ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS

K132595 · Ontex Bvba · HEB · Apr 23, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K132595
• Device Name: ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
• Applicant: Ontex Bvba
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Apr 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

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

Device Story

Menstrual tampon consisting of viscose absorbent pledget with polymeric overwrap and polyester/cotton withdrawal cord; features telescopic plastic (polyethylene) applicator for compact storage. User inserts tampon into vagina to absorb menstrual discharge; applicator facilitates placement and is discarded after use. Available in three absorbencies (6-9g, 9-12g, 12-15g). Device is non-sterile, single-use, and intended for over-the-counter use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and microbiological analysis. Bench tests included Syngina absorptive capacity, fiber loss (<1 mg), cord strength (<50N), and applicator expulsion force (<6N). Microbiological testing confirmed absence of pathogens (Candida albicans, gram-negative bacteria, S. aureus, P. aeruginosa) and compliance with total viable count specifications (<10 cfu/g).

Technological Characteristics

Materials: viscose pledget, polymeric overwrap, polyester/cotton cord, polyethylene applicator. Design: roll wadding form with telescopic compact applicator. Absorbency: 6-15g range. Compliance: ISO 10993-1 for biocompatibility. Single-use, non-sterile.

Indications for Use

Indicated for individuals requiring vaginal 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 Digital and Plastic/Cardboard Applicator Unscented Tampons (K122603)

Submission Summary (Full Text)

{0}------------------------------------------------

### 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: [phone] Contact: HENRI LESAGE, R&D Manager Strategic Projects

#### 2. Submission Correspondent

Emergo Europe Consulting Prinsessegracht 20 2514 AP The Hague Cell Phone: [phone] 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: [e-mail]

- 3. 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:

{1}------------------------------------------------

#### 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.

{2}------------------------------------------------

# K132595
Page 3 of 5

| | Table SA -General Companson of Characteristics | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Manufacturer | ONTEX · | ONTEX | SIGNIFICANT<br>DIFFERENCES |
| Trade Name | ROLL WADDING<br>PLASTIC APPLICATOR<br>COMPACT SIZE<br>UNSCENTED TAMPONS | DIGITAL AND<br>PLASTIC/CARDBOARD<br>UNSCENTED<br>APPLICATOR TAMPONS<br>(K122603) | Roll wadding design<br>combined with a<br>compact size applicator |
| 510(k) Number | Not yet defined | K122603 | |
| Product Code | HEB | HEB | same |
| Regulation<br>Number | 21 CFR PART 884.5470 | 21 CFR PART 884.5470 | same |
| Regulation Name | Unscented menstrual<br>tampons | Unscented menstrual<br>tampons | same |
| Indications for Use | Inserted into the vagina to<br>absorb menstrual<br>discharge | Inserted into the vagina<br>to absorb menstrual<br>discharge | same |
| Material | Absorbent pledget in<br>viscose, polymeric<br>overwrap, cotton<br>polyester cord.<br>Plastic applicators in<br>polyethylene. | Absorbent pledget in<br>viscose, polymeric<br>overwrap, cotton<br>polyester cord.<br>Plastic applicators in<br>polyethylene .<br>Cardboard applicators<br>in paper. | same |
| Tampon Type and<br>Applicator<br>(material and size) | Roll wadding tampon type<br>with a plastic applicator in<br>compact size | Roll wadding tampon<br>digital (without<br>applicator)<br>W wadding tampon<br>type with a plastic<br>applicator in full size<br>(long) and in compact<br>size | Different, roll wadding<br>form combined to<br>compact applicator size |
| Absorbencies | 6-9g, 9-12g, 12-15g | <6g, 6-9g, 9-12g, 12-15g | Different no light<br>absorbency for roll<br>wadding plastic<br>applicator compact size<br>Tampons |
| Sterile | no | no | same |
| Single-Use | yes | yes | same |
| Complies with ISO<br>10993-1 | yes | yes | same |

### てったけ

.

:

:

.

-

: .

:

{3}------------------------------------------------

#### 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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

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.

{6}------------------------------------------------

#### 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 [phone] or [phone] 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

{7}------------------------------------------------

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