ONTEX AND OTHERS PROPRIETARY NAMES

{0}------------------------------------------------ K132208 Page 1 of 6 #### 510(k) Summary for ## ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR 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 Prinsessegracht 20 2514 AP, The Hague The Netherlands Cell Phone: +33 (0)6 89 83 16 09 Office: +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 13th June 2013 #### 4. Device Identification ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS Trade/Proprietary Name: SCENTED MENSTRUAL TAMPONS Common/Usual Name: SCENTED OR SCENTED-DEODORIZED MENSTRUAL TAMPON Classification Name: Classification Regulation: 21 CFR 884.5460 HIL Product Code: Device Class: Class II OBGYN, Obstetrics/Gynecology Classification Panel: #### 5. Legally Marketed Predicate Device(s) Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons K122603 - Page 5-1 -- {1}------------------------------------------------ #### 6. Device Description The Scented Tampons are: 1) Scented Digital 2) Scented Plastic Applicator (full size (long) and compact) They are scented versions because of the presence of a fragrance. | Tampon Type | Applicator Material | Applicator Size | Absorbencies | |--------------|---------------------|------------------|--------------------------| | Roll wadding | n/a, digital | n/a, digital | <6g, 6-9g, 9-12g, 12-15g | | W wadding | plastic | Full size (long) | <6g, 6-9g, 9-12g, 12-15 | | W wadding | plastic | Compact | <6g, 6-9g, 9-12g, 12-15 | Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge. These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super (9-12g), and super plus (12-15g). These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is in polyester and cotton. Applicators are in polyethylene. Roll-tampon: sheet of absorbent material is rolled and pressed. W-tampon: sheet of absorbent material is folded and pressed from two sides simultaneously. Long applicator: inner tube and outer tube are ready to be used immediately. Compact applicator: inner tube and outer tube are slided into each other telescopically. The inner tube needs to be retracted before usage. Except for the perfume, the materials used in these tampons are similar to materials of legally marketed tampons. #### 7. Indication for Use Statement The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge. #### 8. Substantial Equivalence Discussion · The following table compares the DEVICE to the predicate device 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}------------------------------------------------ | Table 5A -General Comparison of Characteristics | | | | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Manufacturer | ONTEX | ONTEX | SIGNIFICANT<br>DIFFERENCES | | Trade Name | SCENTED DIGITAL AND<br>PLASTIC APPLICATOR<br>TAMPONS | UNSCENTED DIGITAL<br>AND PLASTIC AND<br>CARDBOARD<br>APPLICATOR TAMPONS<br>(K122603) | Presence of a fragrance<br>for the scented version. | | 510(k) Number | Not yet defined | K122603 | | | Product Code | HIL | HEB | different | | Regulation<br>Number | 21 CFR PART 884.5460 | 21 CFR PART 884.5470 | different | | Regulation Name | Scented or scented-<br>deodorized menstrual<br>tampon | Unscented menstrual<br>tampon | different | | 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. Plastic<br>applicators in<br>polyethylene. Perfume. | Absorbent pledget in<br>viscose, polymeric<br>overwrap, cotton<br>polyester cord.<br>Plastic applicators in<br>polyethylene .<br>Cardboard applicator in<br>paper. | same except perfume<br>and no applicator in<br>cardboard, only plastic. | | Tampon Type and<br>Applicator<br>(material and size) | Roll wadding digital<br>W wadding plastic<br>applicator full size (long)<br>and compact | Roll wadding digital<br>W wadding plastic<br>applicator full size (long)<br>and compact | same | | Absorbencies | <6g, 6-9g, 9-12g, 12-15g | <6g, 6-9g, 9-12g, 12-15g | same | | Sterile | no | no | same | | Single-Use | yes | yes | same | | Complies with ISO<br>10993-1 | yes | yes | same | {3}------------------------------------------------ | Manufacturer | ONTEX | ONTEX | SIGNIFICANT<br>DIFFERENCES | |-----------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------| | Trade Name | SCENTED DIGITAL AND<br>PLASTIC APPLICATOR<br>TAMPONS | UNSCENTED DIGITAL AND<br>PLASTIC AND CARDBOARD<br>APPLICATOR TAMPONS<br>(K122603) | Presence of a<br>fragrance for the<br>scented version. | | Total weight (g) | 1.2 - 3.7 | 1.2 - 3.7 | Same | | Weight without<br>applicator (g) | NA | NA | NA | | Withdrawal cord<br>Length (mm) | 145 | 145 | Same | | Length with<br>applicator (mm) | NA | NA | NA | | Length without<br>applicator (mm) | 39 - 49 | 39 - 49 | Same | | Diameter with<br>applicator (mm) | NA | NA | NA | | Diameter without<br>applicator | 10.4 - 14.8 | 10.4 - 14.8 | Same | | Pledget | 100% viscose | 100% viscose | Same | | Non-Woven Cover | Polyester/Polyethylene | Polyester/Polyethylene | Same | | Withdrawal cord | Polyester/Cotton | Polyester/Cotton | Same | | Applicator | NA | NA | NA | | Perfume | yes | no | Different | ### Table 5C – Comparison of Characteristics Applicator Tampons | Manufacturer | ONTEX | ONTEX | SIGNIFICANT<br>DIFFERENCES | |-------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------| | Trade Name | SCENTED DIGITAL AND<br>PLASTIC APPLICATOR<br>TAMPONS | UNSCENTED DIGITAL AND<br>PLASTIC AND CARDBOARD<br>APPLICATOR TAMPONS<br>(K122603) | Presence of a<br>fragrance for<br>the scented<br>version. | | Total weight (g) | 3.6 – 6.4 for compact<br>3.6 – 8.1 for full size | 3.6 – 6.4 for compact<br>3.6 – 8.1 for full size | Same | | Weight without<br>applicator (g) | 1.1 – 3.7 for compact<br>1.2 – 3.8 for full size | 1.1 – 3.7 for compact<br>1.2 – 3.8 for full size | Same | | Withdrawal cord<br>Length (mm) | 120 | 120 | Same | | Length with<br>applicator (mm) | 120 for compact<br>125 for full size | 120 for compact<br>125 for full size | Same | | Length without<br>applicator (mm) | 40 – 45 for compact<br>45 for full size | 40 – 45 for compact<br>45 for full size | Same | | Diameter with<br>applicator (mm) | 13.5 – 18.2 for compact<br>11.5 – 16.5 for full size | 13.5 – 18.2 for compact<br>11.5 – 16.5 for full size | Same | | Diameter without<br>applicator (mm) | 11.0 – 15.0 for compact<br>11.5 – 15.5 for full size | 11.0 – 15.0 for compact<br>11.5 – 15.5 for full size | Same | {4}------------------------------------------------ K132208 Page 5 of 6 | Manufacturer | ONTEX | ONTEX | SIGNIFICANT<br>DIFFERENCES | |-----------------|------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------| | Trade Name | SCENTED DIGITAL AND<br>PLASTIC APPLICATOR<br>TAMPONS | UNSCENTED DIGITAL AND<br>PLASTIC AND CARDBOARD<br>APPLICATOR TAMPONS<br>(K122603) | Presence of a<br>fragrance for<br>the scented<br>version. | | Pledget | 100% viscose | 100% viscose | Same | | Non-woven cover | Polypropylene/Polyethylene | Polypropylene/Polyethylene | Same | | Withdrawal cord | Polyester/Cotton | Polyester/Cotton | Same | | Applicator | Plastic polyethylene | Plastic applicator in<br>polyethylene, Cardboard<br>applicator in paper. | Same but no<br>applicator in<br>paper | | Perfume | yes | no | Different | #### 9. Non-Clinical Performance Data Biocompatibility and microbiology testing have been performed to support substantial equivalence: - . The ONTEX SCENTED TAMPONS were tested as 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 indicate a potential for dermal irritation or allergic contact sensitization. - The test tampon does not enhance the growth of Staphylococcus aureus. It does not . increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1). It had no effect on culture pH. The test tampon does not alter the growth of normal vaginal microflora. As part of demonstrating safety and effectiveness of ONTEX SCENTED TAMPONS and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, ONTEX completed a number of tests. The SCENTED TAMPONS meet all the requirements for biocompatibility and microbiology and ONTEX confirms that the output meets the design inputs and specifications. The SCENTED TAMPONS passed all testing stated above as shown by the acceptable results obtained. The SCENTED TAMPONS comply with the applicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards. #### 10. Statement of Substantial Equivalence It can be shown in this 510(k) submission that the difference between the SCENTED TAMPON and the predicate device do not raise any questions regarding its safety and effectiveness: Design, principals of operation, performance characteristics and intended use between the SCENTED TAMPON and the predicate device are identical. The sole difference is the {5}------------------------------------------------ presence of perfume for the SCENTED TAMPON. Biocompatibility and microbiological studies demonstrate that the SCENTED TAMPON is substantially equivalent to the relevant aspects of the predicate device in terms of biocompatibility, microbiological and safety , The SCENTED TAMPON, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white. #### 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 10, 2014 ONTEX BVBA % Rachel Paul Senior Consultant, OA/RA Emergo Europe Consulting Prinsessegracht 20 The Hague 2514AP Netherlands K132208 Re: > Trade/Device Name: ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL Dated: March 13, 2014 Received: March 14, 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. {7}------------------------------------------------ #### Page 2 - Rachel Paul 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 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/CentersOffices/CDRH/CDRHOffices/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/MedicalDevices/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 {8}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 510(k) Number (if known) K132208 Device Name ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS Indications for Use (Describe) The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge. Type of Use (Select one or both, as applicable) J Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) ## Herbert P. Lerne 2014.04.10 14:08:58 -04'00' This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden lime 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@ida.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14) Page 1 of 1 INC Publishing Services (301)-443-6740 E Exhibit 4A - 1