normal vaginal microflora (based on predicate)	Doesn't enhance Staphylococcus aureus growth, doesn't increase TSST-1 production, no effect on culture pH, doesn't alter normal vaginal microflora.
Absorptive Capacity (Syngina)	Within specifications for predicate devices (not quantified in text, but implied to be appropriate for absorption levels like 6-9g, 9-12g, 12-15g)	Gives similar results within predefined specifications (no specific numbers provided)
Fiber Loss	Less than 1 mg (for predicate)	Less than 1 mg
Cord Strength	Less than 50N (same as predicate Roll Digital Tampon in viscose)	Less than 50N
Expulsion Force of Applicator	Less than 6N (specification)	Less than 6N
Microbiology Batch Testing:
- Total Viable Count (TVC)	Less than 200 cfu/g of tampon	Less than 10 cfu/g of tampon
- Yeasts/Moulds	Less than 20 cfu/g of tampon	Less than 10 cfu/g of tampon
- Candida albicans	Absent in 1g of tampon (negativity)	Absent in 1g of tampon
- Gram-negative bacteria	Absent in 1g of tampon (negativity)	Absent in 1g of tampon
- Staphylococcus aureus	Absent in 1g of tampon (negativity)	Absent in 1g of tampon
- Pseudomonas aeruginusa	Absent in 1g of tampon (negativity)	Absent in 1g of tampon

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of a clinical study with human subjects. The testing described is primarily bench testing and relies on the prior testing of the predicate device.

Bench Testing: The sample sizes for "Absorptive Capacity (Syngina)," "Fiber loss," "Cord strength," "Expulsion force of the applicator," and "Microbiology batch testing" are not explicitly stated. These would typically involve a certain number of tampons tested per batch or per absorbency, but no specific numbers are given.
Data Provenance: The data provenance is internal testing performed by the manufacturer (ONTEX) and reliance on prior testing of their own predicate device (K122603). The location of this testing is not specified beyond "ONTEX BVBA SPINNERIJSTRAAT 12 9240 ZELE BELGIUM". It is retrospective in the sense that the biocompatibility and broader microbiology claims are based on the predicate's past performance. New bench tests were performed for the "Performance Testing - Bench" section.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No experts were used to establish ground truth in the context of human-reviewed data, as this is not a study assessing diagnostic accuracy or similar performance. The ground truth for bench tests is the objective measurement against a predefined specification.

4. Adjudication Method for the Test Set

Not applicable. There was no human-reviewed test set or patient data requiring adjudication in a clinical context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document presents a 510(k) summary for a menstrual tampon, which is a medical device, not a diagnostic or AI-driven system. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This submission is for a physical medical device (tampon), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Objective Bench Test Specifications: For metrics like fiber loss, cord strength, expulsion force, and microbiological counts, the "ground truth" is adherence to pre-defined numerical or qualitative specifications that demonstrate safety and performance equivalent to legally marketed devices.
Predicate Device Performance: For biocompatibility and the broader microbiological safety profile, the ground truth relies on the established safety and effectiveness of the predicate device. The new device is considered substantially equivalent because its materials, manufacturing, and intended use are identical, and its design modifications do not adversely alter the safety profile.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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510(k) Summary

for

ONTEX

ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS

1. Submission Sponsor

ONTEX BVBA SPINNERIJSTRAAT 12 9240 ZELE BELGIUM Phone: + 32 9 376 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 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: pmteurope@emergogroup.com

1. Date Prepared
  16th August 2013

4. Device Identification

ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE Trade/Proprietary Name: UNSCENTED TAMPONS UNSCENTED MENSTRUAL TAMPONS Common/Usual Name: UNSCENTED MENSTRUAL TAMPON Classification Name: 21 CFR 884.5470 Classification Regulation: Product Code: HEB Class II Device Class: OBGYN, Obstetrics/Gynecology Classification Panel:

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5. Legally Marketed Predicate Device(s)

Ontex Digital and Plastic/Cardboard Applicator Unscented Tampons K122603

Device Description 6.

The Roll wadding plastic Applicator Compact size Unscented Tampon is a menstrual tampon.

These tampons are unscented tampons it means without any perfume.

These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is made from polyester and cotton.

These tampons have an applicator. The applicator is made from plastic (polyethylene). . The applicator is in a compact size meaning that the inner tube and the outer tube are slided into each other telescopically so the inner tube needs to be retracted before usage.

These tampons have a Roll wadding form. In a roll tampon, the fleece band is folded and then rolled (like a Swiss roll) before being radially pressed.

The Roll wadding plastic Applicator Compact size Unscented Tampon is available in 3 absorbencies: regular, super plus absorbency (regular (6-9g), super (9-12g), and super plus (12-15g)).

Tampon Type	Applicator material	Applicator Size	Absorbencies
Roll wadding	Plastic	Compact	6-9g, 9-12g, 12-15g

The materials used in these tampons are exactly identical to the materials used to manufacture the predicate devices tampons.

7. Indication for Use Statement

The Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.

8. Substantial Equivalence Discussion

The following table compares the ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE, UNSCENTED TAMPONS 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.

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K132595

Page 3 of 5

	Table SA -General Companson of Characteristics
Manufacturer	ONTEX ·	ONTEX	SIGNIFICANTDIFFERENCES
Trade Name	ROLL WADDINGPLASTIC APPLICATORCOMPACT SIZEUNSCENTED TAMPONS	DIGITAL ANDPLASTIC/CARDBOARDUNSCENTEDAPPLICATOR TAMPONS(K122603)	Roll wadding designcombined with acompact size applicator
510(k) Number	Not yet defined	K122603
Product Code	HEB	HEB	same
RegulationNumber	21 CFR PART 884.5470	21 CFR PART 884.5470	same
Regulation Name	Unscented menstrualtampons	Unscented menstrualtampons	same
Indications for Use	Inserted into the vagina toabsorb menstrualdischarge	Inserted into the vaginato absorb menstrualdischarge	same
Material	Absorbent pledget inviscose, polymericoverwrap, cottonpolyester cord.Plastic applicators inpolyethylene.	Absorbent pledget inviscose, polymericoverwrap, cottonpolyester cord.Plastic applicators inpolyethylene .Cardboard applicatorsin paper.	same
Tampon Type andApplicator(material and size)	Roll wadding tampon typewith a plastic applicator incompact size	Roll wadding tampondigital (withoutapplicator)W wadding tampontype with a plasticapplicator in full size(long) and in compactsize	Different, roll waddingform combined tocompact applicator size
Absorbencies	6-9g, 9-12g, 12-15g	<6g, 6-9g, 9-12g, 12-15g	Different no lightabsorbency for rollwadding plasticapplicator compact sizeTampons
Sterile	no	no	same
Single-Use	yes	yes	same
Complies with ISO10993-1	yes	yes	same

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Non-Clinical Performance Data 9.

As the intended use (same type and duration of user contact), raw materials and manufacturing process are the same, it was not necessary to test again the biocompatibility (irritation, sensitization, cytotoxicity and acute systemic toxicity) and microbiology (growth of S. oureus, TSST-1, normal vaginal microflora) of the Roll wadding plastic Applicator Compact Size Unscented Tampons. The results of tests performed on the predicate are still applicable. The modifications do not adverselv alter the safety profile of the tampons.

The Roll wadding plastic Applicator Compact size Unscented Tampons are recognized to be non-cytotoxic, non-irritant, with no terminal or gross observations in the reproductive tracts of any of the animals, with no exhibiting toxic signs, and with a negligible dermal response. They did not present a potential for dermal irritation or allergic contact sensitization.

The Roll wadding plastic Applicator Compact Size Unscented Tampons are recognized to not enhance the growth of Staphylococcus aureus. They do not increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1). They have no effect on culture pH. They do not alter the growth of normal vaginal microflora.

10. Performance Testing - Bench

The following testing has been performed to support substantial equivalence:

Absorptive Capacity (Syngina) ●
Fiber loss ●
Cord strength .
Expulsion force of the applicator ●
Microbiology batch testing (total viable count (TVC), presence of yeasts/moulds, . Candida albicans, gram-negative bacteria, Staphylococcus aureus, Pseudomonas aeruginusa)

The results of this testing have shown that the performance of the subject device is equivalent to the predicates. Indeed, as for the predicates, testing gives similar results which are within the specifications previously defined for the predicates devices.

Fiber loss is less than 1 mg. Cord strength is less than 50N (same as predicate Roll Digital Tampon in viscose), Expulsion force of the applicator is less than the specification of 6N.

As for the predicates, the total viable count is less than 10 cfu/g of tampon and meets the specification of less than 200 cfu/g of tampon. The total presence of yeasts and moulds is less than 10 cfu/g of tampon and meets the specification of less than 20 cfu/g of tampon. As for the predicates, Candida albicans, gram-negative bacteria, Staphylococcus aureus and Pseudomonas aeruginusa are absent in 1g of tampon and meet the specifications of negativity.

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The modifications have no impact on the technological performance and microbiology safety of the device.

11. Statement of Substantial Equivalence

As part of demonstrating safety and effectiveness of ONTEX Roll wadding plastic Applicator Compact size Unscented Tampons and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, ONTEX has completed a number of tests. The Roll wadding plastic Applicator Compact size Unscented Tampons meet all the requirements for biocompatibility, and microbiology and confirms that the output meets the design inputs and specifications.

It can be shown in this 510(k) submission that the difference between the Roll wadding plastic Applicator Compact size Unscented Tampons and the predicate devices do not raise any questions regarding its safety and effectiveness.

Design, principals of operation, performance characteristics and intended use between the Roll wadding plastic Applicator Compact size Unscented Tampons and the predicate devices are identical. Bench testing and standard microbiological controls demonstrate that the Roll wadding plastic Applicator Compact size Unscented Tampons is substantially equivalent to the relevant aspects of the predicate devices, in terms of technological performance and microbiological safety. The Roll wadding plastic Applicator Compact size Unscented Tampons, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 23, 2014

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

Re: K132595

Trade/Device Name: ONTEX ROLL WADDING PLASTIC APPLICATORS COMPACT SIZE UNSCENTED TAMPONS Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: February 21, 2014 Received: February 18, 2014

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.

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Page 2 - Rachel Paul

Please be advised that FDA is 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 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/CentersOfTices/CDRHOfTces/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/McdicalDevices/Safety/ReportalProblem/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/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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510(k) Number : K132595

Device Name: ONTEX ROLL WADDING PLASTIC APPLICATORS COMPACT SIZE UNSCENTED TAMPONS

Indications for Use:

The Ontex Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.

. Prescription Use

AND/OR

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

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner-S
2014.04.23 11:05:37 -04'00'

Page 4 - 1

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).