(247 days)
Not Found
No
The device description and performance studies focus on the physical properties, materials, and biological compatibility of a menstrual tampon, with no mention of AI or ML technologies.
No
The device is a menstrual tampon designed to absorb menstrual discharge, not to treat or cure a disease or condition.
No
This device is a menstrual tampon, designed to absorb menstrual discharge, not to diagnose a medical condition.
No
The device description clearly outlines a physical product (tampon with applicator) made of materials like viscose, polyester, cotton, and plastic. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a menstrual tampon. Its function is to absorb menstrual discharge within the vagina. It does not analyze or test any bodily fluid or tissue to provide diagnostic information.
- Intended Use: The intended use is clearly stated as "inserted into the vagina to absorb menstrual discharge." This is a physical function, not a diagnostic one.
The information provided about performance studies (biocompatibility, microbiology, bench testing) relates to the safety and physical performance of the tampon, not its ability to diagnose or provide information about a medical condition.
N/A
Intended Use / Indications for Use
The Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.
Product codes
HEB
Device Description
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)).
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
Non-Clinical Performance Data
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.
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.
Key Metrics
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.
Predicate Device(s)
Reference Device(s)
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
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: +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 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: pmteurope@emergogroup.com
-
- Date Prepared
16th August 2013
- Date Prepared
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.
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K132595
Page 3 of 5
| Table SA -General Companson of Characteristics | |||
|---|---|---|---|
| Manufacturer | ONTEX · | ONTEX | SIGNIFICANT |
| DIFFERENCES | |||
| Trade Name | ROLL WADDING | ||
| PLASTIC APPLICATOR | |||
| COMPACT SIZE | |||
| UNSCENTED TAMPONS | DIGITAL AND | ||
| PLASTIC/CARDBOARD | |||
| UNSCENTED | |||
| APPLICATOR TAMPONS | |||
| (K122603) | Roll wadding design | ||
| combined with a | |||
| compact size applicator | |||
| 510(k) Number | Not yet defined | K122603 | |
| 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 | Inserted into the vagina to | ||
| absorb menstrual | |||
| discharge | Inserted into the vagina | ||
| to absorb menstrual | |||
| discharge | same | ||
| Material | Absorbent pledget in | ||
| viscose, polymeric | |||
| overwrap, cotton | |||
| polyester cord. | |||
| Plastic applicators in | |||
| polyethylene. | Absorbent pledget in | ||
| viscose, polymeric | |||
| overwrap, cotton | |||
| polyester cord. | |||
| Plastic applicators in | |||
| polyethylene . | |||
| Cardboard applicators | |||
| in paper. | same | ||
| Tampon Type and | |||
| Applicator | |||
| (material and size) | Roll wadding tampon type | ||
| with a plastic applicator in | |||
| compact size | Roll wadding tampon | ||
| digital (without | |||
| applicator) | |||
| W wadding tampon | |||
| type with a plastic | |||
| applicator in full size | |||
| (long) and in compact | |||
| size | Different, roll wadding | ||
| form combined to | |||
| compact applicator size | |||
| Absorbencies | 6-9g, 9-12g, 12-15g | 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 (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
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'
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