(59 days)
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 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.
The provided document is a 510(k) summary for SanPoint AB's digital all-cotton tampons. It does not contain information about acceptance criteria or a study proving device performance in the context of medical imaging, AI diagnostics, or similar technologies.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. The document is for a physical medical device (tampons) and focuses on regulatory submission for market entry, not performance evaluation in the manner described in your request.
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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)
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§ 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).