(268 days)
Not Found
No
The 510(k) summary describes a standard tampon product with different scents and absorbencies. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on biocompatibility and microbiology, not algorithmic performance.
No.
Therapeutic devices are intended to treat or cure a disease or condition, while these tampons are designed to absorb menstrual discharge, which is a physiological process, not a disease or condition requiring therapy.
No
Explanation: The device is a tampon, which is used for absorbing menstrual discharge, not for diagnosing any condition.
No
The device description clearly outlines a physical product (tampons made of viscose, polyester, cotton, and polyethylene) intended for physical insertion and absorption, with no mention of 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 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 focuses on the physical characteristics of the tampons (materials, absorbency, applicator types) and their function of absorption. There is no mention of analyzing a sample or providing diagnostic information.
- Performance Studies: The performance studies described are related to biocompatibility and microbiology, ensuring the safety of the device when in contact with the body and its effect on the vaginal environment. These are not studies evaluating diagnostic accuracy or performance.
- Lack of Diagnostic Elements: There are no mentions of analyzing a sample, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
Product codes (comma separated list FDA assigned to the subject device)
HIL
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. 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 (
§ 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).
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
-
- 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 --
1
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 | 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'
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FORM FDA 3881 (1/14)
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