(22 days)
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).
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.
This document, K092054, is a 510(k) summary for MOXIE tampons. It asserts substantial equivalence to previously marketed tampons, specifically MAXIM tampons (K080775), and other commercial tampons like Tampax Compak and o.b. Non Applicator Tampons.
Based on the provided text, there is no AI device and therefore no study proving an AI device meets acceptance criteria. The document describes a medical device (tampons) and its substantial equivalence to other legally marketed predicate devices, not an AI system.
However, I can extract information related to the assessment of the MOXIE tampons, which can be presented in a format similar to what would be used for an AI device, if we interpret "acceptance criteria" as the criteria for establishing substantial equivalence for the tampons.
Here's an attempt to structure the available information, keeping in mind that this is not a study of an AI device, but rather a regulatory submission for a conventional medical device:
Acceptance Criteria and Device Performance for MOXIE Tampons
Given that this document describes a conventional medical device (tampons) and not an AI device, the "acceptance criteria" are related to establishing substantial equivalence to predicate devices under 510(k) regulations, rather than performance metrics for an AI algorithm. The "study" refers to the testing conducted to support this claim of equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Performance / Assessment |
|---|---|
| Technological Characteristics | "No differences between the technical characteristics of the MOXIE tampons and the predicate characteristic of the substantial equivalent devices MAXIM tampons under K080775." |
| Material Biocompatibility | "Biocompatibility 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." |
| Clinical Safety (Preclinical & Clinical Testing) | "Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial 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." |
| Predicate Device Equivalence | "MOXIE Plastic Applicator tampons are substantially equivalent to current commercially marketed TAMPAX COMPAK... and the MOXIE Non Applicator Tampons are substantially equivalent to o.b. ® Non Applicator Tampons." (Also, identical to MAXIM tampons K080775). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific tests (e.g., how many tampons were tested for biocompatibility, or how many subjects were in clinical testing). The term "commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string" implies standard materials, and testing would have been conducted on these materials or the finished product.
- Data Provenance: The document states that testing was conducted on tampons made with "commercial materials." The manufacturer is "Tosama d.d., Slovenia." The provenance of the specific test data (e.g., country of origin, retrospective/prospective) and internal vs. external lab is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this 510(k) summary for a menstrual tampon. "Ground truth" usually refers to definitive classifications or diagnoses for AI/imaging studies. Here, the "truth" is established through standardized material testing, biocompatibility assays, and clinical safety assessments, whose "experts" would be scientists and clinicians in their respective fields, but no specific number or detailed qualifications are provided.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. The safety and effectiveness of tampons are assessed through laboratory and clinical testing, not interpretive adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI device.
7. The type of ground truth used
The "ground truth" for the claim of substantial equivalence for these tampons comes from:
- Material specifications and composition: "commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string."
- Biocompatibility testing results: Demonstrating equivalence to legally marketed tampons.
- Microbiological testing results: Affirming safety.
- Preclinical and Clinical testing results: Indicating comparable safety to legally marketed tampons.
- Predicate device characteristics: The established safety and performance profile of the MAXIM, Tampax Compak, and o.b. tampons serve as the comparative benchmark ("truth").
8. The sample size for the training set
Not applicable, as this is not an AI device, and therefore there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI device.
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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
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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.
Page 1 of 1
Exhibit 116 006
§ 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).