Ontex and other proprietary names

K162746 · Ontex Bvba · HEB · Mar 3, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K162746
• Device Name: Ontex and other proprietary names
• Applicant: Ontex Bvba
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.

Device Story

W long plastic applicator Tampons are unscented menstrual tampons consisting of an organic cotton absorbent pledget with a W wadding design and a polyethylene applicator. The device is intended for use by women to absorb menstrual discharge. It is a single-use, non-sterile device used in home settings or during normal daily activities. The user manually inserts the tampon into the vagina using the applicator. The device functions by absorbing menstrual fluid, providing menstrual hygiene management. It does not involve electronic components, software, or automated processing.

Clinical Evidence

Bench testing only. Testing included dimensional analysis, Syngyna absorbency testing, applicator expulsion force, string strength, and fiber shedding. Biocompatibility testing per ISO 10993-1 confirmed the device is non-cytotoxic, non-irritating, non-sensitizing, and non-acutely toxic. Microbiology testing per FDA guidance and European Pharmacopeia 2.6.13 confirmed the device does not enhance Staphylococcus aureus growth, increase TSST-1 production, or alter vaginal microflora. Pesticide and dioxin testing confirmed absence of these contaminants.

Technological Characteristics

Materials: Organic cotton (pledget), polyethylene (applicator). Design: W wadding pledget, full-size applicator. Dimensions: Regular (45mm length, 13.5mm diameter) and Super (45mm length, 15.5mm diameter). Single-use, non-sterile. Complies with ISO 10993-1 for biocompatibility and FDA guidance for menstrual tampons regarding microbiology.

Indications for Use

Indicated for women for the absorption of menstrual discharge.

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

• Ontex Tampon (Unscented) (K090819)

Submission Summary (Full Text)

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

March 7, 2017

Ontex BVBA % Rachel Paul Senior Consultant, QA & RA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP The Netherlands

Re: K162746 Trade/Device Name: W long plastic applicator Tampons Regulation Number: 21 CFR§ 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: February 2, 2017 Received: February 3, 2017

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 mav 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); 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely,

Charles Viviano -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) K162746

Device Name W long plastic applicator Tampons

Indications for Use (Describe)

The W long plastic applicator Tampons 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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# 510(k) Summary

## W long plastic applicator Tampons

### K162746

#### 1. Submission Sponsor

Ontex BVBA 5 Genthof Buggenhout Oost-Vlaanderen 9255 Belgium Phone number: [phone] Contact: Henri Lesage Title: Group R&D Manager Strategic Projects & Tampons 2. Submission Correspondent Emergo Europe Consulting Prinsessegracht 20 The Hague 2514AP The Netherlands Cell Phone: [phone]

Office Phone: [phone]/Direct: [phone]

Contact: Rachel Paul, Senior Consultant, QA&RA

Email: [e-mail]

#### 3. Date Prepared

2 March 2017

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#### 4. Device Identification

| Trade/Proprietary Name: | W long plastic applicator Tampons |
|-------------------------|----------------------------------------------|
| Common/Usual Name: | Unscented menstrual tampons |
| Regulation Number: | 21 CFR 884.5470 (Unscented menstrual tampon) |
| Product Code: | HEB (Tampon, Menstrual, Unscented) |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |

#### 5. Legally Marketed Predicate Device(s)

K090819, Ontex Tampon (Unscented)

The predicate device has not been subject to a design-related recall.

#### 6. Device Description

The W long plastic applicator Tampons are conventional unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of organic cotton. The applicator is in polyethylene and of full size (long). The pledget has a W wadding design. The Tampons are available in regular and super absorbencies. The device specifications are listed in the table below.

| Component | | Regular | Super |
|--------------------|----------------|----------------------------------|----------------|
| Tampon | Length (mm) | $45 \pm 5$ | $45 \pm 5$ |
| | Diameter (mm) | $13.5 \pm 0.2$ | $15.5 \pm 0.2$ |
| | Weight (g) | 1.9-2.3 | 3.0-3.4 |
| | Absorbency (g) | 6-9 | 9-12 |
| Applicator | Length (mm) | 77.0 (closed) 115-135 (extended) | |
| | Diameter (mm) | 14.9 | 16.9 |
| Withdrawal<br>Cord | Length (mm) | $120 \pm 15$ | |

#### 7. Indication for Use Statement

The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.

#### 8. Substantial Equivalence Discussion

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The following table compares the W long plastic applicator Tampons to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The different technological characteristics of the subject device do not raise any different questions of safety or effectiveness compared to the predicate device.

| Manufacturer | Ontex BVBA | Ontex BVBA | Significant |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Trade Name | W long plastic<br>applicator Tampons | Ontex Tampons<br>(Unscented) | Differences |
| 510(k) Number | K162746 | K090819 | NA |
| Product Code | HEB | HEB | Same |
| Regulation Number | 884.5470 | 884.5470 | Same |
| Regulation Name | Unscented menstrual<br>tampons | Unscented menstrual<br>tampons | Same |
| Indications for Use | Inserted into the vagina<br>to absorb menstrual<br>discharge | Inserted into the vagina<br>to absorb menstrual<br>discharge | Same |
| Targeted population | Women | Women | Same |
| Anatomical site | Vagina | Vagina | Same |
| Where used | Home and can be<br>transported during<br>normal activities of<br>women | Home and can be<br>transported during<br>normal activities of<br>women | Same |
| Overall design | W wadding<br>With an applicator<br>Full size (long)<br>applicator | W wadding<br>Digital (without<br>applicator) and with<br>applicator<br>Full size (long) applicator | Partially the same;<br>predicate is available<br>without an applicator |
| Absorbencies (sizes) | Regular and super | Regular and super | Same |
| Sterile | No | No | Same |
| Single-Use | Yes | Yes | Same |
| Materials | Applicator in<br>Polyethylene and all the<br>others parts in 100% | Applicator in cardboard<br>and all the others parts in | Partially the same;<br>applicator is not from |
| Manufacturer | Ontex BVBA | Ontex BVBA | Significant Differences |
| Trade Name | W long plastic<br>applicator Tampons | Ontex Tampons<br>(Unscented) | |
| | organic cotton | 100% organic cotton | the same material |
| Complies with ISO<br>10993-1 | Yes | Yes | Same |
| Complies with<br>microbiology<br>requirements of FDA<br>Guidance for<br>Tampons | Yes | Yes | Same |

#### Table 5A – Comparison of Characteristics

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#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of W long plastic applicator Tampons that are subject to this 510(k) submission and in showing substantial equivalence to the predicate device, Ontex BVBA completed a number of non-clinical performance tests. The W long plastic applicator Tampons meet all the requirements for overall design, functionality, biocompatibility, and microbiology results confirming that the design output meets the design inputs and specifications for the device.

The W long plastic applicator Tampons passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- . Dimensional Testing – the dimensions met the final device specifications
- . Syngyna testing, expulsion force of the applicator, string strength and fiber shedding per internal requirements - results meet specifications
- . Biocompatibility testing per ISO 10993-1:2009/(R)2013 – the tampons and applicator tested are found as non-cytotoxic, non-irritating, non-sensitizing, and non-acutely toxic.
- Microbiology testing for growth of Staphylococcus aureus, production of Toxic Shock Syndrome Toxin-1, growth of the normal vaginal microbial species per FDA Guidance on menstrual tampons the test tampon does not enhance the growth of Staphylococcus aureus. It does not increase the production of Toxic Syndrome Toxin-1 (TSST-1). It had no effect on culture pH. The test tampon does not alter the growth of normal vaginal microflora.
- Microbiology batch testing per European Pharmacopeia 2.6.13 – the specifications are met

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- . Pesticides and dioxins testing – no pesticides and dioxins are found from the polyethylene applicator or from the organic cotton.
#### 10. Statement of Substantial Equivalence

The results of the testing described above demonstrate that the W long plastic applicator Tampons are as safe and effective as the predicate device and support a determination of substantial equivalence.