(270 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of tampons and applicators, with no mention of AI or ML.
No
The tampons are for absorbing menstrual discharge, which is a supportive function rather than a therapeutic treatment of a disease or condition. They are not intended to restore, modify or correct body function.
No
The device, Ontex Unscented Tampons, is described as being inserted into the vagina to absorb menstrual discharge. Its intended use and device description do not mention any diagnostic capabilities, such as detecting or identifying a medical condition.
No
The device is a physical tampon with a plastic applicator, not a software-only medical device. The description details physical components and bench testing related to material properties and mechanical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "absorb menstrual discharge" by being "inserted into the vagina." This is a physical function within the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a physical absorbent product (tampon) and an applicator for insertion. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on physical properties (expulsion force), material safety (extraction, leachables, toxicological risk assessment), and absorptive capacity. These are relevant to a physical medical device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.
Product codes (comma separated list FDA assigned to the subject device)
HEB
Device Description
Tampons included in this submission are conventional unscented menstrual tampons consisting of an absorbent pledget (viscose material in a W-shape wadding form), polyester/cotton withdrawal cord, and a polymeric overwrap. The tampon component of this submission is identical to that cleared in the predicate submission (K122603).
Tampons included in this submission are placed in the vagina using a polyethylene applicator. The applicator is available in two sizes: full size (long) or compact size. The full size applicator is ready for use. The compact size consists of an inner and outer tube that requires the inner tube to be retracted prior to use. Applicators included in this submission are provided in different colors including green, yellow, lilac, orange and pink.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to support substantial equivalence:
- Extraction 24h at 37°C in water
- Visual inspection and spectrophotometric analysis
- Gravimetric analysis
- Gas chromatography and mass spectrophotometry (GC-MS)
After extraction of each colored applicator and additional testing for determination of possible leachates, the test results showed there is no potential for leachables to migrate from the colored plastic tampon applicators in water.
A toxicological risk assessment explains that the color variants of the tampon applicator would not be expected to cause any adverse effects under normal and reasonably foreseeable conditions of use and also supports the safety of each of the color variants.
The following test was performed to support substantial equivalence:
- Expulsion force applicator
Expulsion force met the specifications as defined for the predicate.
The modification has no impact on the absorptive capacity (Syngena), fiber loss and cord strength of the device. The predicate testing specifications are still applicable to the subject device for these tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.5470 Unscented menstrual tampon.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
ONTEX BVBA % Rachel Paul Senior Consultant QA/RA Emergo Europe Consulting Prinsessegracht 20 The Hague 2514 AP The Netherlands
Re: K142786
Trade/Device Name: Ontex Unscented Tampons with Colored Plastic Applicators Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: April 30, 2015 Received: May 18, 2015
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.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (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
2
Indications for Use
510(k) Number (if known) K142786
Device Name
Ontex Unscented Tampons with Colored Plastic Applicators
Indications for Use (Describe)
The Ontex Unscented Tampons with Colored Plastic Applicators 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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3
510(k) Summary For Ontex Unscented Tampons with Colored Plastic Applicators
510(k) Number: K142786
1. Submission Sponsor
ONTEX BVBA Genthof 5 9255 Buggenhout Belgium Phone: + 32 9376 77 06 Fax: + 32 9 378 13 33 Contact: HENRI LESAGE, R&D Manager Strategic Projects
2. Submission Correspondent
Emergo Europe Consulting Prinsessegracht 20 2514 AP The Hague The Netherlands Cell Phone: + 33 (0)6 89 83 16 09 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: project.management@emergogroup.com
3. Date Prepared
30/04/2015
4. Device Identification
| Trade/Proprietary Name: | Ontex Unscented Tampons with Colored Plastic Applicators | |
|---|---|---|
| Common/Usual Name: | Unscented Menstrual Tampon | |
| Classification Name: | Unscented Menstrual Tampon | |
| Classification Regulation: | 21 CFR 884.5470 | |
| Product Code: | HEB | |
| Device Class: | Class II | |
| Classification Panel: | OBGYN, Obstetrics/Gynecology |
4
5. Legally Marketed Predicate Device(s)
Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons K122603
6. Device Description
Tampons included in this submission are conventional unscented menstrual tampons consisting of an absorbent pledget (viscose material in a W-shape wadding form), polyester/cotton withdrawal cord, and a polymeric overwrap. The tampon component of this submission is identical to that cleared in the predicate submission (K122603).
Tampons included in this submission are placed in the vagina using a polyethylene applicator. The applicator is available in two sizes: full size (long) or compact size. The full size applicator is ready for use. The compact size consists of an inner and outer tube that requires the inner tube to be retracted prior to use. Applicators included in this submission are provided in different colors including green, yellow, lilac, orange and pink.
7. Indication for Use Statement
The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.
8. Substantial Equivalence Discussion
The following table compares the Unscented Tampons with Colored Plastic Applicators 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.
| Manufacturer | ONTEX | ONTEX | SIGNIFICANT DIFFERENCES |
|---|---|---|---|
| Trade Name | Ontex Unscented Tampons with Colored Plastic Applicators (K142786) | Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons (K122603) | Colored applicators tubes |
| 510(k) Number | K142786 | K122603 | NA. |
| Product Code | HEB | HEB | Same. |
| Regulation Number | 21 CFR PART 884.5470 | 21 CFR PART 884.5470 | Same. |
| Regulation Name | Unscented menstrual tampons. | Unscented menstrual tampons. | Same. |
| Indications for Use | The Ontex Unscented Tampons with Colored Plastic Applicators are | The Ontex Unscented Digital and Plastic and Cardboard Applicator | Only menstrual discharge for K142786. |
| Table 5A -General Comparison of Characteristics | ||
|---|---|---|
5
| Manufacturer | ONTEX | ONTEX | SIGNIFICANT
DIFFERENCES |
|-----------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Trade Name | Ontex Unscented Tampons
with Colored Plastic
Applicators
(K142786) | Ontex Unscented Digital
and Plastic and
Cardboard Applicator
Tampons
(K122603) | Colored applicators
tubes |
| | inserted into the vagina to
absorb menstrual
discharge. | Tampons, available in
light, regular, super and
super plus absorbency
are inserted into the
vagina and used to
absorb menstrual or
other vaginal discharge. | |
| Overall Design | W wadding tampon with
plastic applicators of full
size (long) and compact
size | Roll wadding tampon
digital (without
applicator)
W wadding tampon type
with a plastic/cardboard
applicator in full size
(long) and in compact size | No digital tampon, or
cardboard applicator. |
| Unscented/Scented | Unscented | Unscented | Same |
| Dimensions
Specifications (mm) | Total length (in ready to
push position): 110 - 135
Outside diameter (outer
tube): 13.5 - 18.2 | Total length (in ready to
push position): 110 - 135
Outside diameter (outer
tube): 13.5 - 18.2 | Same |
| Weight
Specifications (g) | 3.6 – 8.1 | 3.6 - 8.1 | Same |
| Absorbent Pledget | Viscose | Viscose | Same |
| Withdrawal Cord | Cotton polyester | Cotton polyester | Same |
| Applicator | Plastic -polyethylene
including pigments | Compact size: Plastic -
polyethylene
Full size (long): plastic -
polyethylene with white
pigment | Different with
pigments of color
green, lilac, orange,
yellow or pink |
| | NA | Cardboard - Paper | Different, no
cardboard applicator |
| Absorbencies | 60N | > 60N | Same |
| Packaging | Primary packaging: | Primary packaging: | Same |
6
| Manufacturer | ONTEX | ONTEX | SIGNIFICANT
DIFFERENCES |
|--------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------|
| Trade Name | Ontex Unscented Tampons
with Colored Plastic
Applicators
(K142786) | Ontex Unscented Digital
and Plastic and
Cardboard Applicator
Tampons
(K122603) | Colored applicators
tubes |
| | individual polymeric
wrapper
Secondary packaging:
cardboard box | individual polymeric
wrapper
Secondary packaging:
cardboard box | |
| Sterile | no | no | Same |
| Single-Use | yes | yes | Same |
9. Non-Clinical Performance Data
The predicate and the subject device are exactly the same at the exception of the presence of different colored pigments in the plastic applicator tubes.
The following tests were performed to support substantial equivalence:
- Extraction 24h at 37°C in water
- Visual inspection and spectrophotometric analysis
- · Gravimetric analysis
- · Gas chromatography and mass spectrophotometry (GC-MS)
After extraction of each colored applicator and additional testing for determination of possible leachates, the test results showed there is no potential for leachables to migrate from the colored plastic tampon applicators in water.
A toxicological risk assessment explains that the color variants of the tampon applicator would not be expected to cause any adverse effects under normal and reasonably foreseeable conditions of use and also supports the safety of each of the color variants.
10. Performance Testing - Bench
The predicate and the subject device are exactly the same at the exception of the presence of different colored pigments in the plastic applicator tubes.
The following test was performed to support substantial equivalence:
- . Expulsion force applicator
Expulsion force met the specifications as defined for the predicate.
The modification has no impact on the absorptive capacity (Syngena), fiber loss and cord strength of the device. The predicate testing specifications are still applicable to the subject device for these tests.
7
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
The proposed device and the predicate have the same intended use. The technological characteristics are identical or similar.
Ontex has completed a number of tests in order to demonstrate that the Ontex Unscented Tampons with Colored Plastic Applicators meet the applicable requirements for bench testing and that there is no potential for leachables to migrate. The toxicological risk assessment supports the safety of each of the color variants under normal and reasonably foreseeable conditions of use.
It has been shown in this 510(k) submission that the difference between the Ontex Unscented Tampons with Colored Plastic Applicators and the predicate devices do not raise any different questions regarding its safety and effectiveness. The Ontex Unscented Tampons with Colored Plastic Applicators, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices.