(268 days)
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
The Scented Tampons are:
- Scented Digital
- Scented Plastic Applicator (full size (long) and compact)
They are scented versions because of the presence of a fragrance.
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.
The provided document describes a 510(k) submission for "ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS". This is a medical device application for tampons, not a diagnostic or AI-driven device. Therefore, the typical acceptance criteria and study designs involving performance metrics like sensitivity, specificity, MRMC studies, and ground truth establishment, which are relevant to image analysis or diagnostic algorithms, are not applicable here.
Instead, the acceptance criteria for this type of device focus on biocompatibility and microbiology to ensure safety and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, while noting the different nature of this device:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated) | Device Performance (Reported) |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Passed (non-cytotoxic) |
| Non-irritant | Passed (non-irritant), no terminal or gross observations in reproductive tracts of animals, no toxic signs, negligible dermal response. | |
| No potential for dermal irritation | Passed (no potential for dermal irritation) | |
| No potential for allergic contact sensitization | Passed (no potential for allergic contact sensitization) | |
| Microbiology | Does not enhance growth of Staphylococcus aureus | Passed (does not enhance growth of Staphylococcus aureus) |
| Does not increase production of Toxic Shock Syndrome Toxin-1 (TSST-1) | Passed (does not increase production of TSST-1) | |
| No effect on culture pH | Passed (no effect on culture pH) | |
| Does not alter growth of normal vaginal microflora | Passed (does not alter growth of normal vaginal microflora) | |
| Voluntary Standards Compliance | Complies with applicable voluntary standards for biocompatibility | Passed all testing in accordance with national and international standards. |
| Substantial Equivalence | Differences from predicate device do not raise concerns regarding safety and effectiveness | Demonstrated through biocompatibility and microbiological studies that the scented tampon is substantially equivalent in terms of biocompatibility, microbiological, and safety aspects. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for specific tests. The tests appear to be laboratory-based and conducted on the materials or final product. The provenance of the data is from ONTEX BVBA, Belgium, as stated in the submission sponsor information. The studies are non-clinical performance data, likely conducted prospectively as part of the device development and submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the non-clinical testing performed for this device. Ground truth, in the context of device performance, typically refers to expert consensus or pathology for diagnostic devices. For biocompatibility and microbiological testing, standardized laboratory protocols and expert analysis of results are followed, but "ground truth" as a consensus of clinical experts is not relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or for diagnostic evaluations where multiple human readers assess cases. The studies described are laboratory-based biocompatibility and microbiology tests, which follow standardized testing procedures rather than human expert adjudication of results from a "test set" in the clinical sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. MRMC studies are specifically for evaluating diagnostic devices, often AI-powered, where human readers interact with or without AI assistance. This device is a tampon, not a diagnostic tool, and involves no AI component or human reader interpretation for its function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as there is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests for this device is based on standardized laboratory testing protocols and established scientific criteria for biocompatibility and microbiological safety. For example, for Staphylococcus aureus growth, the ground truth is "does not enhance growth," which is determined by comparing growth in the presence of the tampon to a control, according to established microbiological methods.
8. The sample size for the training set
This is not applicable, as there is no training set for an AI/algorithm-driven device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/algorithm-driven device.
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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
-
- Date Prepared
13th June 2013
- Date Prepared
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 --
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6. Device Description
The Scented Tampons are:
-
Scented Digital
-
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.
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| Table 5A -General Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | ONTEX | ONTEX | SIGNIFICANTDIFFERENCES |
| Trade Name | SCENTED DIGITAL ANDPLASTIC APPLICATORTAMPONS | UNSCENTED DIGITALAND PLASTIC ANDCARDBOARDAPPLICATOR TAMPONS(K122603) | Presence of a fragrancefor the scented version. |
| 510(k) Number | Not yet defined | K122603 | |
| Product Code | HIL | HEB | different |
| RegulationNumber | 21 CFR PART 884.5460 | 21 CFR PART 884.5470 | different |
| Regulation Name | Scented or scented-deodorized menstrualtampon | Unscented menstrualtampon | different |
| Indications for Use | Inserted into the vagina toabsorb menstrualdischarge | Inserted into the vaginato absorb menstrualdischarge | same |
| Material | Absorbent pledget inviscose, polymericoverwrap, cottonpolyester cord. Plasticapplicators inpolyethylene. Perfume. | Absorbent pledget inviscose, polymericoverwrap, cottonpolyester cord.Plastic applicators inpolyethylene .Cardboard applicator inpaper. | same except perfumeand no applicator incardboard, only plastic. |
| Tampon Type andApplicator(material and size) | Roll wadding digitalW wadding plasticapplicator full size (long)and compact | Roll wadding digitalW wadding plasticapplicator full size (long)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 ISO10993-1 | yes | yes | same |
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| Manufacturer | ONTEX | ONTEX | SIGNIFICANTDIFFERENCES |
|---|---|---|---|
| Trade Name | SCENTED DIGITAL ANDPLASTIC APPLICATORTAMPONS | UNSCENTED DIGITAL ANDPLASTIC AND CARDBOARDAPPLICATOR TAMPONS(K122603) | Presence of afragrance for thescented version. |
| Total weight (g) | 1.2 - 3.7 | 1.2 - 3.7 | Same |
| Weight withoutapplicator (g) | NA | NA | NA |
| Withdrawal cordLength (mm) | 145 | 145 | Same |
| Length withapplicator (mm) | NA | NA | NA |
| Length withoutapplicator (mm) | 39 - 49 | 39 - 49 | Same |
| Diameter withapplicator (mm) | NA | NA | NA |
| Diameter withoutapplicator | 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 | SIGNIFICANTDIFFERENCES |
|---|---|---|---|
| Trade Name | SCENTED DIGITAL ANDPLASTIC APPLICATORTAMPONS | UNSCENTED DIGITAL ANDPLASTIC AND CARDBOARDAPPLICATOR TAMPONS(K122603) | Presence of afragrance forthe scentedversion. |
| Total weight (g) | 3.6 – 6.4 for compact3.6 – 8.1 for full size | 3.6 – 6.4 for compact3.6 – 8.1 for full size | Same |
| Weight withoutapplicator (g) | 1.1 – 3.7 for compact1.2 – 3.8 for full size | 1.1 – 3.7 for compact1.2 – 3.8 for full size | Same |
| Withdrawal cordLength (mm) | 120 | 120 | Same |
| Length withapplicator (mm) | 120 for compact125 for full size | 120 for compact125 for full size | Same |
| Length withoutapplicator (mm) | 40 – 45 for compact45 for full size | 40 – 45 for compact45 for full size | Same |
| Diameter withapplicator (mm) | 13.5 – 18.2 for compact11.5 – 16.5 for full size | 13.5 – 18.2 for compact11.5 – 16.5 for full size | Same |
| Diameter withoutapplicator (mm) | 11.0 – 15.0 for compact11.5 – 15.5 for full size | 11.0 – 15.0 for compact11.5 – 15.5 for full size | Same |
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K132208 Page 5 of 6
| Manufacturer | ONTEX | ONTEX | SIGNIFICANTDIFFERENCES |
|---|---|---|---|
| Trade Name | SCENTED DIGITAL ANDPLASTIC APPLICATORTAMPONS | UNSCENTED DIGITAL ANDPLASTIC AND CARDBOARDAPPLICATOR TAMPONS(K122603) | Presence of afragrance forthe scentedversion. |
| 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 inpolyethylene, Cardboardapplicator in paper. | Same but noapplicator inpaper |
| 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.
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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.
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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
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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'
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FORM FDA 3881 (1/14)
Page 1 of 1
INC Publishing Services (301)-443-6740 E
Exhibit 4A - 1
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).