(175 days)
The MAXIM 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 tampon correctly into . the vagina (only the MAXIM Plastic Applicator Tampon).
The Maxim tampons are used to absorb menstrual fluid.
The Maxim series tampons comes with plastic applicator and without in
sizes: Regular, Super, Super plus, Ultra.
The Maxim tampons are made of commercial cotton and rayon, a
polyethylene/polyester cover, and cotton or rayon string.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is explicitly stated or can be reasonably inferred.
Note: This document is a 510(k) Summary of Safety and Effectiveness for a menstrual tampon. As such, the "device performance" and "acceptance criteria" presented here refer to the performance characteristics required for regulatory equivalence rather than a clinical efficacy study typically associated with AI/software devices. The questions in the prompt, especially those regarding AI, experts, and ground truth, are geared towards AI/ML devices. Therefore, many categories will indicate "Not Applicable" or "Not Provided" as this document does not pertain to an AI/ML device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Absorbency characteristics not significantly different from predicate devices such that safety is compromised. Specifically, the syngyna test method (21 CFR 801.430) is used to quantify absorbency, and any changes must not introduce new safety concerns or alter the intended function beyond acceptable limits for a menstrual tampon. The general safety and efficacy of menstrual tampons, including material composition and design, are implicitly assumed to be similar to legally marketed predicate devices. | The absorbency has increased to 15-18 grams, as measured by the syngyna test method (21 CFR 801.430). This increase was accomplished by slight increases in the weight and dimensions of the tampons. This change is considered within an acceptable range as the device is deemed "substantially equivalent" to predicate devices, implying that this altered absorbency does not introduce new safety or effectiveness concerns. |
| Biocompatibility | Materials must be biocompatible and not elicit adverse biological reactions when in contact with human tissue (intravaginal use). This is typically demonstrated through a series of ISO 10993 compliant tests (e.g., cytotoxicity, sensitization, irritation) and/or comparison to predicate devices with a known history of safe use. Microbiological testing must also demonstrate that the materials and finished product do not pose an undue risk of infection. | Biocompatibility and microbiological testing have been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the Maxim tampons are equivalent to legally marketed tampons. The specific tests mentioned included "Microbiological testing" and "Clinical Testing," suggesting a comprehensive evaluation against established safety standards for similar devices. |
| Intended Use | The device must be suitable for its intended use of intravaginal absorption of menstrual or other vaginal discharge without presenting new or increased risks compared to predicate devices. For applicator versions, the applicator must facilitate correct and safe placement. | The intended use is clearly stated as "intravaginal absorption of menstrual or other vaginal discharge." For the plastic applicator version, its function is "for easing the placement of the tampon correctly into the vagina." This aligns directly with the established intended use of predicate menstrual tampons and is deemed acceptable. |
| Safety and Effectiveness (Overall) | The device must be as safe and effective as legally marketed predicate devices. This is the overarching criterion for substantial equivalence. Any modifications should not raise new questions of safety or effectiveness. | "Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons." This statement summarizes the overall finding of substantial equivalence, indicating that all relevant criteria were met. |
Study Details (Most are Not Applicable for this type of submission)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for biocompatibility, microbiological, or clinical testing. Details regarding the number of tampons tested in the syngyna absorbency test are also not provided in this summary.
- Data Provenance: The manufacturer is Tosama d.d., located in Slovenia. The specific country of origin for the data (e.g., where clinical testing was performed) is not provided. The terms "retrospective or prospective" are not applicable given the nature of the tests (biocompatibility, product performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a medical device 510(k) submission for a tampon, not an AI/ML diagnostic or prognostic device that relies on expert interpretation for ground truth. The evaluation involves standardized physical and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not a study requiring human adjudication of results in the traditional sense of clinical imaging or AI performance. The tests are objective (e.g., syngyna absorbency, microbiological assays).
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. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Absorbency: The "ground truth" is established by the standardized syngyna test method (21 CFR 801.430), which is a reproducible laboratory measurement of fluid retention capacity.
- For Biocompatibility/Microbiological: The "ground truth" is defined by the passing criteria of accepted international standards (e.g., ISO for biocompatibility) and regulatory guidelines for microbiological safety. Pathological or outcomes data would relate to clinical trials, which are referenced as "Clinical Testing" but no specifics provided. Ultimately, the "ground truth" for showing equivalence rests on meeting established safety profiles of predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or associated ground truth.
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SEP 1 0 2008
510(k) Summary of Safety and Effectiveness
| Device name(trade names): | Maxim Compact, plastic Applicator, Regular & SuperMaxim Compact, plastic Applicator, Super plus & UltraMaxim Non Applicator, Regular & SuperMaxim Non Applicator, Super plus & Ultra |
|---|---|
| Classification name | Unscented menstrual tampons |
| Device description | The Maxim tampons are used to absorb menstrual fluid.The Maxim series tampons comes with plastic applicator and without insizes: Regular, Super, Super plus, Ultra.The Maxim tampons are made of commercial cotton and rayon, apolyethylene/polyester cover, and cotton or rayon string. |
| Equivalence to alegally marketeddevice | The Maxim tampons are substantially equivalent to current commercialTAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPOAnd o.b.® Non-applicator Tampons. |
| Intended use | The Maxim unscented menstrual tampon is intended for intravaginalabsorption of menstrual or other vaginal discharge.This is the same intended use as current commercial tampons. |
| Technological | The only difference between the modified ob® tampons and the predicatecharacteristics tampons is the absorbency has increased to 15-18 gramsabsorbency measured by the syngyna test method (21 CFR 801.430). Thisis accomplished by slight increases in the weight and dimensions of thetampons |
| Biocompatibility | Biocompatability and microbiological testing has been conducted ontampons made with these commercial materials. The results of these testsdemonstrate that the Maxim tampons are equivalent to legally marketedtampons. This testing included :- Microbiological testing- Clinical Testing |
| Conclusion | Results of preclinical and clinical testing indicate that the safety of themodified tampon is comparable to current legally marketed, commercialtampons. |
| Contact | Submitted by Tosama d.d., Saranoviceva cesta 35, Vir, 1230 Domzale,SloveniaContact person: Antonija Vidensek / +386 (0) 1 729 03 70 |
| Date | This Summary was prepared on October 20., 2007 |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings and body. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2008
Tosama d.d. % Mr. Harry van Vugt Responsible Third Party Official KEMA Quality B. V. 4377 County Line Road CHALFONT PA 18914
Re: K080775
Trade Name: MAXIM Plastic Applicator Tampon & MAXIM Non-Applicator Tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HEB Dated: August 21, 2008 Received: August 26, 2008
Dear Mr. van Vugt:
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 such 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.
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Page 2
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Arne M. Whang
Joyce M. Whang, Ph.D. 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
K080775 510K Number (if known):
MAXIM Plastic Applicator Tampon & MAXIM non-Applicator Tampon Device Name:
Indications for Use:
The MAXIM 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 tampon correctly into . the vagina (only the MAXIM Plastic Applicator Tampon).
| Prescription Use | |
|---|---|
| (Part 21CFR 801 Subpart D) |
AND/OR
| Over-The Counter Use | X |
|---|---|
| (Part 21CFR 801 Subpart C) | |
| (Optional Format 1-2-96) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu
Anden-
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
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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).