(59 days)
Natracare
Not Found
No
The description focuses on the physical materials and function of a tampon, with no mention of AI or ML.
No.
The device is described as a digital all-cotton tampon for feminine hygiene, used to absorb menstrual and other vaginal discharges, which is a hygienic product, not one intended for therapy, treatment, or diagnosis of a disease or condition.
No
The device is described as a "digital all-cotton tampon for feminine hygiene" used to "absorb menstrual and other vaginal discharges." Its intended use is absorption, not diagnosis of any condition.
No
The device description clearly states the product is a "digital tampon of 100% peroxide bleached virgin cotton," which is a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "digital all-cotton tampons for feminine hygiene" and to "absorb menstrual and other vaginal discharges, when inserted in the vagina." This describes a device used for absorption and hygiene within the body, not for testing or analyzing samples outside the body to diagnose a condition.
- Device Description: The description confirms it's a tampon made of cotton for absorption of vaginal discharges. This aligns with a personal hygiene product, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The SanPoint product comprises a digital tampon of 100% peroxide bleached virgin cotton, and used to absorb menstrual and other vaginal discharges, when inserted in the vagina. The tampon also has a 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)
Natracare
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
Image /page/0/Picture/0 description: The image shows the word "SanPoint" in a bold, serif font. The letters are black against a white background. There is a small, brushstroke-like mark above the "i" in "Point."
JUL 15 1996
K9 6 1926
Your ref
Our ref
Mariefred May 9, 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,
is a manufacturer of digital tampons since 1974, and the first to introduce a 100% cotton tampon in 1988.
The subjects of this submittee's summary are: "digital all-cotton tampons for feminine hygiene", and are of the same make and construction as the brand "Natracare" currently sold by our distributor Body Wise (UK) Ltd., Bristol, with office in Denver, USA, on the US and Canadian market, items which are approved by FDA.
The SanPoint product comprises a digital tampon of 100% peroxide bleached virgin cotton, and used to absorb menstrual and other vaginal discharges, when inserted in the vagina. The tampon also has a 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.
Fertus ar fress.
(Signature of Certifier)
Hans Feikes de Groot (Typed name)
May 9, 1996 (Date)
(Premarket Notification 510(k) No)
Image /page/0/Picture/19 description: The image shows the text "Doc no. AMSAS-6761". The text is in a bold, sans-serif font. The background is white. The text is black.