(182 days)
Not Found
No
The 510(k) summary describes a standard menstrual tampon and its physical characteristics and performance testing, with no mention of AI or ML.
No.
The device is used to absorb menstrual or other vaginal discharge, which is a supportive or assistive function rather than a therapeutic one (treating or curing a disease or condition).
No
Explanation: The device is a menstrual tampon designed to absorb discharge, not to diagnose a medical condition. Its intended use is absorption, and the performance studies focus on physical characteristics, biocompatibility, and microbial impact, not diagnostic accuracy.
No
The device description clearly states it is a physical product (tampons with applicators) made of materials like viscose, polyethylene, and cardboard. It does not mention any software components.
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 or other vaginal discharge" by being "inserted into the vagina." This is a physical function within the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details the physical components of a tampon (absorbent pledget, applicator) and its materials. It does not describe any components or mechanisms for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological fluids, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics (absorbency, strength, integrity), biocompatibility, and microbial impact within the vaginal environment. They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC.
- Anatomical Site: The device is used in vivo (within the body), specifically the vagina. IVDs are performed in vitro (outside the body) on samples taken from the body.
In summary, the Unscented W long plastic and cardboard applicator Tampons are a medical device intended for physical absorption within the body, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
Product codes
HEB
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.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Biocompatibility Studies:
- Study Type: Biocompatibility studies based on ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.
- Results: The device was demonstrated to be non-cytotoxic, non-sensitizing, and non-systemically toxic.
Performance Characteristics:
- Study Type: Assessment of dimensional information, absorbency range (Syngina testing per 21 CFR 801.430(f)(2)), chemical residues, withdrawal cord strength, fiber shedding, tampon integrity, expulsion force, and cardboard applicator dissolving time.
- Results: Not explicitly detailed, but implied to be acceptable for substantial equivalence.
Microbial Testing:
- Study Type: Testing to demonstrate the device does not enhance the growth of Staphylococcus aureus, increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1), or alter the growth of normal vaginal microflora.
- Results: The testing performed met the recommendations of the 2005 FDA guidance document.
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
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 time 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@fda.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."
3
510(k) Summary
Unscented W long plastic and cardboard applicator Tampons
1. Submission Sponsor
Ontex BVBA
5 Genthof
Buggenhout Oost-Vlaanderen
9255
Belgium
Phone number: +32 9 376 77 06
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: 00 33 6 89 83 16 09
Office Phone: +31 (0) 70 345 8570/Direct: +31 (0) 70 850 8249
Contact: Rachel Paul, Senior Consultant, QA&RA
Email: LST.AUS.ProjectManagement@ul.com
3. Date Prepared
19 December 2019
4
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 | ||
| cardboard applicator | |||
| Tampons | |||
| (subject device) | Ontex Unscented Digital | ||
| and Plastic and Cardboard | |||
| Applicator Tampons | |||
| (predicate device) | |||
| 510(k) Number | K191666 | K122603 | Same |
| Table 1 - Comparison of Characteristics | ||
|---|---|---|
| -- | -- | ----------------------------------------- |
5
| Manufacturer | Ontex BVBA | Ontex BVBA | Device Comparison |
|---|---|---|---|
| Trade Name | W long plastic and | ||
| cardboard applicator | |||
| Tampons | |||
| (subject device) | Ontex Unscented Digital | ||
| and Plastic and Cardboard | |||
| Applicator Tampons | |||
| (predicate device) | |||
| Product Code | HEB | HEB | Same |
| Regulation | |||
| Number | 884.5470 | 884.5470 | Same |
| Regulation Name | Unscented menstrual | ||
| tampons | Unscented menstrual | ||
| tampons | Same | ||
| Indications for | |||
| use | The Unscented W long | ||
| plastic and cardboard | |||
| applicator Tampons are | |||
| inserted into the vagina | |||
| to absorb menstrual or | |||
| other vaginal discharge. | The Ontex Unscented | ||
| Digital and Plastic and | |||
| Cardboard Applicator | |||
| Tampons, available in light, | |||
| regular, super, and super | |||
| plus absorbency are | |||
| inserted into the vagina | |||
| and used to absorb | |||
| menstrual or other vaginal | |||
| discharge. | Similar | ||
| Target | |||
| 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 | ||
| applicator (digital) | Different. The subject | ||
| device does not contain a | |||
| digital tampon option. | |||
| However, both the subject | |||
| and predicate device utilize | |||
| an applicator for tampon | |||
| deployment. | |||
| Long (full size) applicator | Long (full) size applicator | Same | |
| Absorbencies | light ( |