Unscented W long plastic and cardboard applicator tampons

K191666 · Ontex Bvba · HEB · Dec 20, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K191666
• Device Name: Unscented W long plastic and cardboard applicator tampons
• Applicant: Ontex Bvba
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

Device Story

Unscented menstrual tampons consisting of an absorbent pledget and an applicator; pledget made of 100% viscose with polymeric overwrap; applicator provided in polyethylene or cardboard. Device inserted into vagina by user to absorb menstrual or vaginal discharge. Available in light, regular, super, and super plus absorbencies. Device is single-use and non-sterile.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1, -5, -10, and -11 confirmed non-cytotoxic, non-sensitizing, and non-systemically toxic. Performance testing per FDA guidance included Syngina absorbency, withdrawal cord strength, fiber shedding, tampon integrity, expulsion force, and cardboard applicator dissolving time. Microbial testing confirmed no enhancement of S. aureus growth, no increase in TSST-1 production, and no alteration of normal vaginal microflora.

Technological Characteristics

Absorbent pledget (100% TCF viscose, polymeric overwrap); polyethylene or cardboard applicator. W wadding design. Dimensions: Tampon length 45-50 mm, diameter 9.8-15.5 mm. Complies with ISO 10993-1 and FDA guidance for menstrual tampons. Non-sterile, single-use.

Indications for Use

Indicated for women for the absorption of menstrual or other vaginal 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 Unscented Digital and Plastic and Cardboard Applicator Tampons (K122603)

Submission Summary (Full Text)

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December 20, 2019

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

Re: K191666

Trade/Device Name: Unscented W long plastic and cardboard applicator Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented Menstrual Tampon Regulatory Class: Class II Product Code: HEB Dated: November 15, 2019 Received: November 19, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K191666

#### Device Name

Unscented W long plastic and cardboard applicator Tampons

Indications for Use (Describe)

The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal 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

## Unscented W long plastic and cardboard applicator Tampons

K191666

#### 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

19 December 2019

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### 4. Device Identification

| Device Trade Name: | Unscented W long plastic and cardboard applicator Tampons |
|---------------------|-----------------------------------------------------------|
| Device Common Name: | Unscented menstrual tampons |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 884.5470 |
| Regulation Name: | Unscented menstrual tampon |
| Product Code: | HEB (tampon, menstrual, unscented) |

#### 5. Legally Marketed Predicate Device

K122603, Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons (Ontex BVBA)

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

#### 6. Device Description

The Unscented W long plastic and cardboard applicator Tampons are unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of 100% viscose with polymeric overwrap. The applicator is a full size applicator provided in polyethylene or cardboard. The absorbent pledget has a W wadding design and is available in light, regular, super and super plus absorbencies. For additional technical information, please see Table 1 below.

#### 7. Indication for Use Statement

The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

#### 8. Substantial Equivalence Discussion

The following table compares the Unscented W long plastic and cardboard applicator Tampons (subject device ) to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing.

| Manufacturer | Ontex BVBA | Ontex BVBA | Device Comparison |
|---------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------|
| Trade Name | W long plastic and<br>cardboard applicator<br>Tampons<br>(subject device) | Ontex Unscented Digital<br>and Plastic and Cardboard<br>Applicator Tampons<br>(predicate device) | |
| 510(k) Number | K191666 | K122603 | Same |

| | | Table 1 - Comparison of Characteristics |
|--|--|-----------------------------------------|
|--|--|-----------------------------------------|

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| Manufacturer | Ontex BVBA | Ontex BVBA | Device Comparison |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | W long plastic and<br>cardboard applicator<br>Tampons<br>(subject device) | Ontex Unscented Digital<br>and Plastic and Cardboard<br>Applicator Tampons<br>(predicate device) | |
| Product Code | HEB | HEB | Same |
| Regulation<br>Number | 884.5470 | 884.5470 | Same |
| Regulation Name | Unscented menstrual<br>tampons | Unscented menstrual<br>tampons | Same |
| Indications for<br>use | The Unscented W long<br>plastic and cardboard<br>applicator Tampons are<br>inserted into the vagina<br>to absorb menstrual or<br>other vaginal discharge. | The Ontex Unscented<br>Digital and Plastic and<br>Cardboard Applicator<br>Tampons, available in light,<br>regular, super, and super<br>plus absorbency are<br>inserted into the vagina<br>and used to absorb<br>menstrual or other vaginal<br>discharge. | Similar |
| Target<br>Population | Women | Women | Same |
| Anatomical site | Vagina | Vagina | Same |
| Overall design | Unscented | Unscented | Same |
| | W wadding tampons | W wadding tampons | Same |
| | With applicator | With and without<br>applicator (digital) | Different. The subject<br>device does not contain a<br>digital tampon option.<br>However, both the subject<br>and predicate device utilize<br>an applicator for tampon<br>deployment. |
| | Long (full size) applicator | Long (full) size applicator | Same |
| Absorbencies | light (< 6g), regular (6-<br>9g), super (9-12g) and<br>super plus (12-15g) | light (< 6g), regular (6-9g),<br>super (9-12g) and super<br>plus (12-15g) | Same |
| Manufacturer | Ontex BVBA | Ontex BVBA | Device Comparison |
| Trade Name | W long plastic and<br>cardboard applicator<br>Tampons<br>(subject device) | Ontex Unscented Digital<br>and Plastic and Cardboard<br>Applicator Tampons<br>(predicate device) | |
| Sterile | No | No | Same |
| Single use | Yes | Yes | Same |
| Materials | Pledget in 100% TCF<br>viscose | Pledget in a mix of TCF/ECF<br>viscose | Similar. The subject device<br>utilizes a different pledget<br>material. |
| | New glue for cardboard<br>applicator | Cardboard glue | Similar. The subject device<br>utilizes a different glue in<br>the cardboard applicator. |
| Dimensions | Tampon<br>Length: 45-50 mm<br>Diameter: 9.8 – 15.5 mm<br>Weight: 1.2 – 4.05<br>Plastic Applicator<br>Length: 115-135 mm<br>Diameter: 12.9 – 16.9 mm<br>Cardboard Applicator<br>Length: 115-125 mm<br>Diameter: 12.0 – 16.0 mm | Tampon<br>Length: 45 mm<br>Diameter: 10.6 – 15.5 mm<br>Weight: 1.0 – 3.8 g<br>Plastic Applicator<br>Length: 125mm (74mm for<br>compact applicator only)<br>Diameter: 13.5 – 16.0 mm<br>Cardboard Applicator<br>Length: 120 mm<br>Diameter: 12.0 – 16.0 mm | Different. The subject<br>device has slightly different<br>dimensions and weight. |
| Complies with<br>ISO 10993-1 | Yes | Yes | Same |
| Complies with<br>microbiology<br>requirements of<br>FDA Guidance<br>for Tampons | Yes | Yes | Same |

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The subject and predicate device have similar indications for use and have the same intended use. The technological characteristics of the subject device are different. The subject device contains different materials and different dimensions and weight. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

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### 9. Non-Clinical Performance Data

#### Biocompatibility

Biocompatibility studies were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:

- ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a । risk management process
- -ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- -ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity
- -ISO 10993-11:2006, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (tampon only)

All tests were performed on the tampon and applicator separately. The results of this testing demonstrated that the subject device is non-cytotoxic, non-sensitizing, and nonsystemically toxic.

#### Performance Characteristics

The following performance characteristics were assessed in accordance with the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) — Guidance for Industry and FDA Staff:

- . Dimensional information
- . Absorbency range (Syngina testing per 21 CFR 801.430(f)(2))
- Chemical residues
- . Withdrawal cord strength
- Fiber shedding
- Tampon integrity
- Expulsion force
- . Cardboard applicator dissolving time

### Microbial Testing

Per the 2005 FDA guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) – Guidance for Industry and FDA Staff, tampon manufacturers should demonstrate that the subject device in its final, finished form does not:

- . enhance the growth of Staphylococcus aureus

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- increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1) .
- . alter the growth of normal vaginal microflora

The testing performed met the recommendations of the 2005 FDA guidance document.

#### 10. Statement of Substantial Equivalence

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