(114 days)
Not Found
No
The device description and performance studies focus on the materials, absorbency, and biocompatibility of tampons, with no mention of AI or ML technology.
No.
The device, a tampon, is used to absorb menstrual or other vaginal discharge and is not intended to treat or cure any medical condition.
No
The device is described as absorbing menstrual or other vaginal discharge, not as diagnosing any condition.
No
The device description clearly indicates the device is a physical product (tampons) made of materials like viscose, cotton, and polymers, and is inserted into the vagina. There is no mention of software as the primary or sole component.
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." This is a physical function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on the materials and physical characteristics of the tampons and applicators, all related to their function of absorption.
- Lack of Diagnostic Elements: There is no mention of analyzing the absorbed discharge for any diagnostic markers, performing tests on the discharge, or providing any information for diagnosis.
- Performance Studies: The performance studies focus on safety (biocompatibility, irritation, allergy) and effectiveness in terms of absorbency, which are relevant to a physical absorption device, not a diagnostic one.
Therefore, the Ontex Tampons described are a medical device intended for absorption, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
HEB
Device Description
The Ontex Tampons are:
-
- Unscented Digital
- Unscented Plastic Applicator 2)
-
- Unscented Cardboard Applicator
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (
§ 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
DEC 1 9 2012
510(k) SUMMARY
Device Name: Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons
Name Address Telephone number of submitter, contact person dated 12/14/12 Robert J Staab, Ph.D. for Ontex bvba as Official Correspondent RTA, Inc., 30 Neck Road, Old Lyme CT 06371 860 434 5872
Ontex bvba Genthof5 9255 Buggenhout Belgium
The registration number is 3003293044
Regulation number, Regulation name, Classification, product code for Ontex tampons OBGYN Panel, Unscented Menstrual Tampons, 21 CFR 884 5470, PRODUCT CODE HEB
Predicate Device: Ontex Organic Tampons, K090819
Indications for Use:
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.
Device description:
The Ontex Tampons are:
-
- Unscented Digital
- Unscented Plastic Applicator 2)
-
- Unscented Cardboard Applicator
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (