(60 days)
Not Found
Not Found
No
The description focuses on the materials and function of a standard tampon, with no mention of AI or ML capabilities.
No
This device, a tampon, is used for absorption of menstrual and other vaginal discharges, which is a hygienic purpose rather than a therapeutic one. It does not treat, diagnose, cure, or prevent any disease or condition.
No
The device, a digital tampon, is intended to absorb menstrual and other vaginal discharges. Its function is for feminine hygiene, not for diagnosing any medical condition.
No
The device description clearly outlines physical components (absorbent material, string, cover) and its function is based on these physical properties, not software.
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 and other vaginal discharges." This is a physical function for feminine hygiene, not a diagnostic test performed in vitro (outside the body) on a sample to determine the state of health or disease.
- Device Description: The description details the materials used for absorption and removal. It doesn't mention any components or mechanisms for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
- Anatomical Site: While the device is used in the vagina, its function is absorption, not diagnosis.
- Intended User/Care Setting: "Feminine hygiene" is a personal care category, not a clinical or laboratory setting for diagnostic testing.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This tampon does not fit that description.
N/A
Intended Use / Indications for Use
"digital tampon for feminine hygiene"
Product codes
Not Found
Device Description
The SanPoint product comprises a digital tampon with the absorbant material being 75 % nonchlorine bleached rayon viscose, 25 % non-chlorine bleached cotton, with a non-woven cover of thermobonded rayon-polypropylene (without chemical binder), and used to absorb menstrual and other vaginal discharges, when inserted in the tampon also has a 100 % non-chorine bleached cotton string attached, enabling the user to remove the tampon after use.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
| 962712
SEP 1 0 1996
Your ref
ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Our ref
Mariefred July 2, 1996
510(K) SUMMARY
SanPoint AB, Bergåsa Industriområde, P.O.Box 55, S-647 22 Mariefred, Sweden, telephone 011-46-159-10610, fax 011-46-159-21317, here represented by
Talbot S. Lindström, Advokatfirman Delphi, Sergels Torg 12, P.O.Box 1432, S-11184 Stockholm, Sweden, telephone 011-46-8-6775400, fax 011-46-8-201884.
has been a manufacturer of digital tampons since 1974, and was the first to introduce a 100% cotton tampon in 1988.
The subject of this submittee's summary is a: "digital tampon for feminine hygiene". It is of essentially the same make and construction as the brand "Kotex" manufactured by Kimberly-Clark Corp. and "O.B." manufactured by Johnson & Johnson, currently sold in the US and which are approved by the FDA. The only distinguishing characteristic is the use of a patented technique for the use of hydrophilic fibers in addition to thermoplastic fibers in the non-woven fabric of the envelope.
The SanPoint product comprises a digital tampon with the absorbant material being 75 % nonchlorine bleached rayon viscose, 25 % non-chlorine bleached cotton, with a non-woven cover of thermobonded rayon-polypropylene (without chemical binder), and used to absorb menstrual and other vaginal discharges, when inserted in the tampon also has a 100 % non-chorine bleached cotton string attached, enabling the user to remove the tampon after use.
An adequate instruction for use, as well as a clear warning for TSS, will accompany each package.
The purpose of this submitment is to enable SanPoint AB to market its product in the US as private brands.
Futher dee thos.
(Signature of Certifier)
Hans Feikes de Groot (Typed name)
July 2, 1996 (Date)
(Premarket Notification 510(k) No)