(14 days)
Not Found
No
The device description and intended use are for a traditional menstrual tampon, and there is no mention of AI or ML in the provided text.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is intended for absorption of menstrual or other vaginal discharge, which is a physiological process, not a disease or condition requiring therapy.
No
The device description clearly states its purpose is for the "absorption of menstrual or other vaginal discharge," indicating it is an absorbent product, not a diagnostic tool.
No
The device description clearly indicates a physical product (tampon) with an absorbent pledget, withdrawal cord, and applicator, which are hardware components.
Based on the provided information, the Naturalena 100% Cotton Tampon is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the absorption of menstrual or other vaginal discharge by insertion into the vagina. This is a physical function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical device for absorption, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor health conditions, or screen for specific substances. The Naturalena tampon does not fit this description.
N/A
Intended Use / Indications for Use
The Naturalena 100% Cotton Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Product codes
HEB
Device Description
The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.
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
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
TECHNICAL DOCUMENT
Naturalena Brands, Inc.
Naturalena 100% Cotton Unscented Menstrual Tampon Traditional 510(k)
Section 5: 510(k) Summary
MAR 2 1 2013
DATE OF PREPARATION: January 28, 2013
COMPANY/OWNER: Naturalena Brands, Inc. 1875 S. Grant St., Suite 570 San Mateo, CA 94402 CONTACT: Josh Ellis Engineering Manager TELEPHONE: 435-238-4961 847-548-8491 FAX: josh@naturalenabrands.com EMAIL:
Veeda 100% Cotton Menstrual Tampon DEVICE TRADE NAME: Unscented Menstrual Tampon COMMON NAME: Tampon, Menstrual, Unscented CLASSIFICATION NAME: 21 CFR §884.5470 REGULATION NUMBER: HEB PRODUCT CODE: DEVICE CLASS: =
Cotton High Tech 100% Orqanic Cotton Tampon PREDICATE DEVICES: (K091084) Cottons 100% Natural Cotton Tampon (K080733)
DEVICE DESCRIPTION: The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.
INTENDED USE:
The device is intended to be inserted into the vagina to absorb menstrual fluid.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE: The Naturalena 100% Cotton Tampon demonstrates substantial equivalence to both the Cotton High Tech 100% Organic Cotton Tampon (K091084) and the Cottons . 100% Natural Cotton Tampon (K080733). Table 5-1 summarizes the key technological characteristics and features of both the predicates and the new device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2013
Naturalena Brands, Inc. % Mr. Ned Devine Sr. Staff Engineer Underwriters Laboratories. Inc. 333 Pfingsten Road NORTHBROOK IL 60062
Re: K130609
Trade/Device Name: Naturalena 100% Cotton Plastic Applicator Tampon Naturalena 100% Cotton Digital Tampon Regulation Number: 21 CFR& 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: March 5, 2013 Received: March 11, 2013
Dear Mr. Devine:
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.
2
Page 2 - Mr. Ned Devine
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/ReportaProblem/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/Resourcesfor You/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
3
Indications for Use Statement Section 4:
K130609 . 510(k) Number:
Naturalena 100% Cotton Plastic Applicator Tampon Device Name: Naturalena 100% Cotton Digital Tampon
Indications for Use: The Naturalena 100% Cotton Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
HerbertPLerner-S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K130609