(22 days)
Not Found
No
The summary describes a standard medical device (tampons) and does not mention any AI or ML components, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as being for "women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge," which is not a therapeutic purpose. Therapeutic devices are generally intended to treat or alleviate a medical condition.
No
Explanation: The provided text describes the MOXIE tampons as products for personal hygiene to absorb menstrual or other vaginal discharge. Their function is purely absorptive and not diagnostic. The "Summary of Performance Studies" mentions "Microbiological testing" and "Clinical Testing," but these refer to testing of the tampons themselves for safety and equivalence to legally marketed tampons, not diagnostic testing performed by the tampons on a patient.
No
The device description clearly indicates it is a physical product (tampons) made of cotton, rayon, and polyethylene/polyester, with an optional plastic applicator. It is 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 for "Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge." This is a physical absorption function, not a diagnostic test performed in vitro (outside the body) on biological samples to detect diseases or conditions.
- Device Description: The device is a tampon made of absorbent materials. It does not contain reagents, assays, or any components typically associated with diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect biomarkers, or provide any diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and microbiological testing, comparing the tampons to legally marketed tampons for safety and equivalence in their intended function (absorption). There are no studies related to diagnostic accuracy or performance metrics like sensitivity, specificity, etc.
In summary, the MOXIE tampons are a medical device intended for absorption and personal hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MOXIE unscented menstrual tampon is intended for intravaginal absorption of menstrual or other vaginal discharge.
This is the same intended use as current commercial tampons.
The MOXIE tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
• The plastic applicator is for easing the placement of the tam pon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).
Product codes
HEB
Device Description
The MOXIE tampons are used to absorb menstrual fluid.
The MOXIE series tampons come with a plastic applicator and without a plastic applicator in sizes: Regular, Super ,Super plus and Ultra.
The MOXIE tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravaginal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatability and microbiological testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the Moxie tampons are equivalent to legally marketed tampons. This testing included :
- · Microbiological testing
- Clinical Testing
Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons.
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
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
JUL 2 9 2009
510(k) Summary of Safety and Effectiveness
The MOXIE Plastic Applicator and Non Applicator Tampons are identical to MAXIM Plastic Applicator and Non Applicator tampons under K080775. The information below is identical to that approved for the MAXIM devices under K080775.
Device name (trade names):
MOXIE Compact, Plastic Applicator, Regular , Super plus and Ultra
MOXIE Non Applicator, Regular, Super ,Super plus and Ultra
Classification name
Unscented menstrual tampons
Device description
The MOXIE tampons are used to absorb menstrual fluid.
The MOXIE series tampons come with a plastic applicator and without a plastic applicator in sizes: Regular, Super ,Super plus and Ultra.
The MOXIE tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
Equivalence to a legally marketed device
The MOXIE Plastic Applicator tampons are substantially equivalent to current commercilly marketed TAMPAX COMPAK, COMPACT PLASTIC APPLICATOR and the MOXIE Non Applicator Tampons are substantially equivalent to o.b. ® Non Applicator Tampons.
Intended use
The MOXIE unscented menstrual tampon is intended for intravaginal absorption of menstrual or other vaginal discharge.
This is the same intended use as current commercial tampons.
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Technological
There are no differences between the technical characteristics of the MOXIE tampons and the predicate characteristic of the substantial equivalent devices MAXIM tampons under K080775.
Biocompatibility
Biocompatability and microbiological testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the Moxie tampons are equivalent to legally marketed tampons. This testing included :
- · Microbiological testing
- Clinical Testing
Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons.
Conclusion
The MOXIE Plastic Applicator Tampons and Moxie Non Applicator Tampons are identical to MAXIM Plastic Applicator Tampons and MAXIM Non Applicator Tampons approved for market under K080775.
Contact
Submitted by Tosama d.d., Šaranovičeva cesta 35, Vir, 1230 Domžale, Slovenia
Contact person: Antonija Videnšek / +386 (0) 1 729 03 70
Signed by Quality Manager Antonija Videnšek
Ardenses
Date : June 19, 2009
Exhibit 116 005
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract depiction of an eagle with three stylized wing segments, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2009
Ms. Antonija Videnšek Quality Manager TOSAMA d.d. Tovarna sanitetnega materiala d.d. Vir. Šaranovičeva cesta 35 1230 Domžale SLOVENIA
Re: K092054
Trade/Device Name: MOXIE Plastic Applicator Tampon & MOXIE Non-Applicator Tampon Regulation Number: 21 CFR §884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: June 22, 2009 Received: July 7, 2009
Dear Ms. Videnšek:
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.
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.
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
3
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/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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K092054 510K Number (if known):
Device Name:
MOXIE Plastic Applicator Tampon & MOXIE Non-Applicator Tampon
Indications for Use:
The MOXIE tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
• The plastic applicator is for easing the placement of the tam pon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).
Prescription Use AND/OR Over-The Counter Use
(Part 21CFR 801 Subpart C) (Optional Format 1-2- 96)
(Part 21 CFR 801 Subpart O)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Noleen
erlas leun
Reproductive, Abdominal.
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Exhibit 116 006